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Roche Diagnostics

Indianapolis, IN, US · 42 510(k) clearances · 77 PMAs

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Total clearances
42
2020-02-27 → 2026-06-12
Last 12 months
12
Product codes
34
Most recent
2026-06-12
Name variants in FDA filings: Roche Diagnostics / Roche Diagnostics GmbH
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
QVP Sars-Cov-2 Serology Test Class II Microbiology 3 2026-04-13
PZI Prescription Use Blood Glucose Meter For Near-Patient Testing Class II Clinical Chemistry 2 2026-06-12
SEI — — — 2 2026-04-07
CFR Hexokinase, Glucose Class II Clinical Chemistry 2 2026-02-12
JZO System, Test, Thyroid Autoantibody Class II Immunology 2 2023-09-15
NBC — — — 2 2023-07-21
QSE Alzheimer’S Disease Pathology Assessment Test Class II Immunology 2 2023-06-05
JKR — — — 1 2026-04-24
LOL Hepatitis A Test (Antibody And Igm Antibody) Class II Microbiology 1 2026-04-07
NQD Cardiac C-Reactive Protein, Antigen, Antiserum, And Control Class II Immunology 1 2026-04-02
CEM Electrode, Ion Specific, Potassium Class II Clinical Chemistry 1 2026-02-12
GJS Test, Time, Prothrombin Class II Hematology 1 2025-10-24
SET Immunoassay Blood Test For Amyloid Pathology Assessment Class II Immunology 1 2025-10-08
JFT — — — 1 2025-07-17
QWH Prognostic Test For Development Or Progression Of Preeclampsia Class II Clinical Chemistry 1 2025-02-07
CGN Acid, Folic, Radioimmunoassay Class II Clinical Chemistry 1 2024-06-17
CEW Radioimmunoassay, Parathyroid Hormone Class II Clinical Chemistry 1 2024-03-22
MSW System, Test, Thyroglobulin Class II Immunology 1 2023-09-30
CEC Radioimmunoassay, Free Thyroxine Class II Clinical Chemistry 1 2023-04-07
MOJ — — — 1 2023-03-30
MZO — — — 1 2023-01-04
JXM — — — 1 2022-12-23
MXJ — — — 1 2022-10-12
LFZ — — — 1 2022-10-12
MYF — — — 1 2022-10-12
LOJ Kit, Test,Alpha-Fetoprotein For Testicular Cancer Class II Immunology 1 2022-09-15
PQO Anti-Müllerian Hormone Test System Class II Clinical Chemistry 1 2022-06-10
CDZ — — — 1 2022-05-06
MMI Immunoassay Method, Troponin Subunit Class II Clinical Chemistry 1 2021-09-21
MRG System, Test, Vitamin D Class II Clinical Chemistry 1 2021-09-01
DHA System, Test, Human Chorionic Gonadotropin Class II Clinical Chemistry 1 2021-08-18
LIP — — — 1 2021-07-20
LKM Counter, Urine Particle Class II Hematology 1 2020-11-06
PRI Procalcitonin Assay Class II Microbiology 1 2020-03-09
Class III

PMA approvals (77)

Total PMA records
77
Originals + supplements
Distinct product codes
5
First decision
2020-02-27
Most recent
2026-04-29
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2026-04-29 P990056-S046 ELECSYS TOTAL PSA IMMUNOASSAY AND TOTAL PSA CALSET 30-Day Notice MTF — —
2026-04-29 P000027-S045 ELECSYS FREE PSA IMMUNOASSAY/CALSET/CALCHECK 30-Day Notice LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers Immunology
2026-02-27 P990056-S045 Elecsys total PSA assay 30-Day Notice MTF — —
2026-02-27 P000027-S044 Elecsys free PSA assay 30-Day Notice LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers Immunology
2025-05-27 P990056-S044 ELECSYS TOTAL PSA IMMUNOASSAY AND TOTAL PSA CALSET 30-Day Notice MTF — —
2025-05-27 P000027-S043 ELECSYS FREE PSA IMMUNOASSAY/CALSET/CALCHECK 30-Day Notice LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers Immunology
2025-05-22 P190034-S010 Elecsys Anti-HBs II, PreciControl Anti-HBs 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2025-05-22 P190005-S007 Elecsys Anti-HBe 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2025-05-22 P160019-S019 Elecsys HBsAg II/Elecsys HBsAg Auto Confirm 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2025-05-22 P110031-S027 Elecsys Anti-HBc IgM 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2025-05-22 P110022-S034 Elecsys Anti-HBc IgM 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2025-05-22 P100032-S023 Elecsys Anti-HBc II 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2025-05-22 P100031-S033 Elecsys Anti-HBc II 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2025-05-22 P010054-S048 Elecsys Anti-HBs 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2024-11-22 P110031-S025 Elecsys Anti-HBc IgM and PreciControl Anti-HBc IgM Normal 180 Day Track LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2024-11-22 P110022-S031 Elecsys Anti-HBc IgM and PreciControl Anti-HBc IgM Normal 180 Day Track LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2024-10-17 P990056-S042 Elecsys total PSA Test System Real-Time Process MTF — —
2024-10-17 P000027-S040 Elecsys free PSA Test System Real-Time Process MTG — —
2024-10-08 P000027-S042 Elecsys free PSA Assay 30-Day Notice LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers Immunology
2024-10-03 P190034-S009 Elecsys Anti-HBs / Elecsys HBs II 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2024-10-03 P190005-S006 Elecsys Anti-HBe 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2024-10-03 P160019-S018 Elecsys HBsAg II 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2024-10-03 P110031-S026 Elecsys Anti-HBc IgM 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2024-10-03 P110022-S033 Elecsys Anti-HBc II / Elecsys Anti-HBc IgM 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2024-10-03 P100031-S032 Elecsys Anti-HBc II / Elecsys Anti-HBc IgM 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2024-10-03 P010054-S047 Elecsys Anti-HBs / Elecsys HBs II 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2024-08-30 P990056-S043 Elecsys total PSA 30-Day Notice MTF — —
2024-08-30 P000027-S041 Elecsys free PSA 30-Day Notice LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers Immunology
2024-08-29 P190034-S008 Elecsys Anti-HBs II 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2024-08-29 P190005-S005 Elecsys Anti-HBe 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2024-08-29 P160019-S017 Elecsys HBsAg II 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2024-08-29 P110022-S032 Elecsys Anti-HBc IgM 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2024-08-29 P100031-S031 Elecsys Anti-HBc II 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2024-08-29 P010054-S046 Elecsys Anti-HBs 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2024-07-23 P190034-S007 Elecsys Anti-HBs II, PreciControl Anti-HBs Normal 180 Day Track LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2024-05-01 P190034-S005 Elecsys Anti-HBs II, PreciControl Anti-HBs Normal 180 Day Track LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2024-02-08 P990056-S041 Elecsys total PSA 30-Day Notice MTF — —
2024-02-08 P190034-S006 Elecsys Anti-HBs II 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2024-02-08 P190005-S004 Elecsys Anti-HBe 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2024-02-08 P160019-S016 Elecsys HBsAg II 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2024-02-08 P110022-S030 Elecsys Anti-HBc IgM 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2024-02-08 P100031-S030 Elecsys Anti-HBc II 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2024-02-08 P010054-S045 Elecsys Anti-HBs 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2024-02-08 P000027-S039 Elecsys free PSA 30-Day Notice LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers Immunology
2024-01-31 P190034-S003 Elecsys Anti-HBs II, PreciControl Anti-HBs Normal 180 Day Track No User Fee LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2024-01-31 P010054-S043 Elecsys Anti-HBs, PreciControl Anti-HBs Normal 180 Day Track No User Fee LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2023-10-31 P190034-S004 Elecsys Anti-HBs II 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2023-10-31 P190005-S003 Elecsys Anti-HBe 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2023-10-31 P160019-S015 Elecsys HBsAg II, Elecsys HBsAg II Auto Confirm 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2023-10-31 P110022-S029 Elecsys Anti-HBc IgM 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2023-10-31 P100031-S029 Elecsys Anti-HBc II 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2023-10-31 P010054-S044 Elecsys Anti-HBs 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2023-10-05 P990056-S040 Elecsys free PSA 30-Day Notice MTF — —
2023-10-05 P000027-S038 Elecsys free PSA 30-Day Notice LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers Immunology
2023-06-13 P190034-S002 Elecsys Anti-HBs II, PreciControl Anti-HBs, Anti-HBs CalCheck Normal 180 Day Track LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2023-05-16 P190005-S002 Elecsys Anti-HBe, PreciControl Anti-HBe Normal 180 Day Track LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2023-05-08 P100031-S028 Elecsys Anti-HBc II Normal 180 Day Track LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2023-04-24 P160019-S014 Elecsys HBsAg II, PreciControl HBsAg II, Elecsys HBsAg Confirmatory Test, Elecsys HBsAg II Auto Confirm, PreciControl HB Normal 180 Day Track LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2023-03-23 P990056-S039 Elecsys total PSA, total PSA CalSet II Normal 180 Day Track MTF — —
2023-03-23 P000027-S037 Elecsys free PSA, free PSA CalSet Normal 180 Day Track MTG — —
2022-04-04 P100032-S021 Elecsys Anti-HBc II Normal 180 Day Track LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2022-04-04 P100031-S027 Elecsys Anti-HBc II Normal 180 Day Track LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2022-01-11 P110022-S028 Elecsys Anti-HBc IgM Immunoassays 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2022-01-11 P010054-S042 Elecsys Anti-HBs 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2021-12-16 P190034-S001 Elecsys Anti-HBs II 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2021-12-16 P160019-S013 Elecsys HBsAg II 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2021-12-16 P010054-S041 Elecsys Anti-HBs 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2021-12-09 P160019-S012 Elecsys HBsAg Confirmatory Test Normal 180 Day Track LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2021-11-16 P990056-S038 Elecsys total PSA Test System 30-Day Notice MTF — —
2021-11-16 P000027-S036 Elecsys free PSA Test System 30-Day Notice LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers Immunology
2021-11-01 P190005-S001 Elecsys Anti-HBe, PreciControl Anti-HBe Normal 180 Day Track LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2021-02-23 P190034 Elecsys Anti-HBs II, PreciControl Anti-HBs, Anti-HBs CalCheck Original SEI — —
2021-02-03 P190005 Elecsys Anti-HBe, PreciControl Anti-HBe Original SEI — —
2020-10-19 P160019-S011 Elecsys HBsAg II Auto Confirm Normal 180 Day Track LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2020-05-12 P990056-S037 Elecsys total PSA Normal 180 Day Track MTF — —
2020-05-12 P000027-S035 Elecsys free PSA Test System, Biotin remediation Normal 180 Day Track MTG — —
2020-02-27 P160019-S010 Elecsys HBsAg II, Elecsys HBsAg Confirmatory Test, and PreciControl HBsAg II Normal 180 Day Track LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
Filings

All 510(k) clearances (42)

Date K-number Device Code Class Specialty
2026-06-12 K252323 cobas pulse blood glucose monitoring system PZI Class II Clinical Chemistry
2026-04-24 K252431 Elecsys Calcitonin JKR — —
2026-04-13 K252280 Elecsys Anti-SARS-CoV-2 S QVP Class II Microbiology
2026-04-07 K260049 Elecsys Anti-HBc IgM SEI — —
2026-04-07 K260048 Elecsys Anti-HAV IgM LOL Class II Microbiology
2026-04-07 K260046 Elecsys Anti-HBc II SEI — —
2026-04-02 K260026 Tina-quant Cardiac high sensitivity CRP III NQD Class II Immunology
2026-02-12 K253491 ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated solutions CEM Class II Clinical Chemistry
2026-02-12 K253490 Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions CFR Class II Clinical Chemistry
2025-12-17 K253839 Elecsys Anti-SARS-CoV-2 QVP Class II Microbiology
2025-10-24 K253188 CoaguChek XS Plus System GJS Class II Hematology
2025-10-08 K252163 Elecsys Phospho-Tau (181P) Plasma SET Class II Immunology
2025-07-17 K242505 Elecsys Cortisol III JFT — —
2025-06-10 K250768 Elecsys Anti-SARS-CoV-2 QVP Class II Microbiology
2025-02-07 K241453 Elecsys sFlt-1 and Elecsys PlGF QWH Class II Clinical Chemistry
2024-06-17 K233060 Elecsys Folate III CGN Class II Clinical Chemistry
2024-04-26 K220272 cobas pulse blood glucose monitoring system PZI Class II Clinical Chemistry
2024-03-22 K231927 Elecsys PTH , Elecsys PTH STAT CEW Class II Clinical Chemistry
2023-09-30 K221890 Elecsys Tg II MSW Class II Immunology
2023-09-15 K222610 Elecsys Anti-Tg JZO Class II Immunology
2023-07-21 K223637 Elecsys proBNP II, Elecsys proBNP II STAT NBC — —
2023-06-05 K231348 Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSF QSE Class II Immunology
2023-04-07 K220456 Elecsys FT4 IV CEC Class II Clinical Chemistry
2023-03-30 K230161 ONLINE TDM Phenytoin - Free Phenytoin application MOJ — —
2023-01-04 K221693 Elecsys Anti-HCV II (08837031190) MZO — —
2022-12-23 K221765 ONLINE DAT Benzodiazepines II JXM — —
2022-12-07 K221842 Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSF QSE Class II Immunology
2022-10-12 K220924 Elecsys HSV-2 IgG (08948887160) MYF — —
2022-10-12 K220923 Elecsys HSV-1 IgG (08948844160) MXJ — —
2022-10-12 K220911 Elecsys CMV IgG LFZ — —
2022-09-16 K220134 cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSH CFR Class II Clinical Chemistry
2022-09-15 K220176 Elecsys AFP LOJ Class II Immunology
2022-06-10 K203757 Elecsys AMH PQO Class II Clinical Chemistry
2022-05-06 K211685 Elecsys Testosterone II CDZ — —
2022-03-31 K210546 Elecsys proBNP II, Elecsys proBNP II STAT NBC — —
2021-09-21 K201441 Elecsys Troponin T Gen 5 MMI Class II Clinical Chemistry
2021-09-01 K210901 Elecsys Vitamin D total III MRG Class II Clinical Chemistry
2021-08-18 K203227 Elecsys HCG STAT DHA Class II Clinical Chemistry
2021-07-20 K211302 Elecsys Syphilis LIP — —
2020-11-06 K200811 cobas u 701 microscopy analyzer LKM Class II Hematology
2020-03-09 K192815 Elecsys BRAHMS PCT PRI Class II Microbiology
2020-02-27 K193313 Elecsys Anti-TSHR JZO Class II Immunology
Data source: openFDA · Generated 2026-08-28 09:16 · Last ingest 2026-08-28T13:16:47.116226 · Pipeline: Chrysalis Intelligence