Pleasanton,, CA, US · 3 510(k) clearances · 35 PMAs · 7 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| QOF | Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents | Class II | Microbiology | 1 | 2025-01-08 |
| QQX | Respiratory Specimen Nucleic Acid Sars-Cov-2 Test | Class II | Microbiology | 1 | 2024-07-10 |
| PCA | Dna Genetic Analyzer | Class II | Clinical Chemistry | 1 | 2020-02-21 |
| Date | PMA # | Trade name | Type | Code | Device name | Specialty |
|---|---|---|---|---|---|---|
| 2026-06-08 | P240040-S006 | Oncomine Dx Express Test | 30-Day Notice | PQP | — | — |
| 2026-03-04 | P160045-S052 | Oncomine Dx Target Test | Special (Immediate Track) | PQP | — | — |
| 2025-11-21 | P160045-S051 | Oncomine Dx Target Test | Special (Immediate Track) | PQP | — | — |
| 2025-11-19 | P160045-S050 | Oncomine Dx Target Test | Normal 180 Day Track | PQP | — | — |
| 2025-10-22 | P240040-S003 | Oncomine Dx Express Test | 30-Day Notice | PQP | — | — |
| 2025-10-15 | P240040-S002 | Oncomine Dx Express Test | Normal 180 Day Track No User Fee | PQP | — | — |
| 2025-08-08 | P160045-S049 | Oncomine Dx Target Test | Normal 180 Day Track | PQP | — | — |
| 2025-08-07 | P240040-S001 | Oncomine Dx Express Test | 30-Day Notice | PQP | — | — |
| 2025-07-02 | P240040 | Oncomine Dx Express Test | Original | PQP | — | — |
| 2024-10-17 | P160045-S046 | Oncomine Dx Target Test | Panel Track | PQP | — | — |
| 2024-07-02 | P160045-S048 | Oncomine Dx Target Test | Special (Immediate Track) | PQP | — | — |
| 2024-06-17 | P160045-S045 | Oncomine Dx Target Test | Normal 180 Day Track No User Fee | PQP | — | — |
| 2024-06-13 | P160045-S047 | Oncomine Dx Target Test | 30-Day Notice | PQP | — | — |
| 2023-11-02 | P160045-S044 | Oncomine Dx Target Test | Special (Immediate Track) | PQP | — | — |
| 2023-09-29 | P160045-S025 | Oncomine Dx Target Test | Panel Track | PQP | — | — |
| 2023-08-17 | P160045-S042 | Oncomine Dx Target Test | Normal 180 Day Track No User Fee | PQP | — | — |
| 2023-08-10 | P160045-S043 | Oncomine Dx Target Test | 30-Day Notice | PQP | — | — |
| 2023-04-07 | P160045-S041 | Oncomine Dx Target Test | Special (Immediate Track) | PQP | — | — |
| 2023-02-10 | P160045-S040 | Oncomine Dx Target Test | 30-Day Notice | PQP | — | — |
| 2023-02-01 | P160045-S038 | Oncomine Dx Target Test | Normal 180 Day Track No User Fee | PQP | — | — |
| 2022-09-21 | P160045-S031 | Oncomine Dx Target Test | Panel Track | PQP | — | — |
| 2022-09-19 | P160045-S037 | Oncomine Dx Target Test | Real-Time Process | PQP | — | — |
| 2022-08-11 | P160045-S036 | Oncomine Dx Target Test | 135 Review Track For 30-Day Notice | PQP | — | — |
| 2022-08-11 | P160045-S035 | Oncomine Dx Target Test | Panel Track | PQP | — | — |
| 2022-01-21 | P160045-S034 | Oncomine Dx Target Test | Normal 180 Day Track No User Fee | PQP | — | — |
| 2021-12-01 | P160045-S027 | Oncomine Dx Target Test | Normal 180 Day Track | PQP | — | — |
| 2021-09-15 | P160045-S029 | Oncomine Dx Target Test (ODxT Test) | Panel Track | PQP | — | — |
| 2021-08-25 | P160045-S028 | Oncomine Dx Target Test | Panel Track | PQP | — | — |
| 2021-06-11 | P160045-S030 | Oncomine Dx Target Test | 30-Day Notice | PQP | — | — |
| 2020-12-01 | P160045-S024 | Oncomine Dx Target Test | 30-Day Notice | PQP | — | — |
| 2020-11-11 | P160045-S023 | Oncomine Dx Target Test | 30-Day Notice | PQP | — | — |
| 2020-10-23 | P160045-S021 | Oncomine Dx Target Test | Real-Time Process | PQP | — | — |
| 2020-10-08 | P160045-S022 | Oncomine Dx Target Test | 30-Day Notice | PQP | — | — |
| 2020-09-04 | P160045-S019 | Oncomine Dx Target Test | Panel Track | PQP | — | — |
| 2020-05-26 | P160045-S020 | Oncomine Dx Target Test | 30-Day Notice | PQP | — | — |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2024-02-07 | Class II | Ongoing | Z-1426-2024 | Torrent Suite Dx Software versions 5.14 and earlier used in connection with Ion PGM DX Systems-IVD intended for targeted… | — | Torrent Suite Dx Software versions 5.14 and earlier used in connection with Ion PGM DX Systems exploitation of the vulnerability by a threat actor may allow the… |
| 2020-08-06 | Class II | Terminated | Z-2979-2020 | The TaqPath RT-PCR COVID-19 Kit with Applied Biosystem's COVID-19 Interpretive Software v2.0 or v2.2 (used with the Quan… | — | COVID-19 Interpretive Software issues that may cause: 1) the risk of invalid or inconclusive tests/false negative and potentially increasing the retesting burd… |
| 2020-08-06 | Class II | Terminated | Z-2978-2020 | The TaqPath RT-PCR COVID-19 Kit with Applied Biosystem's COVID-19 Interpretive Software v1.2 for 7500 RTPCR instruments,… | — | COVID-19 Interpretive Software issues that may cause: 1) the risk of invalid or inconclusive tests/false negative and potentially increasing the retesting burd… |
| 2020-03-16 | Class II | Terminated | Z-1707-2020 | Ion Torrent Dx No Template Control Kit- IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC… | — | Extended Expiration Date prior to clearance |
| 2020-03-16 | Class II | Terminated | Z-1706-2020 | Oncomine Dx Target Test RNA/DNA Panel- IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC)… | — | Extended Expiration Date prior to clearance |
| 2020-03-16 | Class II | Terminated | Z-1705-2020 | Oncomine Dx Target Test RNA Control- IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) t… | — | Extended Expiration Date prior to clearance |
| 2020-03-16 | Class II | Terminated | Z-1704-2020 | Oncomine Dx Target Test DNA Control-IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tu… | — | Extended Expiration Date prior to clearance |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-01-08 | K241806 | Applied Biosystems TaqPath COVID-19, Flu A, Flu B, RSV Select Panel | QOF | Class II | Microbiology |
| 2024-07-10 | K233453 | Applied Biosystems TaqPath COVID-19 Diagnostic PCR Kit | QQX | Class II | Microbiology |
| 2020-02-21 | K191030 | Applied Biosystems 3500 Dx Genetic Analyzer and Applied Biosystems 3500xL Dx Genetic Analyzer | PCA | Class II | Clinical Chemistry |