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PMN · Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays

Microbiology · 18 clearances · 4 unique sponsors

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Device class

Class II

Regulation 866.3920

Total clearances

18

2020-04-02 → 2026-07-17

Last 12 months

5

Unique sponsors

4

Definition

What is Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays

Assayed external quality control material to monitor the performance of microbiology nucleic acid assays for in vitro diagnostic use.

Classification details

Medical specialty

Microbiology

Review panel

MI

Regulation number

866.3920

Implant

N

Life-sustain / support

N

GMP exempt

N

Third-party review

Y

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Maine Molecular Quality Controls, Inc.	9	1	2026-05-19
Streck, LLC	6	3	2026-03-27
Biofire Defense, LLC	2	1	2026-07-17
Zeptometrix	1	0	2022-02-02

Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

Code	Type	Description	Confidence	Rationale
87910	CPT	—	High	Nucleic acid amplification with internal positive control; external quality control material standard
88199	CPT	—	Medium	Laboratory quality control material; assayed external control for NAT assays

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-07-17	K261475	Biofire Defense, LLC	BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit
2026-05-19	K260577	Maine Molecular Quality Controls, Inc.	FilmArray TF Control Panel M527
2026-03-27	K260041	Streck, LLC	MDx-Chex for BCP
2026-03-23	K254166	Streck	MDx-Chex for BCN
2026-03-17	K254167	Streck, LLC	MDx-Chex for BCY
2025-08-14	K251526	Maine Molecular Quality Controls, Inc.	FilmArray GI Control Panel M238
2024-05-30	K241289	Maine Molecular Quality Controls, Inc.	SPOTFIRE RSP Pos & Neg Controls; SPOTFIRE RSP Negative Control
2024-03-26	K233611	Maine Molecular Quality Controls, Inc.	SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738)
2023-07-27	K231223	Streck	MDx-Chex for BC-GN
2023-07-27	K231221	Streck	MDx-Chex for BC-GP
2023-04-13	K230868	Maine Molecular Quality Controls, Inc.	SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative Control
2023-02-03	K221253	Maine Molecular Quality Controls, Inc.	SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control
2022-07-22	K203680	Maine Molecular Quality Controls, Inc.	BioFire JI Control Panel M420
2022-02-02	K201403	Zeptometrix	NATtrol BD MAX Vaginal Panel External Controls
2022-01-19	K212576	Streck, Inc.	MDx-Chex for BCID2
2021-06-24	K202196	Maine Molecular Quality Controls, Inc.	BioFire RP2.1/RP2.1plus Control Panel M441
2020-11-20	K202382	Biofire Defense, LLC	FilmArray Global Fever Panel External Control Kit
2020-04-02	K200010	Maine Molecular Quality Controls, Inc.	FilmArray BCID2 Control Panel M416