Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays
FDA product code PMN · Class II (moderate risk) · 21 CFR 866.3920 · Microbiology
Assayed external quality control material to monitor the performance of microbiology nucleic acid assays for in vitro diagnostic use.
31510(k) clearances
0PMA approvals
4recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261475 | BIOFIRE® FILMARRAY® Tropical Fever Panel Control KitPMN · Traditional | Biofire Defense, LLC | 07/17/2026SE |
| K260577 | FilmArray TF Control Panel M527PMN · Traditional | Maine Molecular Quality Controls, Inc. | 05/19/2026SE |
| K260041 | MDx-Chex for BCPPMN · Traditional | Streck, LLC | 03/27/2026SE |
| K254166 | MDx-Chex for BCNPMN · Traditional | Streck | 03/23/2026SE |
| K254167 | MDx-Chex for BCYPMN · Traditional | Streck, LLC | 03/17/2026SE |
| K251526 | FilmArray GI Control Panel M238PMN · Traditional | Maine Molecular Quality Controls, Inc. | 08/14/2025SE |
| K241289 | SPOTFIRE RSP Pos & Neg Controls; SPOTFIRE RSP Negative ControlPMN · Special | Maine Molecular Quality Controls, Inc. | 05/30/2024SE |
| K233611 | SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE…PMN · Traditional | Maine Molecular Quality Controls, Inc. | 03/26/2024SE |
| K231223 | MDx-Chex for BC-GNPMN · Traditional | Streck | 07/27/2023SE |
| K231221 | MDx-Chex for BC-GPPMN · Traditional | Streck | 07/27/2023SE |
| K230868 | SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative…PMN · Special | Maine Molecular Quality Controls, Inc. | 04/13/2023SE |
| K221253 | SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative ControlPMN · Traditional | Maine Molecular Quality Controls, Inc. | 02/03/2023SE |
| K203680 | BioFire JI Control Panel M420PMN · Traditional | Maine Molecular Quality Controls, Inc. | 07/22/2022SE |
| K201403 | NATtrol BD MAX Vaginal Panel External ControlsPMN · Traditional | Zeptometrix | 02/02/2022SE |
| K212576 | MDx-Chex for BCID2PMN · Traditional | Streck, Inc. | 01/19/2022SE |
| K202196 | BioFire RP2.1/RP2.1plus Control Panel M441PMN · Traditional | Maine Molecular Quality Controls, Inc. | 06/24/2021SE |
| K202382 | FilmArray Global Fever Panel External Control KitPMN · Traditional | Biofire Defense, LLC | 11/20/2020SE |
| K200010 | FilmArray BCID2 Control Panel M416PMN · Traditional | Maine Molecular Quality Controls, Inc. | 04/02/2020SE |
| K190086 | Cepheid Xpert Respiratory Control PanelPMN · Traditional | Microbiologics, Inc. | 10/07/2019SE |
| K191168 | Cepheid Xpert SA Nasal Complete Control PanelPMN · Traditional | Microbiologics, Inc. | 06/25/2019SE |
| K191172 | Cepheid Xpert MRSA NxG Control PanelPMN · Traditional | Microbiologics, Inc. | 06/20/2019SE |
| K190223 | Cepheid Xpert CT/NG Control PanelPMN · Traditional | Microbiologics, Inc. | 05/08/2019SE |
| K190222 | FilmArray Pneumonia/Pneumoniaplus ControlPMN · Traditional | Maine Molecular Quality Controls, Inc. | 05/03/2019SE |
| K190463 | Cepheid Xpert C. difficile/Epi Control PanelPMN · Traditional | Microbiologics, Inc. | 04/19/2019SE |
| K182472 | Cepheid Xpert GBS LB Control PanelPMN · Traditional | Microbiologics, Inc. | 11/08/2018SE |
| K181683 | BD MAX CT/GC/TV 20-Day QC PanelPMN · Traditional | Microbiologics, Inc. | 08/28/2018SE |
| K181711 | BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC PanelPMN · Traditional | Microbiologics, Inc. | 08/15/2018SE |
| K173171 | FilmArray RP2/RP2plus Control PanelPMN · Traditional | Maine Molecular Quality Controls, Inc. | 11/24/2017SE |
| K163522 | FilmArray Warrior Control Panel M290PMN · Traditional | Maine Molecular Quality Controls, Inc. | 03/14/2017SE |
| K161573 | FilmArray RP EZ Control Panel M265PMN · Traditional | Maine Molecular Quality Controls, Inc. | 09/02/2016SE |
| K152679 | Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, Level…PMN · Traditional | Bio-Rad Laboratories | 05/10/2016SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1838-2019 Class III | Cepheid Xpert C. difficile/Epi Control PanelProduct is labeled with expiration date of 2021-10-31, should be 2021-03-31. | Microbiologics Inc | 05/16/2019Open, Classified |
| Z-1731-2019 Class II | Cepheid Xpert SA Nasal Complete Control Panel (Catalog #8196) UDI: 70845357041233…Product with incorrect shelf life. | Microbiologics Inc | 04/09/2019Open, Classified |
| Z-1730-2019 Class II | Cepheid Xpert MRSA/MRSA NxG Control Panel (Catalog #8195) UDI: 70845357041226 Product…Product with incorrect shelf life. | Microbiologics Inc | 04/09/2019Open, Classified |
| Z-0982-2019 Class II | Cepheid Respiratory Control Panel Catalog #8199 for in vitro diagnostic useCepheid Xpert Respiratory Control Panel (Catalog #8199) has an reduced expiration date from 24 months to 13… | Microbiologics Inc | 01/31/2019Terminated |