Simplexa™ Group A Strep Direct MOL2850
Simplexa™ Group A Strep Direct MOL2850 is a Class II device made by DiaSorin Molecular LLC, cleared under FDA 510(k) K143651 on 18 Mar 2015 and listed in FDA GUDID since 22 Sep 2016 (UDI-DI 20816101025569), active as of 23 Oct 2026. One FDA recall is linked to it.
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number20816101025569 | Date22 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK143651 | Date18 Mar 2015 | StatusActive |
Official records
- AccessGUDID record 20816101025569
- FDA 510(k) database K143651
Across registries
- FDA 510(k) K143651 decided 18 Mar 2015 Active
- FDA GUDID UDI-DI 20816101025569 listed 22 Sep 2016 Listed
Recalls
-
- Terminated Z-1274-2016
Focus Diagnostics is recalling the Direct Amplification Discs (DAD) supplied with the Simplexa HSV 1 & 2 Direct (MOL2150), Simplexa Flu A/B & RSV Direct (MOL2650) and Simplexa Group A Strep Direct kits (MOL2850) because it may result in a false negative result, a false positive result or Error code (s) 500 or 505, and it may result in higher invalid rates.
Timeline
- Cleared FDA 510(k) K143651
- Recall initiated FDA recalls Z-1274-2016
- Listed FDA GUDID 20816101025569
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Simplexa™ Group A Strep Direct
- Generic name
- Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)
- Model / Ref / Catalog
- MOL2850
- Primary DI / UDI-DI
- 20816101025569
- 510(k) Number
- FDA product code
- PGX
- GMDN term
- Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)
- Device class
- Class II
- Regulation number
- 866.2680
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code PGX (Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System).
- Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control Pack by Focus Diagnostics, Inc.
- Lyra Direct Strep Assay M112 by Quidel Corp.
- cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190) by Roche Molecular System, Inc.
- Xpert Xpress Strep A by CEPHEID
- Solana Strep Complete Assay by Quidel Corp.
- ID NOW Strep A 2 Control Swab Kit 734-080 by Alere Scarborough, Inc.
- Accula Strep A Test by MESA BIOTECH, INC.
- GenePOC Strep A by Genepoc, Inc.
- LIAT STREP A ASSAY by Iquum, Inc.