Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip
FDA 510(k) clearance K251697 · decided 2025-11-26
Clearance details
- K-number
- K251697
- Device name
- Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip
- Applicant
- ACON Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-06-02
- Decision date
- 2025-11-26
- Days to decision
- 177 days
- Clearance type
- Dual Track
- Product code
- GTY
- Device class
- 1
- Regulation number
- 866.3740
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| AllTest Strep A Rapid Test (K260342) | Hangzhou AllTest Biotech Co., Ltd. | 2026-04-30 |
| Healgen Strep A Rapid Test Strip (Throat Swab) (K212623) | Healgen Scientific,, LLC | 2022-03-16 |
| Sofia Strep A+ FIA, Sofia 2 Analyzer (K171976) | Quidel Corporation | 2017-12-21 |
| SOFIA (R) STREP A+ FIA (K141775) | Quidel Corporation | 2014-12-16 |
| WONDFO RAPID STREP A TEST (K133343) | Guangzhou Wondfo Biotech Co., Ltd. | 2014-01-31 |
| SOFIA STREP A FIA (K123793) | Quidel Corporation | 2013-06-17 |
| BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF GROUP A STREP (K122718) | Becton, Dickinson and Company | 2013-02-06 |
| CLEARVIEW ADVANCED STREP A , MODEL 737-430 (K091489) | Binax, Inc. | 2009-09-04 |
| BIOSTREP A, BIOSIGN STREP A, STATUSFIRST STREP A (K082661) | Princeton BioMeditech Corp. | 2008-10-06 |
| INVERNESS MEDICAL TESTPACK + PLUS STREP A WITH OBC (K051638) | Unipath , Ltd. | 2005-12-06 |
| STATUS FIRST STREP A (K040708) | Princeton BioMeditech Corp. | 2004-11-22 |
| ACON STREP A RAPID TEST DEVICE (K031784) | ACON Laboratories, Inc. | 2003-07-14 |
Recalls involving this device
No recalls on record reference this clearance.