Antigens, All Groups, Streptococcus Spp.
FDA product code GTY · Class I (low risk) · 21 CFR 866.3740 · Microbiology
44510(k) clearances
0PMA approvals
20recalls
Manufacturers
- Quidel Corp. 5
- ACON Laboratories, Inc. 4
- Princeton BioMeditech Corp. 4
- Scientific Device Laboratory, Inc. 3
- Sa Scientific, Inc. 3
- Pharmacia, Inc. 2
- Abbott Laboratories 2
- Biostar, Inc. 2
- Eastman Kodak Company 1
- Hangzhou AllTest Biotech Co., Ltd. 1
- Trinity Biotech, Plc 1
- Becton Dickinson Advanced Diagnostics 1
- Biosearch Medical Products, Inc. 1
- Vitek Systems, Inc. 1
- Bd Becton Dickinson Vacutainer Systems Preanalytic 1
- Hybritech, Inc. 1
- Ncs Diagnostics, Inc. 1
- Orion Diagnostica, Inc. 1
- Hygeia Sciences 1
- Pacific Biotech, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260342 | AllTest Strep A Rapid TestGTY · Traditional | Hangzhou AllTest Biotech Co., Ltd. | 04/30/2026SE |
| K251697 | Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test StripGTY · Dual Track | ACON Laboratories, Inc. | 11/26/2025SE |
| K212623 | Healgen Strep A Rapid Test Strip (Throat Swab)GTY · Traditional | Healgen Scientific,, LLC | 03/16/2022SE |
| K171976 | Sofia Strep A+ FIA, Sofia 2 AnalyzerGTY · Dual Track | Quidel Corporation | 12/21/2017SE |
| K141775 | Sofia (R) Strep A+ FiaGTY · Dual Track | Quidel Corporation | 12/16/2014SE |
| K133343 | Wondfo Rapid Strep a TestGTY · Traditional | Guangzhou Wondfo Biotech Co., Ltd. | 01/31/2014SE |
| K123793 | Sofia Strep a FiaGTY · Traditional | Quidel Corporation | 06/17/2013SE |
| K122718 | BD Veritor(Tm) System for Rapid Detection of Group a StrepGTY · Traditional | Becton, Dickinson and Company | 02/06/2013SE |
| K091489 | Clearview Advanced Strep a , Model 737-430GTY · Traditional | Binax, Inc. | 09/04/2009SE |
| K082661 | Biostrep a, Biosign Strep a, Statusfirst Strep aGTY · Special | Princeton BioMeditech Corp. | 10/06/2008SE |
| K051638 | Inverness Medical Testpack + Plus Strep a with ObcGTY · Traditional | Unipath , Ltd. | 12/06/2005SE |
| K040708 | Status First Strep aGTY · Traditional | Princeton BioMeditech Corp. | 11/22/2004SE |
| K031784 | Acon Strep a Rapid Test DeviceGTY · Special | ACON Laboratories, Inc. | 07/14/2003SE |
| K023766 | Acon Strep a Twist Test DeviceGTY · Traditional | Acon Laboratories Co. | 02/10/2003SE |
| K023270 | SAS StrepalertGTY · Traditional | Sa Scientific, Inc. | 10/17/2002SE |
| K013379 | SAS StrepalertGTY · Traditional | Sa Scientific, Inc. | 12/12/2001SE |
| K011097 | Quickvue Dipstick Strep aGTY · Traditional | Quidel Corp. | 05/08/2001SE |
| K010582 | Acon Strep a Rapid Test StripGTY · Traditional | Acon Laboratories Co. | 05/07/2001SE |
| K993456 | SAS Strep a TestGTY · Traditional | Sa Scientific, Inc. | 03/07/2000SE |
| K992658 | Osom Ultra Strep a Test, Model 147GTY · Traditional | Wyntek Diagnostics, Inc. | 01/18/2000SE |
| K991828 | Strep B OiaGTY · Traditional | Biostar, Inc. | 08/19/1999SE |
| K982373 | Uni-Gold Strep a Test KitGTY · Traditional | Trinity Biotech, Plc | 02/11/1999SE |
| K983386 | Biostrep A-Direct Strep a Antigen TestGTY · Traditional | Princeton BioMeditech Corp. | 11/25/1998SE |
| K971349 | Biosign Strep a - Direct Strep a Antigen TestGTY · Traditional | Princeton BioMeditech Corp. | 07/07/1997SE |
| K945080 | Quickvue In-Line One-Step Strep a Control Swabs (Positive & Negative Swab Specimens)GTY · Traditional | Quidel Corp. | 02/10/1995SE |
| K936112 | Strep B OiaGTY · Traditional | Biostar, Inc. | 07/06/1994SE |
| K935667 | Qtest(R) StrepGTY · Traditional | Becton Dickinson Advanced Diagnostics | 04/21/1994SE |
| K922765 | Biostars Strep a Oia -- ModificationGTY · Traditional | Biosearch Medical Products, Inc. | 08/20/1992SE |
| K922490 | Abbott Strep a ControlsGTY · Traditional | Abbott Laboratories | 07/22/1992SE |
| K905020 | Slidex Strepto-KitGTY · Traditional | Vitek Systems, Inc. | 01/28/1991SE |
| K904589 | Kodak Surecell(Tm) Strep a Control Fluid SetGTY · Traditional | Eastman Kodak Company | 01/18/1991SE |
| K902991 | Icon Strep B Immunoenzymetric AssayGTY · Traditional | Hybritech, Inc. | 10/03/1990SE |
| K882811 | StrepslideGTY · Traditional | Ncs Diagnostics, Inc. | 10/25/1988SE |
| K864752 | Abbott Testpack(Tm) Strep a Positive ControlGTY · Traditional | Abbott Laboratories | 02/26/1987SE |
| K862475 | Respirastick Enzyme Immunoassay TestGTY · Traditional | Orion Diagnostica, Inc. | 09/16/1986SE |
| K862133 | Hygeia Rapid Strep a TestGTY · Traditional | Hygeia Sciences | 06/25/1986SE |
| K861575 | Directatex Strep aGTY · Traditional | Pacific Biotech, Inc. | 06/03/1986SE |
| K840513 | Streptococcus Gr. B ControlGTY · Traditional | Scientific Device Laboratory, Inc. | 03/23/1984SE |
| K840512 | Streptococcus Pneumoniae ControlGTY · Traditional | Scientific Device Laboratory, Inc. | 03/23/1984SE |
| K840511 | Streptococcus Gr. DGTY · Traditional | Scientific Device Laboratory, Inc. | 03/23/1984SE |
| K840048 | Phadebact CSF Positive ControlsGTY · Traditional | Pharmacia, Inc. | 03/02/1984SE |
| K832248 | Phadebact Strep Positive ControlsGTY · Traditional | Pharmacia, Inc. | 09/01/1983SE |
| K831599 | Meritec-Strep Group a Beta-HemolyticGTY · Traditional | Meridian Diagnostics, Inc. | 08/11/1983SE |
| K812808 | BBL Directigen Test KitGTY · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 12/30/1981SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2169-2026 Class II | QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp.Product has the potential for false positive results | Quidel Corporation | 04/06/2026Open, Classified |
| Z-1561-2026 Class II | Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal…Product not cleared by the FDA. | Altruan GmbH | 12/19/2025Open, Classified |
| Z-1560-2026 Class II | Clearest Strep-A Cassette Test. Test to determine the presence of group A streptococci…Product not cleared by the FDA. | Altruan GmbH | 12/19/2025Open, Classified |
| Z-1559-2026 Class II | Wondfo Streptococcal A At-Home Self-Test. At-home test for group A beta-hemolytic…Product not cleared by the FDA. | Altruan GmbH | 12/19/2025Open, Classified |
| Z-2337-2025 Class II | Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived. Catalog Number:…Due to a classification error in the inventory management system, specific medical devices were shipped to… | Mckesson Medical-Surgical Inc. Corporate… | 07/30/2025Open, Classified |
| Z-2545-2025 Class II | QuickVue: Dipstick Strep A Test: 50T, REF: 20108; 25T, REF: 20125; 50T, SCN, REF: 20108SCDipstick strep A test has potential for false positive results. | Quidel Corporation | 06/17/2025Open, Classified |
| Z-3185-2024 Class II | Acceava Respiratory Strep A, CLIA Waived, Catalog Number 4580295008Due to a classification error in our inventory management system, these medical devices were shipped to… | Cypress Medical Products LLC | 08/20/2024Open, Classified |
| Z-2034-2024 Class II | Streptococcal A rapid test kits, labeled as: Wondfo Biotech Co., Ltd, WondView Strep A…Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized… | Wondfo USA Co Ltd | 04/22/2024Open, Classified |
| Z-2033-2024 Class II | Independent Medical Co-op Inc., Streptococcal A rapid test kits, labeled as: IMCO Strep…Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized… | Wondfo USA Co Ltd | 04/22/2024Open, Classified |
| Z-2032-2024 Class II | Streptococcal A rapid test kits, labeled as: Easy Healthcare Corporation, Areta Strep A…Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized… | Wondfo USA Co Ltd | 04/22/2024Open, Classified |
| Z-2031-2024 Class II | Clarity and Clarity Diagnostics LLC, Streptococcal A rapid test kits, Labeled as: a)…Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized… | Wondfo USA Co Ltd | 04/22/2024Open, Classified |
| Z-2030-2024 Class II | Preview Strep A, Streptococcal A rapid test kits, Part Numbers: a) PRE-STA-25, b)…Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized… | Wondfo USA Co Ltd | 04/22/2024Open, Classified |
| Z-1598-2022 Class II | Strep test: a. McKesson Medical-Surgical McKesson Rapid Test Kit McKesson Consult…Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | Mckesson Medical-Surgical Inc. Corporate… | 05/25/2022Open, Classified |
| Z-2351-2015 Class II | PathoDx Strep B Grouping Latex, REF 62031, 3 ml packaged in plastic dropper bottle with…A reagent present may produce weak or slow reactions; continued use may result in a failure to identify… | Remel Inc | 06/30/2015Terminated |
| Z-2350-2015 Class II | PathoDx Strep Grouping Kit, REF 62025, packaged 60 tests per kit. Latex agglutination…A reagent present may produce weak or slow reactions; continued use may result in a failure to identify… | Remel Inc | 06/30/2015Terminated |
| Z-1075-2012 | Strep A Twist Rapid Test Cassette (K023766), IST-502T Twist Cassettes. Brand Name…Alere San Diego is expanding the scope of the voluntary recall of the Strep A Rapid Test Cassette and Twist… | Alere San Diego | 09/01/2011Terminated |
| Z-1074-2012 | Strep A Rapid Test Cassette (K031784), IST-502 Cassettes. Brand Name (Catalog Number):…Alere San Diego is expanding the scope of the voluntary recall of the Strep A Rapid Test Cassette and Twist… | Alere San Diego | 09/01/2011Terminated |
| Z-3054-2011 | @ Home Strep Test Rapid Strep Test Product Usage: For in-vitro diagnostic use -…Home Strep Test does not qualify as a Class I device and needs pre-market approval. | Jay Bird Investments Inc | 07/06/2011Terminated |
| Z-1395-2011 | SP Brand Strep A Cassette; Part Number: B1077-26; Lot #: STA0010037 The SP Brand Strep A…The recall was initiated after the Investigation of customer-reported complaints, testing of market… | Biosite Inc Dba Innovacon Inc. | 01/12/2011Terminated |
| Z-2427-2008 | Mainline Confirms Strep A, Group A Streptococcus; A rapid one-step visual test for the…Use of an incorrect dropper tip on the dispenser may result in false positive A streptococcal results. | Mainline Technology, Inc. | 11/08/2006Terminated |