GTY · Antigens, All Groups, Streptococcus Spp.
Microbiology · 21 CFR 866.3740 · Class 1
Overview
| Product Code | GTY |
|---|---|
| Device Name | Antigens, All Groups, Streptococcus Spp. |
| Regulation | 21 CFR 866.3740 |
| Device Class | Class 1 |
| Review Panel | Microbiology |
Identification
Streptococcus spp. serological reagents are devices that consist of antigens and antisera (excluding streptococcal exoenzyme reagents made from enzymes secreted by streptococci) used in serological tests to identify Streptococcus spp. from cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by bacteria belonging to the genus Streptococcus and provides epidemiological information on these diseases. Pathogenic streptococci are associated with infections, such as sore throat, impetigo (an infection characterized by small pustules on the skin), urinary tract infections, rheumatic fever, and kidney disease.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.
Recent Cleared Devices (20 of 43)
Showing 20 most recent of 43 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K251697 | Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip | ACON Laboratories, Inc. | Nov 26, 2025 | SESE |
| K212623 | Healgen Strep A Rapid Test Strip (Throat Swab) | Healgen Scientific,, LLC | Mar 16, 2022 | SESE |
| K171976 | Sofia Strep A+ FIA, Sofia 2 Analyzer | Quidel Corporation | Dec 21, 2017 | SESE |
| K141775 | SOFIA (R) STREP A+ FIA | Quidel Corporation | Dec 16, 2014 | SESE |
| K133343 | WONDFO RAPID STREP A TEST | Guangzhou Wondfo Biotech Co., Ltd. | Jan 31, 2014 | SESE |
| K123793 | SOFIA STREP A FIA | Quidel Corporation | Jun 17, 2013 | SESE |
| K122718 | BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF GROUP A STREP | Becton, Dickinson and Company | Feb 6, 2013 | SESE |
| K091489 | CLEARVIEW ADVANCED STREP A , MODEL 737-430 | Binax, Inc. | Sep 4, 2009 | SESE |
| K082661 | BIOSTREP A, BIOSIGN STREP A, STATUSFIRST STREP A | Princeton BioMeditech Corp. | Oct 6, 2008 | SESE |
| K051638 | INVERNESS MEDICAL TESTPACK + PLUS STREP A WITH OBC | Unipath , Ltd. | Dec 6, 2005 | SESE |
| K040708 | STATUS FIRST STREP A | Princeton BioMeditech Corp. | Nov 22, 2004 | SESE |
| K031784 | ACON STREP A RAPID TEST DEVICE | ACON Laboratories, Inc. | Jul 14, 2003 | SESE |
| K023766 | ACON STREP A TWIST TEST DEVICE | Acon Laboratories Co. | Feb 10, 2003 | SESE |
| K023270 | SAS STREPALERT | Sa Scientific, Inc. | Oct 17, 2002 | SESE |
| K013379 | SAS STREPALERT | Sa Scientific, Inc. | Dec 12, 2001 | SESE |
| K011097 | QUICKVUE DIPSTICK STREP A | Quidel Corp. | May 8, 2001 | SESE |
| K010582 | ACON STREP A RAPID TEST STRIP | Acon Laboratories Co. | May 7, 2001 | SESE |
| K993456 | SAS STREP A TEST | Sa Scientific, Inc. | Mar 7, 2000 | SESE |
| K992658 | OSOM ULTRA STREP A TEST, MODEL 147 | Wyntek Diagnostics, Inc. | Jan 18, 2000 | SESE |
| K991828 | STREP B OIA | Biostar, Inc. | Aug 19, 1999 | SESE |
Top Applicants
- Princeton BioMeditech Corp. — 4 clearances
- Quidel Corporation — 3 clearances
- Sa Scientific, Inc. — 3 clearances
- Scientific Device Laboratory, Inc. — 3 clearances
- ACON Laboratories, Inc. — 2 clearances
