GTY · Class I · 21 CFR 866.3740

FDA Product Code GTY: Antigens, All Groups, Streptococcus Spp.

Leading manufacturers include Princeton BioMeditech Corp., Sa Scientific, Inc. and Quidel Corporation.

44
Total
44
Cleared
101d
Avg days
1981
Since
Growing category - 2 submissions in the last 2 years vs 0 in the prior period
Review times increasing: avg 132d recently vs 100d historically

FDA 510(k) Cleared Antigens, All Groups, Streptococcus Spp. Devices (Product Code GTY)

44 devices
1–24 of 44
Cleared Apr 30, 2026
AllTest Strep A Rapid Test
K260342
Hangzhou AllTest Biotech Co., Ltd.
Microbiology · 87d
Cleared Nov 26, 2025
Flowflex® Plus Strep A Rapid Test Cassette
K251697
ACON Laboratories, Inc.
Microbiology · 177d
Cleared Mar 16, 2022
Healgen Strep A Rapid Test Strip (Throat Swab)
K212623
Healgen Scientific, LLC
Microbiology · 210d
Cleared Dec 21, 2017
Sofia Strep A+ FIA, Sofia 2 Analyzer
K171976
Quidel Corporation
Microbiology · 174d
Cleared Dec 16, 2014
SOFIA (R) STREP A+ FIA
K141775
Quidel Corporation
Microbiology · 168d
Cleared Jan 31, 2014
WONDFO RAPID STREP A TEST
K133343
Guangzhou Wondfo Biotech Co., Ltd.
Microbiology · 93d
Cleared Jun 17, 2013
SOFIA STREP A FIA
K123793
Quidel Corporation
Microbiology · 189d
Cleared Feb 06, 2013
BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF GROUP A STREP
K122718
Becton, Dickinson and Company
Microbiology · 154d
Cleared Oct 06, 2008
BIOSTREP A, BIOSIGN STREP A, STATUSFIRST STREP A
K082661
Princeton BioMeditech Corp.
Microbiology · 24d
Cleared Dec 06, 2005
INVERNESS MEDICAL TESTPACK + PLUS STREP A WITH OBC
K051638
Unipath , Ltd.
Microbiology · 169d
Cleared Nov 22, 2004
STATUS FIRST STREP A
K040708
Princeton BioMeditech Corp.
Microbiology · 249d
Cleared Jul 14, 2003
ACON STREP A RAPID TEST DEVICE
K031784
ACON Laboratories, Inc.
Microbiology · 34d
Cleared Oct 17, 2002
SAS STREPALERT
K023270
Sa Scientific, Inc.
Microbiology · 16d
Cleared Dec 12, 2001
SAS STREPALERT
K013379
Sa Scientific, Inc.
Microbiology · 61d
Cleared May 08, 2001
QUICKVUE DIPSTICK STREP A
K011097
Quidel Corp.
Microbiology · 27d
Cleared Mar 07, 2000
SAS STREP A TEST
K993456
Sa Scientific, Inc.
Microbiology · 146d
Cleared Nov 25, 1998
BIOSTREP A-DIRECT STREP A ANTIGEN TEST
K983386
Princeton BioMeditech Corp.
Microbiology · 60d
Cleared Jul 07, 1997
BIOSIGN STREP A - DIRECT STREP A ANTIGEN TEST
K971349
Princeton BioMeditech Corp.
Microbiology · 88d
Cleared Feb 10, 1995
QUICKVUE IN-LINE ONE-STEP STREP A CONTROL SWABS (POSITIVE & NEGATIVE SWAB SPECIMENS)
K945080
Quidel Corp.
Microbiology · 116d
Cleared Aug 20, 1992
BIOSTARS STREP A OIA -- MODIFICATION
K922765
Biosearch Medical Products, Inc.
Microbiology · 79d
Cleared Jul 22, 1992
ABBOTT STREP A CONTROLS
K922490
Abbott Laboratories
Microbiology · 56d
Cleared Jan 28, 1991
SLIDEX STREPTO-KIT
K905020
Vitek Systems, Inc.
Microbiology · 82d
Cleared Jan 18, 1991
KODAK SURECELL(TM) STREP A CONTROL FLUID SET
K904589
Eastman Kodak Company
Microbiology · 101d
Cleared Oct 03, 1990
ICON STREP B IMMUNOENZYMETRIC ASSAY
K902991
Hybritech, Inc.
Microbiology · 86d

About Product Code GTY - Regulatory Context

510(k) Submission Activity

44 total 510(k) submissions under product code GTY since 1981, with 44 receiving FDA clearance (average review time: 101 days).

Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - GTY Product Code

Recent submissions under GTY have taken an average of 132 days to reach a decision - up from 100 days historically. Manufacturers should account for longer review timelines in current project planning.

GTY devices are reviewed by the Microbiology panel. Browse all Microbiology devices →