Product Code: GTY FDA class 1 21 CFR 866.3740

Antigens, All Groups, Streptococcus Spp.

Microbiology

The Antigens, All Groups, Streptococcus Spp. is a collection of antigens representing all Lancefield serogroups of Streptococcus species, used in agglutination or precipitation tests for grouping streptococcal isolates in the clinical laboratory. It is an FDA Class 1 device requiring only general controls, with no premarket submission needed. Regulated under 21 CFR 866.3740 with product code GTY in the Microbiology specialty. No special flags apply to this device.

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510(k)s

FEI Numbers

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Basic Information

Product Code: GTY
Device Class: FDA class 1
Regulation Number: 866.3740
Medical Specialty: Microbiology
Review Panel: MI
Submission Type: 4

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

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Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 44 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K260342	AllTest Strep A Rapid Test	Apr 30, 2026	Substantially Equivalent	Hangzhou AllTest Biotech Co., Ltd.
K251697	Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip	Nov 26, 2025	Substantially Equivalent	ACON Laboratories, Inc.
K212623	Healgen Strep A Rapid Test Strip (Throat Swab)	Mar 16, 2022	Substantially Equivalent	Healgen Scientific,, LLC
K171976	Sofia Strep A+ FIA, Sofia 2 Analyzer	Dec 21, 2017	Substantially Equivalent	Quidel Corporation
K141775	SOFIA (R) STREP A+ FIA	Dec 16, 2014	Substantially Equivalent	Quidel Corporation
K133343	WONDFO RAPID STREP A TEST	Jan 31, 2014	Substantially Equivalent	Guangzhou Wondfo Biotech Co., Ltd.
K123793	SOFIA STREP A FIA	Jun 17, 2013	Substantially Equivalent	Quidel Corporation
K122718	BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF GROUP A STREP	Feb 06, 2013	Substantially Equivalent	Becton, Dickinson and Company
K091489	CLEARVIEW ADVANCED STREP A , MODEL 737-430	Sep 04, 2009	Substantially Equivalent	Binax, Inc.
K082661	BIOSTREP A, BIOSIGN STREP A, STATUSFIRST STREP A	Oct 06, 2008	Substantially Equivalent	Princeton BioMeditech Corp.
K051638	INVERNESS MEDICAL TESTPACK + PLUS STREP A WITH OBC	Dec 06, 2005	Substantially Equivalent	Unipath , Ltd.
K040708	STATUS FIRST STREP A	Nov 22, 2004	Substantially Equivalent	Princeton BioMeditech Corp.
K031784	ACON STREP A RAPID TEST DEVICE	Jul 14, 2003	Substantially Equivalent	ACON Laboratories, Inc.
K023766	ACON STREP A TWIST TEST DEVICE	Feb 10, 2003	Substantially Equivalent	Acon Laboratories Co.
K023270	SAS STREPALERT	Oct 17, 2002	Substantially Equivalent	Sa Scientific, Inc.
K013379	SAS STREPALERT	Dec 12, 2001	Substantially Equivalent	Sa Scientific, Inc.
K011097	QUICKVUE DIPSTICK STREP A	May 08, 2001	Substantially Equivalent	Quidel Corp.
K010582	ACON STREP A RAPID TEST STRIP	May 07, 2001	Substantially Equivalent	Acon Laboratories Co.
K993456	SAS STREP A TEST	Mar 07, 2000	Substantially Equivalent	Sa Scientific, Inc.
K992658	OSOM ULTRA STREP A TEST, MODEL 147	Jan 18, 2000	Substantially Equivalent	Wyntek Diagnostics, Inc.
K991828	STREP B OIA	Aug 19, 1999	Substantially Equivalent	Biostar, Inc.
K982373	UNI-GOLD STREP A TEST KIT	Feb 11, 1999	Substantially Equivalent	Trinity Biotech, Plc
K983386	BIOSTREP A-DIRECT STREP A ANTIGEN TEST	Nov 25, 1998	Substantially Equivalent	Princeton BioMeditech Corp.
K971349	BIOSIGN STREP A - DIRECT STREP A ANTIGEN TEST	Jul 07, 1997	Substantially Equivalent	Princeton BioMeditech Corp.
K945080	QUICKVUE IN-LINE ONE-STEP STREP A CONTROL SWABS (POSITIVE & NEGATIVE SWAB SPECIMENS)	Feb 10, 1995	Substantially Equivalent	Quidel Corp.
K936112	STREP B OIA	Jul 06, 1994	Substantially Equivalent	Biostar, Inc.
K935667	QTEST(R) STREP	Apr 21, 1994	Substantially Equivalent	Becton Dickinson Advanced Diagnostics
K922765	BIOSTARS STREP A OIA -- MODIFICATION	Aug 20, 1992	Substantially Equivalent	Biosearch Medical Products, Inc.
K922490	ABBOTT STREP A CONTROLS	Jul 22, 1992	Substantially Equivalent	Abbott Laboratories
K905020	SLIDEX STREPTO-KIT	Jan 28, 1991	Substantially Equivalent	Vitek Systems, Inc.
K904589	KODAK SURECELL(TM) STREP A CONTROL FLUID SET	Jan 18, 1991	Substantially Equivalent	Eastman Kodak Company
K902991	ICON STREP B IMMUNOENZYMETRIC ASSAY	Oct 03, 1990	Substantially Equivalent	Hybritech, Inc.
K882811	STREPSLIDE	Oct 25, 1988	Substantially Equivalent	Ncs Diagnostics, Inc.
K864752	ABBOTT TESTPACK(TM) STREP A POSITIVE CONTROL	Feb 26, 1987	Substantially Equivalent	Abbott Laboratories
K862475	RESPIRASTICK ENZYME IMMUNOASSAY TEST	Sep 16, 1986	Substantially Equivalent	Orion Diagnostica, Inc.
K862133	HYGEIA RAPID STREP A TEST	Jun 25, 1986	Substantially Equivalent	Hygeia Sciences
K861575	DIRECTATEX STREP A	Jun 03, 1986	Substantially Equivalent	Pacific Biotech, Inc.
K840513	STREPTOCOCCUS GR. B CONTROL	Mar 23, 1984	Substantially Equivalent	Scientific Device Laboratory, Inc.
K840512	STREPTOCOCCUS PNEUMONIAE CONTROL	Mar 23, 1984	Substantially Equivalent	Scientific Device Laboratory, Inc.
K840511	STREPTOCOCCUS GR. D	Mar 23, 1984	Substantially Equivalent	Scientific Device Laboratory, Inc.
K840048	PHADEBACT CSF POSITIVE CONTROLS	Mar 02, 1984	Substantially Equivalent	Pharmacia, Inc.
K832248	PHADEBACT STREP POSITIVE CONTROLS	Sep 01, 1983	Substantially Equivalent	Pharmacia, Inc.
K831599	MERITEC-STREP GROUP A BETA-HEMOLYTIC	Aug 11, 1983	Substantially Equivalent	Meridian Diagnostics, Inc.
K812808	BBL DIRECTIGEN TEST KIT	Dec 30, 1981	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic