Product Code: GMQ FDA class 2 21 CFR 866.3820

Antigens, Nontreponemal, All

Microbiology

The Nontreponemal Antigens (All Types) are reagents used in nontreponemal serological tests such as RPR and VDRL for the screening of syphilis caused by Treponema pallidum, detecting non-specific antibodies (reagin) produced in response to infection. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket clearance. The product code is GMQ, regulated under 21 CFR 866.3820 in the Microbiology specialty. This device is eligible for third-party 510(k) review.

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510(k)s

FEI Numbers

Registration Numbers

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Basic Information

Product Code: GMQ
Device Class: FDA class 2
Regulation Number: 866.3820
Medical Specialty: Microbiology
Review Panel: MI
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 32 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K250249	Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System	Oct 10, 2025	Substantially Equivalent	Gold Standard Diagnostics, LLC
K201438	ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer	Oct 21, 2020	Substantially Equivalent	Arlington Scientific, Inc. (Asi)
K182391	ASI Automated ASI RPR Test for Syphilis on the ASI Evolution	Nov 30, 2018	Substantially Equivalent	Arlington Scientific, Inc. (Asi)
K173376	ASI Evolution	Jun 14, 2018	Substantially Equivalent	Arlington Scientific, Inc. (Asi)
K150358	Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test System	Nov 12, 2015	Substantially Equivalent	Gold Standard Diagnostics
K000687	THE DAYA SYPHILIS TEST/THE TRUST ANTIGEN TEST	Jun 12, 2000	Substantially Equivalent	Beacon Biologicals, Inc.
K993633	SYNTHETIC VDRL ANTIGEN	Feb 23, 2000	Substantially Equivalent	Centers for Disease Control and Prevention
K992124	AVANTI POLAR LIPIDS VDRL ANTIGEN SLIDE TEST KIT WITH 10 X 0.5 ML AMPULES, AVANTI POLAR LIPIDS BULK BDRL ANTIGEN, AVANTI	Sep 20, 1999	Substantially Equivalent	Avanti Polar Lipids, Inc.
K954994	TRUST	Oct 18, 1996	Substantially Equivalent	Guardian Scientific, Corp.
K955136	RPR CARD TEST KIT	Jul 29, 1996	Substantially Equivalent	Remel, L.P.
K952802	VISUWELL REAGIN II	May 23, 1996	Substantially Equivalent	Biomira Diagnostics, Inc.
K910541	BIOKIT RPR	Oct 18, 1991	Substantially Equivalent	Biokit USA, Inc.
K904496	CROMATEST SYPHILIS DIAGNOSTIC	Jul 24, 1991	Substantially Equivalent	Biotrax, Inc.
K900338	VISUWELL(R) REAGIN TEST (MODIFICATION)	Apr 10, 1990	Substantially Equivalent	Adi Diagnostics, Inc.
K880144	STANBIO SYPHILIS RPR TEST, NO. 1170	May 23, 1988	Substantially Equivalent	Stanbio Laboratory
K880477	RPR TEST FOR SYPHILIS IN SERUM OR PLASMA	Mar 30, 1988	Substantially Equivalent	Ampcor, Inc.
K880165	TRUST RPR TEST FOR SYPHILIS IN SERUM OR PLASMA	Mar 30, 1988	Substantially Equivalent	Ampcor, Inc.
K871252	RSR CARD TEST	Aug 06, 1987	Substantially Equivalent	Advanced Polymer Systems, Inc.
K871226	SYPHILIS SEROLOGICAL REAGENTS	May 28, 1987	Substantially Equivalent	New Horizons Diagnostics Co.
K864731	OCEAN SCIENTIFIC VDRL TEST	Mar 10, 1987	Substantially Equivalent	Ocean Scientific, Inc.
K863368	SYPH-TRUST	Dec 12, 1986	Substantially Equivalent	I.A.F. Production, Inc.
K852751	TOLVIDINE RED UNHEATED SERUM SYPHILLIS CARD TEST	Aug 20, 1985	Substantially Equivalent	Preco, Inc.
K842541	RAPID PLASMA REAGIN CARD TEST	Jul 26, 1984	Substantially Equivalent	Clinical Sciences, Inc.
K834149	AUTOGROUPER 16C SYS AUTOMATED REAG	Mar 09, 1984	Substantially Equivalent	Technicon Instruments Corp.
K832480	TRUST RPR TITRATION CARD TEST #65145	Sep 12, 1983	Substantially Equivalent	Emd Chemicals, Inc.
K832479	TRUST RPR CARD TEST #65144	Sep 12, 1983	Substantially Equivalent	Emd Chemicals, Inc.
K822662	REAGIN ANTIGEN SUSPENSION	Sep 21, 1982	Substantially Equivalent	Oxoid U.S.A., Inc.
K822661	RAPID REAGIN CARD TEST	Sep 21, 1982	Substantially Equivalent	Oxoid U.S.A., Inc.
K820567	TREP CARD EIKEN	Apr 14, 1982	Substantially Equivalent	Syn-Kit, Inc.
K812894	VDRL CARBON ANTIGEN	Nov 06, 1981	Substantially Equivalent	Oxoid U.S.A., Inc.
K811152	DADE RPR CARD TEST	May 15, 1981	Substantially Equivalent	American Dade
K810658	RPR CARD TEST SYSTEM	Mar 31, 1981	Substantially Equivalent	Beckman Instruments, Inc.