Atlas FDA

GMQ

32 FDA 510(k) clearances · Product code

96 daysmedian time to decision
273 days90th percentile
32clearances measured

FDA profile

Official device name
Antigens, Nontreponemal, All
Device class
Class II (moderate risk)
Regulation
21 CFR 866.3820
Medical specialty
Microbiology
Flags
Third-party review eligible
Adverse events (MAUDE)
2002: 1 · 2006: 2 · 2007: 3 · 2022: 14
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System (K250249)Gold Standard Diagnostics, LLC2025-10-10
ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer (K201438)Arlington Scientific, Inc. (Asi)2020-10-21
ASI Automated ASI RPR Test for Syphilis on the ASI Evolution (K182391)Arlington Scientific, Inc. (Asi)2018-11-30
ASI Evolution (K173376)Arlington Scientific, Inc. (Asi)2018-06-14
Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test System (K150358)Gold Standard Diagnostics2015-11-12
THE DAYA SYPHILIS TEST/THE TRUST ANTIGEN TEST (K000687)Beacon Biologicals, Inc.2000-06-12
SYNTHETIC VDRL ANTIGEN (K993633)Centers for Disease Control and Prevention2000-02-23
AVANTI POLAR LIPIDS VDRL ANTIGEN SLIDE TEST KIT WITH 10 X 0.5 ML AMPULES, AVANTI POLAR LIPIDS BULK BDRL ANTIGEN, AVANTI (K992124)Avanti Polar Lipids, Inc.1999-09-20
TRUST (K954994)Guardian Scientific, Corp.1996-10-18
RPR CARD TEST KIT (K955136)Remel, L.P.1996-07-29
VISUWELL REAGIN II (K952802)Biomira Diagnostics, Inc.1996-05-23
BIOKIT RPR (K910541)Biokit USA, Inc.1991-10-18
CROMATEST SYPHILIS DIAGNOSTIC (K904496)Biotrax, Inc.1991-07-24
VISUWELL(R) REAGIN TEST (MODIFICATION) (K900338)Adi Diagnostics, Inc.1990-04-10
STANBIO SYPHILIS RPR TEST, NO. 1170 (K880144)Stanbio Laboratory1988-05-23
TRUST RPR TEST FOR SYPHILIS IN SERUM OR PLASMA (K880165)Ampcor, Inc.1988-03-30
RPR TEST FOR SYPHILIS IN SERUM OR PLASMA (K880477)Ampcor, Inc.1988-03-30
RSR CARD TEST (K871252)Advanced Polymer Systems, Inc.1987-08-06
SYPHILIS SEROLOGICAL REAGENTS (K871226)New Horizons Diagnostics Co.1987-05-28
OCEAN SCIENTIFIC VDRL TEST (K864731)Ocean Scientific, Inc.1987-03-10
SYPH-TRUST (K863368)I.A.F. Production, Inc.1986-12-12
TOLVIDINE RED UNHEATED SERUM SYPHILLIS CARD TEST (K852751)Preco, Inc.1985-08-20
RAPID PLASMA REAGIN CARD TEST (K842541)Clinical Sciences, Inc.1984-07-26
AUTOGROUPER 16C SYS AUTOMATED REAG (K834149)Technicon Instruments Corp.1984-03-09
TRUST RPR TITRATION CARD TEST #65145 (K832480)Emd Chemicals, Inc.1983-09-12
TRUST RPR CARD TEST #65144 (K832479)Emd Chemicals, Inc.1983-09-12
RAPID REAGIN CARD TEST (K822661)Oxoid U.S.A., Inc.1982-09-21
REAGIN ANTIGEN SUSPENSION (K822662)Oxoid U.S.A., Inc.1982-09-21
TREP CARD EIKEN (K820567)Syn-Kit, Inc.1982-04-14
VDRL CARBON ANTIGEN (K812894)Oxoid U.S.A., Inc.1981-11-06
DADE RPR CARD TEST (K811152)American Dade1981-05-15
RPR CARD TEST SYSTEM (K810658)Beckman Instruments, Inc.1981-03-31

Track GMQ automatically

Every clearance here is in the API, with alerts when new ones post.