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510(k) K250249

Device
Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System
Applicant
Gold Standard Diagnostics, LLC
510(k) number
K250249
Product code
GMQ
Decision
Substantially Equivalent (SESE)
Decision date
2025-10-10
Date received
2025-01-27
Regulation
866.3820
Classification name
Antigens, Nontreponemal, All
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Douglas McGarvey
Address
2795 2nd St. Suite 300 Davis CA US 95618 95618

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code GMQ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K201438ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis AnalyzerArlington Scientific, Inc. (Asi)2020-10-21
K182391ASI Automated ASI RPR Test for Syphilis on the ASI EvolutionArlington Scientific, Inc. (Asi)2018-11-30
K173376ASI EvolutionArlington Scientific, Inc. (Asi)2018-06-14
K150358Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test SystemGold Standard Diagnostics2015-11-12
K000687THE DAYA SYPHILIS TEST/THE TRUST ANTIGEN TESTBeacon Biologicals, Inc.2000-06-12
K993633SYNTHETIC VDRL ANTIGENCenters for Disease Control and Prevention2000-02-23
K992124AVANTI POLAR LIPIDS VDRL ANTIGEN SLIDE TEST KIT WITH 10 X 0.5 ML AMPULES, AVANTI POLAR LIPIDS BULK BDRL ANTIGEN, AVANTIAvanti Polar Lipids, Inc.1999-09-20
K954994TRUSTGuardian Scientific, Corp.1996-10-18
K955136RPR CARD TEST KITRemel, L.P.1996-07-29
K952802VISUWELL REAGIN IIBiomira Diagnostics, Inc.1996-05-23
K910541BIOKIT RPRBiokit USA, Inc.1991-10-18
K904496CROMATEST SYPHILIS DIAGNOSTICBiotrax, Inc.1991-07-24
K900338VISUWELL(R) REAGIN TEST (MODIFICATION)Adi Diagnostics, Inc.1990-04-10
K880144STANBIO SYPHILIS RPR TEST, NO. 1170Stanbio Laboratory1988-05-23
K880165TRUST RPR TEST FOR SYPHILIS IN SERUM OR PLASMAAmpcor, Inc.1988-03-30