GMQ · Antigens, Nontreponemal, All
Microbiology · 21 CFR 866.3820 · Class 2
Overview
| Product Code | GMQ |
|---|---|
| Device Name | Antigens, Nontreponemal, All |
| Regulation | 21 CFR 866.3820 |
| Device Class | Class 2 |
| Review Panel | Microbiology |
| 3rd-Party Reviewable | Yes |
Identification
Treponema pallidum nontreponemal test reagents are devices that consist of antigens derived from nontreponemal sources (sources not directly associated with treponemal organisms) and control sera (standardized sera with which test results are compared) used in serological tests to identify reagin, an antibody-like agent, which is produced from the reaction of treponema microorganisms with body tissues. The identification aids in the diagnosis of syphilis caused by microorganisms belonging to the genus Treponema and provides epidemiological information on syphilis.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 32)
Showing 20 most recent of 32 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K250249 | Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System | Gold Standard Diagnostics, LLC | Oct 10, 2025 | SESE |
| K201438 | ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer | Arlington Scientific, Inc. (Asi) | Oct 21, 2020 | SESE |
| K182391 | ASI Automated ASI RPR Test for Syphilis on the ASI Evolution | Arlington Scientific, Inc. (Asi) | Nov 30, 2018 | SESE |
| K173376 | ASI Evolution | Arlington Scientific, Inc. (Asi) | Jun 14, 2018 | SESE |
| K150358 | Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test System | Gold Standard Diagnostics | Nov 12, 2015 | SESE |
| K000687 | THE DAYA SYPHILIS TEST/THE TRUST ANTIGEN TEST | Beacon Biologicals, Inc. | Jun 12, 2000 | SESE |
| K993633 | SYNTHETIC VDRL ANTIGEN | Centers for Disease Control and Prevention | Feb 23, 2000 | SESE |
| K992124 | AVANTI POLAR LIPIDS VDRL ANTIGEN SLIDE TEST KIT WITH 10 X 0.5 ML AMPULES, AVANTI POLAR LIPIDS BULK BDRL ANTIGEN, AVANTI | Avanti Polar Lipids, Inc. | Sep 20, 1999 | SESE |
| K954994 | TRUST | Guardian Scientific, Corp. | Oct 18, 1996 | SESE |
| K955136 | RPR CARD TEST KIT | Remel, L.P. | Jul 29, 1996 | SESE |
| K952802 | VISUWELL REAGIN II | Biomira Diagnostics, Inc. | May 23, 1996 | SESE |
| K910541 | BIOKIT RPR | Biokit USA, Inc. | Oct 18, 1991 | SESE |
| K904496 | CROMATEST SYPHILIS DIAGNOSTIC | Biotrax, Inc. | Jul 24, 1991 | SESE |
| K900338 | VISUWELL(R) REAGIN TEST (MODIFICATION) | Adi Diagnostics, Inc. | Apr 10, 1990 | SESE |
| K880144 | STANBIO SYPHILIS RPR TEST, NO. 1170 | Stanbio Laboratory | May 23, 1988 | SESE |
| K880477 | RPR TEST FOR SYPHILIS IN SERUM OR PLASMA | Ampcor, Inc. | Mar 30, 1988 | SESE |
| K880165 | TRUST RPR TEST FOR SYPHILIS IN SERUM OR PLASMA | Ampcor, Inc. | Mar 30, 1988 | SESE |
| K871252 | RSR CARD TEST | Advanced Polymer Systems, Inc. | Aug 6, 1987 | SESE |
| K871226 | SYPHILIS SEROLOGICAL REAGENTS | New Horizons Diagnostics Co. | May 28, 1987 | SESE |
| K864731 | OCEAN SCIENTIFIC VDRL TEST | Ocean Scientific, Inc. | Mar 10, 1987 | SESE |
Top Applicants
- Arlington Scientific, Inc. (Asi) — 3 clearances
- Oxoid U.S.A., Inc. — 3 clearances
- Ampcor, Inc. — 2 clearances
- Emd Chemicals, Inc. — 2 clearances
- Adi Diagnostics, Inc. — 1 clearance
