Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GMQ — Predicate Candidate Screening
32 FDA 510(k) clearances under this product code; the 50 most recent screened below.
96 daysmedian FDA review time
273 days90th percentile
32clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250249 | Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin | Gold Standard Diagnostics, LLC | 2025-10-10 | 256 | 0 |
| K201438 | ASI Automated RPR (rapid plasma reagin) Test for Syphilis, f | Arlington Scientific, Inc. (Asi) | 2020-10-21 | 142 | 0 |
| K182391 | ASI Automated ASI RPR Test for Syphilis on the ASI Evolution | Arlington Scientific, Inc. (Asi) | 2018-11-30 | 87 | 0 |
| K173376 | ASI Evolution | Arlington Scientific, Inc. (Asi) | 2018-06-14 | 227 | 0 |
| K150358 | Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) | Gold Standard Diagnostics | 2015-11-12 | 273 | 0 |
| K000687 | THE DAYA SYPHILIS TEST/THE TRUST ANTIGEN TEST | Beacon Biologicals, Inc. | 2000-06-12 | 104 | 0 |
| K993633 | SYNTHETIC VDRL ANTIGEN | Centers for Disease Control and Prevention | 2000-02-23 | 119 | 0 |
| K992124 | AVANTI POLAR LIPIDS VDRL ANTIGEN SLIDE TEST KIT WITH 10 X 0. | Avanti Polar Lipids, Inc. | 1999-09-20 | 89 | 0 |
| K954994 | TRUST | Guardian Scientific, Corp. | 1996-10-18 | 353 | 0 |
| K955136 | RPR CARD TEST KIT | Remel, L.P. | 1996-07-29 | 259 | 0 |
| K952802 | VISUWELL REAGIN II | Biomira Diagnostics, Inc. | 1996-05-23 | 339 | 0 |
| K910541 | BIOKIT RPR | Biokit USA, Inc. | 1991-10-18 | 256 | 0 |
| K904496 | CROMATEST SYPHILIS DIAGNOSTIC | Biotrax, Inc. | 1991-07-24 | 295 | 0 |
| K900338 | VISUWELL(R) REAGIN TEST (MODIFICATION) | Adi Diagnostics, Inc. | 1990-04-10 | 77 | 0 |
| K880144 | STANBIO SYPHILIS RPR TEST, NO. 1170 | Stanbio Laboratory | 1988-05-23 | 131 | 0 |
| K880165 | TRUST RPR TEST FOR SYPHILIS IN SERUM OR PLASMA | Ampcor, Inc. | 1988-03-30 | 77 | 0 |
| K880477 | RPR TEST FOR SYPHILIS IN SERUM OR PLASMA | Ampcor, Inc. | 1988-03-30 | 55 | 0 |
| K871252 | RSR CARD TEST | Advanced Polymer Systems, Inc. | 1987-08-06 | 129 | 0 |
| K871226 | SYPHILIS SEROLOGICAL REAGENTS | New Horizons Diagnostics Co. | 1987-05-28 | 62 | 0 |
| K864731 | OCEAN SCIENTIFIC VDRL TEST | Ocean Scientific, Inc. | 1987-03-10 | 96 | 0 |
| K863368 | SYPH-TRUST | I.A.F. Production, Inc. | 1986-12-12 | 100 | 0 |
| K852751 | TOLVIDINE RED UNHEATED SERUM SYPHILLIS CARD TEST | Preco, Inc. | 1985-08-20 | 53 | 0 |
| K842541 | RAPID PLASMA REAGIN CARD TEST | Clinical Sciences, Inc. | 1984-07-26 | 24 | 0 |
| K834149 | AUTOGROUPER 16C SYS AUTOMATED REAG | Technicon Instruments Corp. | 1984-03-09 | 99 | 0 |
| K832480 | TRUST RPR TITRATION CARD TEST #65145 | Emd Chemicals, Inc. | 1983-09-12 | 48 | 0 |
| K832479 | TRUST RPR CARD TEST #65144 | Emd Chemicals, Inc. | 1983-09-12 | 48 | 0 |
| K822661 | RAPID REAGIN CARD TEST | Oxoid U.S.A., Inc. | 1982-09-21 | 18 | 0 |
| K822662 | REAGIN ANTIGEN SUSPENSION | Oxoid U.S.A., Inc. | 1982-09-21 | 18 | 0 |
| K820567 | TREP CARD EIKEN | Syn-Kit, Inc. | 1982-04-14 | 43 | 0 |
| K812894 | VDRL CARBON ANTIGEN | Oxoid U.S.A., Inc. | 1981-11-06 | 22 | 0 |
| K811152 | DADE RPR CARD TEST | American Dade | 1981-05-15 | 18 | 0 |
| K810658 | RPR CARD TEST SYSTEM | Beckman Instruments, Inc. | 1981-03-31 | 20 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda