Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Gold Standard Diagnostics — Predicate Candidate Screening

14 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

133 daysmedian FDA review time
308 days90th percentile
14clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K203295Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA TesGold Standard Diagnostics2021-03-221330
K203292Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISAGold Standard Diagnostics2021-03-221330
K203296Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA TesGold Standard Diagnostics2021-03-221330
K203289Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgGGold Standard Diagnostics2021-03-221330
K200023Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA TesGold Standard Diagnostics2020-04-06910
K200025Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA TesGold Standard Diagnostics2020-04-06910
K180264Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISAGold Standard Diagnostics2018-05-02920
K150358Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Gold Standard Diagnostics2015-11-122730
K131334HERPES SIMPLEX VIRUS TYPE 1 IGG ELISA TESTGold Standard Diagnostics2014-02-282950
K131330GOLD STANDARD DIAGNOSTICS ANTI-NUCLEAR ANTIBODY (ANA) SCREENGold Standard Diagnostics2014-01-282650
K113846BORRELIA BURGDORFERI IGM BLOT TESTGold Standard Diagnostics2012-06-011550
K113847BORRELIA BURGDORFERI IGG BLOT TESTGold Standard Diagnostics2012-04-111040
K110745HELICOBACTER PYLORI ELISA IGG TEST KITGold Standard Diagnostics2012-03-023510
K110899GOLD STANDARD DIAGNOSTICS H. PYLORI ELISA IGA TEST KITGold Standard Diagnostics2012-02-013080

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