Atlas FDA

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

Genetic Testing Institute — Predicate Candidate Screening

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

107 daysmedian FDA review time
170 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K082205FACTOR VIII ANTIBODY SCREENGenetic Testing Institute2008-11-201070
K071781PF4 IGGGenetic Testing Institute2007-12-191700
K053559PF4 ENHANCED SOLID PHASE ELISAGenetic Testing Institute2006-01-20302
K993553GTI-FVIII INHIBITOR ASSAYGenetic Testing Institute2000-02-011040
K983379GTI-PF4 ELISAGenetic Testing Institute1999-03-091650
K841114ALLO-TYPE HUMAN IMMUNOGLOBULIN-Genetic Testing Institute1984-06-14910

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