Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
GKA — Predicate Candidate Screening
23 FDA 510(k) clearances under this product code; the 50 most recent screened below.
129 daysmedian FDA review time
338 days90th percentile
23clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K232027 | CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument | Sebia | 2024-04-04 | 272 | 0 |
| K222635 | Premier Resolution System | Trinity Biotech (Primus Corporation, Dba Trinity Biotech) | 2023-08-04 | 338 | 0 |
| K192931 | V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control | Helena Laboratories, Corp. | 2022-04-19 | 915 | 0 |
| K180762 | CAPI 3 HEMOGLOBIN(E) | Sebia | 2018-12-14 | 266 | 0 |
| K171664 | Hemoglobin Variants System on Newborn Hemoglobin System with | Bio-Rad Laboratories, Inc. | 2017-09-13 | 100 | 0 |
| K112550 | CAPILLARYS HEMOGLOBIN, CAPILLARYS FLEX PIERCING SYSTEM | Sebia | 2012-05-25 | 267 | 0 |
| K112491 | SEBIA CAPILLARYS HEMOGLOBIN(E) WITH CAPILLARYS 2 | Sebia | 2012-05-24 | 269 | 0 |
| K091283 | CAPILLARYS NEONAT HB (PN 2006) | Sebia | 2010-02-22 | 297 | 0 |
| K082227 | MINICAP HEMOGLOBIN(E) KIT, MODEL 2207, 2227 | Sebia | 2009-03-26 | 231 | 0 |
| K080911 | VARIANT NBS SICKLE CELL PROGRAM REAGENT KIT, VARIANT NBS NEW | Bio-Rad Laboratories Inc., Clinical Systems Divisi | 2008-05-02 | 30 | 0 |
| K052291 | CAPILLARY'S HEMOGLOBIN(E) (PN 2007) | Sebia | 2006-06-27 | 308 | 0 |
| K050709 | RESOLVE HEMOGLOBIN KIT, JB-2 STAINING SYSTEM, MODELS FR-9120 | Wallac OY | 2006-03-08 | 355 | 1 |
| K051072 | BIO-RAD VARIANT NBS SICKLE CELL PROGRAM | Bio-Rad Laboratories, Inc. | 2005-05-12 | 16 | 0 |
| K040146 | INTERLAB ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM | Interlab S.R.L. | 2004-05-04 | 103 | 0 |
| K955355 | VARIANT ALPHA-THALASSEMIA SHORT PROGRAM | Bio-Rad | 1996-04-26 | 157 | 0 |
| K955283 | PRIMUS VARIANT SYSTEM PVS99 | Primus Corp. | 1996-03-01 | 106 | 0 |
| K954048 | VARIANT HEMOGLOBINOPATHY PROGRAM | Bio-Rad | 1995-11-20 | 84 | 0 |
| K924813 | VARIANT SICKLE CELL SHORT PROGRAM | Bio-Rad | 1993-01-14 | 111 | 1 |
| K834595 | PARAGON ACID HEMOGLOBIN REAGENT KIT | Beckman Instruments, Inc. | 1984-05-07 | 129 | 0 |
| K840011 | RESOLVE-HB | Isolab, Inc. | 1984-02-04 | 31 | 2 |
| K822123 | ISOPROPANOL HEMOGLOBIN STABILITY TEST | Helena Laboratories | 1982-08-05 | 17 | 0 |
| K820573 | HELENA HEMOGLOBIN DETECT COLUMN SYS | Helena Laboratories | 1982-04-01 | 30 | 0 |
| K811894 | ORTHO SICKLE CELL CONTROLS | Ortho Diagnostic Systems, Inc. | 1981-07-27 | 26 | 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