Abnormal Hemoglobin Quantitation
FDA product code GKA · Class II (moderate risk) · 21 CFR 864.7415 · Hematology
23510(k) clearances
0PMA approvals
9recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K232027 | CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS InstrumentGKA · Traditional | Sebia | 04/04/2024SE |
| K222635 | Premier Resolution SystemGKA · Traditional | Trinity Biotech (Primus Corporation, Dba Trinity… | 08/04/2023SE |
| K192931 | V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo ControlGKA · Traditional | Helena Laboratories, Corp. | 04/19/2022SE |
| K180762 | Capi 3 Hemoglobin(E)GKA · Traditional | Sebia | 12/14/2018SE |
| K171664 | Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview SoftwareGKA · Special | Bio-Rad Laboratories, Inc. | 09/13/2017SE |
| K112550 | Capillarys Hemoglobin, Capillarys Flex Piercing SystemGKA · Traditional | Sebia | 05/25/2012SE |
| K112491 | Sebia Capillarys Hemoglobin(E) with Capillarys 2GKA · Traditional | Sebia | 05/24/2012SE |
| K091283 | Capillarys Neonat HB (PN 2006)GKA · Traditional | Sebia | 02/22/2010SE |
| K082227 | Minicap Hemoglobin(E) Kit, Model 2207, 2227GKA · Traditional | Sebia | 03/26/2009SE |
| K080911 | Variant NBS Sickle Cell Program Reagent Kit, Variant NBS Newborn Screening System and…GKA · Special | Bio-Rad Laboratories Inc., Clinical Systems Divisi | 05/02/2008SE |
| K052291 | Capillary's Hemoglobin(E) (PN 2007)GKA · Traditional | Sebia | 06/27/2006SE |
| K050709 | Resolve Hemoglobin Kit, JB-2 Staining System, Models FR-9120, FR-9400, FR-9360, FR-9367GKA · Traditional | Wallac OY | 03/08/2006SE |
| K051072 | Bio-Rad Variant NBS Sickle Cell ProgramGKA · Traditional | Bio-Rad Laboratories, Inc. | 05/12/2005SE |
| K040146 | Interlab Acid Hemoglobin Electrophoresis Test SystemGKA · Traditional | Interlab S.R.L. | 05/04/2004SE |
| K955355 | Variant Alpha-Thalassemia Short ProgramGKA · Traditional | Bio-Rad | 04/26/1996SE |
| K955283 | Primus Variant System PVS99GKA · Traditional | Primus Corp. | 03/01/1996SE |
| K954048 | Variant Hemoglobinopathy ProgramGKA · Traditional | Bio-Rad | 11/20/1995SE |
| K924813 | Variant Sickle Cell Short ProgramGKA · Traditional | Bio-Rad | 01/14/1993SE |
| K834595 | Paragon Acid Hemoglobin Reagent KitGKA · Traditional | Beckman Instruments, Inc. | 05/07/1984SE |
| K840011 | Resolve-HbGKA · Traditional | Isolab, Inc. | 02/04/1984SE |
| K822123 | Isopropanol Hemoglobin Stability TestGKA · Traditional | Helena Laboratories | 08/05/1982SE |
| K820573 | Helena Hemoglobin Detect Column SysGKA · Traditional | Helena Laboratories | 04/01/1982SE |
| K811894 | Ortho Sickle Cell ControlsGKA · Traditional | Ortho Diagnostic Systems, Inc. | 07/27/1981SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1208-2022 Class II | Resin UPDATE CD-ROM, REF: 250-3020 inside VARIANTnbs Sickle Cell Program Reorder Pack…The problem is with the Bio-Rad VARIANT nbs Sickle Cell Program Resin Update CD-ROM software; Model Number:… | Bio-Rad Laboratories, Inc. | 04/07/2022Open, Classified |
| Z-0321-2021 Class II | Ultra2 Resolution Variants System for Abnormal Hemoglobin QuantitationThe product did not receive pre-market approval or clearance. | Primus Corporation | 10/09/2020Terminated |
| Z-0624-2019 Class II | Genesys Diluent Reagent, REF 01-03-0019 intended to be used with automated high…lack of 510K | Clark Laboratories, Inc. (dba,Trinity… | 11/01/2018Terminated |
| Z-0623-2019 Class II | Genesys 2 Reagent, REF 01-03-0022 intended to be used with automated high performance…lack of 510K | Clark Laboratories, Inc. (dba,Trinity… | 11/01/2018Terminated |
| Z-0622-2019 Class II | Genesys 1 Reagent, REF 01-03-0020 intended to be used with automated high performance…lack of 510K | Clark Laboratories, Inc. (dba,Trinity… | 11/01/2018Terminated |
| Z-0621-2019 Class II | Genesys Analytical Column, REF 01-05-0017 intended to be used with automated high…lack of 510K | Clark Laboratories, Inc. (dba,Trinity… | 11/01/2018Terminated |
| Z-0620-2019 Class II | ultra2 Genesys Variants Analyzer, REF 03-01-0045 intended to be used with automated high…lack of 510K | Clark Laboratories, Inc. (dba,Trinity… | 11/01/2018Terminated |
| Z-1846-2011 | The VARIANT Sickle Cell Short Program ROM Card; Distributed by and Manufactured by:…The presence of parameters for Version 40400-S on the labeled VARIANT Sickle Cell Short ROM Card instead of… | Bio-Rad Laboratories Inc | 04/22/2010Terminated |
| Z-1984-2011 | VARIANT nbs Sickle Program Resin Update CD-ROM; Model Number:250-3020, included in…The affected resin Update CD-ROMs cause all user-defined settings in the Setup/Test/Data Setup sub screen… | Bio-Rad Laboratories Inc | 04/14/2010Terminated |