GKA · Abnormal Hemoglobin Quantitation
Hematology · 21 CFR 864.7415 · Class 2
Overview
| Product Code | GKA |
|---|---|
| Device Name | Abnormal Hemoglobin Quantitation |
| Regulation | 21 CFR 864.7415 |
| Device Class | Class 2 |
| Review Panel | Hematology |
| 3rd-Party Reviewable | Yes |
Identification
An abnormal hemoglobin assay is a device consisting of the reagents, apparatus, instrumentation, and controls necessary to isolate and identify abnormal genetically determined hemoglobin types.
Classification Rationale
Class II (special controls). A control intended for use with an abnormal hemoglobin assay is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
Special Controls
*Classification.* Class II (special controls). A control intended for use with an abnormal hemoglobin assay is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
Recent Cleared Devices (20 of 23)
Showing 20 most recent of 23 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K232027 | CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument | Sebia | Apr 4, 2024 | SESE |
| K222635 | Premier Resolution System | Trinity Biotech (Primus Corporation, Dba Trinity Biotech) | Aug 4, 2023 | SESE |
| K192931 | V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control | Helena Laboratories, Corp. | Apr 19, 2022 | SESE |
| K180762 | CAPI 3 HEMOGLOBIN(E) | Sebia | Dec 14, 2018 | SESE |
| K171664 | Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software | Bio-Rad Laboratories, Inc. | Sep 13, 2017 | SESE |
| K112550 | CAPILLARYS HEMOGLOBIN, CAPILLARYS FLEX PIERCING SYSTEM | Sebia | May 25, 2012 | SESE |
| K112491 | SEBIA CAPILLARYS HEMOGLOBIN(E) WITH CAPILLARYS 2 | Sebia | May 24, 2012 | SESE |
| K091283 | CAPILLARYS NEONAT HB (PN 2006) | Sebia | Feb 22, 2010 | SESE |
| K082227 | MINICAP HEMOGLOBIN(E) KIT, MODEL 2207, 2227 | Sebia | Mar 26, 2009 | SESE |
| K080911 | VARIANT NBS SICKLE CELL PROGRAM REAGENT KIT, VARIANT NBS NEWBORN SCREENING SYSTEM AND VARIANT NBS WORKSTATION WITH | Bio-Rad Laboratories Inc., Clinical Systems Divisi | May 2, 2008 | SESE |
| K052291 | CAPILLARY'S HEMOGLOBIN(E) (PN 2007) | Sebia | Jun 27, 2006 | SESE |
| K050709 | RESOLVE HEMOGLOBIN KIT, JB-2 STAINING SYSTEM, MODELS FR-9120, FR-9400, FR-9360, FR-9367 | Wallac OY | Mar 8, 2006 | SESE |
| K051072 | BIO-RAD VARIANT NBS SICKLE CELL PROGRAM | Bio-Rad Laboratories, Inc. | May 12, 2005 | SESE |
| K040146 | INTERLAB ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM | Interlab S.R.L. | May 4, 2004 | SESE |
| K955355 | VARIANT ALPHA-THALASSEMIA SHORT PROGRAM | Bio-Rad | Apr 26, 1996 | SESE |
| K955283 | PRIMUS VARIANT SYSTEM PVS99 | Primus Corp. | Mar 1, 1996 | SESE |
| K954048 | VARIANT HEMOGLOBINOPATHY PROGRAM | Bio-Rad | Nov 20, 1995 | SESE |
| K924813 | VARIANT SICKLE CELL SHORT PROGRAM | Bio-Rad | Jan 14, 1993 | SESE |
| K834595 | PARAGON ACID HEMOGLOBIN REAGENT KIT | Beckman Instruments, Inc. | May 7, 1984 | SESE |
| K840011 | RESOLVE-HB | Isolab, Inc. | Feb 4, 1984 | SESE |
Top Applicants
- Sebia — 7 clearances
- Bio-Rad — 3 clearances
- Helena Laboratories — 2 clearances
- Bio-Rad Laboratories, Inc. — 2 clearances
- Wallac OY — 1 clearance
