JPD · Hemoglobin A2 Quantitation
Hematology · 21 CFR 864.7400 · Class 2
Overview
| Product Code | JPD |
|---|---|
| Device Name | Hemoglobin A2 Quantitation |
| Regulation | 21 CFR 864.7400 |
| Device Class | Class 2 |
| Review Panel | Hematology |
| 3rd-Party Reviewable | Yes |
Identification
A hemoglobin A2 assay is a device used to determine the hemoglobin A2 content of human blood. The measurement of hemoglobin A2 is used in the diagnosis of the thalassemias (hereditary hemolytic anemias characterized by decreased synthesis of one or more types of hemoglobin polypeptide chains).
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (13 of 13)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K020489 | G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODE | Tosoh Medics, Inc. | May 14, 2002 | SESE |
| K991127 | VARIANT II B-THALASSEMIA | Bio-Rad | Jun 10, 1999 | SESE |
| K924122 | VARIANT BETA-THALASSEMIA SHORT PROGRAM | Bio-Rad | Mar 11, 1993 | SESE |
| K924496 | GLYCOMAT GREEN HBA2 ESTIMATION REAGENT KIT | Drew Scientific , Ltd. | Nov 16, 1992 | SESE |
| K923318 | COLUMNMATE BETA-THAL HBA2 CONTROL - NORMAL | Helena Laboratories | Aug 25, 1992 | SESE |
| K923317 | COLUMNMATE BETA THAL HBA2 CONTROL-ABNORMAL | Helena Laboratories | Aug 25, 1992 | SESE |
| K913384 | COLUMNMATE(TM) BETA-THAL CAT. NO. 4515 | Helena Laboratories | Dec 17, 1991 | SESE |
| K896168 | HEMOGLOBIN A2 MICRO COLUMN TEST | Bio-Rad | Jan 18, 1990 | SESE |
| K875102 | DETER. OF HEMOGLOBIN A2 USING THE DIAMAT | Bio-Rad | Feb 24, 1988 | SESE |
| K823870 | BETA THALQUIK COLUMN #5341 | Helena Laboratories | Feb 1, 1983 | SESE |
| K812077 | HELENA SICKLE-THAL QUIK COLUMN METHOD | Helena Laboratories | Aug 18, 1981 | SESE |
| K803108 | HELENA HBA2 QUIK COLUMN METHOD | Helena Laboratories | Jan 9, 1981 | SESE |
| K801410 | HEMOHLOBIN A2 CONTROL-LYOPHILIZED | Isolab, Inc. | Jul 21, 1980 | SESE |
Top Applicants
- Helena Laboratories — 6 clearances
- Bio-Rad — 4 clearances
- Drew Scientific , Ltd. — 1 clearance
- Isolab, Inc. — 1 clearance
- Tosoh Medics, Inc. — 1 clearance
