Hemoglobin A2 Quantitation
FDA product code JPD · Class II (moderate risk) · 21 CFR 864.7400 · Hematology
13510(k) clearances
0PMA approvals
5recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K020489 | G7 Automated HPLC Analyzer, Beta-Thalassemia ModeJPD · Traditional | Tosoh Medics, Inc. | 05/14/2002SE |
| K991127 | Variant II B-ThalassemiaJPD · Special | Bio-Rad | 06/10/1999SE |
| K924122 | Variant Beta-Thalassemia Short ProgramJPD · Traditional | Bio-Rad | 03/11/1993SE |
| K924496 | Glycomat Green HBA2 Estimation Reagent KitJPD · Traditional | Drew Scientific , Ltd. | 11/16/1992SE |
| K923318 | Columnmate Beta-Thal HBA2 Control - NormalJPD · Traditional | Helena Laboratories | 08/25/1992SE |
| K923317 | Columnmate Beta Thal HBA2 Control-AbnormalJPD · Traditional | Helena Laboratories | 08/25/1992SE |
| K913384 | Columnmate(Tm) Beta-Thal Cat. No. 4515JPD · Traditional | Helena Laboratories | 12/17/1991SE |
| K896168 | Hemoglobin A2 Micro Column TestJPD · Traditional | Bio-Rad | 01/18/1990SE |
| K875102 | Deter. of Hemoglobin A2 Using the DiamatJPD · Traditional | Bio-Rad | 02/24/1988SE |
| K823870 | Beta Thalquik Column #5341JPD · Traditional | Helena Laboratories | 02/01/1983SE |
| K812077 | Helena Sickle-Thal Quik Column MethodJPD · Traditional | Helena Laboratories | 08/18/1981SE |
| K803108 | Helena HBA2 Quik Column MethodJPD · Traditional | Helena Laboratories | 01/09/1981SE |
| K801410 | Hemohlobin A2 Control-LyophilizedJPD · Traditional | Isolab, Inc. | 07/21/1980SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1537-2014 Class II | Variant II beta-thalassemia Short Program Model Numbers 270-2103 (250 tests) and…There is an issue with the buffers which impacts the quantification of the Hemoglobin F peak. Calibration… | Bio-Rad Laboratories, Inc. | 04/08/2014Terminated |
| Z-3030-2011 | Hemoglobin F & A2 Calibrator, 0.2 mL, 4 brown glass vials/box. Mfr. By: Tosoh…The value after reconstitution appeared to be lower than the assigned value on the label. The measured value… | Tosoh Bioscience Inc | 05/25/2011Terminated |
| Z-1075-2013 Class III | G7 HPLC. Used as an aid in the detection and presumptive identification of abnormal…The Beta-thalessemia Mode of the G7 Analyzer-Beta Thalassemia Mode is an automated High Performance Liquid… | Tosoh Bioscience Inc | 08/18/2010Terminated |
| Z-1589-2008 | VARIANT -thalassemia Short Program Hemoglobin Testing System, Model Number 270-0002 (500…Some product ROM cards have an incorrect program loaded and are unable to be updated. | Bio-Rad Laboratories Inc | 03/18/2008Terminated |
| Z-1588-2008 | VARIANT -thalassemia Short Program Hemoglobin Testing System, Model Number 270-0019 (250…Some product ROM cards have an incorrect program loaded and are unable to be updated. | Bio-Rad Laboratories Inc | 03/18/2008Terminated |