# K991127: Variant II B-Thalassemia

- Pathway: 510(k) (Special)
- Applicant: Bio-Rad
- Decided: Jun 10, 1999 after 69 days
- Product code: JPD (Hemoglobin A2 Quantitation)
- Device class: 2
- Regulation: 21 CFR 864.7400
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K924122 (1993). 1 ancestor in all.
5 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K924122: Variant Beta-Thalassemia Short Program, Bio-Rad (1993) Summary page 1.

## Most influential descendants
- K063643: Modification to Variant II: Hemoglobin A1C Program, Beta-Thalassemia Short Program and Total GHB Program (2006), 1 descendant of its own
- K041444: Bio-Rad D-10 Dual Program (2004), 1 descendant of its own
- K222635: Premier Resolution System (2023), 0 descendants of its own
- K130860: Variant II Hemoglobin A1C Program (New), Variant II Hemoglobin Testing System with CDM Software, CDM Software (2013), 0 descendants of its own
- K060001: D-10 Hemoglobin A1C Program; D-10 Dual Program (2006), 0 descendants of its own

## Recalls of this device
- Apr 8, 2014 · Class II · Z-1537-2014: There is an issue with the buffers which impacts the quantification of the Hemoglobin F peak. Calibration and Quality control are likely to fail if the affected lots are used.
- Sep 12, 2011 · Not classified · Z-0023-2012: A previous recall related to reports of calibration failure and late retention times using Elution Buffer led to an examination of other buffers manufactured during the same time period and a decision
- Sep 12, 2011 · Not classified · Z-0025-2012: A previous recall related to reports of calibration failure and late retention times using Elution Buffer led to an examination of other buffers manufactured during the same time period and a decision
- Sep 12, 2011 · Not classified · Z-0024-2012: A previous recall related to reports of calibration failure and late retention times using Elution Buffer led to an examination of other buffers manufactured during the same time period and a decision

## Indications for use
The VARIANT™ II β-thalassemia Program is intended for the separation and area percent determinations of hemoglobins A2 and F and as an aid in the identification of abnormal hemoglobins in whole blood using ion-exchange high performance liquid chromatography (HPLC). The VARIANT™ II β-thalassemia Program is intended for use only with the Bio-Rad VARIANT™ II Hemoglobin Testing System For in vitro diagnostic use only.

Source page: https://510kreport.com/device/K991127
Methodology: https://510kreport.com/methodology