# K924122: Variant Beta-Thalassemia Short Program

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: Mar 11, 1993 after 209 days
- Product code: JPD (Hemoglobin A2 Quantitation)
- Device class: 2
- Regulation: 21 CFR 864.7400
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K991127: Variant II B-Thalassemia (1999), 5 descendants of its own
- 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

## Recalls of this device
- 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
- Mar 18, 2008 · Not classified · Z-1589-2008: Some product ROM cards have an incorrect program loaded and are unable to be updated.
- Mar 18, 2008 · Not classified · Z-1588-2008: Some product ROM cards have an incorrect program loaded and are unable to be updated.

Source page: https://510kreport.com/device/K924122
Methodology: https://510kreport.com/methodology