# K992199: Acid Hemoglobin Kit

- Pathway: 510(k) (Traditional)
- Applicant: Helena Laboratories
- Decided: Sep 21, 1999 after 83 days
- Product code: JBD (System, Analysis, Electrophoretic Hemoglobin)
- Device class: 2
- Regulation: 21 CFR 864.7440
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Acid Hemoglobin system is intended as a qualitative screening method for the presence of abnormal hemoglobins such as HbS, HbC or HbF using agar electrophoresis. The system will provide two kits for use on the REP, REP 3 and the SPIFE electrophoresis analyzers.

Source page: https://510kreport.com/device/K992199
Methodology: https://510kreport.com/methodology