# K040146: Interlab Acid Hemoglobin Electrophoresis Test System

- Pathway: 510(k) (Traditional)
- Applicant: Interlab S.R.L.
- Decided: May 4, 2004 after 103 days
- Product code: GKA (Abnormal Hemoglobin Quantitation)
- Device class: 2
- Regulation: 21 CFR 864.7415
- 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. The FDA summary names no predicate by number.

## Indications for use
The Interlab Acid Hemoglobin Electrophoresis is a qualitative test system clinically intended for the electrophoretic separation of hemoglobins to confirm the identity of relevant hemoglobins such as A, F, S and C. It is to be used in conjunction with the Interlab Alkaline Hemoglobin Electrophoresis test kit. The Acid Hemoglobin test kit employs cellulose acetate supported on Mylar® as the medium and is for in vitro diagnostic use. The test can be automated on the Microtech 672 PC and Microtech 648 ISO instruments.

Source page: https://510kreport.com/device/K040146
Methodology: https://510kreport.com/methodology