# K053571: Microgel Alkaline Hemoglobin Electrophoresis Test System, Microgel Acid Hemoglobin Electrophoresis Test System

- Pathway: 510(k) (Traditional)
- Applicant: Interlab S.R.L.
- Decided: Jun 30, 2006 after 190 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 Microgel Alkaline Hemoglobin Electrophoresis test kit is intended for qualitative and semi-quantitative determination of normal hemoglobins (A1, A2 and F) as well as certain abnormal or variant hemoglobins (S or D and C or E) using agarose gel. To distinguish hemoglobins S from D or C from E an alternate confirmatory test such as acid hemoglobin electrophoresis is necessary. The electrophoretic test is performed at alkaline pH and provides a valuable screening method for hemoglobin patterns. Densitometry of the pattern allows the relative quantification of hemoglobin bands. The kit SRE604K has been designed for use with the fully automated Microgel instrument. The Microgel Acid Hemoglobin Electrophoresis kit is a qualitative test for the identification of both normal and abnormal or variant hemoglobins, and to confirm the identity of clinically relevant hemoglobins such as A, F, S and C. The Acid Hemoglobin test kit employs agarose gel at acidic pH and is for in vitro diagnostic use. The kit has been designed for use with the fully automated Microgel instrument.

Source page: https://510kreport.com/device/K053571
Methodology: https://510kreport.com/methodology