# K032862: Interlab Alkaline Hemoglobin Electrophoresis Test System

- Pathway: 510(k) (Traditional)
- Applicant: Interlab S.R.L.
- Decided: Feb 3, 2004 after 144 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. The FDA summary names its predicate without a number.
- (no number) commercially available agarose gel test system: named in the summary without a submission number

## Indications for use
The Interlab Alkaline Hemoglobin Electrophoresis test system is intended for the separation of normal hemoglobins(Al, A2 and F) as well as certain abnormal or variant hemoglobins (S or D and C or E) using cellulose acetate supported on Mylar®. The test is a screening method for in vitro diagnostic use on the Microtech 672 PC and the Microtech 648 ISO fully automated analyzers. To distinguish hemoglobins S from D or C from E an alternate confirmatory test such as acid hemoglobin electrophoresis is necessary.

Source page: https://510kreport.com/device/K032862
Methodology: https://510kreport.com/methodology