# K041871: Interlab Microcal Serum Controls

- Pathway: 510(k) (Traditional)
- Applicant: Trouble Shooter Consuling, Inc.
- Decided: Aug 16, 2004 after 38 days
- Product code: JJX (Single (Specified) Analyte Controls (Assayed And Unassayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- 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 Microcal Normal and Abnormal Controls are lyophilized human sera intended for use as assayed quality control sera to monitor the precision of cellulose acetate based protein electrophoresis testing methods.

Source page: https://510kreport.com/device/K041871
Methodology: https://510kreport.com/methodology