# K133960: Lypochek Specialty Immunoassay Control

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad Laboratories
- Decided: Jan 22, 2014 after 29 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- 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
Longest line of descent: 3 generations back to K891475 (1989). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043108: Liquichek Specialty Immunoassay Control, Bio-Rad Laboratories, Inc. (2004)

## Indications for use
Lyphochek Specialty Immunoassay Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in this package insert.

Source page: https://510kreport.com/device/K133960
Methodology: https://510kreport.com/methodology