# K143379: Liquichek Maternal Serum II Control

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad Laboratories
- Decided: Mar 13, 2015 after 108 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)
- K984594: Lyphochek Maternal Serum Control, Model 220, Bio-Rad (1999) Summary page 4.

## Indications for use
Liquichek Maternal Serum II Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. Analytes are: AFP hCG Unconjugated Estriol Inhibin A

Source page: https://510kreport.com/device/K143379
Methodology: https://510kreport.com/methodology