# K041561: Liquichek Whole Blood Volatiles Control

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: Jul 6, 2004 after 26 days
- Product code: DIF (Drug Mixture Control Materials)
- Device class: 1
- Regulation: 21 CFR 862.3280
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K821975 (1982). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K821975: Ortho*-BI-Level Assayed Whole Blood Tox, Ortho Diagnostic Systems, Inc. (1982) Summary page 1.

## Indications for use
Liquichek Whole Blood Volatiles Control is intended for use as a quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.

Source page: https://510kreport.com/device/K041561
Methodology: https://510kreport.com/methodology