# K040273: Lyphochek Assayed Chemistry Control

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad Laboratories, Inc.
- Decided: Mar 4, 2004 after 28 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K874280 (1988). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K874280: Lyphochek Assayed Chemistry Control (Human), I/II, Bio-Rad (1988) Summary page 1.

## Most influential descendants
- K111996: Elitech Clinical Sysems Ise Control 1 and 2 (2011), 0 descendants of its own

## Recalls of this device
- Dec 4, 2009 · Not classified · Z-1233-2010: Vital Diagnostics observed a bias in the Quality Control Consensus Program between published values for ALP on the ATAC 8000 and reported customer means. The ranges were adjusted to reflect the analyz
- Dec 4, 2009 · Not classified · Z-1234-2010: Vital Diagnostics observed a bias in the Quality Control Consensus Program between published values for ALP on the ATAC 8000 and reported customer means. The ranges were adjusted to reflect the analyz

## Indications for use
For use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.

Source page: https://510kreport.com/device/K040273
Methodology: https://510kreport.com/methodology