# K990928: Lyphocheck Urine Metals Control, Item NO.400, 405

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: Apr 16, 1999 after 28 days
- Product code: DIE (Heavy Metals 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 K891691 (1989). 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)
- K891691: Lyphochek Urine Metals Control, Levels I and II, Bio-Rad (1989) Summary page 1.

## Indications for use
Lyphochek Urine Metals Control is intended for use as an assayed quality control urine to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.

Source page: https://510kreport.com/device/K990928
Methodology: https://510kreport.com/methodology