# K992395: Urine Drug Screening Control

- Pathway: 510(k) (Traditional)
- Applicant: Seracare Technology
- Decided: Aug 26, 1999 after 38 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: 2 generations back to K903430 (1990). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971691: Liquichek Urine Toxicology Control - Level S1, S2, S3, Bio-Rad (1997) Summary page 1.

## Indications for use
Urine Drug Screening Control is a liquid human urine based assayed quality control material intended to monitor the performance of screening, semi-quantitative and confirmatory drug-of-abuse testing procedures.

Source page: https://510kreport.com/device/K992395
Methodology: https://510kreport.com/methodology