# K982024: Opiates 2000 Liquid Opiates Drugs of Abuse Control Levels 2 and 3

- Pathway: 510(k) (Traditional)
- Applicant: Medical Analysis Systems, Inc.
- Decided: Jun 29, 1998 after 20 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Opiates 2000 Drugs of Abuse Controls are intended for use as a consistent test sample of known concentration for monitoring assay conditions in quantitative and qualitative analyses of patient urine specimens. Include the controls with patient urine specimens when assaying for opiates.

Source page: https://510kreport.com/device/K982024
Methodology: https://510kreport.com/methodology