# K023316: Single Analyte Urine Drugs of Abuse Calibrators and Controls

- Pathway: 510(k) (Traditional)
- Applicant: Lin-Zhi International, Inc.
- Decided: Dec 16, 2002 after 74 days
- Product code: DLJ (Calibrators, Drug Specific)
- Device class: 2
- Regulation: 21 CFR 862.3200
- 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 K983159 (1998). 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)
- K983159: Drugs of Abuse Urine Calibrators and Controls, Diagnostic Reagents, Inc. (1998) Summary page 1.

## Indications for use
The Methadone or Proposyphene Urine Drugs of Abuse Calibrators are intended for in vitro diagnostic use for the calibration of their respective enzyme immunoassays to detect methadone or propoxyphene in human urine. The Methadone or Propoxyphene Urine Drugs of Abuse Controls are intended for in vitro diagnostic use for the validation of their respective enzyme immunoassays to detect methadone or proposyphene in human urine.

Source page: https://510kreport.com/device/K023316
Methodology: https://510kreport.com/methodology