# K983159: Drugs of Abuse Urine Calibrators and Controls

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Reagents, Inc.
- Decided: Nov 5, 1998 after 57 days
- Product code: DKB (Calibrators, Drug Mixture)
- 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
No predicates in its family tree.
23 later devices descend from it; 4 cite it directly.
0 of 24 devices 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.

## Most influential descendants
- K012109: Dri Ecstasy Urine Calibrators (2001), 8 descendants of its own
- K051088: Multiple Analyte Urine Drugs of Abuse Calibrators and Controls (2005), 6 descendants of its own
- K043028: Emit II Plus Ecstasy Assay (2005), 6 descendants of its own
- K020769: Single Analyte Urine Drugs of Abuse Calibrators and Controls (2002), 5 descendants of its own
- K120761: Lzi Opiate 2000 Homogeneous Enzyme Immunoassay, Lzi Opiate 2000 Calibrators, Lzi Opiate 2000 Controls (2012), 2 descendants of its own

## Indications for use
The Multi-Drug Urine Calibrators and Controls are intended to be used for calibration and validation of DRI’s drugs of abuse enzyme immunoassay to detect amphetamines, barbiturates, benzodiazepines, cocaine metabolites, methadone, methaqualone, opiates, phencyclidine and propoxyphene in human urine.

Source page: https://510kreport.com/device/K983159
Methodology: https://510kreport.com/methodology