# K020769: Single Analyte Urine Drugs of Abuse Calibrators and Controls

- Pathway: 510(k) (Traditional)
- Applicant: Lin-Zhi International, Inc.
- Decided: Apr 3, 2002 after 27 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.
5 later devices descend from it; 2 cite it directly.
0 of 7 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.

## Most influential descendants
- K120761: Lzi Opiate 2000 Homogeneous Enzyme Immunoassay, Lzi Opiate 2000 Calibrators, Lzi Opiate 2000 Controls (2012), 2 descendants of its own
- K141803: Immunalysis Tramadol Urine Enzyme Immunoassay (2015), 1 descendant of its own
- K113139: Lzi Cocaine Metabolite Homogeneous Enzyme Immunoassay,Calibrators,Controls (2011), 1 descendant of its own
- K203527: Immunalysis Tapentadol Urine HEIA (2022), 0 descendants of its own
- K191638: Pointe Scientific Cocaine Metabolite Enzyme Immunoassay (2020), 0 descendants of its own

## Indications for use
The Single Analyte Urine Drugs of Abuse (DAU) Calibrators are intended for in vitro diagnostic use for the calibration of their respective DAU enzyme immunoassays to detect phencyclidine, opiates, cocaine metabolite, or amphetamines in human urine. The Single Analyte Urine Drugs of Abuse (DAU) Controls are intended for in vitro diagnostic use for the validation of their respective DAU enzyme immunoassays to detect phencyclidine, opiates, cocaine metabolite, or amphetamines in human urine.

Source page: https://510kreport.com/device/K020769
Methodology: https://510kreport.com/methodology