# K051088: Multiple Analyte Urine Drugs of Abuse Calibrators and Controls

- Pathway: 510(k) (Traditional)
- Applicant: Lin-Zhi International, Inc.
- Decided: Jun 24, 2005 after 57 days
- Product code: DKB (Calibrators, Drug Mixture)
- Device class: 2
- Regulation: 21 CFR 862.3200
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K983159 (1998). 2 ancestors in all.
6 later devices descend from it; 6 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993755: Emit Calibrater/Control Level 0, Level 1, Level 2, Level 3, Level 4, Level 5, Syva Co. (1999) Summary page 1.
- K983159: Drugs of Abuse Urine Calibrators and Controls, Diagnostic Reagents, Inc. (1998) Summary page 1.

## Most influential descendants
- K153693: Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators (2016), 0 descendants of its own
- K151771: Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators (2016), 0 descendants of its own
- K152176: Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators (2015), 0 descendants of its own
- K143502: Immunalysis Opiates Urine Enzyme Immunoassay, Immunalysis Opiates Urine Calibrators 300, Immunalysis Opiates Urine Calibrators 2000, Immunalysis Multi-Drug Controls (2015), 0 descendants of its own
- K133710: Lzi Multiple Analyte Set a;B;C Drugs of Abuse Controls (2014), 0 descendants of its own

## Recalls of this device
- Oct 11, 2011 · Not classified · Z-0847-2012: Catalog # 0804 Multi-Analyte Urine DAU Intermediate Calibrators were incorrectly labeled and mistakenly filled with Catalog # 0805 DAU High Calibrators.
- Aug 23, 2011 · Not classified · Z-0868-2012: Multi Analyte Urine DAU Cutoff Calibrator Gives a decreased absorbance reading due to a loss of the BZO (oxazepam) analyte from the solution and may cause false positive readings.
- Aug 5, 2011 · Not classified · Z-0838-2012: Customer complaint investigation found that the Multi-Analyte Urine DAU Level 2 control was incorrectly labeled and actually contained Multi-Analyte DAU Low Level Calibrators.

## Indications for use
The Multiple Analyte (Benzoylecgonine, Methamphetamine, Methadone, Morphine, Oxazepam, Secobarbital, Phencyclidine, and Propoxyphene) Urine Drugs of Abuse Calibrators are intended for in vitro diagnostic use for the calibration of their respective enzyme immunoassays to detect d-methainphetamine, benzoylecgonine, opiate, benzodiazepines, barbiturates, methadone, phencyclidine or propoxyphene in human urine. The Multiple Analyte (Benzoylecgonine, Methamphetamine, Methadone, Morphine, Oxazepam, Secobarbital, Phencyclidine, and Propoxyphene) Urine Drugs of Abuse Controls are intended for in vitro diagnostic use for the validation of their respective enzyme immunoassays to detect d-methamphetamine, benzoylecgonine, opiate, benzodiazepines. barbiturates, methadone, phencyclidine or propoxyphene in human urine.

Source page: https://510kreport.com/device/K051088
Methodology: https://510kreport.com/methodology