# K113139: Lzi Cocaine Metabolite Homogeneous Enzyme Immunoassay,Calibrators,Controls

- Pathway: 510(k) (Traditional)
- Applicant: Lin-Zhi International, Inc.
- Decided: Nov 22, 2011 after 29 days
- Product code: DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites)
- Device class: 2
- Regulation: 21 CFR 862.3250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K983159 (1998). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020763: Cocaine Metabolite Enzyme Immunoassay Models #0030 (500 Tests Kit), #0031 (5000 Tests Kit), Lin-Zhi International, Inc. (2002) Summary page 2.
- K020769: Single Analyte Urine Drugs of Abuse Calibrators and Controls, Lin-Zhi International, Inc. (2002) Summary page 2.

## Most influential descendants
- K191638: Pointe Scientific Cocaine Metabolite Enzyme Immunoassay (2020), 0 descendants of its own

## Indications for use
The Cocaine Metabolite Enzyme Immunoassay is intended for the qualitative and semniquantitative determination of benzoylecgonine in human urine, at the cutoff value of 150 ng/mL. The assay is designed for professional use with a number of automated clinical chemistry analyzers. The semi-quantitative mode is for purposes of (l) enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GCMS or (2) permitting laboratories to establish quality control procedures. The Cocaine Metabolite Drugs of Abuse (DAU) Calibrators are for use as calibrators in the qualitative and semi -quantitative calibration of the Cocaine Metabolite Enzyme Immunoassay at a cutoff value of 150 ng/mL. The Cocaine Metabolite Drugs of Abuse (DAU) Controls are for use as assayed quality control materials to monitor the precision of the Cocaine Metabolite Enzyme Immunoassay at a cutoff value of 150 ng/mL. The assay provides only a preliminary analyticalresult.A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas or liquid chromatography/mass spectrometry (GC'/MS or LCAIS) is the preferred confirmatory method). Clinical consideration and professionaljudgment should be exercised with any drug of abuse test result, particularly when the preliminary test result ispositive

Source page: https://510kreport.com/device/K113139
Methodology: https://510kreport.com/methodology