# K192299: LZI Cotinine II Enzyme Immunoassay

- Pathway: 510(k) (Traditional)
- Applicant: Lin-Zhi International, Inc.
- Decided: Nov 21, 2019 after 90 days
- Product code: MKU (Enzyme Immunoassay, Nicotine And Nicotine Metabolites)
- Device class: 1
- Regulation: 21 CFR 862.3220
- 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 K963733 (1996). 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)
- K963733: Niccheck I, Dynagen, Inc. (1996) Summary page 5.

## Indications for use
The LZI Cotinine II Enzyme Immunoassay is intended for the qualitative and semi-quantitative determination of cotinine in human urine at the cutoff value of 200 ng/mL when calibrated against cotinine. The assay is intended as an aid in the detection of cotinine after use or exposure to tobacco products. The assay is designed for prescription use with a number of automated clinical chemistry analyzers. The semi-quantitative mode is for purposes of (1) enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as gas or liquid chromatography/mass spectrometry (GC/MS or LC/MS) or (2) permitting laboratories to establish quality control procedures. The assay provides only a preliminary analytical result. A more specific alternative chemical method (e.g., gas or liquid chromatography and mass spectrometry) must be used in order to obtain a confirmed analytical result. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive.

Source page: https://510kreport.com/device/K192299
Methodology: https://510kreport.com/methodology