# K131653: Lzi Oral Fluid Amphetamine Enzyme Immunoassay, Calibrators, Controls

- Pathway: 510(k) (Traditional)
- Applicant: Lin-Zhi International, Inc.
- Decided: Feb 4, 2014 after 244 days
- Product code: DKZ (Enzyme Immunoassay, Amphetamine)
- Device class: 2
- Regulation: 21 CFR 862.3100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K924446 (1992). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063024: Lzi Amphetamine-Specific Oral Fluid Homogeneous Enztme Immunoassay: Lzi Amphetamine Oral Fluid Calibrators and Controls, Lin-Zhi International, Inc. (2006) Summary page 2.

## Indications for use
The LZI Oral Fluid Amphetamine Enzyme Immunoassay is intended for the qualitative and semi-quantitative determination of d-amphetamine in neat human oral fluid, collected into the LZI Oral Fluid Collector, at the cutoff value of 50 ng/mL. 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 GCMS and LCMS or (2) permitting laboratories to establish quality control procedures. The LZI Oral Fluid Amphetamine Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the LZI Oral Fluid Amphetamine Enzyme Immunoassay at the cutoff value of 50 ng/mL. The LZI Oral Fluid Amphetamine Controls are for use as assayed quality control materials to monitor the precision of the LZI Oral Fluid Amphetamine Enzyme immunoassay at the cutoff value of 50 ng/mL. The assay provides only a preliminary analytical result. 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 LC/MS) is the preferred confirmatory method. 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/K131653
Methodology: https://510kreport.com/methodology