# K141205: Lzi Oral Fluid 6-Acetylmorphine Enzyme Immunoassay, Lzi Oral Fluid 6-Acetylmorphine Calibrators (5 ML), Lzi Oral Fluid 6

- Pathway: 510(k) (Traditional)
- Applicant: Lin-Zhi International, Inc.
- Decided: Feb 13, 2015 after 280 days
- Product code: DJG (Enzyme Immunoassay, Opiates)
- Device class: 2
- Regulation: 21 CFR 862.3650
- 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 K001178 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101195: 6-Acetylmorphine Enzyme Immunoassay with 6-Acetylmorphine Calibrators and Controls, Lin-Zhi International, Inc. (2010) Summary page 5.

## Indications for use
The LZI Oral Fluid 6-Acetylmorphine Enzyme Immunoassay is intended for the qualitative and semi-quantitative determination of 6-Acetylmorphine in neat human oral fluid, collected into the LZI Oral Fluid Collector, at the cutoff value of 4 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 6-Acetylmorphine Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the LZI Oral Fluid 6-Acetylmorphine Enzyme Immunoassay at the cutoff value of 4 ng/mL. The LZI Oral Fluid 6-Acetylmorphine Controls are for use as assayed quality control materials to monitor the precision of the LZI Oral Fluid 6-Acetylmorphine Enzyme Immunoassay at the cutoff value of 4 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/K141205
Methodology: https://510kreport.com/methodology