# K101195: 6-Acetylmorphine Enzyme Immunoassay with 6-Acetylmorphine Calibrators and Controls

- Pathway: 510(k) (Traditional)
- Applicant: Lin-Zhi International, Inc.
- Decided: Jul 6, 2010 after 68 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: 1 generation back to K001178 (2000). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001178: Cedia Dau 6-Acetylmorphine Assay, Microgenics Corp. (2000) Summary page 2.

## Most influential descendants
- K141205: Lzi Oral Fluid 6-Acetylmorphine Enzyme Immunoassay, Lzi Oral Fluid 6-Acetylmorphine Calibrators (5 ML), Lzi Oral Fluid 6 (2015), 0 descendants of its own

## Indications for use
The 6-Acetylmorphine Enzyme Immunoassay is intended for the qualitative and semi-quantitative determination of 6-Acetylmorphine in human urine, at a cutoff value of 10 ng/mL. The assay is designed for professional use with a number of automated clinical chemistry analyzers. The 6-Acetylmorphine Drugs of Abuse (DAU) Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the 6-Acetylmorphine Enzyme Immunoassay. The 6-Acetylmorphine Drugs of Abuse (DAUI) Controls are for use as assayed quality control materials to monitor the precision of the 6-Acetylmorphine Enzyme Immunoassay. The assay provides only a preliminary analytical result. A more specijfic 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/K101195
Methodology: https://510kreport.com/methodology