# K023317: Methadone Enzyme Immunoassay

- Pathway: 510(k) (Traditional)
- Applicant: Lin-Zhi International, Inc.
- Decided: Dec 12, 2002 after 70 days
- Product code: DJR (Enzyme Immunoassay, Methadone)
- Device class: 2
- Regulation: 21 CFR 862.3620
- 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 K972526 (1997). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972526: Methadone Eia Assay, Diagnostic Reagents, Inc. (1997) Summary page 1.

## Most influential descendants
- K192433: LZI Methadone II Enzyme Immunoassay (2019), 0 descendants of its own
- K033885: BMBP Enzyme Immunoassay, Cat #0610, 0611 (500, 5000 Test Kit) (2004), 0 descendants of its own

## Indications for use
The Methadone Enzyme Immunoassay is a homogeneous enzyme immunoassay with a 300 ng/mL cutoff. The assay is intended for use in the qualitative and semi-quantitative analyses of methadone in human urine. The assay is designed for professional use with a number of automated clinical chemistry analyzers. The Methadone Enzyme Immunoassay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatogaphy/mass spectrometry (GUMS) is the preferred confirmatory method. Clinical consideration and professional judgement should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used.

Source page: https://510kreport.com/device/K023317
Methodology: https://510kreport.com/methodology