# K051058: Methadone Oral Fluid Homogeneous Enzyme Immunoassay, Calibrators and Controls

- Pathway: 510(k) (Traditional)
- Applicant: Lin-Zhi International, Inc.
- Decided: Mar 29, 2006 after 337 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 K002010 (2000). 1 ancestor in all.
6 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002010: STC Methadone Intercept Micro-Plate Eia, Model 11421, OraSure Technologies, Inc. (2000) Summary page 2.

## Most influential descendants
- K062242: Methamphetamine Oral Fluid Homogeneous Enzyme Immunoassay; Calibrators and Controls (2006), 3 descendants of its own
- K131652: Lzi Oral Fluid Methamphetamine Enzyme Immunoassay, Calibrators, Controls (2014), 2 descendants of its own
- K063024: Lzi Amphetamine-Specific Oral Fluid Homogeneous Enztme Immunoassay: Lzi Amphetamine Oral Fluid Calibrators and Controls (2006), 1 descendant of its own
- K203647: SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay (2021), 0 descendants of its own
- K142293: Rapidfret Oral Fluid Assay for Methamphetamine, Rapidfret Oral Fluid Methamphetamine Calibrators, Rapidfret Oral Fluid Methamphetamine Controls (2015), 0 descendants of its own

## Indications for use
The Methadone Enzyme Immunoassays for Drugs of Abuse in Oral Fluid is a homogeneous enzyme immunoassay system to detect methadone in human saliva with a cutoff of 30 ng/mL when testing oral fluid specimen collected with Salivette collector (manufactured by Sarstedt and diluted with I mL of buffer. The calibrators and controls of the analyte (Methadone) are prepared with oral fluid buffer so that it can be used to verify and validate the assay. The assay is intended for use in the qualitative determination for Methadone drugs. The assay is designed for professional use with a number of automated clinical chemistry analyzers. The Methadone Oral FluidEnzyme Immunoassay is a homogeneous enzyme immunoassay system provides only a preliminary analyticaltest result. A more specific alternativechemical method must be used to obtain a confirmed analyticalresult. Gas chromatography/mass spectrometry (GCIMS) is the preferredconfirmatory method. Clinical considerationandprofessionaljudgment should be applied to any drug-of-abuse test result, particularlywhen preliminarypositive results are used

Source page: https://510kreport.com/device/K051058
Methodology: https://510kreport.com/methodology