# K062242: Methamphetamine Oral Fluid Homogeneous Enzyme Immunoassay; Calibrators and Controls

- Pathway: 510(k) (Traditional)
- Applicant: Lin-Zhi International, Inc.
- Decided: Sep 29, 2006 after 58 days
- Product code: LAF (Gas Chromatography, Methamphetamine)
- Device class: 2
- Regulation: 21 CFR 862.3610
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K924446 (1992). 7 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993208: STC Methamphetamine Intercept Micro-Plate Eia, Model 1104I, OraSure Technologies, Inc. (2000) Summary page 2.
- K050988: Opiate Oral Fluid Homogeneous Enzyme Immunoassay, Calibrators and Controls, Lin-Zhi International, Inc. (2006) Summary page 2.
- K051058: Methadone Oral Fluid Homogeneous Enzyme Immunoassay, Calibrators and Controls, Lin-Zhi International, Inc. (2006) Summary page 2.

## Cited in the summary but kept off the family tree
- K050904: Cpap Humidifier, Model HC238JHU, Fisher & Paykel Healthcare, Ltd. (2005). Our reading of the summary gave K050904, FDA’s number for Cpap Humidifier, Model HC238JHU (Fisher & Paykel Healthcare, Ltd.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Oral Fluid Cocaine Homogeneous Enzyme Immunoassay”. Kept off the family tree. Summary page 2.

## Most influential descendants
- K131652: Lzi Oral Fluid Methamphetamine Enzyme Immunoassay, Calibrators, Controls (2014), 2 descendants 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 Methamphetamine Enzyme Immunoassays for Drugs of Abuse in Oral Fluid is a homogeneous enzyme immunoassay system to detect methamphetamine in human saliva with a cutoff of 45 ng/mL when testing oral fluid specimen collected with Salivette collector (manufactured by Sarstedt) and diluted with I mL of buffer. The calibtators and controls of the analyte (d-methamphetamine) 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 methamphetamine. The assay is designed for professional use with a number of automated clinical chemistry analyzers. The Oral Fluid Methamphetamine Enzyme Immunoassay is a homogeneous enzyme immunoassay system provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method Clinical consideration and professional judgment should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used.

Source page: https://510kreport.com/device/K062242
Methodology: https://510kreport.com/methodology