# K050988: Opiate Oral Fluid Homogeneous Enzyme Immunoassay, Calibrators and Controls

- Pathway: 510(k) (Traditional)
- Applicant: Lin-Zhi International, Inc.
- Decided: Apr 6, 2006 after 352 days
- Product code: DLG (Coating, Liquid, Glc)
- Device class: 1
- Regulation: 21 CFR 862.2250
- 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 K924446 (1992). 2 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981341: STC Opiates Micro-Plate Eia (Orasure Application), OraSure Technologies, Inc. (1998) 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 Opiate Oral Fluid Enzyme Immunoassay is a homogeneous enzyme immunoassay system to detect opiates 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 1 mL of buffer. The calibrators and controls of the analyte Morphine 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 opiate drugs. The assay is designed for professional use with a number of automated clinical chemistry analyzers. The Opiate Oral Fluid Enzyme Immunoassay is a homogeneous enzyme immunoassaysystem provides only a preliminary analyticaltest result. A more specific alternative chemical method must be used to obtain a confirmed analyticalresult Gas chromatography/massspectrometry (GC/MS) is the preferred confirmatory method. Clinical considerationandprofessional judgment should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used.

Source page: https://510kreport.com/device/K050988
Methodology: https://510kreport.com/methodology