# K993208: STC Methamphetamine Intercept Micro-Plate Eia, Model 1104I

- Pathway: 510(k) (Traditional)
- Applicant: OraSure Technologies, Inc.
- Decided: Apr 3, 2000 after 192 days
- Product code: LAF (Gas Chromatography, Methamphetamine)
- Device class: 2
- Regulation: 21 CFR 862.3610
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K933052 (1993). 1 ancestor in all.
7 later devices descend from it; 3 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)
- K933052: Abuscreen Online (R) for Amphetamines, Modified, Roche Diagnostic Systems, Inc. (1993) Summary page 1.

## 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
- K101753: Thermo Scientific Cedia Methamphetamine Oft Assay (2011), 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

## Recalls of this device
- Feb 5, 2021 · Class III · Z-1183-2021: Incorrect lot of Substrate Reagent (TMB) may be included in the kit. The original kit box labeling and the specification sheet listed the Substrate Reagent (TMB) lot 6676239, but contained Substrate R

## Indications for use
The STC Methamphetamine Intercept™ MICRO-PLATE EIA is intended for use in the qualitative determination of methamphetamine in oral fluid collected with the Intercept™ Drugs of Abuse (DOA) Oral Specimen Collection Device. For In Vitro Diagnostic Use.

Source page: https://510kreport.com/device/K993208
Methodology: https://510kreport.com/methodology