510(k) · Cleared

Recalled · Class III · 2021

STC Methamphetamine Intercept Micro-Plate Eia, Model 1104I

K993208510(k) TraditionalCleared Apr 3, 2000192-day reviewClass II21 CFR 862.3610Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

OraSure Technologies, Inc. · LAF Gas Chromatography, Methamphetamine

Cleared on Apr 3, 2000 as substantially equivalent to K933052 (Roche Diagnostic Systems, Inc., 1993) after a 192-day review. Its family tree reaches back 1 generation to 1993. 7 later devices descend from it. It has been recalled once.

Decided: Apr 3, 2000
Review: 192 days
Class: Class II
Product code: LAF
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K933052 (1993). 7 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK933052 Abuscreen Online (R) for Amphetamines, ModifiedRoche Diagnostic Systems, Inc. · 1993
This deviceK993208 STC Methamphetamine Intercept Micro-Plate Eia, Model 1104IOraSure Technologies, Inc. · 2000
Descendant · cites it directly · 3 of its ownK062242 Methamphetamine Oral Fluid Homogeneous Enzyme Immunoassay…Lin-Zhi International, Inc. · 2006
Descendant · 2 generations on · 2 of its ownK131652 Lzi Oral Fluid Methamphetamine Enzyme Immunoassay, Calibrators…Lin-Zhi International, Inc. · 2014
Descendant · cites it directly · 1 of its ownK101753 Thermo Scientific Cedia Methamphetamine Oft AssayMicrogenics Corp. · 2011
Descendant · 3 generations on · 0 of its ownK203647 SEFRIA Methamphetamine Oral Fluid Enzyme ImmunoassayImmunalysis Corporation · 2021
Descendant · 3 generations on · 0 of its ownK142293 Rapidfret Oral Fluid Assay for Methamphetamine, Rapidfret Oral Fluid…Biophor Diagnostics, Inc. · 2015

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2006high 2 (2011) · low 0 (2007)2026

Most influential descendants

Showing 5 of 7 · See all

K062242Methamphetamine Oral Fluid Homogeneous Enzyme Immunoassay; Calibrators and ControlsLin-Zhi International, Inc. · 2006 · cites it directly3descendants
K131652Lzi Oral Fluid Methamphetamine Enzyme Immunoassay, Calibrators, ControlsLin-Zhi International, Inc. · 2014 · 2 generations on2descendants
K101753Thermo Scientific Cedia Methamphetamine Oft AssayMicrogenics Corp. · 2011 · cites it directly1descendant
K203647SEFRIA Methamphetamine Oral Fluid Enzyme ImmunoassayImmunalysis Corporation · 2021 · 3 generations on0descendants
K142293Rapidfret Oral Fluid Assay for Methamphetamine, Rapidfret Oral Fluid Methamphetamine…Biophor Diagnostics, Inc. · 2015 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K933052	Abuscreen Online (R) for Amphetamines, Modified	Roche Diagnostic Systems, Inc.	1993	—
0 (this device)	K993208	STC Methamphetamine Intercept Micro-Plate Eia, Model 1104I	OraSure Technologies, Inc.	2000	—
+1	K062242	Methamphetamine Oral Fluid Homogeneous Enzyme Immunoassay; Calibrators and…	Lin-Zhi International, Inc.	2006	—
+2	K131652	Lzi Oral Fluid Methamphetamine Enzyme Immunoassay, Calibrators, Controls	Lin-Zhi International, Inc.	2014	—
+1	K101753	Thermo Scientific Cedia Methamphetamine Oft Assay	Microgenics Corp.	2011	—
+3	K203647	SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay	Immunalysis Corporation	2021	—
+3	K142293	Rapidfret Oral Fluid Assay for Methamphetamine, Rapidfret Oral Fluid…	Biophor Diagnostics, Inc.	2015	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2011	2	0
2014	2	0
2015	1	0
2021	1	0

FIG. 1 — Lineage of K993208, 1993–2021Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LAF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new LAF device

#1 K203647 SEFRIA Methamphetamine Oral Fluid Enzyme…score 3.8 · 5 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K933052	Abuscreen Online (R) for Amphetamines, Modified Summary page 1 …Name. Enzyme Immunoassay, Amphetamines 3. Device to Which Substantial Equivalence Is Claimed: Roche Diagnostic Systems, Abuscreen ONLINE® kit for amphetamines (urine); K933052 4. Description of Device: Principle of the Assay The STC Methamphetamine Intercept™ MICRO-PLATE EIA is a competitive micro-plat…	Roche Diagnostic Systems, Inc.	1993	—

Also cleared against K933052: 2 other devices →

What descends from it? (7)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K062242	Methamphetamine Oral Fluid Homogeneous Enzyme Immunoassay; Calibrators and Controls	Lin-Zhi International, Inc.	2006	3
K101753	Thermo Scientific Cedia Methamphetamine Oft Assay	Microgenics Corp.	2011	1
K093884	Roche Fludi Methamphetamine	Roche Diagnostics	2011	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Feb 5, 2021	Class III	Z-1183-2021	Packaging process control	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 Reagent (TMB) lot 6679623, should not…

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K062242 (Lin-Zhi International, Inc., 2006) has gone furthest, with 3 descendants of its own.
2 other devices also cite its predicate K933052.

How does its category compare?

All LAF devices

LAF Gas Chromatography, Methamphetamine: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LAF

2in 2021

2007high 4 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LAF

43in 2015

2007high 345 (2011) · low 43 (2015)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LAF

No recall names LAF since 2007.

Adverse event reports per year · LAF

No MAUDE report names LAF since 2007.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	2	—	0
2009	0	—	0
2010	0	—	0
2011	4	345	0
2012	2	—	0
2013	0	—	0
2014	2	—	0
2015	3	43	0
2016	1	—	0
2017	1	—	0
2018	0	—	0
2019	0	—	0
2020	1	—	0
2021	2	—	0
2022	0	—	0
2023	0	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

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.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K993208 · printed Nov 3, 2026

Cite this page

510(k) Report. “K993208: STC Methamphetamine Intercept Micro-Plate Eia, Model 1104I.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K993208

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026