510(k) · Cleared

Cleared

STC Amphetamine-Specific Intercept Micro-Plate Eia, Model 1103I

K992918510(k) TraditionalCleared Apr 3, 2000217-day reviewClass II21 CFR 862.3100

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

OraSure Technologies, Inc. · DKZ Enzyme Immunoassay, Amphetamine

Cleared on Apr 3, 2000 as substantially equivalent to K933052 (Roche Diagnostic Systems, Inc., 1993) after a 217-day review. Its family tree reaches back 1 generation to 1993. 14 later devices descend from it.

Decided: Apr 3, 2000
Review: 217 days
Class: Class II
Product code: DKZ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K933052 (1993). 14 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK933052 Abuscreen Online (R) for Amphetamines, ModifiedRoche Diagnostic Systems, Inc. · 1993
This deviceK992918 STC Amphetamine-Specific Intercept Micro-Plate Eia, Model 1103IOraSure Technologies, Inc. · 2000
Descendant · cites it directly · 6 of its ownK103227 Oratect Oral Fluid Drug Screen DevicesBranan Medical Corporation · 2012
Descendant · 2 generations on · 3 of its ownK171403 OralTox Oral Fluid Drug TestPremier Biotech, Inc. · 2018
Descendant · cites it directly · 2 of its ownK033743 Cozart Eia Amphetamines Oral Fluid Microplate KitCozart Bioscience, Ltd. · 2004
Descendant · 3 generations on · 1 of its ownK181305 OralTox Oral fluid Drug TestPremier Biotech, Inc. · 2018
Descendant · 2 generations on · 1 of its ownK132688 Salivabuse Liquid Oral Fluid Control, Salivabuse Liquid Oral Fluid…Biochemical Diagnostics, Inc. · 2013

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2004high 2 (2013) · low 0 (2005)2026

Most influential descendants

Showing 5 of 14 · See all

K103227Oratect Oral Fluid Drug Screen DevicesBranan Medical Corporation · 2012 · cites it directly6descendants
K171403OralTox Oral Fluid Drug TestPremier Biotech, Inc. · 2018 · 2 generations on3descendants
K033743Cozart Eia Amphetamines Oral Fluid Microplate KitCozart Bioscience, Ltd. · 2004 · cites it directly2descendants
K181305OralTox Oral fluid Drug TestPremier Biotech, Inc. · 2018 · 3 generations on1descendant
K132688Salivabuse Liquid Oral Fluid Control, Salivabuse Liquid Oral Fluid Control, AU/NZBiochemical Diagnostics, Inc. · 2013 · 2 generations on1descendant

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)	K992918	STC Amphetamine-Specific Intercept Micro-Plate Eia, Model 1103I	OraSure Technologies, Inc.	2000	—
+1	K103227	Oratect Oral Fluid Drug Screen Devices	Branan Medical Corporation	2012	—
+2	K171403	OralTox Oral Fluid Drug Test	Premier Biotech, Inc.	2018	—
+1	K033743	Cozart Eia Amphetamines Oral Fluid Microplate Kit	Cozart Bioscience, Ltd.	2004	—
+3	K181305	OralTox Oral fluid Drug Test	Premier Biotech, Inc.	2018	—
+2	K132688	Salivabuse Liquid Oral Fluid Control, Salivabuse Liquid Oral Fluid Control…	Biochemical Diagnostics, Inc.	2013	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2006	1	0
2011	1	0
2012	1	0
2013	2	0
2014	2	0
2015	1	0
2018	2	0
2021	1	0
2025	1	0
2026	1	0

FIG. 1 — Lineage of K992918, 1993–2026Source: 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 DKZ? 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 DKZ device

#1 K233019 AllTest Multi-Drug Rapid Test Cup; AllTest…score 14.6 · 8 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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 …ion Name: Enzyme Immunoassay, Amphetamines Device to Which Substantial Equivalence Is Claimed: Roche Diagnostic Systems, Abuscreen ONLINE® kit for amphetamines (urine); K933052 Description of Device: Principle of the Assay The STC Amphetamine-Specific Intercept™ MICRO-PLATE EIA is a competitive micro-p…	Roche Diagnostic Systems, Inc.	1993	—

Also cleared against K933052: 2 other devices →

What descends from it? (14)

See all 14

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

Number	Device	Applicant	Decided	Descendants
K103227	Oratect Oral Fluid Drug Screen Devices	Branan Medical Corporation	2012	6
K033743	Cozart Eia Amphetamines Oral Fluid Microplate Kit	Cozart Bioscience, Ltd.	2004	2
K110446	Roche Oral Fluid Amphetamine, Roche Oral Fluid Dat Qual Cal B, Roche Oral Fluid Dat…	Roche Diagnostics	2011	1
K063024	Lzi Amphetamine-Specific Oral Fluid Homogeneous Enztme Immunoassay: Lzi Amphetamine Oral…	Lin-Zhi International, Inc.	2006	1

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K103227 (Branan Medical Corporation, 2012) has gone furthest, with 6 descendants of its own.
2 other devices also cite its predicate K933052.

How does its category compare?

All DKZ devices

DKZ Enzyme Immunoassay, Amphetamine: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DKZ

1in 2024

2007high 8 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DKZ

180in 2019

2007high 233 (2010) · low 55 (2012)2026

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

Recalls per year · DKZ

1in 2017

2007high 5 (2009) · low 0 (2010)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DKZ

2in 2025

2007high 12 (2008) · low 0 (2007)2025

MAUDE reports naming product code DKZ, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	0	—	1	0
2008	2	—	3	12
2009	2	—	5	1
2010	4	233	0	1
2011	6	123	4	2
2012	5	55	0	0
2013	8	103	1	1
2014	8	128	3	9
2015	5	107	0	8
2016	5	215	0	8
2017	0	—	1	0
2018	3	128	0	0
2019	3	180	0	0
2020	1	—	0	0
2021	0	—	0	3
2022	0	—	0	4
2023	2	—	0	7
2024	1	—	0	1
2025	0	—	0	2
2026	0	—	0	—

What is it indicated for?

The STC Amphetamine-Specific Intercept™ MICRO-PLATE EIA is intended for use in the qualitative determination of amphetamine 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/K992918 · printed Nov 6, 2026

Cite this page

510(k) Report. “K992918: STC Amphetamine-Specific Intercept Micro-Plate Eia, Model 1103I.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992918

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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