510(k) · Cleared

Recalled · 2008

STC Cannabinoids Intercept Micro-Plate Eia, Model 1118I

K002375510(k) TraditionalCleared Jan 26, 2001175-day reviewClass II21 CFR 862.3870Recalls 4

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

OraSure Technologies, Inc. · LDJ Enzyme Immunoassay, Cannabinoids

Cleared on Jan 26, 2001 after a 175-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 9 later devices descend from it. It has been recalled 4 times.

Decided: Jan 26, 2001
Review: 175 days
Class: Class II
Product code: LDJ
Recalls: 4
Predicates: 0

9 later devices descend from it, 2 citing it directly.

This deviceK002375 STC Cannabinoids Intercept Micro-Plate Eia, Model 1118IOraSure Technologies, Inc. · 2001
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 · 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
Descendant · cites it directly · 1 of its ownK101744 Thermo Scientific Cedia Cannabinoids Oft AssayMicrogenics Corp. · 2011

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2011high 2 (2013) · low 0 (2015)2026

Most influential descendants

Showing 5 of 9 · 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
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
K101744Thermo Scientific Cedia Cannabinoids Oft AssayMicrogenics Corp. · 2011 · cites it directly1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K002375	STC Cannabinoids Intercept Micro-Plate Eia, Model 1118I	OraSure Technologies, Inc.	2001	—
+1	K103227	Oratect Oral Fluid Drug Screen Devices	Branan Medical Corporation	2012	—
+2	K171403	OralTox Oral Fluid Drug Test	Premier Biotech, Inc.	2018	—
+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	—
+1	K101744	Thermo Scientific Cedia Cannabinoids Oft Assay	Microgenics Corp.	2011	—

Descendants by year cleared

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

FIG. 1 — Lineage of K002375, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Planning a device in LDJ? 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 LDJ device

#1 K232732 Rapid Marijuana (THC) Test Strip 20, Rapid…score 9.4 · 10 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (9)

2 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
K101744	Thermo Scientific Cedia Cannabinoids Oft Assay	Microgenics Corp.	2011	1

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Sep 8, 2008	Not classified	Z-0478-2009	Nonconforming Material/Component	Results, false-positive test: low % displacement result of 36.0% (spec 39-60%). For further information, please contact the firm at 610-882-1820.
Sep 8, 2008	Not classified	Z-0477-2009	Nonconforming Material/Component	Results, false-positive test: low % displacement result of 36.0% (spec 39-60%). For further information, please contact the firm at 610-882-1820.
Sep 8, 2008	Not classified	Z-0479-2009	Nonconforming Material/Component	Results, false-positive test: low % displacement result of 36.0% (spec 39-60%). For further information, please contact the firm at 610-882-1820.
Sep 8, 2008	Not classified	Z-0481-2009	Other	Readings, high: intermittent high absorbance readings. For further information, please contact the firm at 610-882-1820.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K103227 (Branan Medical Corporation, 2012) has gone furthest, with 6 descendants of its own.

How does its category compare?

All LDJ devices

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

FDA decisions per year · LDJ

2in 2024

2007high 4 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LDJ

48in 2015

2007high 219 (2011) · low 48 (2015)2026

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

Recalls per year · LDJ

1in 2023

2007high 4 (2008) · low 0 (2007)2026

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

Adverse event reports per year · LDJ

1in 2015

2007high 1 (2015) · low 0 (2007)2025

MAUDE reports naming product code LDJ, 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	—	0	0
2008	2	—	4	0
2009	1	—	0	0
2010	0	—	0	0
2011	4	219	0	0
2012	4	193	0	0
2013	3	162	0	0
2014	2	—	0	0
2015	3	48	0	1
2016	1	—	0	0
2017	0	—	0	0
2018	0	—	0	0
2019	1	—	0	0
2020	0	—	0	0
2021	0	—	0	0
2022	0	—	0	0
2023	1	—	1	0
2024	2	—	0	0
2025	0	—	0	0
2026	0	—	0	—

https://510kreport.com/device/K002375 · printed Nov 6, 2026

Cite this page

510(k) Report. “K002375: STC Cannabinoids Intercept Micro-Plate Eia, Model 1118I.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002375

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026