510(k) · Cleared

Cleared

Labone Cocaine Metabolite Micro-Plate Eia

K040198510(k) TraditionalCleared Mar 5, 200436-day reviewClass II21 CFR 862.3250

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

Labone, Inc. · DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites

Cleared on Mar 5, 2004 as substantially equivalent to K973651 (OraSure Technologies, Inc., 1998) after a 36-day review. Its family tree reaches back 1 generation to 1998.

Decided: Mar 5, 2004
Review: 36 days
Class: Class II
Product code: DIO
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K973651 (1998). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK973651 STC Cocaine Metabolite Micro-Plate EiaOraSure Technologies, Inc. · 1998
This deviceK040198 Labone Cocaine Metabolite Micro-Plate EiaLabone, Inc. · 2004

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K973651	STC Cocaine Metabolite Micro-Plate Eia	OraSure Technologies, Inc.	1998	—
0 (this device)	K040198	Labone Cocaine Metabolite Micro-Plate Eia	Labone, Inc.	2004	—

FIG. 1 — Lineage of K040198, 1998–2004Source: 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 DIO? 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 DIO device

#1 K213211 Carolina Liquid Chemistries Cocaine and…score 3.1 · 2 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
*	K973651	STC Cocaine Metabolite Micro-Plate Eia Summary page 1 …3250 Substantially Equivalent Device: Product: STC Cocaine Metabolite Micro-Plate EIA Manufactured by: OraSure® Technologies, Inc. 5 10(k) Number: K973 651 Product Description: LabOne Cocaine Metabolite Micro-Plate EIA is a solid phase competitive enzyme immunoassay fo…	OraSure Technologies, Inc.	1998	—

What descends from it?

No later submission names this one as a predicate yet.

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.

How does its category compare?

All DIO devices

DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DIO

1in 2022

2007high 5 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DIO

267in 2017

2007high 267 (2017) · low 65 (2011)2026

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

Recalls per year · DIO

1in 2013

2007high 1 (2013) · low 0 (2007)2026

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

Adverse event reports per year · DIO

1in 2023

2007high 22 (2019) · low 0 (2007)2025

MAUDE reports naming product code DIO, 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	0	—	0	0
2009	1	—	0	0
2010	0	—	0	0
2011	5	65	0	4
2012	5	139	0	0
2013	2	—	1	0
2014	2	—	0	1
2015	2	—	0	7
2016	3	88	0	9
2017	3	267	0	16
2018	1	—	0	12
2019	0	—	0	22
2020	1	—	0	0
2021	1	—	0	0
2022	1	—	0	1
2023	0	—	0	1
2024	0	—	0	0
2025	0	—	0	0
2026	0	—	0	—

What is it indicated for?

The LabOne Inc Cocaine Metabolite Micro-Plate Enzyme ImmunoAssay (EIA) is intended for the qualitative detection of cocaine and its metabolite, benzylecgonine, in oral fluid with the Orasure® Oral Specimen Device. It is a screen test with a cutoff set at 10 ng/ml of benzoylecgonine per ml of oral fluid. (See Cross Reactivity section for information on cross-reactivity with cocaine). This test is intended for laboratory use only. For in vitro diagnostic…

Read the full statement (203 words)

The LabOne Inc Cocaine Metabolite Micro-Plate Enzyme ImmunoAssay (EIA) provides only a preliminary result. Clinical consideration and professional iudiment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. To obtain confirmed analytical results a more specific alternate chemical method is needed. Gas chromatography/mass spectroscopy/mass spectroscopy (GC/MS/MS) is the recommended confirmatory method.

The LabOne Cocaine Metabolite Micro-Plate EIA Calibrators are intended for medical purposes for use with the LabOne Cocaine Metabolite Micro-Plate EIA to establish points of reference that are used in determination of values in the measurement of cocaine metabolite in saliva.

The LabOne Cocaine Metabolite Micro-Plate EIA Controls are intended for use as an assayed quality control matrix to monitor the precision and accuracy of the laboratory testing procedures for cocaine metabolite.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K040198 · printed Nov 4, 2026

Cite this page

510(k) Report. “K040198: Labone Cocaine Metabolite Micro-Plate Eia.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040198

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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