510(k) · Cleared

Cleared

DRI Cocaine Metabolite Assay

K181499510(k) TraditionalCleared Jul 6, 201829-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

Microgenics Corporation · DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites

Cleared on Jul 6, 2018 as substantially equivalent to K960187 (Diagnostic Reagents, Inc., 1996) after a 29-day review. Its family tree reaches back 1 generation to 1996. 1 later device descends from it.

Decided: Jul 6, 2018
Review: 29 days
Class: Class II
Product code: DIO
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K960187 (1996). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK960187 Cocaine Metabolite Eia TestDiagnostic Reagents, Inc. · 1996 · Recalled
This deviceK181499 DRI Cocaine Metabolite AssayMicrogenics Corporation · 2018
Descendant · cites it directly · 0 of its ownK211973 DRI Cocaine Metabolite AssayMicrogenics Corporation · 2021

Most influential descendants

Showing 1 of 1 · See all

K211973DRI Cocaine Metabolite AssayMicrogenics Corporation · 2021 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K960187	Cocaine Metabolite Eia Test	Diagnostic Reagents, Inc.	1996	1
0 (this device)	K181499	DRI Cocaine Metabolite Assay	Microgenics Corporation	2018	—
+1	K211973	DRI Cocaine Metabolite Assay	Microgenics Corporation	2021	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2021	1	0

FIG. 1 — Lineage of K181499, 1996–2021Source: 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 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 3.0 · 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
*	K960187	Cocaine Metabolite Eia Test Summary page 4 …Cocaine Metabolite Enzyme Immunoassay Predicate Device Diagnostic Reagents, Inc. Manufacturer: Predicate Device Premarket K960187 Notification #: B. Date Summary Prepared July 06, 2018 C. Description of Device The DRI Cocaine Metabolite Assay is…	Diagnostic Reagents, Inc.	1996	1

Also cleared against K960187: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K211973	DRI Cocaine Metabolite Assay	Microgenics Corporation	2021	0

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 a recall.
Of its descendants, K211973 (Microgenics Corporation, 2021) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K960187.

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. 2018, this device’s year, is highlighted.

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 DRI Cocaine Metabolite Assay is a homogeneous enzyme immunoassay intended for the qualitative and/or semi-quantitative determination of benzoylecgonine (Cocaine Metabolite) in human urine at a cutoff concentration of either 150 ng/mL or 300 ng/mL. The semi-quantitative mode is for the purpose of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as Liquid Chromatography/tandem…

Read the full statement (154 words)

The semi-quantitative mode is for the purpose of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as Liquid Chromatography/tandem mass spectrometry (LC-MS/MS) or permitting laboratories to establish quality control procedures.

The assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography / Mass spectrometry (GC/MS) or Liquid chromatography/tandem mass spectrometry (LC-MS/MS) is the preferred confirmatory method. Tests for cocaine metabolite cannot distinguish between abused drugs and certain prescribed medications.

Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary results are used. For In Vitro Diagnostic Use Only.

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/K181499 · printed Nov 6, 2026

Cite this page

510(k) Report. “K181499: DRI Cocaine Metabolite Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181499

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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