510(k) Report

510(k) · Cleared

Cleared

Omega Laboratories Hair Drug Screening Assay for Cocaine and Cocaine Metabolites

K112808510(k) TraditionalCleared Jan 23, 2012118-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

Omega Laboratories, Inc. · DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites

Cleared on Jan 23, 2012 as substantially equivalent to K023626 (Quest Diagnostics, Inc., 2003) after a 118-day review. Its family tree reaches back 1 generation to 2003. 1 later device descends from it.

Decided
Jan 23, 2012
Review
118 days
Class
Class II
Product code
DIO
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K023626 (2003). 1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2013: 1 descendant clearedK023626 · Aml Haircheck-DT (Cocaine) · Quest Diagnostics, Inc. · 2003200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant K023626 · Aml Haircheck-DT (Cocaine) · Quest Diagnostics, Inc. · 20030
  1. Root · 1 generation backK023626 Aml Haircheck-DT (Cocaine)Quest Diagnostics, Inc. · 2003
  2. This deviceK112808 Omega Laboratories Hair Drug Screening Assay for Cocaine and Cocaine…Omega Laboratories, Inc. · 2012
  3. Descendant · cites it directly · 0 of its ownK131128 Omega Laboratories Hair Drug Screening Assay for Cocaine and Cocaine…Omega Laboratories, Inc. · 2013

Most influential descendants

Showing 1 of 1 · See all
  • K131128Omega Laboratories Hair Drug Screening Assay for Cocaine and Cocaine MetabolitesOmega Laboratories, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K023626Aml Haircheck-DT (Cocaine)Quest Diagnostics, Inc.2003—
0 (this device)K112808Omega Laboratories Hair Drug Screening Assay for Cocaine and Cocaine MetabolitesOmega Laboratories, Inc.2012—
+1K131128Omega Laboratories Hair Drug Screening Assay for Cocaine and Cocaine MetabolitesOmega Laboratories, Inc.2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
FIG. 1 — Lineage of K112808, 2003–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K213211 Carolina Liquid Chemistries Cocaine and…score 3.0 · 2 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #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.

TypeNumberDeviceApplicantDecidedRecalls
*K023626Aml Haircheck-DT (Cocaine)
Summary page 1
…CD Predicate Device: Quest Diagnostics HairCheck-DT (Cocaine) k023626; 0…
Quest Diagnostics, Inc.2003—

Also cleared against K023626: 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.

NumberDeviceApplicantDecidedDescendants
K131128Omega Laboratories Hair Drug Screening Assay for Cocaine and Cocaine MetabolitesOmega Laboratories, Inc.20130

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, K131128 (Omega Laboratories, Inc., 2013) has gone furthest, with 0 descendants of its own.
  • 1 other device also cites its predicate K023626.

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. 2012, this device’s year, is highlighted.

FDA decisions per year · DIO

1in 2022

2009: 12011: 52012: 52013: 22014: 22015: 22016: 32017: 32018: 12020: 12021: 12022: 1
2007high 5 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DIO

267in 2017

2011: 65 days median2012: 139 days median2016: 88 days median2017: 267 days median
2007high 267 (2017) · low 65 (2011)2026

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

Recalls per year · DIO

1in 2013

2013: 1
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

2011: 42014: 12015: 72016: 92017: 162018: 122019: 222022: 12023: 1
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20091—00
20100—00
201156504
2012513900
20132—10
20142—01
20152—07
201638809
20173267016
20181—012
20190—022
20201—00
20211—00
20221—01
20230—01
20240—00
20250—00
20260—0—

What is it indicated for?

The Omega Laboratories Hair Drug Screening Assay for Cocaine and Cocaine Metabolites (Cocaine) is a laboratory developed test that is intended to be used for the determination of the presence of Cocaine in human hair from the head. The Omega Laboratories Hair Drug Screening Assay Cocaine utilizes the International Diagnostics Systems Corp. One-Step enzyme linked inmmosorbent assay (ELISA) for Cocaine Testing Kit, for the qualitative detection of Cocaine…

Read the full statement (169 words)

The Omega Laboratories Hair Drug Screening Assay for Cocaine and Cocaine Metabolites (Cocaine) is a laboratory developed test that is intended to be used for the determination of the presence of Cocaine in human hair from the head. The Omega Laboratories Hair Drug Screening Assay Cocaine utilizes the International Diagnostics Systems Corp. One-Step enzyme linked inmmosorbent assay (ELISA) for Cocaine Testing Kit, for the qualitative detection of Cocaine at or above 500 pglmg of hair for the purpose of identifying the use of Cocaine. To confirmn a screen positive result, a more specific alternate chemical method, such as Gas Chromatography/Mass Spectrometry (GCIMS) operating in the selected ion monitoring (SIM mode is the preferred method with deuterated internal standards. Professional judgment should be applied to any drug of abuse test result, particularly when presumptive positive results are obtained.

This laboratory developed test is intended exclusively for in-house laboratory use only and is not intended for sale to anyone. Omega offers this laboratory developed test as a service to its clients.

Indications for use as stated in the FDA summary.

Also cleared against K023626

1 other device cites the same predicate.

  • K152232Quest Diagnostics HairCheck-DT (Cocaine)Quest Diagnostics Incorporated · 2016

More from Omega Laboratories, Inc.

9 FDA decisions under this applicant name. See the company

  • K142855Omega Laboratories Hair Drug Screening Assay Methamphetamine (Meth) and -3, 4-methylenedioxymethamphetamine…Omega Laboratories, Inc. · 2015
  • K140671Omega Laboratories Hair Drug Screening Assay for Opiates, Oxycodone and HydrocodoneOmega Laboratories, Inc. · 2015
  • K131128Omega Laboratories Hair Drug Screening Assay for Cocaine and Cocaine MetabolitesOmega Laboratories, Inc. · 2013
  • K131181Omega Laboratories Hair Drug Screening Assay PhencyclidineOmega Laboratories, Inc. · 2013
  • K122759Omega Laboratories Hair Drug Screening Assay Cardoxy-THC (Thca)Omega Laboratories, Inc. · 2012

Recent decisions in DIO

The DIO category page

  • K213211Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test SystemCarolina Liquid Chemistries Corp. · 2022
  • K211973DRI Cocaine Metabolite AssayMicrogenics Corporation · 2021
  • K191638Pointe Scientific Cocaine Metabolite Enzyme ImmunoassayMedtest DX · 2020
  • K181499DRI Cocaine Metabolite AssayMicrogenics Corporation · 2018
  • K170293Emit II Plus Cocaine Metabolite AssaySiemens Healthcare Diagnostics, Inc. · 2017

https://510kreport.com/device/K112808 · printed Nov 6, 2026

Cite this page

510(k) Report. “K112808: Omega Laboratories Hair Drug Screening Assay for Cocaine and Cocaine Metabolites.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112808

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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