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 immunosorbent assay (ELISA) for Cocaine Testing Kit, for the qualitative detection of Cocaine at or above 500 pg/mg of hair for the purpose of identifying the use of Cocaine. To confirm a screen positive result, a more specific alternate chemical method, such as Gas Chromatography/Mass Spectrometry (GC/MS) 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.

Device Description

The Omega Laboratories Hair Drug Screening Assay for Cocaine and Cocaine Metabolites, is a test system using ELISA reagents and microplate reader for the qualitative detection of Cocaine and Cocaine Metabolites in hair samples at or above 500 pg/mg.

AI/ML Overview

This 510(k) summary describes a new diagnostic device, the Omega Laboratories Hair Drug Screening Assay for Cocaine and Cocaine Metabolites, and its substantial equivalence to a predicate device. Below is a breakdown of the requested information based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly list numerical acceptance criteria in the format typically seen for sensitivity, specificity, or accuracy targets. Instead, it states that the device demonstrated "substantial agreement" and "substantially equivalent" performance to the predicate device across various performance characteristics.

Acceptance Criteria (Implied)	Reported Device Performance
Substantial agreement with predicate device (qualitative detection of Cocaine and Cocaine Metabolites)	"All performance studies demonstrated that the Omega assay is in substantial agreement with the predicate products."
Performance of Detection Limits and Reportable Range	Demonstrated substantial agreement with predicate.
Performance of Precision	Demonstrated substantial agreement with predicate.
Performance of Agreement	Demonstrated substantial agreement with predicate.
Performance regarding Cosmetic Treatment effects	Demonstrated substantial agreement with predicate.
Performance regarding Cross-reactivity	Demonstrated substantial agreement with predicate.
Performance regarding Environmental Contamination	Demonstrated substantial agreement with predicate.
Performance involving Calibrator and Control	Demonstrated substantial agreement with predicate.
Performance regarding Extraction Recovery	Demonstrated substantial agreement with predicate.
Performance regarding Shipping Study	Demonstrated substantial agreement with predicate.
Performance regarding Stability of Hair Sample	Demonstrated substantial agreement with predicate.
Substantial equivalence to Quest Diagnostics HairCheck-DT (Cocaine) K023626	"The Omega Laboratories Hair Drug Screening Assay for Cocaine and Cocaine Metabolites is substantially equivalent to the Quest Diagnostics HairCheck-DT (Cocaine) K023626."
Qualitative results from new assays in substantial agreement with predicate devices when using donor specimens	"Results obtained from donor specimens showed that the qualitative results from the new assays are substantially equivalent to those obtained from the predicate devices."

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific sample size used for the test set during performance characteristic studies. It mentions "donor specimens" but doesn't provide a numerical count.

The data provenance is not explicitly detailed regarding country of origin or whether it was retrospective or prospective. Given the nature of a 510(k) submission for a laboratory-developed test, the data would likely originate from samples processed within Omega Laboratories or collected specifically for their studies.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not provide information on the number of experts or their qualifications used to establish ground truth for the test set. For a substance abuse test, ground truth is typically established through a confirmation method.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

The document does not specify an adjudication method. For confirmation of presumptive positive results, it states: "To confirm a screen positive result, a more specific alternate chemical method, such as Gas Chromatography/Mass Spectrometry (GC/MS) operating in the selected ion monitoring (SIM) mode is the preferred method with deuterated internal standards." This implies a confirmatory testing approach rather than an expert adjudication panel.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described. This type of study is more common for imaging-based diagnostic devices where human interpretation is a key component. The Omega assay is a laboratory-developed test using ELISA, where the result is determined by the assay itself, not by human interpretation of complex images.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone study was effectively done. The performance characteristic studies described (Detection Limits, Precision, Agreement, etc.) evaluate the performance of the assay itself (the "algorithm only") in detecting cocaine and its metabolites in hair samples. The statement that the test is "intended exclusively for in-house laboratory use only" and "offers this laboratory developed test as a service to its clients" further supports that it's the device's analytical performance being assessed, not human interpretation.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The primary ground truth described for confirming screen positive results is a more specific alternate chemical method, specifically Gas Chromatography/Mass Spectrometry (GC/MS) operating in the selected ion monitoring (SIM) mode with deuterated internal standards. This is a highly sensitive and specific analytical method widely considered the gold standard for confirming drug presence in toxicology.

8. The Sample Size for the Training Set

The document does not provide any information about a training set or its sample size. This type of detail is more relevant for machine learning or AI-driven devices. For a traditional immunoassay, there isn't a "training set" in the same sense; instead, the assay's parameters are developed and optimized during its creation, and then validated through performance studies.

9. How the Ground Truth for the Training Set Was Established

As no training set is described in the context of this immunoassay, there is no information on how its ground truth was established. For the validation of the device, the ground truth was established by GC/MS as described above.

Summary

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JAN 23 2012

K//2808

Omega Laboratories, Inc. 510(k) Summary Omega Hair Drug Screening Assay for Cocaine and Cocaine Metabolites

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92

510(k) Number:

Date of Summary:

September 23, 2011

Vice President of Operations Omega Laboratories, Inc. 400 North Cleveland Mogadore, OH 44260 Tel: 330-628-5748 Fax: 330-628-5803

William R. Corl

Robert J Bard, JD

Omega Laboratories

Applicant:

. 2 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 -

Correspondent:

Name:

Address:

Phone Number:

E-mail

400 North Cleveland, Mogadore, OH 44260 248-573-5040 rbard@reglaw.net

Product Name:

Trade Name:

Common Name:

Classification Name:

Classification Panel:

Product Description:

Indication for Use:

Predicate Device:

Requlation Number:

Omega Laboratories Hair Drug Screening Assay for Cocaine and Cocaine Metabolites

Hair Drug Screening Assay Cocaine and Cocaine Metabolites

CFR 862.3250 (ProCode DIO)

Enzyme immunoassay, Cocaine and Cocaine Metabolites test System

91 (Toxicology)

Quest Diagnostics HairCheck-DT (Cocaine) K023626;

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(GC/MS) 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.

When used to qualitatively detect Cocaine and Cocaine Metabolites in head hair specimens collected with the Omega Specimen Collection Device, the Omega assays yield results in substantial agreement with the predicate device.

Performance characteristic studies were conducted for

Detection Limits and Reportable Range

Precision

Agreement

Cosmetic Treatment

Cross reactivity

Environmental Contamination

Calibrator and Control

Extraction Recovery

Shipping Study

Stability of Hair Sample

All performance studies demonstrated that the Omega assay is in substantial agreement with the predicate products.

Results obtained from donor specimens showed that the qualitative results from the new assays are substantially equivalent to those obtained from the predicate devices.

The Omega Laboratories Hair Drug Screening Assay for Cocaine and Cocaine Metabolites is substantially equivalent to the Quest Diagnostics HairCheck-DT (Cocaine) K023626.

Comparison:

ﺔ "ﺷﻴﺘﺴﺎ

Comparison Performance Data:

Conclusion:

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10903 New Hampshire Avenue Silver Spring, MD 20993

Omega Laboratories, Inc. c/o Mr. Robert Bard 400 N. Cleveland Avenue Mogadore, OH 44260

JAN 2 3 2012

K112808 Re:

Trade Name: Omega Laboratories Hair Drug Screening Assay for Cocaine and Cocaine Metabolites Regulation Number: 21 CFR §862.3250 Regulation Name: Cocaine and Cocaine Metabolite Test System Regulatory Class: Class II Product Codes: DIO Dated: December 17, 2011 Received: December 19, 2011

Dear Mr. Bard:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical

Devices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance ...

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm

Sincerely yours,

signature

Counney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indication for Use

K112808

Device Name: Omega Laboratories Hair Drug Screening Assay for Cocaine and Cocaine Metabolites

Indication for Use:

Prescription Use (21 CFR Part 801 Subpart D)

and/or

Over the Counter Use X (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K112808

Regulation Number and Section

§ 862.3250 Cocaine and cocaine metabolite test system.

(a)
Identification. A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.(b)
Classification. Class II (special controls). A cocaine and cocaine metabolite test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).