(399 days)
The Omega Laboratories Hair Drug Screening Assay Methamphetamine and ,4-Methylenedioxymethamphetamine (MDMA) is a laboratory developed test that is intended to be used for the determination of the presence of Methamphetamine and 3,4-Methylenedioxymethamphetamine (MDMA) in human hair from the crown of the head. The Omega Laboratories Hair Drug Screening Assay (Meth MDMA) utilizes International Diagnostics Systems Corp One-Step Methamphetamine ELISA for Hair Testing Kit for the qualitative detection of Methamphetamine and MDMA at or above 500 pg/mg of hair for the purpose of identifying the use of Methamphetamine and MDMA. D-Methamphetamine is used as the standard for the assay. 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.
The Omega Laboratories Hair Drug Screening Assays for Opiates, Oxycodone and Hydrocodone are test systems using ELISA reagents and micro-plate reader for the qualitative detection of Opiates, Oxycodone and Hydrocodone in hair samples at or above 300 pg/mg.
Here's a breakdown of the acceptance criteria and study information for the Omega Laboratories Hair Drug Screening Assay for Methamphetamine and MDMA, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided summary does not explicitly state numerical acceptance criteria in the typical sense (e.g., minimum sensitivity, specificity thresholds). Instead, the primary acceptance criterion appears to be "substantial agreement" and "substantial equivalence" with the predicate device, Quest Diagnostics HairCheck-DT (Amphetamines) K051161.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Substantial agreement with predicate device (Quest Diagnostics HairCheck-DT for Amphetamines) when qualitatively detecting methamphetamine and/or MDMA in head hair specimens. | Performance characteristic studies for Precision, Agreement, Cosmetic Treatment, Cross-reactivity, and Environmental Contamination "demonstrated that the Omega assay is in substantial agreement with the Quest Diagnostic product." |
| Qualitative results from new assays are substantially equivalent to those obtained from predicate devices for 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
- Sample Size: The document does not specify exact sample sizes for the "donor specimens" or "performance characteristic studies." It generically refers to "donor specimens."
- Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be presented as comparative performance against a predicate device rather than on a pre-existing dataset. The term "donor specimens" implies prospective collection for the purpose of the study, but this is not definitively stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. For a drug screening assay, the "ground truth" would typically be established by a more specific, confirmatory method. The document mentions: "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." However, it doesn't specify if experts were involved in interpreting these GC/MS results for the purpose of establishing ground truth for the study, nor their number or qualifications.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study typically applies to imaging or diagnostic interpretation tasks where multiple human readers assess cases, and the technology's impact on their performance is measured. This device is a laboratory assay.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, implicitly. The "Omega Laboratories Hair Drug Screening Assay" is an automated ELISA-based test system, and the performance studies inherently assess its standalone accuracy in detecting Methamphetamine and MDMA in hair samples. There is no mention of a human-in-the-loop component for the screening portion of the assay. The indication for use does mention that "Professional judgment should be applied to any drug of abuse test result," particularly for presumptive positives, and that GC/MS confirmation is preferred, implying human oversight in the overall diagnostic process, but the performance studies focus on the assay's output itself.
7. The Type of Ground Truth Used
The ground truth used for confirmation of screen positive results is a more specific alternate chemical method, such as Gas Chromatography/Mass Spectrometry (GC/MS) operating in the selected ion monitoring (SIM) mode with deuterated internal standards. For the purpose of the performance studies (e.g., agreement), the results of the predicate device (Quest Diagnostics HairCheck-DT) were used as a comparative benchmark to demonstrate equivalence.
8. The Sample Size for the Training Set
This information is not applicable and not provided. This device is a laboratory assay, not a machine learning algorithm that requires a separate "training set." The development of such assays involves analytical validation, not machine learning model training.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no "training set" in the context of this traditional laboratory assay.
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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: | K101973 |
|---|---|
| Date of Summary: | August 2, 2011 |
| Applicant: | William R. CorlVice President of OperationsOmega Laboratories, Inc.400 North ClevelandMogadore, OH 44260Tel: 330-628-5748Fax: 330-628-5803 |
| Correspondent:Name: | Robert J Bard, JD |
| Address: | Omega Laboratories400 North Cleveland, Mogadore, OH 44260 |
| Phone Number: | 248-573-5040 |
| rbard@reglaw.net | |
| Product Name: | |
| Trade Name: | the Omega Laboratories Hair Drug Screening AssayMethamphetamine_3, 4-methylenedioxymethamphetamine(Meth_MDMA) |
| Common Name: | Hair Drug Screening Assay Methamphetamine |
| Regulation Number: | CFR 862.3610 (ProCode LAF) |
| Classification Name: | Enzyme immunoassay, MethamphetamineMethamphetamine test System |
| Classification Panel: | 91 (Toxicology) |
| Predicate Device: | Quest Diagnostics HairCheck-DT (Amphetamines) K051161; |
| Product Description: | The Omega Laboratories Hair Drug Screening Assays for Opiates,Oxycodone and Hydrocodone are test systems using ELISA reagentsand micro-plate reader for the qualitative detection of Opiates,Oxycodone and Hydrocodone in hair samples at or above 300 pg/mg. |
| Indication for Use: | The Omega Laboratories Hair Drug Screening Assay forMethamphetamine and MDMA is a laboratory developed test that isintended to be used for the determination of the presence ofMethamphetamine and 3,4-Methylenedioxymethamphetamine (MDMA)in human hair from the crown of the head. The Omega LaboratoriesHair Drug Screening Assay (AMP) utilizes International DiagnosticsSystems Corp One-Step Methamphetamine ELISA for Hair Testing Kitfor the qualitative detection of Methamphetamine and MDMA at orabove 500 pg/mg of hair for the purpose of identifying the use ofMethamphetamine and MDMA. D-Methamphetamine is used as the |
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| standard for the assay. To confirm a screen positive result a morespecific alternate chemical method, such as GasChromatography/Mass Spectrometry (GC/MS) operating in the selectedion monitoring (SIM) mode is the preferred method with deuteratedinternal standards. Professional judgment should be applied to anydrug of abuse test result, particularly when presumptive positive resultsare obtained. | |
|---|---|
| Comparison: | When used to qualitatively detect methamphetamine and/or MDMA inhead hair specimens collected with the Omega Specimen CollectionDevice, the Omega assays yield results in substantial agreement withthe predicate device. |
| Comparison PerformanceData: | Performance characteristic studies were conducted for |
| Precision | |
| Agreement | |
| Cosmetic Treatment | |
| Cross-reactivity | |
| Environmental Contamination | |
| All performance studies demonstrated that the Omega assay is insubstantial agreement with the Quest Diagnostic product. | |
| Results obtained from donor specimens showed that the qualitativeresults from the new assays are substantially equivalent to thoseobtained from the predicate devices. | |
| Conclusion: | The Omega Laboratories Hair Drug Screening Assay forMethamphetamine and MDMA is substantially equivalent to the QuestDiagnostics HairCheck-DT (Amphetamines) K051161. |
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is simple and monochromatic.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
AUG 1 8 2011
Omega Laboratories, Inc. c/o Mr. Robert J Bard JD Managing Director PO Box 506 South Lyon, Michigan 48178
Re: K101973
Trade Name: Omega Laboratories Hair Drug Screening Assay for Methamphetamine and 4-Methylenedioxymethamphetamine (MDMA) Regulation Number: 862.3610 Regulatory Class: Class II Product Codes: LAF Dated: August 02, 2011 Received: August 05, 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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11 you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (01) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/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) 796-7100 or at its Internet address. http://www.fda.gov/cdrlv/industry/support/index.html.
Sincerely vours.
G.C.
Courtney Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indication for Use
Device Name: Omega Laboratories Hair Drug Screening Assay Methamphetamine and 4-Methylenedioxymethamphetamine (MDMA)
Indication for Use:
The Omega Laboratories Hair Drug Screening Assay Methamphetamine and ,4-Methylenedioxymethamphetamine (MDMA) is a laboratory developed test that is intended to be used for the determination of the presence of Methamphetamine and 3,4-Methylenedioxymethamphetamine (MDMA) in human hair from the crown of the head. The Omega Laboratories Hair Drug Screening Assay (Meth MDMA) utilizes International Diagnostics Systems Corp One-Step Methamphetamine ELISA for Hair Testing Kit for the qualitative detection of Methamphetamine and MDMA at or above 500 pg/mg of hair for the purpose of identifying the use of Methamphetamine and MDMA. D-Methamphetamine is used as the standard for the assay. 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.
Prescription Use (21 CFR Part 801 Subpart D) Over the Counter Use X (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW.THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
And/Or
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
RA
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K101973
§ 862.3610 Methamphetamine test system.
(a)
Identification. A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.(b)
Classification. Class II (special controls). A methamphetamine 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).