(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.
§ 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).