(118 days)
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.
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.
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.
§ 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).