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The Omega Laboratories Hair Drug Screening Assay for Cocaine and Cocaine Metabolites (Cocaine) is an in vitro diagnostic test that is intended for the qualitative detection of Cocaine at or above 500 pg/mg in human head and body hair. 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 test is intended exclusively for single laboratory use only and is not intended for sale to anyone.

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Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance for Omega Hair Drug Screening Assay for Cocaine and Cocaine Metabolites

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for substantial equivalence are demonstrated through various performance studies showing the device's agreement with a reference method (GC/MS) and its precision. Specific quantitative acceptance criteria for parameters like sensitivity, specificity, and accuracy are not explicitly stated with numerical targets, but the overall conclusion is based on "substantial agreement" and "acceptability."

• 31 GC/MS Negative (250-499 pg/mg) identified as Positive by ELISA (discordant).
  (Specific sensitivity/specificity/accuracy metrics are not provided in percentage form, but raw counts are given.) |
  | Cross-Reactivity | Structurally similar compounds (Benzoylecgonine isopropyl ester, Cocaethylene, Cocaine, Benzoylecgonine, Meta-Hydroxybenzoylecgonine, Ecgonine, Norbenzoylecgonine, Norcocaine, Norcocaethylene, Ecgonine methyl ester, Anhydroecgonine methyl ester) demonstrated varying degrees of cross-reactivity. The report notes that these contributed to a positive ELISA result, but GC/MS confirmation would differentiate them. |
  | Interfering Compounds | Structurally unrelated compounds did not interfere with the assay. Only structurally cross-reactive compounds produced a positive response. No expected positive samples produced a negative result. |
  | Calibrator and Control Validation | Successfully demonstrated validation and stability of in-house prepared calibrator and control solutions, traceable to NIST standards. |
  | Stability (Long-term storage) | Mean variance in concentration of combined cocaine + metabolites was -23% over ~2 years. Largest decrease was -46%, largest increase was 17%. General trend of decreasing cocaine and increasing benzoylecgonine noted. |
  | Shipping Effects | No adverse effect on head hair samples and no discordant results (pre- and post-shipping) when exposed to extreme temperatures and humidity. Average percent change in positive cocaine GC/MS results was +5% for all locations combined. |
  | Cosmetic Treatment Effects | Device is not an exception to the phenomenon that cosmetic treatments can reduce drug amounts. Four initially positive ELISA assays reported negative after treatment (bleach or perm). |
  | Environmental Contamination | Acknowledged that preliminary positive results could be due to environmental contamination, emphasizing the need for GC/MS confirmation to distinguish true positives. |

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

• Test Set Sample Size: For the agreement study, 424 hair samples were used.
• Data Provenance: The origin of the data (e.g., country of origin, retrospective or prospective) is not specified in the provided text. It only states that testing was performed on "body and head hair samples from different ages, gender, ethnicities and hair color."

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

• Number of Experts: Not explicitly stated.
• Qualifications of Experts: The ground truth for the agreement study was established using Gas Chromatography/Mass Spectrometry (GC/MS), which is a "more specific alternate chemical method" and "the preferred method with deuterated internal standards." This implies analysis by qualified laboratory personnel, but their specific number or qualifications (e.g., experience level) are not provided.

4. Adjudication Method for the Test Set

• Adjudication Method: The text states, "Each specimen was divided into two aliquots and one was used for screening and the other for GC/MS confirmation." This indicates that any discrepancies between the ELISA screening and the GC/MS confirmation would be resolved by the GC/MS result, as it is considered the "reference method" and "preferred method." There is no explicit mention of a multi-reader adjudication panel (like 2+1 or 3+1). The GC/MS acts as the definitive adjudicator.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was it done?: No. This study evaluates an in vitro diagnostic test (ELISA assay), not a device that assists human readers in interpreting images or other data. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study with human readers assisting with AI vs. without AI assistance is not applicable to this type of device and was not performed.

6. Standalone Performance Study

• Was it done?: Yes. The document presents standalone performance data for the ELISA assay against the GC/MS reference method. The "Agreement" section (Table 4a and 4b) directly compares the results of the Omega Laboratories Hair Drug Screening Assay (algorithm only, without human intervention in the interpretation of the assay result itself) to the GC/MS ground truth. The precision studies also represent standalone performance.

7. Type of Ground Truth Used

• Type of Ground Truth: The primary ground truth used for the agreement study and for confirming screen positive results is Gas Chromatography/Mass Spectrometry (GC/MS) results, specifically mentioned as operating in the selected ion monitoring (SIM) mode with deuterated internal standards. This is a highly accurate and accepted analytical chemistry method for drug detection and quantification.

8. Sample Size for the Training Set

• Training Set Sample Size: The document describes performance studies, but it does not provide information on a specific training set size for the development of the ELISA assay. This assay likely relies on established biochemical principles and reagent formulation rather than machine learning algorithms that typically require a distinct training set. The various "performance studies" described are for validation, not typically for training.

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

• Ground Truth for Training Set: As no explicit training set is described for this type of immunoassay, the concept of establishing ground truth for a training set in the context of an AI/ML algorithm is not applicable. The assay's development would involve optimizing antibody specificity and binding characteristics against known concentrations of cocaine and its metabolites, with the performance ultimately validated against a gold standard like GC/MS.

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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.

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.

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