(73 days)
Immunoassay for the qualitative detection of methamphetamine, opiates. cocaine metabolites, THC metabolites, phencyclidine, benzodiazepines, barbiturates, tricyclic antidepressants, methadone, and medionein, phonoyoneans, on assist in screening of drug of abuse samples. The detecting cut-off concentrations are as follows:
| MET | D-Methamphetamine | 1000 ng/mL |
|---|---|---|
| OPI | Morphine | 300 ng/mL |
| COC | Benzoylecgonine | 300 ng/mL |
| THC | 11-nor-Δ 9-9-carboxylic acid | 50 ng/mL |
| PCP | Phencyclidine | 25 ng/mL |
| Benzodiazepine | Oxazepam | 300 ng/mL |
| Barbiturate | Secobarbital | 300 ng/mL |
| Methadone | Methadone | 300 ng/mL |
| TCA | Nortriptyline | 1000 ng/mL |
Not Found
The provided document is a 510(k) premarket notification letter from the FDA for a device called "AccuSign® DOA 10" and related products. It outlines the FDA's determination of substantial equivalence to legally marketed predicate devices. However, this document primarily grants market authorization and does not contain the detailed study information, acceptance criteria, or performance data typically found in a clinical study report or a summary of safety and effectiveness data (SSED).
Therefore, I cannot fulfill all parts of your request with the information provided. Specifically, the document does not include:
- A table of acceptance criteria and reported device performance (beyond the cut-off concentrations listed for each substance).
- Sample sizes used for test sets.
- Data provenance.
- Number of experts and their qualifications for ground truth.
- Adjudication method for the test set.
- Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
- Information on standalone algorithm performance.
- Type of ground truth used (beyond implying chemical analysis for cut-off concentrations).
- Sample size for the training set.
- How ground truth for the training set was established.
What can be extracted from the provided document is the stated indications for use and the cut-off concentrations, which serve as a foundational aspect of the device's intended performance.
Here's the closest I can get to your request using the available information:
Device Description and Intended Use:
The AccuSign® DOA 10 (and related AccuSign DOA Panel, AccuSign MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP) is an immunoassay for the qualitative detection of various drugs of abuse and their metabolites in samples. It is intended to assist in the screening of drug of abuse samples.
Acceptance Criteria and Reported Device Performance
The core "acceptance criteria" presented in this document relate to the cut-off concentrations at which the device is designed to qualitatively detect the various substances. These cut-off concentrations define the threshold for a positive result.
| Substance | Detecting Cut-off Concentration (Acceptance Criteria) |
|---|---|
| MET (Methamphetamine) | 1000 ng/mL |
| OPI (Morphine) | 300 ng/mL |
| COC (Benzoylecgonine) | 300 ng/mL |
| THC (11-nor-Δ9-THC-carboxylic acid) | 50 ng/mL |
| PCP (Phencyclidine) | 25 ng/mL |
| Benzodiazepine (Oxazepam) | 300 ng/mL |
| Barbiturate (Secobarbital) | 300 ng/mL |
| Methadone | 300 ng/mL |
| TCA (Nortriptyline) | 1000 ng/mL |
Note: The document states "The detecting cut-off concentrations are as follows:" implying these are the performance targets the device aims to meet. Actual reported performance metrics like sensitivity, specificity, accuracy, or concordance with a reference method are not detailed in this document. Such information would typically be found in the device's intended use instructions or 510(k) summary (which is not this letter).
Missing Information and Limitations:
Based solely on the provided FDA 510(k) letter, the following information required by your request is not available:
- Sample size used for the test set: Not mentioned.
- Data provenance (e.g., country of origin, retrospective/prospective): Not mentioned.
- Number of experts used to establish ground truth & qualifications: Immunoassay performance is typically validated against laboratory reference methods (e.g., GC/MS), not through expert consensus in the same way as image interpretation. The concept of "experts" for ground truth as traditionally applied to image analysis or clinical diagnosis is not directly applicable here. The "ground truth" for these devices is usually the precise chemical concentration determined by a more definitive laboratory method.
- Adjudication method for the test set: Not applicable for this type of test (validation against a reference method).
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as this is a diagnostic assay, not an AI interpretation of complex data by human readers.
- Standalone (algorithm only) performance: This device is a standalone diagnostic assay. Its performance would be assessed directly without human interpretation as part of the "device performance" (e.g., accuracy against a gold standard). However, the specific metrics (sensitivity, specificity) are not provided in this letter.
- Type of ground truth used: Implied to be quantitative chemical analysis (e.g., GC/MS) to establish the true concentration of drug metabolites, which then determines if it's above or below the cut-off. This document does not explicitly state the method.
- Sample size for the training set: Not applicable in the context of an immunoassay. The "training" for such devices involves assay development and calibration, not machine learning on a distinct training set.
- How the ground truth for the training set was established: See point 8.
Conclusion:
This FDA 510(k) letter confirms the market clearance of the AccuSign® DOA 10 device based on substantial equivalence to existing devices. It defines the substances detected and their respective cut-off concentrations, which are fundamental to the device's intended performance. However, it does not include the detailed performance study results or methodologies (like expert adjudication, sample sizes, provenance, or specific validation metrics) that would typically be found in a comprehensive technical report or FDA's decision summary for substantial equivalence. For those details, one would need to consult the full 510(k) submission summary, if publicly available.
§ 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).