(25 days)
Immunoassay for the qualitative detection of amphetamine, THC metabolites, methamphetamine, opiates, and phencyclidine in human urine to assist in screening of drugs of abuse samples. The detecting cut-off concentrations are as follows:
| AMP | Amphetamine | 1000 ng/mL |
|---|---|---|
| THC | 11-nor-A9-9-carboxylic acid | 50 ng/mL |
| COC | Benzoylecgonine | 300 ng/mL |
| MET | D-Methamphetamine | 1000 ng/mL |
| OPI | Morphine | 300 ng/mL |
| PCP | Phencyclidine | 25 ng/mL |
Not Found
The provided FDA document (K991751) is a 510(k) clearance letter for the Status Cup™ drug testing device. It does not contain a detailed study report with acceptance criteria and performance data in the format requested. The document primarily confirms that the device is substantially equivalent to legally marketed predicate devices for the qualitative detection of multiple drugs in human urine.
However, based on the Indications For Use section (page 3), we can infer the implied acceptance criteria and the claimed device performance with respect to the detecting cut-off concentrations.
Here's an attempt to structure the information based on the prompt, drawing directly from the provided text and acknowledging the limitations:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states the "detecting cut-off concentrations" for each substance. While not explicitly termed "acceptance criteria" in a typical study report, these are the thresholds the device is designed to meet for qualitative detection. The "reported device performance" is the claim that the device does detect at these concentrations.
| Drug Abbreviation | Drug Name | Acceptance Criteria (Cut-off Concentration) | Reported Device Performance (Detection at Cut-off) |
|---|---|---|---|
| AMP | Amphetamine | 1000 ng/mL | Qualitatively detects at 1000 ng/mL |
| THC | 11-nor-Δ9-9-carboxylic acid | 50 ng/mL | Qualitatively detects at 50 ng/mL |
| COC | Benzoylecgonine | 300 ng/mL | Qualitatively detects at 300 ng/mL |
| MET | D-Methamphetamine | 1000 ng/mL | Qualitatively detects at 1000 ng/mL |
| OPI | Morphine | 300 ng/mL | Qualitatively detects at 300 ng/mL |
| PCP | Phencyclidine | 25 ng/mL | Qualitatively detects at 25 ng/mL |
2. Sample size used for the test set and the data provenance:
- Sample size for test set: Not specified in the provided document.
- Data provenance: Not specified in the provided document (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of experts: Not specified.
- Qualifications of experts: Not specified.
4. Adjudication method for the test set:
- Not specified.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- MRMC study: Not applicable. This device is an in-vitro diagnostic (IVD) immunoassay, not an AI-assisted diagnostic tool requiring human reader interpretation in the context of an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This device is an immunoassay cup. Its performance is inherently "standalone" in that it produces a result directly from a biochemical reaction. There is no separate "algorithm" performance beyond the cup's chemical reactivity.
7. The type of ground truth used:
- While not explicitly stated, for IVD drug screens, the ground truth for performance studies is typically established using confirmatory analytical methods (e.g., Gas Chromatography-Mass Spectrometry (GC-MS) or Liquid Chromatography-Mass Spectrometry (LC-MS)) on urine samples spiked with known concentrations of the target analytes or using clinically characterized urine samples.
8. The sample size for the training set:
- Training set size: Not applicable/not specified. For an immunoassay, there isn't typically a "training set" in the machine learning sense. Performance is based on chemical design and validation studies.
9. How the ground truth for the training set was established:
- Ground truth establishment for training set: Not applicable, as there's no "training set" in the machine learning sense for this type of device.
Summary of Limitations:
The provided document is a 510(k) clearance letter, which confirms substantial equivalence. It does not include the detailed study reports or performance data that would typically contain the requested information about sample sizes, ground truth establishment, expert qualifications, or specific study methodologies. These details would be found within the premarket notification (510(k) submission) itself, which is not publicly available in this format.
§ 862.3870 Cannabinoid test system.
(a)
Identification. A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds includedelta -9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use.(b)
Classification. Class II (special controls). A cannabinoid 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).