(20 days)
The Redi-Screen is designed for the qualitative determination of five (5) DOA and their metabolites in human urine specimens. The five DOA include THC, PCP, Opiates, Cocaine and Methamphetamine. The presence of these drugs and their cross-reacting metabolites in human urine can be detected above the following cut off levels:
THC 50ng/mL
PCP 25ng/mL
Opiates 300ng/mL
Cocaine 300ng/mL
Methamphetamine 1,000ng/mL
The test is qualitative and provides only a preliminary analytical result, which must be confirmed by an alternate methodology preferably, GC/MS,
This test is for use in clinical laboratories by health care and forensic professionals only.
The Redi-Screen is an immunochromatographic based one step in vitro test.
Here's a breakdown of the acceptance criteria and the study information for the Redi-Screen device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" as a pass/fail threshold for the device's performance compared to a gold standard. Instead, it describes comparison studies that show the device's agreement with predicate devices. The "acceptance criteria" here implicitly refers to showing substantial equivalence.
| Analyte | Stated Cut-off Level | Predicate Device Agreement (% Range) |
|---|---|---|
| THC | 50 ng/mL | >96% to >99% |
| PCP | 25 ng/mL | >96% to >99% |
| Opiates | 300 ng/mL | >96% to >99% |
| Cocaine | 300 ng/mL | >96% to >99% |
| Methamphetamine | 1,000 ng/mL | >96% to >99% |
Note: The agreement percentage is a range provided for "all aspects" of the comparison studies against commercially available EIA DOA tests, not specific to each analyte.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not explicitly stated. The document only mentions "comparison studies" and "precision studies."
- Data Provenance: Not explicitly stated. Given it's a submission to the FDA for a device intended for clinical laboratories, it's likely the data was collected in a controlled laboratory setting, but the country of origin is not specified, nor whether it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
Not applicable. This device is an in-vitro diagnostic (IVD) for drug screening. Ground truth for such devices is typically established through analytical methods like GC/MS, not expert consensus on interpretations.
4. Adjudication Method for the Test Set:
Not applicable. As noted above, this isn't a device that requires human expert adjudication for establishing ground truth. The confirmation method is "alternate methodology, preferably GC/MS."
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No. This is an in-vitro diagnostic device and does not involve human readers interpreting results in the way an imaging AI would. Therefore, an MRMC study is not relevant.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Yes, essentially. The Redi-Screen is a standalone immunochromatographic test. Its performance is evaluated intrinsically through comparison studies, precision studies, specificity, and validation of cut-offs. It provides "only a preliminary analytical result," indicating it operates independently to provide that result, which then requires external confirmation (GC/MS).
7. The Type of Ground Truth Used:
The primary "ground truth" or reference method for comparison is:
- "Commercially available EIA DOA tests"
- For confirmation of results, "alternate methodology preferably, GC/MS" (Gas Chromatography/Mass Spectrometry), which is considered a gold standard for drug detection.
8. The Sample Size for the Training Set:
Not applicable. The Redi-Screen is an immunochromatographic assay, not an AI/machine learning algorithm that requires a training set in the conventional sense. Its "training" is inherent in the design and optimization of its biochemical components (antibodies, reagents) during manufacturing and development.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there isn't a "training set" in the context of an AI algorithm. The performance of the biochemical reagents and device design is validated against known concentrations of analytes and cross-reacting substances, using methods like GC/MS to prepare and verify those samples.
§ 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).