(42 days)
The Redi-Test THC is designed for the qualitative determination of cannabinoids (THC) and its metabolites in human urine specimens. The presence of 11nor-Δ°-ΤΗC-9-COOH in human urine as low as 50 ng/ml can be detected. This test is for use in clinical laboratories by health care professionals and forensic professionals only.
The Redi-Test THC is a rapid immunochromatographic competitive assay used to screen human urine for the presence of cannabinoids at a cutoff concentration of 50ng/mL. The test is qualitative and provides only a preliminary analytical result which must be confirmed by an alternate methodology preferably GC/MS.
The Redi-Test THC is an immunochromatograpic based one step in vitro test.
Acceptance Criteria and Study Details for Redi-Test THC (K990870)
1. Table of Acceptance Criteria and Reported Device Performance
| Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Correlation | Not explicitly stated, but high correlation with predicate is implied for substantial equivalence. | 99% correlation with the predicate device (DRI Cannabinoids Enzyme Immunoassay). |
| Sensitivity | Similar to predicate device (DRI Cannabinoids Enzyme Immunoassay). | Detected 11-Hydroxy-Δ⁹-THC at a cutoff of 50ng/mL. Predicate detected at 20ng/mL. |
| Specificity | Similar to predicate device (DRI Cannabinoids Enzyme Immunoassay). | Found to be similar to the predicate device. |
| Accuracy | Similar to predicate device (DRI Cannabinoids Enzyme Immunoassay). | Found to be similar to the predicate device. |
| Precision | Similar to predicate device (DRI Cannabinoids Enzyme Immunoassay). | Found to be similar to the predicate device. |
| Cutoff | The device needs to detect 11-nor-Δ⁹-ΤΗC-9-COOH at a specified cutoff. | Detects 11-nor-Δ⁹-ΤΗC-9-COOH as low as 50 ng/ml. |
Note: The acceptance criteria were not explicitly defined as numerical thresholds in this 510(k) summary but were implied by the claim of "substantial equivalence" to the predicate device in terms of sensitivity, specificity, accuracy, and precision, and the 99% correlation.
2. Sample Size and Data Provenance for the Test Set
- Sample Size: 100 specimens
- 50 positive samples
- 50 negative samples
- Data Provenance: Not specified (e.g., country of origin). The data is retrospective, as existing specimens were used for comparison.
3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set)
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/not described. The ground truth was established by GC/MS confirmation and comparison to a legally marketed predicate device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No. This device is an in vitro diagnostic (IVD) assay, not an imaging-based AI device, and therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or applicable.
6. Standalone (Algorithm Only) Performance Study
- Was a standalone study done? Yes. The study directly assessed the performance of the Redi-Test THC device by comparing its results to the predicate device and GC/MS confirmation on 100 specimens. The device's performance was evaluated independently in this context.
7. Type of Ground Truth Used
- Type of Ground Truth:
- External Reference Standard: Gas Chromatography/Mass Spectrometry (GC/MS) confirmation was used for objective determination of positive and negative samples below 24.7ng/mL and above 31ng/mL.
- Comparison to Predicate Device: The DRI Cannabinoids Enzyme Immunoassay served as a comparative ground truth for evaluating correlation, sensitivity, specificity, accuracy, and precision.
8. Sample Size for the Training Set
- Sample Size: Not applicable. As an immunochromatographic assay, the Redi-Test THC does not involve a "training set" in the context of machine learning or AI algorithms. Its performance is based on its chemical and biological reactions.
9. How Ground Truth for the Training Set Was Established
- How Ground Truth Was Established: Not applicable, as there is no training set for this type of device.
§ 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).