(182 days)
Immunoassay for the qualitative detection of THC metabolite, 11-nor-A2-THC-9-carboxylic acid, at the cut-off of 50 ng/mL in urine to assist in screening of drugs of abuse samples at home. For In vitro Diagnostic Use
Immunoassay for the qualitative detection of THC metabolite, 11-nor-A -THC-9-carboxylic acid, at the cut-off of 50 ng/mL in urine to assist in screening of drugs of abuse samples. For In vitro Diagnostic Use
Status Stik™ THC is simple one step immunochromatographic test for the rapid, qualitative detection of THC.
LifeSign®Home Drug Test (THC) is simple one sten immunochromatographic test for the rapid, qualitative detection of THC.
Here's a breakdown of the acceptance criteria and study information for the provided devices, based on the input text:
Acceptance Criteria and Device Performance
The provided text describes two devices, "Status Stik™ THC" (and its variants) and "LifeSign® Home Drug Test (THC)," both intended for the qualitative detection of THC. The studies conducted prove their substantial equivalence to a predicate device, K990786 Status DS™ DOA10.
Acceptance Criteria for Substantial Equivalence:
The primary acceptance criterion mentioned across both submissions is 100% correlation with the legally marketed predicate device (K990786 Status DS™ DOA10) when tested against a specific set of specimens.
| Acceptance Criteria | Reported Device Performance (Status Stik™ THC / LifeSign® Home Drug Test (THC)) |
|---|---|
| 100% correlation with predicate device | 100% correlation |
| Detection cutoff of 50 ng/mL in human urine | Same cutoff of 50 ng/mL |
| Same assay principle | Uses the same assay principle |
| Same immunochromatographic assay | Uses the same immunochromatographic assay |
| Same antibody to detect THC metabolite | Uses the same antibody |
For the "LifeSign® Home Drug Test (THC)" specifically, an additional acceptance criterion related to consumer use was evaluated:
| Acceptance Criteria | Reported Device Performance (LifeSign® Home Drug Test (THC)) |
|---|---|
| Over 95% overall accuracy in a consumer study | Showed over 95% overall accuracy |
Study Details for Substantial Equivalence
2. Sample size used for the test set and the data provenance:
- Sample Size: 100 specimens (50 negative and 50 positive for THC).
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, given it's an in vitro diagnostic device, the specimens would likely be human urine samples. The nature of the comparison to a legally marketed device suggests a retrospective analysis of previously collected or prepared samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the summaries. The ground truth for the 100 specimens would have been established by a reference method to categorize them as "positive" or "negative" for THC at the specified cutoff.
4. Adjudication method for the test set:
- This information is not provided in the summaries. The assessment described is a direct comparison (correlation) between the new device and the predicate device.
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:
- No. This type of study (MRMC with AI assistance) is not applicable as the devices described are single-step immunochromatographic tests for direct detection, not AI-powered interpretation tools.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in essence. The devices described (Status Stik™ THC, LifeSign® Home Drug Test (THC), and their variants) are standalone tests. Their performance is assessed based on the qualitative result (positive/negative line appearance) generated by the device itself. While a human reads the result, the "performance" described (100% correlation) refers to the device's ability to match the predicate, not a human's interpretation proficiency. For the "LifeSign® Home Drug Test (THC)"'s "consumer study," human interpretation is part of the "overall accuracy," but it's still about the device's performance in that context.
7. The type of ground truth used:
- The ground truth for the 100 specimens used in the equivalence study was established by the predicate device (K990786 Status DS™ DOA10) itself, against which the new devices showed 100% correlation. This implies the predicate device's results were considered the "truth" for this comparison. For the "consumer study" of the LifeSign® Home Drug Test (THC), the "overall accuracy" would have been determined by comparing the consumer's test result to an independent, more definitive laboratory method (e.g., GC/MS or another high-accuracy lab-based immunoassay).
8. The sample size for the training set:
- This information is not applicable/provided. These are immunoassay devices, not machine learning algorithms that typically require a distinct "training set." The development of the assay (e.g., antibody selection, assay conditions) would have involved extensive R&D, but this is distinct from a "training set" in the AI/ML context.
9. How the ground truth for the training set was established:
- This information is not applicable/provided for the reasons stated above.
§ 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).