(24 days)
The Abuscreen ONLINE for Cannabinoids (100 Test Kit) is an in vitro diagnostic test for the qualitative and semi-quantitative detection of cannabinoids in human urine at 50 and 100 ng/mL cutoffs and the qualitative detection at 20 ng/mL cutoff. Semi-Quantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program.
The Abuscreen ONLINE for Cannabinoids (100 Test Kit) is an in vitro diagnostic test for the qualitative and semi-quantitative detection of cannabinoids in human urine at 50 and 100 ng/mL cutoffs and the qualitative detection at 20 ng/mL cutoff. Semi-Quantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. This product has been modified to include an additional cutoff of 20 ng/mL for detecting cannabinoids in human urine. This cutoff is in addition to the two cutoffs of 50 and 100 ng/mL which are supported in the previously cleared product.
Here's an analysis of the provided text regarding the Abuscreen® OnLine for Cannabinoids (100 Test Kit) device, structured according to your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (New Device) | Reported Device Performance (New Device) | Acceptance Criteria (Predicate) | Reported Device Performance (Predicate) |
|---|---|---|---|---|
| Precision Qualitative: | ||||
| 20 ng/mL Cutoff | >95% negative at 10 ng/mL, >95% positive at 30 ng/mL | >95% negative at 10 ng/mL, >95% positive at 30 ng/mL | N/A (new cutoff for this submission) | N/A (new cutoff for this submission) |
| 50 ng/mL Cutoff | >95% negative at 40 ng/mL, >95% positive at 60 ng/mL | >95% negative at 40 ng/mL, >95% positive at 60 ng/mL | >95% negative at 40 ng/mL, >95% positive at 60 ng/mL, >95% positive at 80 ng/mL, >95% positive at 120 ng/mL (Note: Predicate criteria more extensive) | The predicate device demonstrated: >95% negative at 40 ng/mL and >95% positive at 60 ng/mL. The table lists predicate values for 80 ng/mL and 120 ng/mL, but it's unclear if these were explicit criteria or just observed performance. For direct comparison, the 40/60 ng/mL align. |
| 100 ng/mL Cutoff | >95% negative at 80 ng/mL, >95% positive at 120 ng/mL | >95% negative at 80 ng/mL, >95% positive at 120 ng/mL | Not explicitly stated for predicate in the same format, but implied by the 50 ng/mL criteria and context. | Not explicitly stated for predicate in the same format, but implied by the 50 ng/mL criteria and context. |
| Precision Quantitative: | ||||
| 20 ng/mL Cutoff | Not explicitly stated as acceptance criteria based on CV% | Within Run: Conc. 10 ng/mL, Mean (OD) 598, CV% 17; Conc. 30 ng/mL, Mean (OD) 1740, CV% 4. Day-to-Day: Conc. 10 ng/mL, Mean (OD) 509, CV% 19; Conc. 30 ng/mL, Mean (OD) 1582, CV% 11. | N/A (new cutoff) | N/A (new cutoff) |
| 50 ng/mL Cutoff | Not explicitly stated as acceptance criteria based on CV% (but implicit that performance should be comparable) | Within Run: Conc. 40 ng/mL, Mean (ng/mL) 41.5, CV% 6; Conc. 50 ng/mL, Mean (ng/mL) 52.5, CV% 7; Conc. 60 ng/mL, Mean (ng/mL) 61.7, CV% 4. | Not explicitly stated as acceptance criteria based on CV% | Within Run: Conc. 40 ng/mL, CV% 10; Conc. 50 ng/mL, CV% 11; Conc. 60 ng/mL, CV% 13. Day-to-Day: Conc. 50 ng/mL, CV% 8.4; Conc. 50 ng/mL, CV% 10.4. |
| 100 ng/mL Cutoff | Not explicitly stated as acceptance criteria based on CV% (but implicit that performance should be comparable) | Within Run: Conc. 80 ng/mL, Mean (ng/mL) 87.2, CV% 7; Conc. 100 ng/mL, Mean (ng/mL) 100.6, CV% 5; Conc. 120 ng/mL, Mean (ng/mL) 137.7, CV% 7. | Not explicitly stated as acceptance criteria based on CV% | Within Run: Conc. 80 ng/mL, CV% 11; Conc. 100 ng/mL, CV% 11; Conc. 120 ng/mL, CV% 8. Day-to-Day: Conc. 100 ng/mL, CV% 5.0; Conc. 100 ng/mL, CV% 8.0. |
| Accuracy Qualitative: | ||||
| 20 ng/mL Cutoff | Not explicitly stated as numerical % accuracy (but implied by substantial equivalence) | N = 55 Confirmed Pos., 54 Pos. (detected by device), 1 Neg. (detected by device). | N/A (new cutoff) | N/A (new cutoff) |
| 50 ng/mL Cutoff | Not explicitly stated as numerical % accuracy (but implied by substantial equivalence) | N = 55 Confirmed Pos., 41 Pos. (detected by device), 14 Neg. (detected by device). | Not explicitly stated as numerical % accuracy | N = 247 Confirmed Pos., 245 Pos. (detected by device), 2 Neg. (detected by device). |
| 100 ng/mL Cutoff | Not explicitly stated as numerical % accuracy (but implied by substantial equivalence) | N = 55 Confirmed Pos., 31 Pos. (detected by device), 24 Neg. (detected by device). | Not explicitly stated as numerical % accuracy | N = 206 Confirmed Pos., 187 Pos. (detected by device), 19 Neg. (detected by device). |
| Sensitivity (Analytical) | 5 ng/mL (This is the analytical sensitivity requirement for the device) | 5 ng/mL (Reported performance meets the criterion) | 5 ng/mL | 5 ng/mL |
Note on Acceptance Criteria: For the precision and accuracy sections, precise numerical acceptance criteria beyond the ">95% positive/negative for qualitative limits" are not explicitly stated in the document. The submission focuses on demonstrating substantial equivalence to the predicate device, implying that the new device's performance should be comparable or acceptable for its intended use. The "Acceptance Criteria" for the (new) modified product are inferred directly from the "Reported Device Performance" for the modified product where explicit values are given, and from the predicate's established performance for the 50 and 100 ng/mL cutoffs.
2. Sample size used for the test set and the data provenance
- Test Set Sample Sizes:
- Accuracy (20 ng/mL Cutoff): N = 55 Confirmed Positive samples.
- Accuracy (50 ng/mL Cutoff): N = 55 Confirmed Positive samples.
- Accuracy (100 ng/mL Cutoff): N = 55 Confirmed Positive samples.
- For precision (qualitative and quantitative), the sample sizes are not explicitly stated as 'N' counts in the table, but the results for 'Within Run' and 'Day-to-Day' suggest multiple replicates were tested.
- Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- The document does not specify the number of experts, their qualifications, or their role in establishing the ground truth.
- The ground truth for accuracy is referred to as "Confirmed Pos." which implies a confirmatory method, likely GC/MS (Gas Chromatography/Mass Spectrometry) as mentioned in the "Intended Use" section for semi-quantitative results ("determine dilutions for GC/MS").
4. Adjudication method for the test set
- The document does not describe any adjudication method (e.g., 2+1, 3+1, none) for reaching a ground truth consensus. The "Confirmed Pos." designation suggests a definitive method was used (likely GC/MS), which often doesn't require reader adjudication in the same way imaging studies might.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an in vitro diagnostic test (an assay), not an imaging or interpretive AI device that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is a standalone device. The "Abuscreen® OnLine for Cannabinoids" is an enzyme immunoassay kit. Its performance characteristics (precision, accuracy, sensitivity) are evaluated intrinsically as a laboratory test, not as an AI algorithm that assists human interpretation. There is no human-in-the-loop component in the evaluation of the assay's performance itself.
7. The type of ground truth used
- The ground truth used for the accuracy studies is referred to as "Confirmed Pos." (Confirmed Positive). While the exact method isn't explicitly detailed for these specific "N=" entries, the general context of drug testing assays and the mention of semi-quantitative results being used to "determine dilutions for GC/MS" strongly implies that Gas Chromatography/Mass Spectrometry (GC/MS) was used as the confirmatory method for determining the true positive/negative status of the samples. GC/MS is a gold standard for confirming drug presence and concentration in urine.
8. The sample size for the training set
- The document does not mention a "training set." This type of device (an immunoassay kit) does not involve machine learning or AI algorithms that require training sets in the conventional sense. Its performance is inherent to its biochemical design.
9. How the ground truth for the training set was established
- Since there is no training set for this type of device, this question is not applicable.
§ 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).