(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.
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510(k) Summary
Abuscreen® OnLine for Cannabinoids (100 Test Kit)
In accordance with the Safe Medical Devices Act of 1990, a 510(k) summary is provided as outlined in 21 CFR 807.92.
The assigned 510(k) number is: K981584
Identification of 510(k) Sponsor I.
MAY 2 8 1998
Roche Diagnostic Systems, Inc. a subsidiary of Hoffmann-La Roche, Inc. Branchburg Township 1080 US Highway 202 Somerville, New Jersey 08876-3771
510(k) Submission dated: April 30, 1998
Rita Smith contact: Senior Regulatory Affairs Associate Phone: 908-253-7545 908-253-7547 Fax: E-mail: rita.smith@roche.com
II. Device Name
| Proprietary Name | Classification Name | Product Code |
|---|---|---|
| Abuscreen® OnLine forCannabinoids (1000 Test Kit) | Enzyme Immunoassay,Cannabinoids | LDJ |
Branchburg Township 1080 U.S. Highway 202 Somerville, New Jersey 08876-3771
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Identification of the legally marketed device to which the 510(k) sponsor III. claims equivalence.
| Product Name (modified) | Predicate Product Name | K Number | Date of SE |
|---|---|---|---|
| Abuscreen® OnLine forCannabinoids (1000 Test Kit) | Abuscreen® OnLine forCannabinoids (100 Test Kit) | K913414 | 9/25/91 |
Description of the Device / Statement of Intended Use: IV.
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.
V. Summary of the technological characteristics of the new device in comparison to those of the predicate.
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.
Although the NIDA recommended cutoff for Cannabinoids is 50 ng/mL, this lower cutoff is beneficial to a user who is interested in determining the presence of cannabinoids at a lower level.
The Intended Use statement has also been revised to include an indication for the use of semi-quantitative test results. Previously, the indication for semiquantitative test results was stated in the "Results" section of the package insert but not in the "Intended Use" section. There is no change in the way results are printed or the utility of the semi-quantitative results. Semi-quantitative values are still only indicated to follow trends in quality control data and to determine dilutions for GC/MS but not to be used in evaluating an individual's test results.
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VI. Brief discussion of the clinical and nonclinical tests relied on for a determination of substantial equivalence.
The following table summarizes the significant performance characteristics relied on for a determination of substantial equivalence. This information concludes that the performance of these devices are essentially equivalent.
| Modified Product:Abuscreen ONLINE for Cannabinoids(100 Test Kit) | Previously Cleared: (K913414)Abuscreen ONLINE forCannabinoids (100 Test Kit) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Performance Characteristics: | |||||||||
| Precision Qualitative: | |||||||||
| 20 ng/mL Cutoff | >95% negative at 10 ng/mL>95% positive at 30 ng/mL | ||||||||
| 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% positive at 80 ng/mL>95% positive at 120 ng/mL | |||||||
| 100 ng/mL Cutoff | >95% negative at 80 ng/mL>95% positive at 120 ng/mL | ||||||||
| Precision Quantitative: | Within Run | Day-to-Day | Within Run | Day-to-Day | |||||
| 20 cutoff: | |||||||||
| Conc. (ng/mL) | 10 | 30 | 10 | 30 | |||||
| Mean (OD) | 598 | 1740 | 509 | 1582 | |||||
| CV % | 17 | 4 | 19 | 11 | |||||
| 50 cutoff: | |||||||||
| Conc. (ng/mL) | 40 | 50 | 60 | 40 | 50 | 60 | 50 | 50 | |
| Mean (ng/mL) | 41.5 | 52.5 | 61.7 | 40.2 | 52.0 | 67.4 | 49 | 49 | |
| CV % | 6 | 7 | 4 | 10 | 11 | 13 | 8.4 | 10.4 | |
| 100 cutoff: | |||||||||
| Conc. (ng/mL) | 80 | 100 | 120 | 80 | 100 | 120 | 100 | 100 | |
| Mean (ng/mL) | 87.2 | 100.6 | 137.7 | 83.9 | 100.5 | 133.6 | 98 | 98 | |
| CV % | 7 | 5 | 7 | 11 | 11 | 8 | 5.0 | 8.0 | |
| Accuracy | |||||||||
| 20 ng/mL Cutoff | N = 55 Confirmed Pos.54 Pos. 1 Neg. | ||||||||
| 50 ng/mL Cutoff | N = 55 Confirmed Pos.41 Pos. 14 Neg. | N = 247 Confirmed Pos.245 Pos. 2 Neg. | |||||||
| 100 ng/mL Cutoff | N= 55 Confirmed Pos.31 Pos. 24 Neg. | N = 206 Confirmed Pos.187 Pos. 19 Neg. | |||||||
| Sensitivity(Analytical) | 5 ng/mL | 5 ng/mL |
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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with a more abstract and flowing design.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 2 8 1998
Rita Smith . Senior Regulatory Affairs Associate Roche Diagnostics Systems, Inc. 1080 U.S. Hiqhway 202 Somerville, New Jersey 08876-3771
Re : K981584 Abuscreen ONLINE for Cannabinoids - 100 Test Kit Requlatory Class: II Product Code: LDJ Dated: April 30, 1998 Received: May 4, 1998
Dear Ms. Smith:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate able beated in the envilor, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, -as -forth in the Quality System Regulation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for vour device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Litman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of
510(k) Number (if known)
Device Name: Abuscreen ONLINE for Cannabinoids
Indications for Use:
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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Montgomery is a city in Alabama.
§ 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).