(24 days)
No
The summary describes a standard in vitro diagnostic test kit based on chemical reactions and cutoff values, with no mention of AI/ML terms or methodologies.
No.
This device is an in vitro diagnostic test used for detecting cannabinoids in human urine, not for treating any condition or disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "an in vitro diagnostic test for the qualitative and semi-quantitative detection of cannabinoids in human urine." The "Device Description" also refers to it as "an in vitro diagnostic test."
No
The device is described as an "in vitro diagnostic test for the qualitative and semi-quantitative detection of cannabinoids in human urine." This indicates it is a physical test kit that interacts with a biological sample (urine) to produce results, which is not characteristic of a software-only medical device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states it is an "in vitro diagnostic test." It is designed to detect cannabinoids in human urine, which is a biological sample tested outside of the body.
- Device Description: The device description reiterates that it is an "in vitro diagnostic test."
- Nature of the Test: The test performs qualitative and semi-quantitative analysis of a biological sample (urine) to detect the presence of a substance (cannabinoids). This is a core function of IVD devices.
- Intended User: The intended user is "Laboratories," which is a typical setting for performing IVD tests.
The information provided clearly aligns with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
LDJ
Device Description
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. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human urine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
laboratories
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Precision Qualitative:
20 ng/mL Cutoff: >95% negative at 10 ng/mL, >95% positive at 30 ng/mL
50 ng/mL Cutoff (Modified Product): >95% negative at 40 ng/mL, >95% positive at 60 ng/mL
50 ng/mL Cutoff (Previously Cleared K913414): >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:
20 cutoff:
Conc. (ng/mL): 10 (Within Run), 30 (Within Run), 10 (Day-to-Day), 30 (Day-to-Day)
Mean (OD): 598 (Within Run), 1740 (Within Run), 509 (Day-to-Day), 1582 (Day-to-Day)
CV %: 17 (Within Run), 4 (Within Run), 19 (Day-to-Day), 11 (Day-to-Day)
50 cutoff:
Conc. (ng/mL): 40 (Within Run), 50 (Within Run), 60 (Within Run), 40 (Day-to-Day), 50 (Day-to-Day), 60 (Day-to-Day), 50, 50
Mean (ng/mL): 41.5 (Within Run), 52.5 (Within Run), 61.7 (Within Run), 40.2 (Day-to-Day), 52.0 (Day-to-Day), 67.4 (Day-to-Day), 49, 49
CV %: 6 (Within Run), 7 (Within Run), 4 (Within Run), 10 (Day-to-Day), 11 (Day-to-Day), 13 (Day-to-Day), 8.4, 10.4
100 cutoff:
Conc. (ng/mL): 80 (Within Run), 100 (Within Run), 120 (Within Run), 80 (Day-to-Day), 100 (Day-to-Day), 120 (Day-to-Day), 100, 100
Mean (ng/mL): 87.2 (Within Run), 100.6 (Within Run), 137.7 (Within Run), 83.9 (Day-to-Day), 100.5 (Day-to-Day), 133.6 (Day-to-Day), 98, 98
CV %: 7 (Within Run), 5 (Within Run), 7 (Within Run), 11 (Day-to-Day), 11 (Day-to-Day), 8 (Day-to-Day), 5.0, 8.0
Accuracy:
20 ng/mL Cutoff: N = 55 Confirmed Pos. 54 Pos. 1 Neg.
50 ng/mL Cutoff (Modified Product): N = 55 Confirmed Pos. 41 Pos. 14 Neg.
50 ng/mL Cutoff (Previously Cleared K913414): N = 247 Confirmed Pos. 245 Pos. 2 Neg.
100 ng/mL Cutoff (Modified Product): N= 55 Confirmed Pos. 31 Pos. 24 Neg.
100 ng/mL Cutoff (Previously Cleared K913414): N = 206 Confirmed Pos. 187 Pos. 19 Neg.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity (Analytical): 5 ng/mL (for both Modified Product and Previously Cleared Product)
Precision Qualitative:
20 ng/mL Cutoff: >95% negative at 10 ng/mL, >95% positive at 30 ng/mL
50 ng/mL Cutoff (Modified Product): >95% negative at 40 ng/mL, >95% positive at 60 ng/mL
50 ng/mL Cutoff (Previously Cleared K913414): >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
Accuracy:
20 ng/mL Cutoff: N = 55 Confirmed Pos. 54 Pos. 1 Neg.
50 ng/mL Cutoff (Modified Product): N = 55 Confirmed Pos. 41 Pos. 14 Neg.
50 ng/mL Cutoff (Previously Cleared K913414): N = 247 Confirmed Pos. 245 Pos. 2 Neg.
100 ng/mL Cutoff (Modified Product): N= 55 Confirmed Pos. 31 Pos. 24 Neg.
100 ng/mL Cutoff (Previously Cleared K913414): N = 206 Confirmed Pos. 187 Pos. 19 Neg.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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Image /page/0/Picture/1 description: The image shows the logo for Roche. The logo is a hexagon with the word "Roche" in bold, sans-serif font inside. The hexagon is outlined in black, and the word "Roche" is also in black.
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 for | ||
| Cannabinoids (1000 Test Kit) | Enzyme Immunoassay, | |
| Cannabinoids | LDJ |
Branchburg Township 1080 U.S. Highway 202 Somerville, New Jersey 08876-3771
1
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 for | |||
| Cannabinoids (1000 Test Kit) | Abuscreen® OnLine for | ||
| Cannabinoids (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.
2
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 for
Cannabinoids (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.
4
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.