ABUSCREEN ONLINE FOR CANNABINOIDS (100 TEST KIT)

K981584 · Roche Diagnostic Systems, Inc. · LDJ · May 28, 1998 · Clinical Toxicology

Device Facts

• Record ID: K981584
• Device Name: ABUSCREEN ONLINE FOR CANNABINOIDS (100 TEST KIT)
• Applicant: Roche Diagnostic Systems, Inc.
• Product Code: LDJ · Clinical Toxicology
• Decision Date: May 28, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3870
• Device Class: Class 2

Intended 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.

Device Story

Abuscreen ONLINE for Cannabinoids is an in vitro diagnostic enzyme immunoassay for detecting cannabinoids in human urine. Device processes urine samples to provide qualitative results at 20, 50, and 100 ng/mL cutoffs, and semi-quantitative results for quality control assessment. Operated by laboratory personnel in clinical settings. Output is provided as qualitative presence/absence or semi-quantitative values. Semi-quantitative data assists in monitoring assay performance and determining dilutions for confirmatory GC/MS testing; not intended for direct clinical evaluation of individual patient status. Benefit includes enhanced sensitivity for cannabinoid detection at lower concentrations (20 ng/mL) compared to standard 50 ng/mL cutoffs.

Clinical Evidence

Bench testing only. Precision evaluated via qualitative and quantitative studies. Qualitative precision: >95% agreement at cutoffs. Quantitative precision: CV% reported for 20, 50, and 100 ng/mL cutoffs across within-run and day-to-day conditions. Accuracy assessed against confirmed positive samples (N=55 for 20, 50, 100 ng/mL cutoffs). Analytical sensitivity reported as 5 ng/mL.

Technological Characteristics

Enzyme immunoassay (EIA) for cannabinoid detection in urine. Supports qualitative and semi-quantitative analysis. Cutoffs: 20, 50, 100 ng/mL. No specific materials, energy sources, or software algorithm architectures (e.g., ML/DL) described; standard immunoassay methodology.

Indications for Use

Indicated for qualitative and semi-quantitative detection of cannabinoids in human urine. Cutoffs: 50 and 100 ng/mL (qualitative/semi-quantitative) and 20 ng/mL (qualitative). Intended for laboratory use to assess assay performance via quality control; not for evaluating individual test results.

Regulatory Classification

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 include delta-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.

Special Controls

*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).

Predicate Devices

• Abuscreen® OnLine for Cannabinoids (100 Test Kit) (K913414)

Submission Summary (Full Text)

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K981584/

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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: [phone] Fax: E-mail: [e-mail]

#### II. Device Name

| Proprietary Name | Classification Name | Product Code |
|-------------------------------------------------------|-------------------------------------|--------------|
| Abuscreen® OnLine for<br>Cannabinoids (1000 Test Kit) | Enzyme Immunoassay,<br>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 for<br>Cannabinoids (1000 Test Kit) | Abuscreen® OnLine for<br>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.

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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:<br>Abuscreen ONLINE for Cannabinoids<br>(100 Test Kit) | | Previously Cleared: (K913414)<br>Abuscreen ONLINE for<br>Cannabinoids (100 Test Kit) | | | | | |
|-----------------------------|------------------------------|--------------------------------------------------------------------------|------------|-------------------------------------------------------------------------------------------------------------------|------------|------------|-------|-----|------|
| | Performance Characteristics: | | | | | | | | |
| | Precision Qualitative: | | | | | | | | |
| 20 ng/mL Cutoff | | >95% negative at 10 ng/mL<br>>95% positive at 30 ng/mL | | | | | | | |
| 50 ng/mL Cutoff | | >95% negative at 40 ng/mL<br>>95% positive at 60 ng/mL | | >95% negative at 40 ng/mL<br>>95% positive at 60 ng/mL<br>>95% positive at 80 ng/mL<br>>95% positive at 120 ng/mL | | | | | |
| 100 ng/mL Cutoff | | >95% negative at 80 ng/mL<br>>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.<br>54 Pos. 1 Neg. | | | | | | | |
| 50 ng/mL Cutoff | | N = 55 Confirmed Pos.<br>41 Pos. 14 Neg. | | N = 247 Confirmed Pos.<br>245 Pos. 2 Neg. | | | | | |
| 100 ng/mL Cutoff | | N= 55 Confirmed Pos.<br>31 Pos. 24 Neg. | | N = 206 Confirmed Pos.<br>187 Pos. 19 Neg. | | | | | |
| Sensitivity<br>(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 [phone].

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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