MODIFICATION TO ABUSCREEN ONLINE FOR CANNABINOIDS

K983701 · Roche Diagnostic Systems, Inc. · LDJ · Dec 11, 1998 · Clinical Toxicology

Device Facts

• Record ID: K983701
• Device Name: MODIFICATION TO ABUSCREEN ONLINE FOR CANNABINOIDS
• Applicant: Roche Diagnostic Systems, Inc.
• Product Code: LDJ · Clinical Toxicology
• Decision Date: Dec 11, 1998
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.3870
• Device Class: Class 2

Intended Use

Abuscreen ONLINE for Cannabinoids is an in vitro diagnostic test for the qualitative and semiquantitative detection of cannabinoids in human urine on automated clinical chemistry analyzers at cutoff concentrations of 20 ng/mL, 50 ng/mL, and 100 ng/mL. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. Measurements obtained by this device are used in the diagnosis of cannabinoid use or abuse.

Device Story

Abuscreen ONLINE Cannabinoids is an in vitro diagnostic assay for detecting cannabinoids in human urine. It utilizes kinetic interaction of microparticles in a solution, measured by changes in light transmission. The device is designed for use on automated clinical chemistry analyzers, specifically the Hitachi 917. The assay reagents include a monoclonal antibody (mouse) reagent, a conjugated cannabinoid derivative microparticle reagent, and a buffer diluent. The system automates sample processing, photometric measurement, and result transmission. Healthcare providers use the qualitative or semiquantitative results to assist in the diagnosis of cannabinoid use or abuse. The device provides laboratories with the ability to assess assay performance via semiquantitative results as part of a quality control program.

Clinical Evidence

Bench testing only. Precision studies (within-run and day-to-day) were conducted at 20, 50, and 100 ng/mL cutoffs, reporting mean OD and CV% values. Accuracy was evaluated by comparing results against confirmed positive samples (N=69 for proposed device vs N=50 for predicate). Limit of detection was reported as 7 ng/mL.

Technological Characteristics

Methodology: Kinetic interaction of microparticles in solution measured by light transmission. Reagents: Mouse monoclonal antibody, conjugated cannabinoid derivative microparticles, and buffer diluent. Platform: Automated clinical chemistry analyzer (Hitachi 917).

Indications for Use

Indicated for qualitative and semiquantitative detection of cannabinoids and metabolites in human urine for diagnosis of cannabinoid use or abuse. Intended for use on automated clinical chemistry analyzers (specifically Hitachi 917) at 20, 50, and 100 ng/mL cutoffs.

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 (K981585)

Reference Devices

• Hitachi 917 Analyzer System (K953239)

Submission Summary (Full Text)

{0}------------------------------------------------

# Roche

# Diagnos

# 510(k) Summary

# Abuscreen ONLINE® Cannabinoids

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:

### Identification of 510(k) Sponsor: I.

Roche Diagnostic Systems, Inc. a subsidiary of Hoffmann-La Roche, Inc. Branchburg Township 1080 U.S. Highway 202 Somerville, New Jersey 08876-3771

510(k) Submission dated October 20, 1998

Rita Smith Contact: Senior Regulatory Affairs Associate Phone: [phone] [phone] Fax:

Branchburg Township 1080 U.S. Highway 202 Somerville, New Jersey 08876-3771

{1}------------------------------------------------

### II. Device Name:

The device name, including both the trade/proprietary name and the classification name are provided in the table below.

| C<br>1<br>abl<br>1<br>le<br>1 |
|-------------------------------|
|-------------------------------|

| Product Name | Classification<br>Name | Product<br>Code | CFR<br>Number and<br>Regulatory Class |
|--------------------------------------|-------------------------------------|-----------------|---------------------------------------|
| Abuscreen ONLINE for<br>Cannabinoids | Enzyme Immunoassay,<br>Cannabinoids | LDJ | 862.3870<br>Class II |

### Identification of the legally marketed device to which the 510(k) sponsor claims III. equivalence:

The following table identifies the legally marketed devices to which Roche Diagnostic Systems, Inc. claims equivalence.

# Table 2

| Product Name | Predicate Product Name | 510(k) Number and Date<br>Predicate Cleared |
|--------------------------------------|--------------------------------------|---------------------------------------------|
| Abuscreen ONLINE for<br>Cannabinoids | Abuscreen ONLINE for<br>Cannabinoids | K981585 5/28/98 |

{2}------------------------------------------------

### IV. Description of the Device/Statement of Intended Use:

Abuscreen ONLINE Cannabinoids is an in vitro diagnostic test for the qualitative and semiquantitative detection of cannabinoids and its metabolites in human urine on automated clinical chemistry analyzers at cutoff concentrations of 20 ng/mL, 50 ng/mL, and 100 ng/mL. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. Measurements obtained by this device are used in the diagnosis of cannabinoid use or abuse.

The proposed Abuscreen ONLINE Cannabinoids test kit is specifically intended for use on the Hitachi 917 Analyzer and future similar analyzer models. It was adapted from the currently marketed Abuscreen ONLINE Cannabinoids test kit. The labeling and packaging have been changed for use on the Hitachi 917 Analyzer as well as an addition of a surfactant to the diluent. This modified test kit is not a replacement to the currently marketed kit.

The Hitachi 917 Analyzer System is a fully automatic, computer-controlled system for clinical chemistry. It was conceived for both quantitative and qualitative in vitro determination using a large variety of tests for analysis, e.g. in serum and urine. Integrated in the system is an ion-selective unit for determination of electrolytes. The throughout per hour is 800 tests for clinical chemistry (1200 with electrolytes). The system consists of the analyzer which performs all functions required for fully automatic sample and test processing. Beginning with the automatic recording of patient samples - provided that they are supplied in barcode-labeled vessels - up to the photometric measurement and results transmission to the computer unit. Additional detailed information about the Hitachi 917 Analyzer is contained in volume II of the premarket notification (K953239) cleared on September 25, 1995.

### V. Summary of the technological characteristics of the new device in comparison to those of the predicate.

Tables 3 outlines the technological characteristics (methodologies) of the Abuscreen ONLINE Cannabinoids in comparison to that of the legally marketed product.

{3}------------------------------------------------

### Brief discussion of the clinical and nonclinical tests relied on for a determination of VI. substantial equivalence:

Tables 3 demonstrates the results of clinical and nonclinical studies performed using the Abuscreen ONLINE Cannabinoids test kit. The significant performance characteristics relied upon for a determination of substantial equivalence are summarized in this chart. This information concludes that the performance of this device is essentially equivalent to the legally marketed predicate device.

{4}------------------------------------------------

# Abuscreen ONLINE Cannabinoids for Hitachi 917 Table 1

| | Proposed: | | Previously Cleared: (K981585) |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Abuscreen ONLINE | | Abuscreen ONLINE |
| | | Cannabinoids for Hitachi 917 | Cannabinoids (1000 Test Kit) |
| Methodology | | Kinetic interaction of microparticles<br>in a solution as measured by<br>changes in light transmission | Kinetic interaction of microparticles<br>in a solution as measured by<br>changes in light transmission |
| Sample type | urine | | urine |
| Intended Use | qualitative and semiquantitative<br>detection of cannabinoids and its<br>metabolites | | qualitative and semiquantitative<br>detection of cannabinoids |
| Calibrator | | Abuscreen ONLINE Cannabinoids<br>Calibration Pack | Abuscreen ONLINE Cannabinoids<br>Calibration Pack or Abuscreen<br>Cannabinoids Calibration Pack 20 |
| Cutoff(s) | 20, 50, 100 ng/mL | | 20, 50, 100 ng/mL |
| Reagent (active<br>ingredients) | 1. Ab reagent: cannabinoids<br>monclonal (mouse) antibody in<br>buffer<br>2. Microparticle reagent:<br>Conjugated cannabinoid derivative<br>microparticles in buffer<br>3. Diluent: Buffer | | 1. Ab reagent: cannabinoids<br>monclonal (mouse) antibody in<br>buffer<br>2. Microparticle reagent:<br>Conjugated cannabinoid derivative<br>microparticles in buffer<br>3. Diluent: Buffer |
| Performance Characteristics: | | | |
| Precision Qualitative ( 20 ng/mL Cutoff): | | | |
| | >95% negative at 15 ng/mL | | >95% negative at 15 ng/mL |
| | >95% positive at 25 ng/mL | | >95% positive at 25 ng/mL |
| Within Run | Mean (OD) | CV% | |
| 15 ng/mL | 5607 | 0.9 | |
| 20 ng/mL | 4990 | 1.0 | |
| 25 ng/mL | 4614 | 1.3 | |
| 50 ng/mL | 2660 | 1.1 | |
| 60 ng/mL | 2153 | 2.0 | |
| Day-to-Day | Mean (OD) | CV% | |
| 15 ng/mL | 5651 | 1.3 | |
| 20 ng/mL | 5054 | 1.4 | |
| 25 ng/mL | 4670 | 1.6 | |
| 50 ng/mL | 2729 | 2.2 | |
| 60 ng/mL | 2237 | 2.9 | |

{5}------------------------------------------------

______________________________________________________________________________________________________________________________________________________________________________

# Abuscreen ONLINE Cannabinoids for Hitachi 917 Table 1 (Continued)

| Proposed: | | | Previously Cleared: (K981585) | | |
|---------------------------------------------------------------|--------------------------------------------------------|-----|--------------------------------------------------------------------------------|-----------------------------|-----------|
| Abuscreen ONLINE | | | Abuscreen ONLINE Cannabinoids | | |
| Cannabinoids for Hitachi 917 | | | (1000 Test Kit) | | |
| | 50 ng/mLCutoff ):<br>Precision Qualitative | | | | |
| | >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 | | |
| | | | | | |
| Within Run | Mean (OD) | CV% | | | |
| 25 ng/mL | 2403 | 2.9 | | | |
| 40 ng/mL | 1732 | 1.1 | | | |
| 50 ng/mL | 1340 | 1.5 | | | |
| 60 ng/mL | 1169 | 2.2 | | | |
| 75 ng/mL | 823 | 1.3 | | | |
| Day-to-Day | Mean (OD) | CV% | | | |
| 25 ng/mL | 2404 | 1.1 | | | |
| 40 ng/mL | 1749 | 1.4 | | | |
| 50 ng/mL | 1354 | 2.2 | | | |
| 60 ng/mL | 1177 | 2.5 | | | |
| 75 ng/mL | 824 | 4.2 | | | |
| Precision Qualitative | 100 ng/mL Cutoff ): | | | | |
| | >95% negative at 80 ng/mL | | >95% negative at 75 ng/mL | | |
| | >95% positive at 120 ng/mL | | | >95% positive at 125 ng/mLL | |
| Within Run | Mean (OD) | CV% | | | |
| 50 ng/mL | 3180 | 1.4 | | | |
| 80 ng/mL | 2469 | 1.3 | | | |
| 100 ng/mL | 1755 | 1.2 | | | |
| 120 ng/mL | 1547 | 2.5 | | | |
| 150 ng/mL | 1120 | 2.9 | | | |
| Day-to-Day | Mean (OD) | CV% | | | |
| 50 ng/mL | 3194 | 1.6 | | | |
| 80 ng/mL | 2483 | 1.8 | | | |
| 100 ng/mL | 1764 | 2.7 | | | |
| 120 ng/mL | 1536 | 2.7 | | | |
| 150 ng/mL | 1119 | 3.2 | | | |
| Precision Quantitative | ( 20 ng/mL Cutoff ): | | | | |
| Within Run | Mean (ng/mL) | CV% | Conc. (ng/mL) | Mean (ng/mL) | CV% |
| 15 ng/mL | 13 | 5.0 | 15 | 13 | 6 |
| 20 ng/mL | 20 | 3.2 | 20 | 19 | 7 |
| 25 ng/mL | 23 | 2.9 | 25 | 23 | 4 |
| 50 ng/mL | 50 | 1.5 | 40 | 40 | 2 |
| 60 ng/mL | 94 | 1.3 | | | |
| Proposed:<br>Abuscreen ONLINE<br>Cannabinoids for Hitachi 917 | | | Previously Cleared: (K981585)<br>Abuscreen ONLINE Cannabinoids (1000 Test Kit) | | |
| Precision Quantitative (20 ng/mL Cutoff ): | | | | | |
| Day-to-Day | Mean (ng/mL) | CV% | Conc. (ng/mL) | Mean (ng/mL) | CV% |
| 15 ng/mL | 14 | 9.1 | 15 | 14 | 7 |
| 20 ng/mL | 18 | 8.5 | 20 | 20 | 6 |
| 25 ng/mL | 24 | 4.6 | 25 | 25 | 5 |
| 50 ng/mL | 48 | 3.3 | 40 | 41 | 2 |
| 60 ng/mL | 97 | 7.6 | | | |
| Precision Quantitative ( 50 ng/mL Cutoff ): | | | | | |
| Within Run | Mean (ng/mL) | CV% | Conc. (ng/mL) | Mean (ng/mL) | CV% |
| 25 ng/mL | 23 | 2.9 | 25 | 23 | 4 |
| 40 ng/mL | 39 | 1.1 | 40 | 40 | 2 |
| 50 ng/mL | 50 | 1.5 | 50 | 49 | 1 |
| 60 ng/mL | 62 | 2.2 | 60 | 66 | 3 |
| 75 ng/mL | 94 | 1.3 | 100 | 101 | 1 |
| Day-to-Day | Mean (ng/mL) | CV% | Conc. (ng/mL) | Mean (ng/mL) | CV% |
| 25 ng/mL | 24 | 4.6 | 25 | 25 | 5 |
| 40 ng/mL | 39 | 4.0 | 40 | 41 | 2 |
| 50 ng/mL | 48 | 3.3 | 50 | 50 | 3 |
| 60 ng/mL | 60 | 5.8 | 60 | 68 | 3 |
| 75 ng/mL | 97 | 7.6 | 100 | 100 | 1 |
| Precision Quantitative ( 100 ng/mL Cutoff ): | | | | | |
| Within Run | Mean (ng/mL) | CV% | Conc. (ng/mL) | Mean (ng/mL) | CV% |
| 50 ng/mL | 54 | 2.3 | 50 | 50 | 4 |
| 80 ng/mL | 74 | 1.7 | 80 | 75 | 4 |
| 100 ng/mL | 103 | 2.0 | 100 | 95 | 2 |
| 120 ng/mL | 118 | 1.9 | 120 | 123 | 2 |
| 150 ng/mL | 154 | 1.5 | 150 | 148 | 1 |
| Day-to-Day | Mean (ng/mL) | CV% | Conc. (ng/mL) | Mean (ng/mL) | CV% |
| 50 ng/mL | 53 | 2.7 | 50 | 52 | 6 |
| 80 ng/mL | 75 | 2.6 | 80 | 76 | 3 |
| 100 ng/mL | 106 | 3.8 | 100 | 96 | 2 |
| 120 ng/mL | 120 | 3.2 | 120 | 125 | 2 |
| 150 ng/mL | 154 | 3.3 | 150 | 149 | 1 |
| Accuracy | | | | | |
| 20 ng/mL Cutoff | N= 69 Confirmed Pos.<br>69 Pos. 0 Neg. | | N= 50 Confirmed Pos.<br>50 Pos. 0 Neg. | | |
| 50 ng/mL Cutoff | N= 69 Confirmed Pos.<br>53 Pos. 16 Neg. | | N = 50 Confirmed Pos.<br>38 Pos. 12 Neg. | | |
| 100 ng/mL Cutoff | N= 69 Confirmed Pos.<br>37 Pos. 32 Neg. | | N= 50 Confirmed Pos.<br>21 Pos. 29 Neg. | | |
| Limit of Detection | 7 ng/mL | | | | < 5 ng/mL |

: 上一

{6}------------------------------------------------

# Abuscreen ONLINE Cannabinoids for Hitachi 917 Table 1 (Continued)

{7}------------------------------------------------

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/7/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, depicted in black.

DEC 1 1 1998

Ms. Rita Smith Senior Regulatory Affairs Associate Roche Diagnostic Systems, Inc. A Subsidiary of Hoffmann-La Roche, Inc. Branchburg Township 1080 U.S. Highway 202 Somerville, New Jersey 08876-3771

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Re : K983701 Abuscreen ONLINE® Cannabinoids Assay Trade Name: Regulatory Class: II Product Code: LDJ Dated: October 20, 1998 October 21, 1998

Dear Ms. Smith:

Received:

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 legally marketed predicate devices marketed in interstate commerce prior to May 28, 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 of the Act. The general controls provisions 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 A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, 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 concerning action. 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.

{8}------------------------------------------------

### Page 2

This letter will allow you to beqin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a leqally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (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 qeneral 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/dsma/dsmamain.html".

Sincerely yours,

Steven Autman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

{9}------------------------------------------------

Page of

510(k) Number (if known)

Device Name: Abuscreen ONLINE® Cannabinoids

Indications for Use:

Abuscreen ONLINE for Cannabinoids is an in vitro diagnostic test for the qualitative and semiquantitative detection of cannabinoids in human urine on automated clinical chemistry analyzers at cutoff concentrations of 20 ng/mL, 50 ng/mL, and 100 ng/mL. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. Measurements obtained by this device are used in the diagnosis of cannabinoid use or abuse.

## (PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)


scription Use

1

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use (Optional Format 1-2-96)

(Division Sign-Off)

Division of Clinical Laboratory Devices
510(k) Number K983701