MODIFICATION TO ABUSCREEN ONLINE COCAINE METABOLITE

K983697 · Roche Diagnostic Systems, Inc. · DIO · Dec 11, 1998 · Clinical Toxicology

Device Facts

• Record ID: K983697
• Device Name: MODIFICATION TO ABUSCREEN ONLINE COCAINE METABOLITE
• Applicant: Roche Diagnostic Systems, Inc.
• Product Code: DIO · Clinical Toxicology
• Decision Date: Dec 11, 1998
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.3250
• Device Class: Class 2

Intended Use

Abuscreen ONLINE Cocaine Metabolite is an in vitro diagnostic test for the qualitative and semiquantitative detection of benzoylecgonine, the primary metabolite of cocaine in human urine on automated clinical chemistry analyzers at a cutoff concentrations of 300 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 cocaine use or abuse.

Device Story

Abuscreen ONLINE Cocaine Metabolite is an in vitro diagnostic reagent kit for use on automated clinical chemistry analyzers (specifically Hitachi 917). The device detects benzoylecgonine in human urine samples. Principle of operation involves kinetic interaction of microparticles in solution, measured by changes in light transmission. The assay provides qualitative and semiquantitative results at a 300 ng/mL cutoff. Used in clinical laboratory settings by trained personnel. Results assist healthcare providers in diagnosing cocaine use or abuse. The device is an adaptation of a previously cleared kit, modified for use on the Hitachi 917 analyzer system.

Clinical Evidence

Bench testing only. Performance evaluated via precision (within-run and day-to-day) and accuracy studies. Precision studies showed CV% ranging from 0.6% to 2.9% across various concentrations. Accuracy was assessed using 50 confirmed positive urine samples, showing 100% agreement (50/50 positive). Limit of detection reported as 26 ng/mL.

Technological Characteristics

Reagents: benzoylecgonine polyclonal (sheep) antibody, conjugated benzoylecgonine derivative microparticles, and buffer. Methodology: Kinetic interaction of microparticles in solution measured by light transmission changes. Sample type: human urine. Platform: Automated clinical chemistry analyzer (Hitachi 917).

Indications for Use

Indicated for the qualitative and semiquantitative detection of benzoylecgonine (cocaine metabolite) in human urine to aid in the diagnosis of cocaine use or abuse.

Regulatory Classification

Identification

A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.

Special Controls

*Classification.* Class II (special controls). A cocaine and cocaine metabolite 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 Cocaine (K933053)

Reference Devices

• Hitachi 917 Analyzer System (K953239)

Submission Summary (Full Text)

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# 510(k) Summary

## Abuscreen ONLINE® Cocaine Metabolite

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:

DEC 1 1 1998

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

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#### II. Device Name:

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

| Product Name | Classification<br>Name | Product<br>Code | CFR<br>Number and<br>Regulatory Class |
|--------------------------------------------|-----------------------------------------------------------|-----------------|---------------------------------------|
| Abuscreen ONLINE for Cocaine<br>Metabolite | Enzyme Immunoassay,<br>Cocaine and Cocaine<br>Metabolites | DIO | 862.3250<br>Class II |

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

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

### Table 2

| Product Name | Predicate Product<br>Name | 510(k) Number and Date<br>Predicate Cleared |
|--------------------------------------------|------------------------------|---------------------------------------------|
| Abuscreen ONLINE for Cocaine<br>Metabolite | Abuscreen ONLINE for Cocaine | K933053 8/30/93 |

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

Abuscreen ONLINE Cocaine Metabolite is an in vitro diagnostic test for the qualitative and semiquantitative detection of benzoylecgonine, the primary metabolite of cocaine in human urine on automated clinical chemistry analyzers at a cutoff concentrations of 300 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 cocaine use or abuse.

The proposed Abuscreen ONLINE Cocaine Metabolite 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 Cocaine Metabolite test kit. The reagent compositions are the same as the previously cleared Abuscreen ONLINE Cocaine Metabolite kit; although the labeling and packaging have been modified for use on the Hitachi 917 Analyzer. 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 throughput 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.

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

Tables 3 outlines the technological characteristics (methodologies) of the Abuscreen ONLINE Cocaine Metabolite in comparison to those of the legally marketed predicate product.

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

Tables 3 demonstrates the results of clinical and nonclinical studies performed using the Abuscreen ONLINE Cocaine Metabolite 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.

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## Abuscreen ONLINE Cocaine Metabolite for Hitachi 917 Table 1

and the comments of the comments of the comments of the comments of the contribution of the contribution of the contribution of the contribution of the contribution of the fi

| | Proposed: | | Previously Cleared: (K933053) | | |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|-----|
| | Abuscreen ONLINE Cocaine for<br>Hitachi 917 | | Abuscreen ONLINE Cocaine<br>(1000 Test Kit) | | |
| Methodology | Kinetic interaction of<br>microparticles in a solution as<br>measured by changes in light<br>transmission | | Kinetic interaction of<br>microparticles in a solution as<br>measured by changes in light<br>transmission | | |
| Sample type | urine | | urine | | |
| Intended Use | qualitative and semiquantitative<br>detection of benzoylecgonine,<br>the primary metabolite of<br>cocaine | | qualitative and semiquantitative<br>detection of benzoylecgonine,<br>the primary metabolite of<br>cocaine | | |
| Calibrator | Abuscreen ONLINE Calibration<br>Pack or Abuscreen ONLINE<br>Calibrator Level 3 | | Abuscreen ONLINE Calibration<br>Pack or Abuscreen ONLINE<br>Calibrator Level 3 | | |
| Cutoff(s) | 300 ng/mL | | 150, 300 ng/mL | | |
| Reagent (active<br>ingredients) | 1. Ab reagent: benzoylecgonine<br>polyclonal (sheep) antibody in<br>buffer<br>2. Microparticle reagent:<br>Conjugated benzoylecgonine<br>derivative microparticles in<br>buffer<br>3. Diluent: Buffer | | 1. Ab reagent: benzoylecgonine<br>polyclonal (sheep) antibody in<br>buffer<br>2. Microparticle reagent:<br>Conjugated benzoylecgonine<br>derivative microparticles in<br>buffer<br>3. Diluent: Buffer | | |
| Performance Characteristics: | | | | | |
| Precision Qualitative (300 ng/mL Cutoff): | | | | | |
| | >95% negative at 225 ng/mL<br>>95% positive at 375 ng/mL | | >95% negative at 240 ng/mL<br>>95% positive at 360 ng/mLL | | |
| Within Run | Mean (OD) | CV% | | | |
| 150 ng/mL | 6245 | 1.3 | | | |
| 225 ng/mL | 4436 | 1.0 | | | |
| 300 ng/mL | 2746 | 1.1 | | | |
| 375 ng/mL | 1907 | 1.4 | | | |
| 450 ng/mL | 1708 | 1.9 | | | |
| Day-to-Day | Mean (OD) | CV% | | | |
| 150 ng/mL | 6178 | 1.7 | | | |
| 225 ng/mL | 4379 | 2.0 | | | |
| 300 ng/mL | 2696 | 2.4 | | | |
| 375 ng/mL | 1873 | 2.9 | | | |
| 450 ng/mL | 1661 | 2.5 | | | |
| | Proposed:<br>Abuscreen ONLINE Cocaine<br>for Hitachi 917 | | Previously Cleared: (K933052)<br>Abuscreen ONLINE Cocaine<br>(1000 Test Kit) | | |
| Precision Quantitative ( 300 ng/mL Cutoff ): | | | | | |
| Within Run | Mean (ng/mL) | CV% | Conc. (ng/mL) | Mean (ng/mL) | CV% |
| 150 ng/mL | 154 | 1.1 | 200 | 215 | 2 |
| 225 ng/mL | 230 | 1.1 | 300 | 300 | 2 |
| 300 ng/mL | 301 | 0.9 | 340 | 340 | 2 |
| 375 ng/mL | 407 | 0.6 | | | |
| 450 ng/mL | 441 | 0.6 | | | |
| Day-to-Day | Mean (ng/mL) | CV% | Conc. (ng/mL) | Mean (ng/mL) | CV% |
| 150 ng/mL | 150 | 2.9 | 200 | 211 | 4 |
| 225 ng/mL | 228 | 1.4 | 300 | 298 | 2 |
| 300 ng/mL | 300 | 1.0 | 340 | 336 | 2 |
| 375 ng/mL | 406 | 0.7 | | | |
| 450 ng/mL | 441 | 0.7 | | | |
| Accuracy | | | | | |
| 300 ng/mL Cutoff | N= 50 Confirmed Pos. | | N = 98 Confirmed Pos. | | |
| | 50 Pos.<br>0 Neg. | | 98 Pos. 0 Neg. | | |
| Limit of Detection | 26 ng/mL | | < 5 ng/mL | | |

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## Abuscreen ONLINE Cocaine Metabolite for Hitachi 917 Table 1 (Continued)

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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: K983697 Abuscreen ONLINE® Cocaine Metabolite Trade Name: Requlatory Class: II Product Code: DIO Dated: October 20, 1998 October 21, 1998 Received:

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 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (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 requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. 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 regulations.

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### Page 2

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 your 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/dsma/dsmamain.html".

Sincerely yours,

Steven Toutman

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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510(k) Number (if known)

Device Name: Abuscreen ONLINE® Cocaine Metabolite

Indications for Use:

Abuscreen ONLINE Cocaine Metabolite is an in vitro diagnostic test for the qualitative and semiquantitative detection of benzoylecgonine, the primary metabolite of cocaine in human urine on automated clinical chemistry analyzers at a cutoff concentrations of 300 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 cocaine use or abuse.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

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

(Division Sign-Off)
Division of General, Restorative and Neurological Devices
510(k) Number K983697