MODIFICATION TO ABUSCREEN ONLINE BARBITURATES

K983698 · Roche Diagnostic Systems, Inc. · DIS · May 3, 1999 · Clinical Toxicology

Device Facts

• Record ID: K983698
• Device Name: MODIFICATION TO ABUSCREEN ONLINE BARBITURATES
• Applicant: Roche Diagnostic Systems, Inc.
• Product Code: DIS · Clinical Toxicology
• Decision Date: May 3, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3150
• Device Class: Class 2

Intended Use

Abuscreen ONLINE for Barbiturates is an in vitro diagnostic test for the qualitative and semiquantitative detection of barbiturates in human urine on the Hitachi 917 analyzer at a cutoff of 200 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 barbiturate use or abuse.

Device Story

Abuscreen ONLINE Barbiturates is an in vitro diagnostic enzyme immunoassay for detecting barbiturates in human urine. The device utilizes a kinetic interaction of microparticles in solution, measured by changes in light transmission. The assay is designed for use on the Hitachi 917 automated clinical chemistry analyzer. The system processes patient samples in barcode-labeled vessels, performs photometric measurements, and transmits results to a computer unit. The test provides qualitative and semiquantitative results at a 200 ng/mL cutoff, aiding clinicians in diagnosing barbiturate use or abuse. The kit includes a secobarbital polyclonal antibody reagent, conjugated secobarbital derivative microparticles, and a buffer diluent. It is intended for professional laboratory use.

Clinical Evidence

Bench testing only. Performance evaluated on the Hitachi 917 analyzer. Precision studies (within-run and day-to-day) conducted at concentrations ranging from 100-300 ng/mL, showing CVs generally <5%. Accuracy assessed against confirmed positive samples (N=50), demonstrating 100% agreement. Limit of detection reported as 2 ng/mL. Comparison to predicate (K914468) confirms equivalent performance characteristics.

Technological Characteristics

Enzyme immunoassay using kinetic interaction of microparticles in solution; measured by light transmission changes. Reagents: secobarbital polyclonal (sheep) antibody, conjugated secobarbital derivative microparticles, and buffer diluent. Designed for automated clinical chemistry analyzers (Hitachi 917).

Indications for Use

Indicated for the qualitative and semiquantitative detection of barbiturates in human urine for the diagnosis of barbiturate use or abuse. Intended for use on the Hitachi 917 analyzer.

Regulatory Classification

Identification

A barbiturate test system is a device intended to measure barbiturates, a class of hypnotic and sedative drugs, in serum, urine, and gastric contents. Measurements obtained by this device are used in the diagnosis and treatment of barbiturate use or overdose and in monitoring levels of barbiturate to ensure appropriate therapy.

Special Controls

*Classification.* Class II (special controls). A barbiturate 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 Barbiturates (K914468)

Reference Devices

• Hitachi 917 Analyzer (K953239)

Submission Summary (Full Text)

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4/3/95

483698

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# 510(k) Summary

## Abuscreen ONLINE® Barbiturates

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: K983698

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

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] Fax: [phone]

Roche Diagnostic Systems, Inc.

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.

| 'able<br>T | |
|------------|--|
|------------|--|

| Product Name | Classification<br>Name | Product<br>Code | CFR<br>Number and<br>Regulatory Class |
|--------------------------------------|------------------------------------|-----------------|---------------------------------------|
| Abuscreen ONLINE for<br>Barbiturates | Enzyme Immunoassay,<br>Barbiturate | DIS | 862.3150<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.

| 'able | ( |
|-------|---|
| T | 2 |

| Product Name | Predicate Product<br>Name | 510(k) Number and Date<br>Predicate Cleared |
|--------------------------------------|--------------------------------------|---------------------------------------------|
| Abuscreen ONLINE for<br>Barbiturates | Abuscreen ONLINE for<br>Barbiturates | K914468 10/30/91 |

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

Abuscreen ONLINE Barbiturates is an in vitro diagnostic test for the qualitative and semiquantitative detection of barbiturates in human urine on automated clinical chemistry analyzers at a cutoff of 200 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 barbiturate use or abuse.

The proposed Abuscreen ONLINE Barbiturates 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 Barbiturates test kit. The labeling and packaging have been modified for use on the Hitachi 917 Analyzer as well as a modification to the buffer formulation and the 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 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.

#### 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 Barbiturates test kit in comparison to that of the legally marketed predicate product.

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### 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 Barbiturates test kit on the Hitachi 917 Analyzer. 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 Barbiturates for Hitachi 917 Table 3

| | Proposed: | | Previously Cleared: (K914468) | |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|
| | Abuscreen ONLINE Barbiturates | | Abuscreen ONLINE Barbiturates<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 barbiturates | | qualitative detection of<br>barbiturates | |
| 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) | 200 ng/mL | | 200 ng/mL | |
| Reagent (active<br>ingredients) | 1. Ab reagent: secobarbital<br>polyclonal (sheep) antibody in<br>buffer<br>2. Microparticle reagent:<br>Conjugated secobarbital<br>derivative microparticles in<br>buffer<br>3. Diluent: Buffer | | 1. Ab reagent: secobarbital<br>polyclonal (sheep) antibody in<br>buffer<br>2. Microparticle reagent:<br>Conjugated secobarbital<br>derivative microparticles in<br>buffer<br>3. Diluent: Buffer | |
| Performance Characteristics: | | | | |
| Precision Qualitative (200 ng/mL Cutoff): | | | | |
| | >95% negative at 150 ng/mL<br>>95% positive at 250 ng/mL | | >95% negative at 160 ng/mL<br>>95% positive at 240 ng/mLL | |
| Within Run | Mean (OD) | CV% | | |
| 100 ng/mL | 3538 | 2.4 | | |
| 150 ng/mL | 3027 | 2.1 | | |
| 200 ng/mL | 2427 | 2.0 | | |
| 250 ng/mL | 2138 | 1.9 | | |
| 300 ng/mL | 1926 | 1.5 | | |
| Day-to-Day | Mean (OD) | CV% | | |
| 100 ng/mL | 3602 | 3.3 | | |
| 150 ng/mL | 3134 | 3.7 | | |
| 200 ng/mL | 2498 | 4.1 | | |
| 250 ng/mL | 2210 | 4.1 | | |
| 300 ng/mL | 1992 | 3.7 | | |
| | Proposed: | | Previously Cleared: (K914468) | |
| | Abuscreen ONLINE | | Abuscreen ONLINE Barbiturates | |
| | Barbiturates for Hitachi 917 | | (1000 Test Kit) | |
| Precision Quantitative (200 ng/mL): | | | | |
| Within Run | Mean (ng/mL) | CV% | Mean (ng/mL) | CV% |
| 100 ng/mL | 97 | 3.9 | 105 | 3.7 |
| 150 ng/mL | 144 | 3.0 | 163 | 2.5 |
| 200 ng/mL | 207 | 2.8 | 194 | 1.5 |
| 250 ng/mL | 275 | 1.5 | 221 | 1.8 |
| 300 ng/mL | 311 | 1.2 | 289 | 0.8 |
| Day-to-Day | Mean (ng/mL) | CV% | Mean (ng/mL) | CV% |
| 100 ng/mL | 98 | 3.6 | 110 | 5.5 |
| 150 ng/mL | 144 | 3.3 | 169 | 3.4 |
| 200 ng/mL | 203 | 2.8 | 201 | 2.6 |
| 250 ng/mL | 270 | 2.6 | 229 | 2.6 |
| 300 ng/mL | 309 | 2.2 | 294 | 4.2 |
| Accuracy | | | | |
| 200 ng/mL Cutoff | N= 50 Confirmed Pos. | | N = 74 Confirmed Pos. | |
| | 50 Pos.<br>0 Neg. | | 74 Pos. 0 Neg. | |
| Limit of Detection | 2 ng/mL | | 20 ng/mL | |

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## Abuscreen ONLINE Barbiturates for Hitachi 917 Table 3 (Continued)

.27

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing to the right. The profiles are arranged in a way that they appear to be connected. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.

3 1999 MAY

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re: K983698

> Trade Name: Abuscreen ONLINE® Barbiturates Regulatory Class: II Product Code: DIS Dated: March 23, 1999 Received: March 24, 1999

### 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 Regulations, 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 regulatory 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

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 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 Putman

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 of 1

510(k) Number (if known): K983698

Device Name: Abuscreen ONLINE® Barbiturates

Indications for Use:

Abuscreen ONLINE for Barbiturates is an in vitro diagnostic test for the qualitative and semiquantitative detection of barbiturates in human urine on the Hitachi 917 analyzer at a cutoff of 200 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 barbiturate use or abuse.

Lucin Cooper
(Division Sign-Off)

Division of Clinical Laboratory Devices 510(k) Number____ K 983698

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

✓

scription Use

Prescription Use (Per 21 CFR 801.109) OR

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