ABUSCREEN ONLINE BENZ 300 CALIBRATORS

K983556 · Roche Diagnostic Systems, Inc. · DLJ · Dec 15, 1998 · Clinical Toxicology

Device Facts

• Record ID: K983556
• Device Name: ABUSCREEN ONLINE BENZ 300 CALIBRATORS
• Applicant: Roche Diagnostic Systems, Inc.
• Product Code: DLJ · Clinical Toxicology
• Decision Date: Dec 15, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3200
• Device Class: Class 2

Indications for Use

Abuscreen ONLINE BENZ 300 Calibrators are designed for the calibration of the Roche assays for Benzodiazepines. This clinical toxicology calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens.

Device Story

Abuscreen ONLINE BENZ 300 Calibrators are liquid reference materials used in clinical toxicology laboratories to calibrate Roche benzodiazepine assays. The device provides specific concentration levels (0, 150, 300, 600 ng/mL) of benzodiazepines in a urine matrix. By establishing these reference points, the calibrators enable the assay system to quantify benzodiazepine levels in patient urine samples. The output is used by laboratory professionals to ensure the accuracy and reliability of diagnostic test results, which informs clinical decisions regarding drug screening and toxicology assessment.

Clinical Evidence

No clinical or nonclinical tests were necessary to establish substantial equivalence.

Technological Characteristics

The device consists of a urine-based matrix containing benzodiazepines at defined concentrations (0, 150, 300, 600 ng/mL). It functions as a calibrator for in vitro diagnostic test systems. No specific materials, energy sources, or software algorithms are described.

Indications for Use

Indicated for the calibration of Roche benzodiazepine assays in human urine specimens to establish reference points for clinical toxicology testing.

Regulatory Classification

Identification

A clinical toxicology calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (See also § 862.2 in this part.)

Special Controls

*Classification.* Class II (special controls). 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.

Predicate Devices

• Abuscreen ONLINE Calibration Pack (K951595)

Submission Summary (Full Text)

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DEC 1 5 1998

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# 510(k) Summary

# Abuscreen ONLINE® BENZ 300 Calibrators

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:________________________________________________________________________________________________________________________________________________

#### 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 9, 1998

Contact: Maria Feijoo Manager, Regulatory Affairs Phone: [phone] [phone] Fax:

#### 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 BENZ 300<br>Calibrators | Calibrators, Drug Specific | DLJ | 862.3200<br>Class II |

## Tahle 1

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## 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.

| र<br>1<br>1<br>able | 1 |
|---------------------|---|
|---------------------|---|

| Product Name | Predicate Product<br>Name | 510(k) Number and Date<br>Predicate Cleared |
|------------------------------------------|--------------------------------------|---------------------------------------------|
| Abuscreen ONLINE BENZ 300<br>Calibrators | Abuscreen ONLINE Calibration<br>Pack | K951595 9/8/95 |

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

Abuscreen ONLINE BENZ 300 Calibrators are designed for the calibration of the Roche assays for Benzodiazepines. This clinical toxicology calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens.

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

Tables 3 outlines the characteristics of the Abuscreen ONLINE BENZ 200 Calibrators in comparison to those of legally marketed predicate products.

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

No clinical or nonclinical tests were necessary to establish substantial equivalence.

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# Comparison Summary

| | Proposed:<br>Abuscreen ONLINE BENZ<br>300 Calibrators | Previously Cleared:<br>(K951595)<br>Abuscreen ONLINE<br>Calibration Pack |
|-----------------------------------------|------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Matrix | urine | urine |
| Intended use | for the calibration of Roche<br>assays for benzodiazepines | for the calibration of Roche<br>assays for amphetamines,<br>barbiturates,<br>benzodiazepines, cocaine<br>metabolite, methadone,<br>opiates and pcp |
| Levels of<br>Benzodiazepines<br>(ng/mL) | 0<br>150<br>300<br>600 | 0<br>50<br>100<br>200 |

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DEC 15 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Maria Feijoo Manager, Requlatory Affairs Roche Diagnostic Systems, Inc. Branchburq Township 1080 U.S. Highway 202 Somerville, New Jersey 08876-3771

Re: K983556 Abuscreen ONLINE® BENZ 300 Calibrators Trade Name: Requlatory Class: II Product Code: DLJ Dated: October 9, 1998 Received: October 13, 1998

Dear Ms. Feijoo:

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 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 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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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 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 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 Dutman

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® BENZ 300 Calibrators

Indications for Use:

Abuscreen ONLINE BENZ 300 Calibrators are designed for the calibration of the Roche assays for Benzodiazepines. This clinical toxicology calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens.

# (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 Clinical Laboratory Devices | |
| 510(k) Number | k983556 |