PRECISET DAT AMPHETAMINE CALIBRATORS; CFAS DAT QUALITATIVE AMPHETAMINE CALIBRATORS

K033165 · Roche Diagnostics Corp. · DLJ · Oct 14, 2003 · Clinical Toxicology

Device Facts

• Record ID: K033165
• Device Name: PRECISET DAT AMPHETAMINE CALIBRATORS; CFAS DAT QUALITATIVE AMPHETAMINE CALIBRATORS
• Applicant: Roche Diagnostics Corp.
• Product Code: DLJ · Clinical Toxicology
• Decision Date: Oct 14, 2003
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.3200
• Device Class: Class 2

Intended Use

The Preciset DAT Amphetamine calibrators are designed for the calibration of the Roche Abuscreen OnLine assay for Amphetamines and the cassette COBAS Integra Amphetamines (AMPS) for the determination of amphetamines in human urine on automated clinical chemistry analyzers. The Cfas DAT Qualitative Amphetamine calibrator is designed for the qualitative calibration of the Roche Abuscreen OnLine assay for Amphetamines and the cassette COBAS Integra Amphetamines (AMPS) for the determination of amphetamines in human urine on automated clinical chemistry analyzers.

Device Story

Preciset DAT and Cfas DAT Qualitative Amphetamine Calibrators; used for calibration of Roche Abuscreen OnLine and COBAS Integra Amphetamine assays. Preciset DAT contains 6 levels (0, 250, 500, 1000, 1500, 2000 ng/mL d-amphetamine in human urine); Cfas DAT contains single level (1000 ng/mL d-amphetamine in human urine). Concentrations verified by GC/MS. Used in clinical chemistry laboratories on automated analyzers. Provides reference points for assay calibration to ensure accurate quantification or qualitative determination of amphetamines in patient urine samples. Supports clinical decision-making regarding drug testing.

Clinical Evidence

No clinical data. Bench testing only; drug concentrations in calibrators verified by GC/MS.

Technological Characteristics

Matrix: drug-free human urine. Analyte: d-amphetamine. Concentrations verified by GC/MS. Form factor: liquid calibrator bottles. Intended for use on automated clinical chemistry analyzers. ISO 14971:2000 risk management applied.

Indications for Use

Indicated for the calibration of Roche Abuscreen OnLine and COBAS Integra Amphetamine assays to determine amphetamine levels in human urine samples using automated clinical chemistry analyzers.

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

• Roche Abuscreen OnLine Preciset DAT I Calibrators (K951595)

Submission Summary (Full Text)

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| | OCT 1 4 2003 |
|----------------|--------------|
| 510(k) Summary | K033165 |

Introduction

According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.

| 1) Submitter name, address, contact | Roche Diagnostics Corporation<br>9115 Hague Rd.<br>Indianapolis, IN 46250<br>[phone] |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| | Contact Person: Kerwin Kaufman<br>Date Prepared: September 26, 2003 |
| 2) Device name | Proprietary name: Preciset DAT Amphetamine and Cfas DAT Qualitative Amphetamine Calibrators |
| | Common name: Calibrators, Drug Specific<br>Classification name: Clinical Toxicology Calibrator |
| 3) Predicate devices | We claim substantial equivalence to the currently marketed Roche calibrators: |
| | Abuscreen OnLine Preciset DAT I Calibrators, cleared in 510(k) K951595 (formerly Abuscreen OnLine Calibration Pack). |

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## 510(k) Summary. Continued

Roche Preciset DAT Amphetamine calibrators contain 6 levels of 4) Device Description amphetamines, prepared by the quantitative addition of d-amphetamine to drug-free human urine. Drug concentrations are verified by GC/MS. The calibrator set contains six levels of amphetamines in bottles 1-6. Bottle 1 is negative (drug free) human urine, followed by bottles 2-6 containing increasing amounts of amphetamines. The respective target concentrations of amphetamines included is as follows:

Amphetamines: 0, 250, 500, 1000, 1500, 2000 ng/ml

Roche Cfas DAT Qualitative Amphetamine calibrators contain a single level of amphetamines at a target concentration of 1000 ng/ml, prepared by the quantitative addition of d-amphetamine to drug-free human urine. Drug concentrations are verified by GC/MS. The calibrator set contains 3 bottles of the single level amphetamines at 5 ml each.

5.) Intended Use

The Preciset DAT Amphetamine calibrators are designed for the calibration of the Roche Abuscreen OnLine assay for Amphetamines and the cassette COBAS Integra Amphetamines (AMPS) for the determination of amphetamines in human urine on automated clinical chemistry analyzers.

The Cfas DAT Qualitative Amphetamine calibrator is designed for the qualitative calibration of the Roche Abuscreen OnLine assay for Amphetamines and the cassette COBAS Integra Amphetamines (AMPS) for the determination of amphetamines in human urine on automated clinical chemistry analyzers.

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## 510(k) Summary, Continued

6.) Comparison The Roche Preciset DAT Amphetamine and Cfas DAT Qualitative to the Predicate Amphetamine calibrators are substantially equivalent to other products Device cleared for commercial distribution intended for similar use. Most notably, they are substantially equivalent to the currently marketed Roche Abuscreen OnLine Preciset DAT I multianalyte calibrators, manufactured for Roche Diagnostics and cleared in 510(k) submission K951595 by Roche Diagnostics.

> Preciset DAT Amphetamine calibrators contain 6 levels of The amphetamines, prepared by the quantitative addition of d-amphetamine to drug-free human urine with added preservative. The Cfas DAT Qualitative Amphetamine calibrator contains a single level of amphetamines, prepared by the quantitative addition of d-amphetamine to drug-free human urine with added preservative.

> The predicate device, Abuscreen OnLine Preciset DAT I calibrators contains a mixture of 9 different drugs, prepared by the quantitative addition of drug or drug metabolite to drug-free human urine with added preservatives and stabilizers. Drugs included are amphetamines, barbiturates, benzodiazepines, methadone, methaqualone, opiates, phencyclidine, and cocaine. propoxyphene. The calibrator set contains four levels for each drug.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 features a stylized image of an eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

OCT 1 4 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Kerwin Kaufman Regulatory Affairs Consultant Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250-0457

Re: k033165

> Trade/Device Name: Preciset DAT Amphetamine Calibrators and Cfas DAT Qualitative Amphetamine Calibrator

Regulation Number: 21 CFR 862.3200 Regulation Name: Clinical Toxicology Calibrator Regulatory Class: Class II Product Code: DLJ Dated: September 26, 2003 Received: September30, 2003

Dear Mr. Kaufman:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The gencral 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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 Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement

| 510(k) Number (if known): | K03 3165 |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Preciset DAT Amphetamine Calibrators and<br>Cfas DAT Qualitative Amphetamine Calibrator |
| Indications for Use: | The Preciset DAT Amphetamine calibrators are designed for the calibration of the Roche Abuscreen OnLine assay for Amphetamines and the cassette COBAS Integra Amphetamines (AMPS) for the determination of amphetamines in human urine on automated clinical chemistry analyzers.<br><br>The Cfas DAT Qualitative Amphetamine calibrator is designed for the qualitative calibration of the Roche Abuscreen OnLine assay for Amphetamines and the cassette COBAS Integra Amphetamines (AMPS) for the determination of amphetamines in human urine on automated clinical chemistry analyzers. |

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use (Per 21 CFR 801.109) | <div> <img alt="Checkmark" src="checkmark.png"/> </div> |
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OR Over-the-Counter Use ______

(Optional format 1-2-96)

Carol C Benson / Jean Cooper, DVM
Division Sign-Off

Office of In Vitro Diagnostic Device
Evaluation and Safety

510(k) K03 3165

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