PRECISET DAT PLUS I, PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS CALIBRATORS

K060645 · Roche Diagnostics Corp. · DKB · May 30, 2006 · Clinical Toxicology

Device Facts

• Record ID: K060645
• Device Name: PRECISET DAT PLUS I, PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS CALIBRATORS
• Applicant: Roche Diagnostics Corp.
• Product Code: DKB · Clinical Toxicology
• Decision Date: May 30, 2006
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.3200
• Device Class: Class 2

Intended Use

The Preciset DAT Plus I calibrators are designed for the calibration of the Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers. The Preciset DAT Plus II calibrators are designed for the calibration of the Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers. The Cfas DAT Qualitative Plus calibrator is designed for the qualitative calibration of the Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers.

Device Story

Preciset DAT Plus I, Plus II, and Cfas DAT Qualitative Plus are multi-analyte calibrators; consist of drug/metabolite mixtures added to drug-free human urine with preservatives. Preciset DAT Plus I/II provide up to six concentration levels for quantitative calibration; Cfas DAT Qualitative Plus provides single-level calibration. Used in clinical laboratories on automated chemistry analyzers; operated by laboratory technicians. Calibrators establish reference points for Roche drugs of abuse assays; enable accurate quantification or qualitative detection of drugs (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, methaqualone, opiates, phencyclidine, propoxyphene) in patient urine. Results assist healthcare providers in toxicology screening and clinical decision-making regarding substance use.

Clinical Evidence

No clinical data. Bench testing only. Analyte concentrations are traceable to and verified by GC-MS primary reference methods.

Technological Characteristics

Multi-analyte calibrators; matrix is drug-free human urine with added preservatives/stabilizers. Form factor: liquid in bottles (up to 6 levels for quantitative, single level for qualitative). No energy source, connectivity, or software algorithms; purely chemical/biological reference material.

Indications for Use

Indicated for calibration of Roche drugs of abuse assays in human urine using automated clinical chemistry analyzers. Prescription use only.

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

• Preciset DAT Plus I calibrators (K031775)
• Preciset DAT Plus II and Cfas DAT Qualitative Plus (K033306)

Submission Summary (Full Text)

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# MAY 3 0 2006

Ka060645

510(k) Summary
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]<br><br>Contact Person: Dimitris Demirtzoglou<br><br>Date Prepared: March 9, 2006 |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2) Device name | Proprietary name: Preciset DAT Plus I, Preciset DAT Plus II and Cfas DAT Qualitative Plus Calibrators<br><br>Common name: Calibrators, Drug Mixture<br><br>Classification name: Clinical Toxicology Calibrator |
| 3) Predicate devices | We claim substantial equivalence to the currently marketed Roche calibrators:<br><br>Preciset DAT Plus I calibrators, cleared in 510(k) K031775 and<br>Preciset DAT Plus II and Cfas DAT Qualitative Plus cleared in 510(k) K033306. |

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:

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4) Device Roche Preciset DAT Plus I calibrators contain a mixture of 10 different drugs, Description prepared by the quantitative addition of drug or drug metabolite to drug-free human urine. Drugs included are amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, methaqualone, opiates, phencyclidine and propoxyphene. The calibrator set contains up to six levels for each drug contained in bottles 1-6. Bottle 1 is negative (drug free) human urine, followed by bottles 2-6 containing increasing amounts of each drug in a multi-analyte mixture. Drug or drug metabolite and their respective levels included are as follows:

> Amphetamines: 0, 250, 500, 1000, 3000, 5000 (ng/mL) Barbiturates: 0, 100, 200, 400 (ng/mL) {no 5th and 6th level] Benzodiazepines: 0, 150, 300, 600, 1000, 3000 (ng/mL) Cannabinoids: 0, 20, 50, 100, 200, 300 (ng/mL) Cocaine: 0, 75, 150, 300, 1000, 5000 (ng/mL) Methadone: 0, 150, 300, 600, 2000 (ng/mL) [no 6th level] Methaqualone: 0, 150, 300, 600 (ng/mL) [no 5tt and 6th level] Opiates: 0, 600, 1000, 2000, 4000, 8000 (ng/mL) PCP: 0, 12.5, 25.0, 50.0 (ng/mL) [no 5th and 6th level] Propoxyphene: 0, 150, 300, 600 (ng/mL) [no 5th and 6th levell

Roche Preciset DAT Plus II calibrators contain a mixture of 4 different drugs. prepared by the quantitative addition of drug or drug metabolite to drug-free human urine. Drugs included are amphetamines, benzodiazepines. cannabinoids, and opiates. The calibrator set contains up to six levels for each drug contained in bottles 1-6. Bottle 1 is negative (drug free) human urine, followed by bottles 2-6 containing increasing amounts of each drug in a multianalyte mixture. Drug or drug metabolite and their respective levels included are as follows:

Amphetamines: 0, 150, 300, 600, 1000, 2000 (ng/mL) Benzodiazepines: 0, 50, 100, 200, 400, 1000 (ng/mL) Cannabinoids: 0, 10, 20, 40, 100 (ng/mL) [no 6th level] Opiates: 0, 150, 300, 600, 1000, 2000 (ng/mL)

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4) Device Description Roche Cfas DAT Qualitative Plus calibrator contains a mixture of 10 different (continued) drugs, prepared by the quantitative addition of drug or drug metabolite to drugfree human urine. Drugs included are amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, methaqualone, opiates, phencyclidine, and propoxyphene. The calibrator set contains a single level for each drug in a drug mixture. Drugs or drug metabolites and their respective levels included are as follows: Amphetamines: 500 ng/ml Barbiturates: 200 ng/ml Benzodiazepines: 300 ng/ml Cannabinoids: 50 ng/ml Cocaine: 150 ng/ml Methadone: 300 ng/ml Methaqualone: 50 ng/ml Opiates: 2000 ng/ml Phencyclidine: 25 ng/ml Propoxyphene: 300 ng/ml

5.) Intended The Preciset DAT Plus I calibrators are designed for the calibration of the Use Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers.

> The Preciset DAT Plus II calibrators are designed for the calibration of the Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers.

> The Cfas DAT Qualitative Plus calibrator is designed for the qualitative calibration of the Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers.

> > Continued on next page

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6.) Comparison The Roche Preciset DAT Plus I, Preciset DAT Plus II and Cfas DAT to the Predicate Qualitative Plus multianalyte calibrators are substantially equivalent to other Device products cleared for commercial distribution intended for similar use. Most notably, they are substantially equivalent to the currently marketed Roche Preciset DAT Plus I calibrators, cleared in 510(k) K031775 and Preciset DAT Plus II and Cfas DAT Qualitative Plus cleared in 510(k) K033306. The Preciset DAT Plus I calibrators contain a mixture of 10 different drugs, prepared by the quantitative addition of drug or drug metabolite to drug-free human urine with added preservative. Drugs included are amphetamines. barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, methaqualone, opiates, phencyclidine and propoxyphene. The calibrator set contains up to six levels for each drug. The Preciset DAT Plus II calibrators contain a mixture of 4 different drugs, prepared by the quantitative addition of drug or drug metabolite to drug-free human urine with added preservative. Drugs included are amphetamines. benzodiazepines, cannabinoids, and opiates. The calibrator set contains up to six levels for each drug. The Cfas DAT Qualitative Plus calibrators contain a mixture of 10 different drugs, prepared by the quantitative addition of drug or drug metabolite to drug- free human urine with added preservative. Drugs included are amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, methaqualone, opiates, phencyclidine, and propoxyphene. The calibrator contains only a single level of each drug. The predicate device, Preciset DAT Plus I calibrators contain 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, cannabinoids cocaine, methadone, opiates, phencyclidine, and propoxyo hene. The calibrator set contains up to six levels for each drug.

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The predicate device, Preciset DAT Plus II calibrators contain a mixture of 2 6.) Comparison different drugs, prepared by the quantitative addition of drug or drug to the Predicate Device metabolite to drug-free human urine with added preservative. Drugs included (continued) are benzodiazepines and opiates. The calibrator set contains up to six levels for each drug.

> The predicate device, Cfas DAT Qualitative Plus calibrators contain a mixture of 7 different drugs, prepared by the quantitative addition of drug or drug metabolite to drug-free human urine with added preservative. Drugs included are barbiturates, benzodiazepines, cocaine, methadone, opiates, phencyclidine, and propoxyphene. The calibrator contains only a single level of each drug.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Dimitris Demirtzoglou Regulatory Affairs Consultant Roche Diagnostics Corp. 9115 Hague Road Indianapolis, IN 46250-0457

MAY 3 0 2006

Re: k060645

> Trade/Device Name: Preciset DAT Plus I, Preciset DAT Plus II and Cfas DAT Qualitative Plus Calibrators Regulation Number: 21 CFR§862.3200 Regulation Name: Clinical toxicology calibrator Regulatory Class: Class II Product Code: DKB Dated: March 9, 2006 Received: March 10, 2006

Dear Mr. Demirtzoglou:

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 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 (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/industry/support/index.html.

Sincerely yours,

Alberto Guts

Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indications for Use

#### C060645 510(k) Number (if known):

#### Device Name: Preciset DAT Plus I, Preciset DAT Plus II and Cfas DAT Qualitative Plus Calibrators

Indications For Use:

The Preciset DAT Plus I calibrators are designed for the calibration of the Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers.

The Preciset DAT Plus II calibrators are designed for the calibration of the Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers.

The Cfas DAT Qualitative Plus calibrator is designed for the qualitative calibration of the Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off

:10(k)

Office of In Vitro Diagnostic Device Evaluation and Safety

k160645

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