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 Description

Roche 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. 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.

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.

Roche Cfas DAT Qualitative Plus calibrator contains a mixture of 10 different drugs, 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 a single level for each drug in a drug mixture.

AI/ML Overview

This 510(k) premarket notification is for calibrators used with drug abuse assays, not a diagnostic device with performance metrics like sensitivity and specificity. Therefore, many of the requested categories (e.g., expert consensus, MRMC studies, standalone performance) are not applicable in the traditional sense for this type of device.

This submission focuses on demonstrating substantial equivalence to already marketed calibrators by Roche. The "acceptance criteria" here are implicitly meeting the performance characteristics and intended use of the legally marketed predicate devices.

Here's an attempt to structure the available information according to your request, with significant caveats for the non-applicability of certain criteria:

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit from Predicate Equivalence)	Reported Device Performance (Summary)
Preciset DAT Plus I Calibrators:
- Intended for calibration of Roche assays for drugs of abuse in human urine.	- Preciset DAT Plus I calibrators contain a mixture of 10 drugs (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, methaqualone, opiates, phencyclidine, propoxyphene) at up to six specified levels (e.g., Amphetamines: 0, 250, 500, 1000, 3000, 5000 ng/mL).
- Composition (drugs included and their levels) similar to predicate device (K031775).	- Quantitative addition of drug or drug metabolite to drug-free human urine.
Preciset DAT Plus II Calibrators:
- Intended for calibration of Roche assays for drugs of abuse in human urine.	- Preciset DAT Plus II calibrators contain a mixture of 4 drugs (amphetamines, benzodiazepines, cannabinoids, opiates) at up to six specified levels (e.g., Amphetamines: 0, 150, 300, 600, 1000, 2000 ng/mL).
- Composition (drugs included and their levels) similar to predicate device (K033306).	- Quantitative addition of drug or drug metabolite to drug-free human urine.
Cfas DAT Qualitative Plus Calibrator:
- Intended for qualitative calibration of Roche assays for drugs of abuse in human urine.	- Cfas DAT Qualitative Plus calibrator contains a mixture of 10 drugs (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, methaqualone, opiates, phencyclidine, propoxyphene) at a single specified level for each (e.g., Amphetamines: 500 ng/ml, Barbiturates: 200 ng/ml).
- Composition (drugs included and their levels) similar to predicate device (K033306).	- Quantitative addition of drug or drug metabolite to drug-free human urine.
Overall: Functionally equivalent to predicates, enabling calibration of assays.	- The submission states the devices "are substantially equivalent to other 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 description highlights the specific drug mixtures and concentrations in the new and predicate devices, demonstrating the scope of the substantial equivalence claim. The primary "proof" is the detailed comparison of the new devices' components and concentrations to those of the predicate devices, showing they serve the same function (calibration) with comparable drug panels and levels, facilitating a determination of substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

N/A (for traditional diagnostic device testing): This submission is for calibrators, not a diagnostic test that processes patient samples to generate a "test set" in the conventional sense. The "test" here involves comparing the composition and intended use of the new calibrators to existing, cleared predicate calibrators.
Data Provenance: The calibrators themselves are "prepared by the quantitative addition of drug or drug metabolite to drug-free human urine." This suggests an in-house manufacturing process rather than external data provenance like country of origin or clinical data collection. The submission doesn't specify any external "testing" data from a large population.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not Applicable: For calibrators, "ground truth" isn't established by expert consensus on clinical images or patient data. The "ground truth" concerning the calibrators' composition is established by the manufacturing process – the quantitative addition of specified drug concentrations to drug-free human urine. Analytical techniques would verify these concentrations during manufacturing and quality control.

4. Adjudication Method for the Test Set

Not Applicable: There is no clinical "test set" and thus no need for an adjudication method for disagreements among experts, as would be common in diagnostic imaging or clinical assessment studies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No: MRMC studies are used to assess the impact of a diagnostic device (often AI-based) on human reader performance. This submission is for calibrators, which are reagents used to set the measurement scale for an assay, not a diagnostic tool read by humans.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not Applicable: Calibrators do not have an "algorithm" or standalone "performance" in the way an AI diagnostic device would. Their function is to provide known reference points for an assay. Their performance is related to their stability, accuracy of stated concentrations, and ability to correctly calibrate the associated assays, which would be validated during manufacturing and quality control, not as a standalone "algorithm."

7. The Type of Ground Truth Used

Manufacturing Specifications / Quantitative Addition: The "ground truth" for these calibrators is their precisely defined chemical composition. They are "prepared by the quantitative addition of drug or drug metabolite to drug-free human urine." This means the concentration of each drug in each level of the calibrator is precisely known and controlled during the manufacturing process.

8. The Sample Size for the Training Set

Not Applicable: Calibrators are physical reference materials, not algorithms that require a "training set" of data.

9. How the Ground Truth for the Training Set Was Established

Not Applicable: As above, there is no training set for this type of device.

Summary

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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 Corporation9115 Hague Rd.Indianapolis, IN 46250(317) 521-7688Contact Person: Dimitris DemirtzoglouDate Prepared: March 9, 2006
2) Device name	Proprietary name: Preciset DAT Plus I, Preciset DAT Plus II and Cfas DAT Qualitative Plus CalibratorsCommon name: Calibrators, Drug MixtureClassification name: Clinical Toxicology Calibrator
3) Predicate devices	We claim substantial equivalence to the currently marketed Roche calibrators:Preciset DAT Plus I calibrators, cleared in 510(k) K031775 andPreciset DAT Plus II and Cfas DAT Qualitative Plus cleared in 510(k) K033306.

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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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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.

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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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Page 2 –

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 (240) 276-0484. 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 (800) 638-2041 or (301) 443-6597 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

Page 1 of

Regulation Number and Section

§ 862.3200 Clinical toxicology calibrator.

(a)
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.)(b)
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.