(14 days)
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.
Roche Preciset DAT Amphetamine calibrators contain 6 levels of 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.
The provided text describes a 510(k) summary for Roche Preciset DAT Amphetamine and Cfas DAT Qualitative Amphetamine Calibrators. It details the device, its intended use, and its comparison to a predicate device. However, it does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. The document is a regulatory submission for substantial equivalence based on comparison to an existing device, rather than a performance study report.
Therefore, I cannot provide the requested table and study details.
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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 Corporation9115 Hague Rd.Indianapolis, IN 46250(317) 521-7637 |
|---|---|
| Contact Person: Kerwin KaufmanDate Prepared: September 26, 2003 | |
| 2) Device name | Proprietary name: Preciset DAT Amphetamine and Cfas DAT Qualitative Amphetamine Calibrators |
| Common name: Calibrators, Drug SpecificClassification 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 (301) 594-3084. 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/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 andCfas 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.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. |
(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) | |
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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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20
§ 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.