(62 days)
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.
Roche Preciset DAT Plus II calibrators contain a mixture of 2 different drugs, prepared by the quantitative addition of drug or drug metabolite to drug-free human urine. Drugs included are benzodiazepines 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 multi-analyte mixture. Drug or drug metabolite and their respective levels included are as follows: Benzodiazepines: 0, 50, 100, 200, 400 ng/ml (no 6th level) Opiates: 0, 150, 300, 600, 1000, 2000 ng/ml. Roche Cfas DAT Qualitative Plus calibrator contains a mixture of 7 different drugs, prepared by the quantitative addition of drug or drug metabolite to drug-free human urine. Drugs included are barbiturates, benzodiazepines, cocaine, methadone, opiates, phencyclidine, and propoxyphene. The calibrator set contains a single level for each drug mixture. Drugs or drug metabolites and their respective levels included are as follows: Barbiturates: 200 ng/ml Benzodiazepines: 300 ng/ml Cocaine: 150 ng/ml Methadone: 300 ng/ml Opiates: 2000 ng/ml Phencyclidine: 25 ng/ml Propoxyphene: 300 ng/ml
The provided text describes a 510(k) summary for Roche Preciset DAT Plus II and Cfas DAT Qualitative Plus Calibrators, which are devices used for calibrating drug of abuse assays in human urine on automated clinical chemistry analyzers. As such, the information does not contain acceptance criteria or study results in the typical sense of measuring device performance against a predefined clinical or technical threshold.
Instead, this document focuses on demonstrating substantial equivalence to a predicate device. This regulatory pathway does not require new efficacy studies if the new device is sufficiently similar to a previously cleared one.
Therefore, many of the requested elements for describing acceptance criteria and study results are not applicable to this type of regulatory submission and the provided documentation.
Here's an assessment based on the available information:
1. Table of acceptance criteria and the reported device performance:
- Not applicable. The document does not describe specific acceptance criteria (e.g., sensitivity, specificity, accuracy targets) for its own performance. Instead, it aims to show substantial equivalence to a predicate device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable. This document does not describe a performance study with a test set in the way you might expect for a diagnostic device measuring patient outcomes. The "data" here refers to the quantitative addition of drug or drug metabolite to drug-free human urine for calibrator preparation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. Ground truth in this context would relate to the precise concentration of drugs in the calibrators, which is established by the manufacturer through quantitative addition, not by expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No adjudication method is described as this is not a study assessing diagnostic performance against a clinical ground truth.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Definitely Not applicable. This device is a calibrator for laboratory assays, not an AI-powered diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm, but a physical calibrator product.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the calibrators is the known, quantitatively added concentration of drug or drug metabolite in drug-free human urine. This is an engineered "truth" rather than a discovery-based one (like pathology).
8. The sample size for the training set:
- Not applicable. There is no "training set" in the context of this device. The calibrators are manufactured to precise specifications.
9. How the ground truth for the training set was established:
- Not applicable. As above, no training set for this product. The "ground truth" for the calibrators themselves is established by the quantitative addition process during manufacturing.
Summary of what the document DOES provide regarding comparison:
The core of the submission is to establish substantial equivalence to the predicate device: "Abuscreen OnLine Preciset DAT I Calibrators" (K951595).
The comparison focuses on:
- Intended Use: Both the new device and the predicate are designed for the calibration of Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers.
- Device Description (Composition):
- Preciset DAT Plus II: Contains Benzodiazepines (0, 50, 100, 200, 400 ng/ml) and Opiates (0, 150, 300, 600, 1000, 2000 ng/ml). Up to six levels.
- Cfas DAT Qualitative Plus: Contains Barbiturates (200 ng/ml), Benzodiazepines (300 ng/ml), Cocaine (150 ng/ml), Methadone (300 ng/ml), Opiates (2000 ng/ml), Phencyclidine (25 ng/ml), Propoxyphene (300 ng/ml). Single level.
- Predicate Device (Abuscreen OnLine Preciset DAT I): Contains a mixture of 9 different drugs (amphetamines, barbiturates, benzodiazepines, cocaine, methadone, methaqualone, opiates, phencyclidine, and propoxyphene). Four levels for each drug.
- All calibrators are prepared by the quantitative addition of drug or drug metabolite to drug-free human urine.
The primary argument for substantial equivalence rests on the similar intended use and the fact that both the new and predicate devices are calibrators for drug of abuse assays, even though the specific drug mixtures and number of levels differ. The regulatory approval letter confirms that the FDA determined the device to be substantially equivalent to legally marketed predicate devices.
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DEC 1 5 2003
DEC 15 2003
K033306
page 1 of 3
| 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 9115 Hague Rd. Indianapolis, IN 46250 (317) 521-7637 |
| Contact Person: Kerwin Kaufman Date Prepared: October 13, 2003 | |
| 2) Device name | Proprietary name: Preciset DAT Plus II and Cfas DAT Qualitative Plus Calibrators |
| Common name: Calibrators, Drug Mixture | |
| 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). |
Continued on next page
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510(k) Summary, Continued
paje 2 of 3
Roche Preciset DAT Plus II calibrators contain a mixture of 2 different drugs, 4) Device propared by the quantitative addition of drug or drug metabolite to drug-free Description human urine. Drugs included are benzodiazepines 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 multi-analyte mixture. Drug or drug metabolite and their respective levels included are as follows:
Benzodiazepines: 0, 50, 100, 200, 400 ng/ml (no 6th level) Opiates: 0, 150, 300, 600, 1000, 2000 ng/ml
Roche Cfas DAT Qualitative Plus calibrator contains a mixture of 7 different drugs, prepared by the quantitative addition of drug or drug metabolite to drug-free human urine. Drugs included are barbiturates, benzodiazepines, cocaine, methadone, opiates, phencyclidine, and propoxyphene. The calibrator set contains a single level for each drug mixture. Drugs or drug metabolites and their respective levels included are as follows:
Barbiturates: 200 ng/ml Benzodiazepines: 300 ng/ml Cocaine: 150 ng/ml Methadone: 300 ng/ml Opiates: 2000 ng/ml Phencyclidine: 25 ng/ml Propoxyphene: 300 ng/ml
Continued on next page
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page 3 of 3
510(k) Summary, Continued
| 5.) Intended Use | 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. | |
| 6.) Comparison to the Predicate Device | The Roche Preciset DAT Plus II and Cfas DAT Qualitative Plus multianalyte calibrators 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 Abuscreen OnLine Preciset DAT I multianalyte calibrators, manufactured for Roche Diagnostics and cleared in 510(k) submission K951595 by Roche Diagnostics. |
| The Preciset DAT Plus Il calibrators contain a mixture of 2 different drugs, prepared by the quantitative addition of drug or drug metabolite to drug-free human urine with added preservative. Drugs included are benzodiazepines and opiates. The calibrator set contains up to six levels for each drug. | |
| The Cfas DAT Qualitative Plus calibrator 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. | |
| The predicate device, Abuscreen OnLine Preciset DAT 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, cocaine, methadone, methaqualone, opiates, phencyclidine, and 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 shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three horizontal bars above it, representing the department's mission to protect the health of all Americans and provide essential human services.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 1 5 2003
Mr. Kerwin Kaufman Regulatory Affairs Consultant Roche Diagnostics Corporation 9115 Hague Road, P.O. Box 50457 Indianapolis, IN 46250-0457
Re: K033306
Trade/Device Name: Roche 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: October 13, 2003 Received: October 14, 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 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 (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 Putman
Steven 1. 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): | K033306 |
|---|---|
| Device Name: | Roche Preciset DAT Plus II and Cfas DAT Qualitative Plus Calibrators |
| Indications for Use: | 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. |
(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) | X OR Over-the-Counter Use ______ |
|---|---|
| --------------------------------------- | --------------------------------------------------------------------------- |
(Optional format 1-2-96)
Division Sign-Off for Jean Cooper
Office of In Vitro Diagnostic Device Evaluation and Safety
KO333 06 510(k) _______________________________________________________________________________________________________________________________________________________________________
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§ 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.