(56 days)
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.
Roche 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. Drugs included are amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, 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.
This document is a 510(k) Summary for the Roche Preciset DAT Plus I Calibrators. It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study proving device performance in the way typically expected for a medical device's analytical or clinical performance.
Instead, this submission is for calibrators, which are used to standardize other assays. The "performance" in this context refers to their composition and their equivalence to a legally marketed predicate calibrator.
Therefore, many of the requested categories (acceptance criteria, device performance, sample sizes for test/training, number of experts, adjudication, MRMC studies, standalone studies, ground truth types) are not applicable or not reported in this type of submission for a calibrator device.
Here's a breakdown of the information that can be extracted, and where the requested information is absent:
1. A table of acceptance criteria and the reported device performance:
This document does not explicitly state acceptance criteria or report performance data for the calibrators in terms of accuracy, precision, or other analytical metrics. The claim of performance is based on the contents and the comparison to an existing predicate calibrator.
| Acceptance Criteria (Not explicitly stated in the document) | Reported Device Performance (Implied by description) |
|---|---|
| (Not stated) | The calibrators contain a mixture of 9 different drugs at specified concentrations, quantitatively added to drug-free human urine (as described in {1}). The device is substantially equivalent to a predicate calibrator {2}. |
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 describes the calibrator itself, not a study evaluating its performance with test samples. The "test set" in this context would implicitly be the various drug assays that would be calibrated using this device, which are not detailed here.
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. This device is a calibrator, and its "ground truth" is its precisely defined chemical composition. There are no human experts involved in establishing this type of ground truth for a calibrator.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No test set or adjudication process is described.
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:
Not applicable. This device is a calibrator, not an AI-powered diagnostic tool, and involves no human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This device is a calibrator and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for these calibrators is their known, quantitative chemical composition. They are prepared by the "quantitative addition of drug or drug metabolite to drug-free human urine" {1}.
8. The sample size for the training set:
Not applicable. This document describes a calibrator, not a machine learning model that would require a training set.
9. How the ground truth for the training set was established:
Not applicable. No training set is involved.
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Ko 31775
AUG 06 2003
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) 521-7637Contact Person: Kerwin KaufmanDate Prepared: June 9, 2003 |
| 2) Device name | Proprietary name: Preciset DAT Plus I CalibratorsCommon name: Calibrators, Drug MixtureClassification 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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AUG 0 6 2003
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510(k) Summary, Continued
Roche Preciset DAT Plus I calibrators contain a mixture of 9 different drugs, 4) Device prepared by the quantitative addition of drug or drug metabolite to drug-free Description Drugs included are amphetamines, barbiturates, human urine. benzodiazepines, cannabinoids, cocaine, methadone, 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 Drugs or drug metabolites and their respective levels included are as follows:
Amphetamines: 0, 250, 500, 1000, 3000, 5000 ng/ml Barbiturates: 0, 100, 200, 400 ng/ml Benzodiazepines: 0, 150, 300, 600 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 Opiates: 0, 600, 1000, 2000, 4000, 8000 ng/ml Phencyclidine: 0, 12.5, 25.0, 50.0 ng/ml Propoxyphene: 0, 150, 300, 600 ng/ml
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510(k) Summary, Continued
The Preciset DAT Plus I calibrators are designed for the calibration of the 5.) Intended Use Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers.
6.) Comparison The Roche Preciset DAT Plus I multianalyte calibrators are substantially to the Predicate equivalent to other products cleared for commercial distribution intended for Device 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 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 preservative. Drugs included are amphetamines. barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opiates, phencyclidine, and propoxyphene. The calibrator set contains up to six levels for each drug.
The predicate device, Abuscreen OnLine Preciset DAT I calibrators also 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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Image /page/3/Picture/1 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the border. In the center of the seal is a stylized image of three wavy lines, which are likely meant to represent a flag or banner.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Kerwin Kaufman
AUG - 6 2003
Regulatory Affairs Consultant Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, Indiana 46250-0457
Re: K031775
Trade/Device Name: Roche Preciset DAT Plus I Calibrators Regulation Number: 21 CFR § 862.3200 Regulation Name: Clinical toxicology calibrator Regulatory Class: II Product Code: DKB Dated: June 9, 2003 Received: June 10, 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). 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.
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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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AUG - 6 2003
Indications for Use Statement
:
| 510(k) Number (if known): | K031775 |
|---|---|
| Device Name: | Roche Preciset DAT Plus I 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. |
(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) (Optional format 1-2-96) | X OR Over-the-Counter Use ______ |
|---|---|
| ---------------------------------------------------------------- | ----------------------------------------------------------------------------------------------------------- |
| Division Sign-Off | For: Jean Cooper |
|---|---|
| ------------------- | ------------------ |
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K031775
§ 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.