(56 days)
The Preciset DAT THC calibrators are designed for the calibration of the Roche assays for cannabinoids in human urine on automated clinical chemistry analyzers.
The Preciset DAT THC 20 calibrators are designed for the calibration of the Roche assays for cannabinoids in human urine on automated clinical chemistry analyzers.
Roche Preciset DAT THC calibrators contain 6 levels of cannabinoids, prepared by the quantitative addition of △'-THC-COOH to drug-free human urine. Drug concentrations are verified by GC/MS. The calibrator set contains six levels of cannabinoids in bottles 1-6. Bottle 1 is negative (drug free) human urine, followed by bottles 2-6 containing increasing amounts of cannabinoids. The respective target concentrations of cannabinoids included is as follows:
Δ -THC-COOH: 0, 20, 50, 100, 200, 300 ng/ml
Roche Preciset DAT THC 20 calibrators contain 5 levels of cannabinoids, prepared by the quantitative addition of A -THC-COOH to drug-free human urine. Drug concentrations are verified by GC/MS. The calibrator set contains five levels of cannabinoids in bottles 1-5. Bottle 1 is negative (drug free) human urine, followed by bottles 2-5 containing increasing amounts of cannabinoids. The respective target concentrations of cannabinoids included is as follows:
△3-THC-COOH: 0, 10, 20, 40, 100 ng/ml
The provided document is a 510(k) summary for calibrators, not a study describing the performance of an AI or medical device with acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth cannot be extracted from this document.
The document describes the Preciset DAT THC and Preciset DAT THC 20 Calibrators, which are used to calibrate Roche assays for cannabinoids in human urine on automated clinical chemistry analyzers. The focus is on demonstrating substantial equivalence to a predicate device (Abuscreen OnLine THC Calibration Pack 20), not on proving performance against specific acceptance criteria in the way an AI or diagnostic device would typically be evaluated.
Here's what can be extracted based on the document:
1. A table of acceptance criteria and the reported device performance:
This document does not contain a table of acceptance criteria or reported device performance in the context of an AI or diagnostic study. The "performance" described is the chemical composition and intended use of the calibrators, and their verification by GC/MS.
2. Sample size used for the test set and the data provenance:
Not applicable. This is a description of calibrator products, not a study involving a test set of patient data. The calibrators themselves are prepared by adding known concentrations of Δ⁹-THC-COOH to drug-free human urine.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth for the calibrators is established by the quantitative addition of Δ⁹-THC-COOH and verified by GC/MS, which is a chemical analytical method, not expert interpretation.
4. Adjudication method for the test set:
Not applicable. No test set adjudication 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 document is not about an AI device or a comparative effectiveness study 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 or AI device.
7. The type of ground truth used:
For the calibrators, the "ground truth" for the concentration of Δ⁹-THC-COOH is established by quantitative addition of the substance to drug-free human urine and verified by GC/MS (Gas Chromatography/Mass Spectrometry). This is an objective chemical measurement.
8. The sample size for the training set:
Not applicable. This document does not describe a training set for an algorithm.
9. How the ground truth for the training set was established:
Not applicable. This document does not describe a training set.
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DEC = 2 2003
. .
510(k) Summary
ﻬ
033246
| 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: October 6, 2003 |
| 2) Device name | Proprietary name: Preciset DAT THC and Preciset DAT THC 20 CalibratorsCommon name: Calibrators, Drug SpecificClassification name: Clinical Toxicology Calibrator |
| 3) Predicate devices | We claim substantial equivalence to the currently marketed Roche calibrators:Abuscreen OnLine THC Calibration Pack 20, cleared in 510(k) K961726. |
Continued on next page
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Ko33246
Roche Preciset DAT THC calibrators contain 6 levels of cannabinoids, 4) Device Description prepared by the quantitative addition of △'-THC-COOH to drug-free human urine. Drug concentrations are verified by GC/MS. The calibrator set contains six levels of cannabinoids in bottles 1-6. Bottle 1 is negative (drug free) human urine, followed by bottles 2-6 containing increasing amounts of cannabinoids. The respective target concentrations of cannabinoids included is as follows:
Δ -THC-COOH: 0, 20, 50, 100, 200, 300 ng/ml
Roche Preciset DAT THC 20 calibrators contain 5 levels of cannabinoids, prepared by the quantitative addition of A -THC-COOH to drug-free human urine. Drug concentrations are verified by GC/MS. The calibrator set contains five levels of cannabinoids in bottles 1-5. Bottle 1 is negative (drug free) human urine, followed by bottles 2-5 containing increasing amounts of cannabinoids. The respective target concentrations of cannabinoids included is as follows:
△3-THC-COOH: 0, 10, 20, 40, 100 ng/ml
The Preciset DAT THC calibrators are designed for the calibration of the 5.) Intended Roche assays for cannabinoids in human urine on automated clinical Use chemistry analyzers.
The Preciset DAT THC 20 calibrators are designed for the calibration of the Roche assays for cannabinoids in human urine on automated clinical chemistry analyzers.
Continued on next page
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510(k) Summary, Continued
Ko33246
The Roche Preciset DAT THC and Preciset DAT THC 20 calibrators are 6.) Comparison substantially equivalent to other products cleared for commercial distribution to the Predicate intended for similar use. Most notably, they are substantially equivalent to Device the currently marketed Roche Abuscreen OnLine THC Calibration Pack 20, manufactured for Roche Diagnostics and cleared in 510(k) submission K961726 by Roche Diagnostics.
The Preciset DAT THC calibrators contain 6 levels of cannabinoids, prepared by the quantitative addition of A3-THC-COOH to drug-free human urine with added preservative. The Preciset DAT THC 20 calibrators contain 5 levels of cannabinoids, prepared by the quantitative addition of A - THC-COOH to drug-free human urine with added prescrvative.
The predicate device, Abuscreen OnLine THC Calibration Pack 20, contains 5 levels of cannabinoids, prepared by the quantitative addition of A -THC-COOH to drug-free human urine with added preservatives.
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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 & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC - 2 2003
Mr. Kerwin Kaufman Regulatory Affairs Consultant Roche Diagnostics Corporation 9115 Hague Road, P.O. Box 50457 Indianapolis, IN 46250-0457
Re: K033246
Trade/Device Name: Preciset DAT THC Calibrators and Preciset DAT THC 20 Calibrators Regulation Number: 21 CFR 862.3200 Regulation Name: Clinical toxicology calibrator Regulatory Class: Class II Product Code: DLJ Dated: October 6, 2003 Received: October 7, 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 interstatc 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 (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 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): | K 033246 |
|---|---|
| Device Name: | Preciset DAT THC Calibrators and Preciset DAT THC 20 Calibrators |
| Indications for Use: | The Preciset DAT THC calibrators are designed for the calibration of the Roche assays for cannabinoids in human urine on automated clinical chemistry analyzers. |
| The Preciset DAT THC 20 calibrators are designed for the calibration of the Roche assays for cannabinoids in human urine on automated clinical chemistry analyzers. |
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Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use (Per 21 CFR 801.109) | 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
510(k) K033246
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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.