(56 days)
Not Found
No
The summary describes calibrators for drug testing, which are chemical reagents, and does not mention any computational or algorithmic components indicative of AI/ML.
No
The device is a calibrator for drug assays, used to ensure the accuracy of testing equipment, not to treat a medical condition.
No
Explanation: This device is described as a calibrator for Roche assays, meaning it is used to ensure the accuracy of other diagnostic tests rather than performing a diagnosis itself. It contains known quantities of substances to create a standard for comparison.
No
The device description clearly states that the device is a physical calibrator containing a mixture of drugs in human urine, not a software product.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the calibrators are "designed for the calibration of the Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers." This clearly indicates that the device is used in vitro (outside the body) to analyze a human specimen (urine) for diagnostic purposes (detecting drugs of abuse).
- Device Description: The description confirms that the calibrators contain drugs added to "drug-free human urine," further supporting the in vitro nature of the device and its use with human biological material.
- Predicate Device: The mention of a predicate device (K951595; Abuscreen OnLine Preciset DAT I Calibrators) which is also an IVD, strongly suggests that this device falls under the same regulatory category.
Therefore, based on the provided information, the Roche Preciset DAT Plus I calibrators are an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
DKB
Device Description
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 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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human urine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 Corporation |
| 9115 Hague Rd. | |
| Indianapolis, IN 46250 | |
| (317) 521-7637 | |
| Contact Person: Kerwin Kaufman | |
| Date Prepared: June 9, 2003 | |
| 2) Device name | Proprietary name: Preciset DAT Plus I 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). |
۰۰ ۳۴۰
AUG 0 6 2003
Continued on next page
1
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
Continued on next page
2
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.
3
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.
4
Page 2 –
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
5
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