(81 days)
Not Found
No
The device description focuses on the chemical composition and preparation of calibrators for drug testing, with no mention of AI or ML technologies.
No
The device is a calibrator for drug assays, designed for analytical purposes in laboratory settings, not for treating or diagnosing medical conditions in patients.
No
This device is a calibrator, used to calibrate automated clinical chemistry analyzers for drug of abuse testing. It does not directly diagnose a condition or disease.
No
The device description clearly states that the device is a set of calibrators containing mixtures of drugs in human urine, which are physical substances, not software.
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 indicates the device is used in vitro (outside the body) to calibrate instruments that perform diagnostic tests on human samples (urine).
- Device Description: The description details the composition of the calibrators, which are mixtures of drugs and drug metabolites in human urine. These are reagents used in a laboratory setting for diagnostic purposes.
- Predicate Devices: The mention of predicate devices with K numbers (K031775 and K033306) strongly suggests that these devices have gone through the FDA's regulatory process for IVDs. K numbers are associated with 510(k) submissions, which are required for many IVD devices.
The core function of these calibrators is to ensure the accuracy and reliability of diagnostic tests performed on human urine samples to detect drugs of abuse. This directly aligns with the definition of 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.
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.
Product codes
DKB
Device Description
Roche Preciset DAT Plus I calibrators contain a mixture of 10 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, methaqualone, 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. Drug or drug metabolite and their respective levels included are as follows:
Amphetamines: 0, 250, 500, 1000, 3000, 5000 (ng/mL) Barbiturates: 0, 100, 200, 400 (ng/mL) [no 5th and 6th level] Benzodiazepines: 0, 150, 300, 600, 1000, 3000 (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) [no 6th level] Methaqualone: 0, 150, 300, 600 (ng/mL) [no 5tt and 6th level] Opiates: 0, 600, 1000, 2000, 4000, 8000 (ng/mL) PCP: 0, 12.5, 25.0, 50.0 (ng/mL) [no 5th and 6th level] Propoxyphene: 0, 150, 300, 600 (ng/mL) [no 5th and 6th level]
Roche Preciset DAT Plus II calibrators contain a mixture of 4 different drugs. prepared by the quantitative addition of drug or drug metabolite to drug-free human urine. Drugs included are amphetamines, benzodiazepines. cannabinoids, 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 multianalyte mixture. Drug or drug metabolite and their respective levels included are as follows:
Amphetamines: 0, 150, 300, 600, 1000, 2000 (ng/mL) Benzodiazepines: 0, 50, 100, 200, 400, 1000 (ng/mL) Cannabinoids: 0, 10, 20, 40, 100 (ng/mL) [no 6th level] Opiates: 0, 150, 300, 600, 1000, 2000 (ng/mL)
Roche Cfas DAT Qualitative Plus calibrator contains a mixture of 10 different drugs, prepared by the quantitative addition of drug or drug metabolite to drugfree human urine. Drugs included are amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, methaqualone, opiates, phencyclidine, and propoxyphene. The calibrator set contains a single level for each drug in a drug mixture. Drugs or drug metabolites and their respective levels included are as follows: Amphetamines: 500 ng/ml Barbiturates: 200 ng/ml Benzodiazepines: 300 ng/ml Cannabinoids: 50 ng/ml Cocaine: 150 ng/ml Methadone: 300 ng/ml Methaqualone: 50 ng/ml Opiates: 2000 ng/ml Phencyclidine: 25 ng/ml Propoxyphene: 300 ng/ml
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Not Found
Key Metrics
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
MAY 3 0 2006
Ka060645
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) 521-7688
Contact Person: Dimitris Demirtzoglou
Date Prepared: March 9, 2006 |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2) Device name | Proprietary name: Preciset DAT Plus I, 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:
Preciset DAT Plus I calibrators, cleared in 510(k) K031775 and
Preciset DAT Plus II and Cfas DAT Qualitative Plus cleared in 510(k) K033306. |
Continued on next pageand the comments of the comments of the comments of
. . . .
:
1
- Device Roche Preciset DAT Plus I calibrators contain a mixture of 10 different drugs, Description prepared by the quantitative addition of drug or drug metabolite to drug-free human urine. Drugs included are amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, methaqualone, 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. Drug or drug metabolite and their respective levels included are as follows:
Amphetamines: 0, 250, 500, 1000, 3000, 5000 (ng/mL) Barbiturates: 0, 100, 200, 400 (ng/mL) {no 5th and 6th level] Benzodiazepines: 0, 150, 300, 600, 1000, 3000 (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) [no 6th level] Methaqualone: 0, 150, 300, 600 (ng/mL) [no 5tt and 6th level] Opiates: 0, 600, 1000, 2000, 4000, 8000 (ng/mL) PCP: 0, 12.5, 25.0, 50.0 (ng/mL) [no 5th and 6th level] Propoxyphene: 0, 150, 300, 600 (ng/mL) [no 5th and 6th levell
Roche Preciset DAT Plus II calibrators contain a mixture of 4 different drugs. prepared by the quantitative addition of drug or drug metabolite to drug-free human urine. Drugs included are amphetamines, benzodiazepines. cannabinoids, 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 multianalyte mixture. Drug or drug metabolite and their respective levels included are as follows:
Amphetamines: 0, 150, 300, 600, 1000, 2000 (ng/mL) Benzodiazepines: 0, 50, 100, 200, 400, 1000 (ng/mL) Cannabinoids: 0, 10, 20, 40, 100 (ng/mL) [no 6th level] Opiates: 0, 150, 300, 600, 1000, 2000 (ng/mL)
Continued on next page
2
- Device Description Roche Cfas DAT Qualitative Plus calibrator contains a mixture of 10 different (continued) drugs, prepared by the quantitative addition of drug or drug metabolite to drugfree human urine. Drugs included are amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, methaqualone, opiates, phencyclidine, and propoxyphene. The calibrator set contains a single level for each drug in a drug mixture. Drugs or drug metabolites and their respective levels included are as follows: Amphetamines: 500 ng/ml Barbiturates: 200 ng/ml Benzodiazepines: 300 ng/ml Cannabinoids: 50 ng/ml Cocaine: 150 ng/ml Methadone: 300 ng/ml Methaqualone: 50 ng/ml Opiates: 2000 ng/ml Phencyclidine: 25 ng/ml Propoxyphene: 300 ng/ml
5.) Intended The Preciset DAT Plus I calibrators are designed for the calibration of the Use Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers.
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.
Continued on next page
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6.) Comparison The Roche Preciset DAT Plus I, Preciset DAT Plus II and Cfas DAT to the Predicate Qualitative Plus multianalyte calibrators are substantially equivalent to other Device products cleared for commercial distribution intended for similar use. Most notably, they are substantially equivalent to the currently marketed Roche Preciset DAT Plus I calibrators, cleared in 510(k) K031775 and Preciset DAT Plus II and Cfas DAT Qualitative Plus cleared in 510(k) K033306. The Preciset DAT Plus I calibrators contain a mixture of 10 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, methaqualone, opiates, phencyclidine and propoxyphene. The calibrator set contains up to six levels for each drug. The Preciset DAT Plus II calibrators contain a mixture of 4 different drugs, prepared by the quantitative addition of drug or drug metabolite to drug-free human urine with added preservative. Drugs included are amphetamines. benzodiazepines, cannabinoids, and opiates. The calibrator set contains up to six levels for each drug. The Cfas DAT Qualitative Plus calibrators contain a mixture of 10 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, methaqualone, opiates, phencyclidine, and propoxyphene. The calibrator contains only a single level of each drug. The predicate device, 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 preservatives and stabilizers. Drugs included are amphetamines, barbiturates, benzodiazepines, cannabinoids cocaine, methadone, opiates, phencyclidine, and propoxyo hene. The calibrator set contains up to six levels for each drug.
Continued on next page
4
The predicate device, Preciset DAT Plus II calibrators contain a mixture of 2 6.) Comparison different drugs, prepared by the quantitative addition of drug or drug to the Predicate Device metabolite to drug-free human urine with added preservative. Drugs included (continued) are benzodiazepines and opiates. The calibrator set contains up to six levels for each drug.
The predicate device, Cfas DAT Qualitative Plus calibrators 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.
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Dimitris Demirtzoglou Regulatory Affairs Consultant Roche Diagnostics Corp. 9115 Hague Road Indianapolis, IN 46250-0457
MAY 3 0 2006
Re: K060645
Trade/Device Name: Preciset DAT Plus I, 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: March 9, 2006 Received: March 10, 2006
Dear Mr. Demirtzoglou:
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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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 (240) 276-0484. 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/industry/support/index.html.
Sincerely yours,
Alberto Guts
Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
7
Indications for Use
C060645 510(k) Number (if known):
Device Name: Preciset DAT Plus I, Preciset DAT Plus II and Cfas DAT Qualitative Plus 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.
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.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
:10(k)
Office of In Vitro Diagnostic Device Evaluation and Safety
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