(42 days)
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No
The document describes a chemical calibrator for drug testing, with no mention of AI or ML in its function or development.
No
The device is a calibrator for drug of abuse assays, used to ensure the accuracy of diagnostic tests, not to treat any condition.
No
This device is a calibrator, used to calibrate diagnostic devices (Roche assays for drugs of abuse). It is not itself a diagnostic device that performs a diagnosis.
No
The device is a liquid calibrator supplied in a glass bottle, containing chemical components. This clearly indicates it is a physical product, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "calibration of the Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers." This clearly indicates it's used in vitro (outside the body) to calibrate a diagnostic test that analyzes a human sample (urine).
- Device Description: The description details the composition of the calibrator, which is a liquid containing drugs of abuse in a human urine matrix. This material is designed to be used with an analytical instrument to determine the concentration of substances in a biological sample.
- Function: Calibrators are essential components of many IVD tests. They are used to establish a known relationship between the signal produced by the analytical instrument and the concentration of the analyte (in this case, drugs of abuse) in the sample. This calibration is crucial for obtaining accurate and reliable diagnostic results.
The fact that it's used with "automated clinical chemistry analyzers" further reinforces its role in a clinical laboratory setting for diagnostic testing.
N/A
Intended Use / Indications for Use
The Preciset DAT Plus calibrators are designed for the calibration of the Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers.
Product codes (comma separated list FDA assigned to the subject device)
DKB
Device Description
The Quantimetrix Preciset® DAT Plus drug of abuse calibrator is supplied liquid in a glass bottle. It consists of drug-free human urine to which preservative, stabilizer and drugs of abuse have been added to achieve six distinct levels. The drugs added are: metamphetamine, nordiazepam, barbiturates, cocaine metabolites, methadone, morphine, phencyclidine, propoxyphene, cannabinoids
Drug concentrations are determined using GC/MS.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
human urine
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Accelerated stability studies (25°C and 37°C) and real time studies were performed to validate the shelf life claim and the opened vial claim of the calibrators. When tested with the Roche immunoassays (currently under development) the calibrators were found to perform well and to be sufficiently stable for their intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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.
0
Image /page/0/Picture/0 description: The image shows a date written in bold, black font. The date is 'JUN 13 2002'. The month is abbreviated to three letters, followed by the day and then the year.
Image /page/0/Picture/1 description: The image shows the logo for Quantimetrix Corporation. The logo consists of two interlocking letter C's above the company name. The address "2005 Manhattan Beach Boulevard Redondo Beach, CA 90278-1205" is printed to the right of the company name.
(800) 624-8380 or (310) 57 (800) 845-1834 or (310) 5
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92
The assigned 510(k) number is:________________________________________________________________________________________________________________________________________________
| Proprietary Name: | Preciset® DAT Plus |
|---|---|
| Common Name: | Calibrators/Controls |
| Classification Name: | Calibrators, Drug Mixture |
| Medical specialty: | Clinical Toxicology |
| Product Code: | DKB |
| Device class: | 2 |
| Regulation No: | 862.3200 |
| Manufacturer: | Quantimetrix Corporation |
| 2005 Manhattan Beach Boulevard | |
| Redondo Beach CA 90278 | |
| Phone: 310/536-0006 FAX: 310/536-9977 | |
| Contact Persons: | Gebhard Neyer, Ph.D., Director of R&D, 310-536-0006 |
| Registration No: | 2020715 |
The Quantimetrix Preciset® DAT Plus drug of abuse calibrator is supplied liquid in a glass bottle. It consists of drug-free human urine to which preservative, stabilizer and drugs of abuse have been added to achieve six distinct levels. The drugs added are: metamphetamine, nordiazepam, barbiturates, cocaine metabolites, methadone, morphine, phencyclidine, propoxyphene, cannabinoids
Drug concentrations are determined using GC/MS.
Quantimetrix Corp.
1
The Quantimetrix calibrator is substantially equivalent to the currently marketed Emit® Calibrators/controls manufactured by Syva Company.
Both feature similar matrices, constituents and stability claims.
Intended Use
a
The Preciset DAT Plus calibrators are designed for the calibration of the Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers.
Performance Characteristics
Accelerated stability studies (25°C and 37°C) and real time studies were performed to validate the shelf life claim and the opened vial claim of the calibrators. When tested with the Roche immunoassays (currently under development) the calibrators were found to perform well and to be sufficiently stable for their intended use.
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three wing-like shapes, representing health, services, and people. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Garther Road Rockville MD 20850
JUN 1 3 2002
Dr. Gebhard Neyer Director, Research & Development Quantimetrix Corporation 2005 Manhattan Beach Boulevard Redondo Beach, CA 90278-1205
Re: K021393
Trade/Device Name: Preciset® DAT Plus Regulation Number: 21 CFR 862.3200 Regulation Name: Clinical toxicology calibrator Regulatory Class: Class II Product Code: DKB Dated: May 1, 2002 Received: May 2, 2002
Dear Dr. Gebhard:
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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 -
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrb/dsma/dsmamain.html".
Sincerely yours,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page_1_of__1__
510(k) Number (if known):__KOZ1393
Device Name: Preciset® DAT Plus
Druq of Abuse Calibrators
Indications For Use:
The Preciset DAT Plus calibrators are designed for the calibration of the Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers.
Frank
(Division Sign-Of)
Division of Clinical Laboratory Devices
510(k) Number K021393
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_
OR
Over-The-Counter Use_
(Per 21 CFR 801.109)
(Optional Format 1-2-96)