(57 days)
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No
The summary describes calibrators and controls for immunoassay tests, which are chemical reagents, not software or hardware that would typically incorporate AI/ML. There are no mentions of AI, ML, image processing, or data analysis methods that would suggest AI/ML is used.
No
The device is used for calibration and validation of immunoassay tests for drugs of abuse in urine, which is a diagnostic rather than a therapeutic purpose.
No
Explanation: The device is described as "Multi-Drug Urine Calibrators and Controls," which are used for calibration and validation of immunoassay tests, not for directly diagnosing a condition in a patient. They are tools for ensuring the accuracy of diagnostic tests.
No
The device is described as "Multi-Drug Urine Calibrators and Controls" which are physical substances used for calibration and validation of an immunoassay. This indicates a hardware component (the calibrators and controls themselves) is central to the device's function, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is used for "calibration and validation of DRI's drugs of abuse enzyme immunoassay to detect... in human urine." This clearly indicates that the device is used to perform tests on samples taken from the human body (urine) outside of the body (in vitro).
- Sample Type: The device is used with "human urine," which is a biological sample.
- Purpose: The purpose is to "detect" the presence of various drugs of abuse. This is a diagnostic purpose, as it aims to identify the presence of specific substances in the sample.
The definition of an IVD generally includes reagents, calibrators, control materials, and other devices intended for use in the in vitro examination of specimens derived from the human body for the purpose of providing information for diagnostic, monitoring, or compatibility purposes. This device fits that description perfectly as it is a calibrator and control material used for a diagnostic test on a human specimen.
N/A
Intended Use / Indications for Use
The Multi-Drug Urine Calibrators and Controls are intended to be used for calibration and validation of DRI's drugs of abuse enzyme immunoassay to detect amphetamines, barbiturates, benzodiazepines, cocaine metabolites, methadone, methaqualone, opiates, phencyclidine and propoxyphene in human urine.
Product codes
DKB
Device Description
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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
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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
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features the department's symbol, which is a stylized representation of a human figure embracing another. The symbol is positioned to the right of the text, which is arranged in a circular pattern around the symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
5 1998 NOV
Yuh-geng Tsay, Ph.D. President Diagnostic Reagents, Inc. 601 California Avenue Sunnyvale, CA 94086
Re: K983159 Trade Name: Drugs of Abuse Urine Calibrators and Controls Regulatory Class: II Product Code: DKB Dated: September 8. 1998 Received: September 9, 1998
Dear Dr. Tsay:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.
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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours.
Steven Sutman
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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510(K) Number (if known): ___________________________________________________________________________________________________________________________________________________
MULTI-DRUG URINE CALIBRATORS AND CONTROLS Device Name:
Indications For Use:
The Multi-Drug Urine Calibrators and Controls are intended to be used for calibration and validation of DRI's drugs of abuse enzyme immunoassay to detect amphetamines, barbiturates, benzodiazepines, cocaine metabolites, methadone, methaqualone, opiates, phencyclidine and propoxyphene in human urine.
(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) | |
|---|---|
| ------------------------------------------ | -- |
OR
| Over-The-Counter Use | |
|---|---|
| ---------------------- | -- |
(Optional Format 1-2-96)