(28 days)
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No
The summary describes a calibrator for a cocaine metabolite immunoassay, which is a chemical-based test. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The device is a calibrator for a diagnostic immunoassay, not a device used to treat a condition.
No
This device is a calibrator, used to calibrate immunoassays for drug detection in urine. While the immunoassay it calibrates can provide a preliminary analytical result, the device itself is not a diagnostic tool; it aids in the function of a diagnostic tool. The document explicitly states that the assay results are preliminary and require confirmation by other methods.
No
The device is a calibrator for a cocaine metabolite enzyme immunoassay, which is a physical substance used in a laboratory setting, not a software program.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "calibrating cocaine metabolite enzyme immunoassay for qualitative and semi-quantitative determination of cocaine and its metabolites in human urine." This involves testing a sample taken from the human body (urine) in vitro (outside the body) to provide information about a physiological state (presence of cocaine metabolites).
- Sample Type: The device is used with "human urine," which is a biological sample.
- Purpose: The purpose is to calibrate an immunoassay used for diagnostic purposes (determining the presence of a substance in the body).
While the device itself is a calibrator and not the immunoassay kit, it is an essential component used with an IVD immunoassay to ensure accurate results. Therefore, it falls under the umbrella of IVD devices.
N/A
Intended Use / Indications for Use
This 50 ng/mL cocaine metabolite urine calibrator is intended to be used for calibrating cocaine : metabolite enzyme immunoassay for qualitative and semi-quantitative determination of cocaine and its metabolites in human urine.
The assay results obtained with the cocaine metabolite enzyme immunoassay in combination with the use of such calibrator provide only a preliminary analytical result. A more specific alternate method must be used in order to obtain a confirmed analytical result. Gas chromatograph/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
Product codes (comma separated list FDA assigned to the subject device)
DLJ
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
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)
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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.
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Image /page/0/Picture/0 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, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the perimeter of the circle. The logo is presented in black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 28 1997
Yuh-geng Tsay, Ph.D. President Diagnostic Reagents, Inc. 601 California Avenue Sunnyvale, California 94086 - - ------
Re : K972835 50 ng/mL Cocaine Metabolite Urine Calibrator Trade Name: Requlatory Class: II Product Code: DLJ Dated: July 29, 1997 Received: July 31, 1997
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 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, labelinq, and prohibitions aqainst 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 requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (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 requlatory 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 requlation (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 qeneral 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 Autman
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
2
510(k) Number (if known):
50 ng/mL COCAINE METABOLITE CALIBRATOR Device Name: .......
Indications For Use:
This 50 ng/mL cocaine metabolite urine calibrator is intended to be used for calibrating cocaine : metabolite enzyme immunoassay for qualitative and semi-quantitative determination of cocaine and its metabolites in human urine.
The assay results obtained with the cocaine metabolite enzyme immunoassay in combination with the use of such calibrator provide only a preliminary analytical result. A more specific alternate method must be used in order to obtain a confirmed analytical result. Gas chromatograph/mass spectrometry (GC/MS) is the preferred Clinical consideration and professional judgment should be confirmatory method. applied to any drug of abuse test result, particularly when preliminary positive results are used.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
ision Sign-Off)
ivision of Clinical Laboratory vices
510(k) Numbe: K0972830
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)