(32 days)
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No
The document describes a quality control material for laboratory testing and contains no mention of AI or ML.
No
The device is a control for monitoring the performance of laboratory methods used to detect cotinine levels in urine specimens, which is a diagnostic procedure, not a therapeutic intervention.
No
The device is a quality control material intended to monitor the performance of analytical methods for detecting cotinine levels, not to diagnose a condition or disease in a patient. While quality control is part of diagnostic procedures, the device itself is for method validation, not direct patient diagnosis.
No
The device is a urine control, which is a physical substance used for quality control in laboratory testing. It is not a software application.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is for "monitoring the performance of GC/MS and other drugs of Cotinine methods used for detecting the Cotinine levels in unknown urine specimens." This clearly indicates that the device is used in vitro (outside the body) to analyze a biological specimen (urine) for diagnostic purposes (monitoring the performance of tests that detect Cotinine levels).
- Role in Diagnostic Procedures: The description mentions that "Use of quality control materials is an integral part of diagnostic procedures." This further reinforces its role in the diagnostic process.
While the "Device Description" is not found, the "Intended Use" alone is sufficient to classify this device as an IVD.
N/A
Intended Use / Indications for Use
The Quantimetrix Corp. NiCosure Cotinine Urine Control is intended as a means of monitoring the performance of GC/MS and other drugs of Cotinine methods used for detecting the Cotinine levels in unknown urine specimens.
Use of quality control materials is an integral part of diagnostic procedures. Daily monitoring of control values establishes intralaboratory parameters for accuracy and precision of the test method.
Product codes
LAS
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 (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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§ 862.3280 Clinical toxicology control material.
(a)
Identification. A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.(b)
Classification. Class I (general 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black.
Public Health Service
Food and Druq Administration 2098 Gaither Road Rockville MD 20850
OCT 3 0 2006
Ms. Bernice Novarro Regulatory Affairs Manager Quantimetrix Corporation 2005 Manhattan Beach Blvd. Redondo Beach, CA 90278
Re: K062942 Trade/Device Name: Quantimetrix NiCosure Cotinine Urine Control Regulation Number: 21 CFR 862.3280 Regulation Name: Clinical toxicology control material Regulatory Class: Class I Product Code: LAS
Dated: September 28, 2006 Received: September 28, 2006
Dear Ms. Novarro:
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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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 Gutt
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
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Indications for Use
510(k) Number: K062942
Device Name: Quantimetrix NiCosure Cotinine Urine Control
Indications For Use:
The Quantimetrix Corp. NiCosure Cotinine Urine Control is intended as a means of monitoring the performance of GC/MS and other drugs of Cotinine methods used for detecting the Cotinine levels in unknown urine specimens.
Use of quality control materials is an integral part of diagnostic procedures. Daily monitoring of control values establishes intralaboratory parameters for accuracy and precision of the test method.
Prescription Use V (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)
Carol Benson
ivision Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
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