(19 days)
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No
The summary describes a quality control material for monitoring cardiac analyte methods, with no mention of AI or ML technology.
No
The device is a quality control material intended for monitoring cardiac analyte measurement methods, not for treating any condition or disease.
No
Explanation: The device is a control material for monitoring cardiac analyte methods, not a diagnostic device itself. It helps validate the measurement of patient samples, which is part of diagnostic procedures, but it does not diagnose patients directly.
No
The 510(k) summary describes a "Cardiac Markers Control," which is a quality control material used to monitor serum cardiac analyte monitoring methods. This is a physical substance (a control material) and not a software-only device.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is "intended as a means of monitoring serum cardiac analyte monitoring methods to validate measurement of patient serum samples." This clearly indicates that the device is used in vitro (outside the body) to assess the performance of diagnostic tests that analyze patient samples (serum).
- Role in Diagnostic Procedures: The statement "Use of quality control materials is an integral part of diagnostic procedures" further reinforces its role in the diagnostic process. Quality control materials are a key component of IVD testing to ensure accuracy and reliability.
Therefore, the description aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Quantimetrix Corp. Cardiasure Cardiac Markers Control is intended as a means of monitoring serum cardiac analyte monitoring methods to validate measurement of patient serum samples. 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
JJT
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)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are 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 the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of a human figure embracing or supporting another, often interpreted as representing care and support.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Jennifer Morais, Ph.D. R&D Manager Quantimetrix Corporation 2005 Manhattan Beach Blvd. Redondo Beach, CA 90278
CT - 3 2006
Re: K062751 Trade/Device Name: Quantimetrix Cardiac Markers Control Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJT Dated: September 14, 2006 Received: September 14, 2006
Dear Dr. Morais:
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. Iisting 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,
Albert G. A.
Alberto Guticarez, 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 STATEMENT
510(k) Number (if known): K062751
Device Name:
Quantimetrix Cardiasure Cardiac Markers Control
Indication for Use:
The Quantimetrix Corp. Cardiasure Cardiac Markers Control is intended as a means of monitoring serum cardiac analyte monitoring methods to validate measurement of patient serum samples. 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 | |
|---|---|
| ------------------ | -- |
(Per 21 CFR 801. 109) OR Over-The-Counter UsePLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurence of CDRH, Office of In Vitro Diagnostic Device (OIVD)
Division Sign-Off
Office of In Vitro Diagnostic Device
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