(81 days)
The Chemistry calibrator is for use as a calibrator of Pointe Scientific, Inc. clinical chemistry assays. The analyte constituents, set-point values and instruments are provided in the product labeling.
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The provided text is a 510(k) premarket notification letter from the FDA regarding a Multi-Analyze Chemistry Calibrator. This document approves the device based on its substantial equivalence to a legally marketed predicate device.
It is crucial to understand that this document does not contain information about the performance or acceptance criteria of a diagnostic imaging AI device. Instead, it concerns an in-vitro diagnostic (IVD) calibrator product. Therefore, the details requested in the prompt, such as "test set," "ground truth," "MRMC study," "human readers improve with AI," and "standalone algorithm performance," are not applicable to the content provided.
The document discusses regulatory approval for a calibrator, not a device that analyzes images or medical data for diagnosis using AI.
As such, I cannot extract the requested information as it is not present in the provided text.
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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 or bird-like figure with three wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Pointe Scientific, Inc. c/o Mr. Ron Jamison, Technical Service Manager 5449 Research Drive Canton, MI 48188
APR 13 2007
Re: K070207
Trade/Device Name: Multi-Analyze Chemistry Calibrator Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator, Multi-analyte mixture. Regulatory Class: Class II Product Code: JIX Dated: January 19, 2007 Received: January 30, 2007
Dear Mr. Jamison:
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) 276-0490. 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean M. Cooper, M.S., D.V.M.
Jean M. Cooper, M.S., D.V.M. 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
K070207 510(k) Number (if known):
Device Name:
Multi-Analyte Chemistry Calibrator
Indications For Use:
The Chemistry calibrator is for use as a calibrator of Pointe Scientific, Inc. clinical chemistry assays. The analyte constituents, set-point values and instruments are provided in the product labeling.
Prescription Use _______________
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(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)
C
Page 1 of 1_
Office of In Vitro Diagnostic Device
Evaluation and Safety
§ 862.1150 Calibrator.
(a)
Identification. A 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. (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.