(24 days)
The InView™ multi-use test provides quantitative measurement of the percent of glycated hemoglobin (%HbA1c, %A1C) levels in whole blood samples. The test is for home use and professional use for monitoring glycemic control in people with diabetes.
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This document is a 510(k) clearance letter from the FDA for a device called InView™, a glycosylated hemoglobin assay. It does not contain the specific details about acceptance criteria or the study that proves the device meets those criteria. My analysis of the given text is as follows:
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A table of acceptance criteria and the reported device performance: This information is not present in the provided document. The document is a regulatory clearance letter, not a detailed study report.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): This information is not present in the provided document.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): This information is not present in the provided document.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: This information is not present in the provided document.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This device is a quantitative assay for glycated hemoglobin, not an imaging device or an AI diagnostic tool that human readers would use in conjunction with. Therefore, an MRMC study and analysis of human reader improvement with AI assistance are not applicable and not mentioned.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The InView™ is described as a "multi-use test" for measuring %HbA1c levels. It is presented as a standalone device ("algorithm only" equivalent for an in-vitro diagnostic) in the sense that it provides a quantitative measurement. The FDA clearance confirms its performance for "home use and professional use for monitoring glycemic control in people with diabetes." This implies a standalone performance without a human-in-the-loop interacting with an AI algorithm for diagnosis. However, specific performance metrics are not given.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): This information is not present in the provided document. For a quantitative assay like HbA1c, the ground truth would typically be established by a reference method or a highly accurate laboratory assay.
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The sample size for the training set: This information is not present in the provided document.
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How the ground truth for the training set was established: This information is not present in the provided document.
Summary: The provided FDA 510(k) clearance letter confirms that the InView™ glycated hemoglobin assay is substantially equivalent to legally marketed predicate devices. It states the intended use as quantitative measurement of %HbA1c for home and professional use in monitoring glycemic control. However, this document does not contain the detailed technical or clinical study data (such as acceptance criteria, sample sizes, ground truth establishment, or performance metrics) that would typically be found in the 510(k) submission itself or a comprehensive study report. The letter is a regulatory approval, not a scientific publication of study results.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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JUN 1 3 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Erika B. Ammirati, RAC, MT (ASCP) Regulatory Consultant Metrika, Inc. 510 Oakmead Parkway Sunnyvale CA 94085
Re: K051321 Trade/Device Name: InView™M Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated hemoglobin assay Regulatory Class: Class II Product Code: LCP Dated: May 19, 2005 Received: May 20, 2005
Dear Ms. Ammirati:
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,
Carol C. Benson
Carol C. Benson, M.A. Acting 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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May 19, 2005
AlcNow® Multi-Use for Home and Professional Use (InView™) Special 510(k)- Device Modification for K033847
STATEMENT OF INTENDED USE
510(K) Number (if known): K051321
Device Name: InView™
Indications for Use:
The InView™ multi-use test provides quantitative measurement of the percent of glycated hemoglobin (%HbA1c, %A1C) levels in whole blood samples. The test is for home use and professional use for monitoring glycemic control in people with diabetes.
Prescription Use _ >> (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Rute Chealer
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K051321
§ 864.7470 Glycosylated hemoglobin assay.
(a)
Identification. A glycosylated hemoglobin assay is a device used to measure the glycosylated hemoglobins (A1a , A1b , and A1c ) in a patient's blood by a column chromatographic procedure. Measurement of glycosylated hemoglobin is used to assess the level of control of a patient's diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient.(b)
Classification. Class II (performance standards).