(24 days)
Not Found
No
The summary provides no information about the device's internal workings, and there are no mentions of AI, ML, image processing, or training/test sets, which are common indicators of AI/ML use in medical devices.
No
The device is a diagnostic test for monitoring glycemic control, not for treating a condition.
Yes
The device is described as providing "quantitative measurement of the percent of glycated hemoglobin (%HbA1c, %A1C) levels in whole blood samples" and is "for home use and professional use for monitoring glycemic control in people with diabetes." This direct measurement and monitoring of a physiological parameter for a medical condition clearly indicates a diagnostic purpose.
No
The device description is not found, but the intended use clearly describes a "test" that measures %HbA1c in "whole blood samples." This strongly implies a physical component (e.g., a test strip, analyzer) is required to interact with the blood sample, making it a hardware-based device with potential software components, not a software-only device.
Yes, based on the provided information, the InView™ multi-use test is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the test provides quantitative measurement of %HbA1c levels in whole blood samples. This involves testing a sample taken from the body, which is a key characteristic of an in vitro diagnostic.
- Measurement of a Biomarker: The test measures glycated hemoglobin (%HbA1c), which is a biomarker used for monitoring glycemic control in people with diabetes. Measuring biomarkers in samples outside the body is a core function of IVDs.
- Home and Professional Use: While the use setting doesn't define it as an IVD, the fact that it's used to diagnose or monitor a medical condition using a sample taken from the body does.
The definition of an IVD generally involves devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The InView™ test fits this description perfectly.
N/A
Intended Use / 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.
Product codes
LCP
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
home use and professional use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the words "Public Health Service" in a simple, sans-serif font. The text is black against a white background. The words are arranged on a single line and are evenly spaced.
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the bird.
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
2
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