(82 days)
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Not Found
No
The summary does not mention AI, ML, or related terms, and the device description and performance study sections are not available to provide further clues.
No
Explanation: The device is for in vitro diagnostic use only, specifically for the quantitative determination of hemoglobin A1c. It is used for evaluation and indication, not for treating or preventing disease.
Yes
This device is used for the quantitative determination of hemoglobin A1c to evaluate glycemic control in diabetes, which is a diagnostic purpose. The text explicitly states it is "intended for in vitro diagnostic use only."
No
The description clearly states the device is a "reagent set" for in vitro diagnostic use, which implies physical components (reagents) are involved in the measurement process, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "This reagent set is intended for in vitro diagnostic use only."
Furthermore, the intended use is to determine hemoglobin A1c in human blood for the evaluation of glycemic control in diabetes, which is a diagnostic purpose performed outside of the body (in vitro).
N/A
Intended Use / Indications for Use
This product is to be used for the quantitative determination of hemoglobin A1c in human blood. The determination of hemoglobin A1c is most commonly performed for the evaluation of glycemic control in diabetes. Hemoglobin A1c values provide an indication of glucose levels over the preceding 4-8 weeks. A higher hemoglobin A1c value indicates poorer glycemic control. This reagent set is intended for in vitro diagnostic use only.
Product codes
LCP
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
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§ 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
Public Health Service
Image /page/0/Picture/2 description: The image is a black and white circular seal. The seal contains the symbol of the U.S. Department of Health and Human Services in the center. The text "U.S. Health & Human Services" is written around the perimeter of the circle.
AUG - 6 2003
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. William F. Walters, Jr. V.P. - Technical Operations Pointe Scientific, Inc. 1025 John A Papalas Drive Lincoln Park, MI 48146
Re: K031539
Trade/Device Name: Hemoglobin A 1 c Reagent Set Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated hemoglobin assay Regulatory Class: Class II Product Code: LCP Dated: May 02, 2003 Received: May 16, 2003
Dear Mr. Walters:
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 (301) 594-3084. 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/dsma/dsmamain.html.
Sincerely yours,
Steven Putman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510 (k) Number (if known): Unknown at this time
Device Name: Hemoglobin A1c Reagent Set
Indications for use:
This product is to be used for the quantitative determination of hemoglobin A1c in human blood. The determination of hemoglobin A1c is most commonly performed for the evaluation of glycemic control in diabetes. Hemoglobin A1c values provide an indication of glucose levels over the preceding 4-8 weeks. A higher hemoglobin A1c value indicates poorer glycemic control. This reagent set is intended for in vitro diagnostic use only.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over the Counter Use
Jean Cooper
Division Sign-Off
(Optional Format 1-2-96)
ro Diagnostic Device fice of In Vit tion and l
510(k) K 031539