(169 days)
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No
The description details a standard immunological assay for measuring haemoglobin levels and calculating a percentage. There is no mention of AI or ML algorithms being used for analysis, interpretation, or calculation beyond basic arithmetic.
No
Explanation: This device is an in vitro diagnostic reagent used for measuring hemoglobin levels to monitor diabetes. It does not provide any therapeutic benefit or treatment to the patient.
Yes
The device is described as an "in vitro diagnostic reagent" for determining haemoglobin levels, which is used for "monitoring long-term glucose control in individuals with diabetes mellitus." This directly indicates its use for diagnostic purposes.
No
The device is described as an "in vitro diagnostic reagent" and a "test kit," which are physical components used in laboratory testing, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states it is an "in vitro diagnostic reagent" and is used for the "quantitative determination of haemoglobin Ay, (HbAz) in whole blood." It also mentions its use in "monitoring long-term glucose control in individuals with diabetes mellitus," which is a diagnostic purpose.
- Device Description: The description reiterates that it is an "in vitro diagnostic reagent."
- Anatomical Site: It specifies "whole blood," which is a sample taken from the human body for in vitro testing.
- Intended User/Care Setting: It is intended for "suitably qualified laboratory personnel under appropriate clinical laboratory conditions," which is typical for IVD devices used in a clinical laboratory setting.
All these points align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the compatibility of a potential recipient with a potential donor, or to monitor therapeutic measures.
N/A
Intended Use / Indications for Use
The Randox Laboratories Limited Haemoglobin Are Test Kit is an in vitro diagnostic reagent for the quantitative determination of haemoglobin Ay, (HbAz) in whole blood. The method is an immunological assay. Both the concentration of HbAr, and the concentration of total haemoglobin are measured. The reported HbAzz result is calculated as a percentage of the total haemoglobin concentration. Measurements of percentage HbAy, are effective in monitoring long-term glucose control in individuals with diabetes mellitus. This application sheet has been developed for the Hitachi 717 clinical chemistry analyser and must be used by suitably qualified laboratory personnel under appropriate clinical laboratory conditions.
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
suitably qualified laboratory personnel under appropriate clinical laboratory conditions.
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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§ 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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "HUMAN SERVICES - USA" are arranged in a circular pattern above the caduceus, and the word "DEPARTMENT" is placed below it. The logo is black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 2 6 2002
Dr. Lynne Hamilton Regulatory Affairs Randox Laboratories Ltd. Ardmore, Diamond Road, Crumlin, Co. Antrim United Kingdom BT29 4QY
Re: K021897
Trade/Device Name: HAEMOGLOBIN Asc Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated hemoglobin assay Regulatory Class: Class II Product Code: LCP Dated: November 15, 2002 Received: November 19, 2002
Dear Dr. Hamilton:
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 (OS) 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). Other general information on your responsibilities under the Act may be obtained 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 Sutman
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) | Not Known |
|---|---|
| Device Name | HAEMOGLOBIN A1c |
Indications For Use :
The Randox Laboratories Limited Haemoglobin Are Test Kit is an in vitro diagnostic reagent for the quantitative determination of haemoglobin Ay, (HbAz) in whole blood. The method is an immunological assay. Both the concentration of HbAr, and the concentration of total haemoglobin are measured. The reported HbAzz result is calculated as a percentage of the total haemoglobin concentration.
Measurements of percentage HbAy, are effective in monitoring long-term glucose control in individuals with diabetes mellitus.
This application sheet has been developed for the Hitachi 717 clinical chemistry analyser and must be used by suitably qualified laboratory personnel under appropriate clinical laboratory conditions.
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | |
|---|---|
| (Per 21 CFR 801.109) |
OR
| Over-The-Counter Use | |
|---|---|
| (Optional format 1-2-96) |
| (Division Sign-Off) | J P Reeves for J. Bautista |
|---|---|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | 14021897 |