(66 days)
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No
The document describes a standard in vitro diagnostic enzymatic assay for fructosamine and does not mention any AI or ML components.
No
This device is an in vitro diagnostic test for measuring fructosamine levels, which is used for diagnostic purposes rather than for treating a condition.
Yes
The text explicitly states "The Randox Laboratories Limited Fructosamine test kit is an in vitro diagnostic enzymatic assay for the quantitative determination of glycated protein (fructosamine) in human serum or plasma." and notes it is "For in vitro diagnostic use only."
No
The 510(k) summary describes an in vitro diagnostic test kit, which is a physical product containing reagents and calibrators, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
- "The Randox Laboratories Limited Fructosamine test kit is an in vitro diagnostic enzymatic assay..."
- "For in vitro diagnostic use only." (repeated for the test kit, calibrator, and controls)
This language clearly indicates that the device is intended for use in vitro (outside of a living organism) to diagnose or aid in the diagnosis of a condition (by measuring glycated protein levels).
N/A
Intended Use / Indications for Use
The Randox Laboratories Limited Fructosamine test kit is an in vitro diagnostic enzymatic assay for the quantitative determination of glycated protein (fructosamine) in human serum or plasma.
Measurement of glycated serum protein is representative of the mean blood glucose levels over the preceding 2-3 weeks.
For in vitro diagnostic use only.
For calibration of the Fructosamine assay.
To monitor the performance of the Fructosamine assay.
For in vitro diagnostic use only.
Product codes
LCP; JIT; JJX
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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 & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged around the caduceus in a circular fashion. The logo is presented in black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN 1 3 2003
Dr. Lynne Hamilton Regulatory Affairs Randox Laboratories, Ltd. Biochemical Manufacturers Ardmore, Diamond Road Crumlin, Co. Antrim United Kingdom BT29 40Y
Re: K023763
Trade/Device Name: Fructosamine, Frutosamine Calibrator, Fructosamine Controls Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated hemoglobin assay Regulatory Class: Class II Product Code: LCP; JIT; JJX Dated: November 7, 2002 Received: November 8, 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 (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). 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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510(k) Number (if known) NOT KNOWN
Fructosamine, Fructosamine Calibrator, Fructosamine Controls Device Name 2.3763
Indications For Use :
Fructosamine
The Randox Laboratories Limited Fructosamine test kit is an in vitro diagnostic enzymatic assay for the quantitative determination of glycated protein (fructosamine) in human serum or plasma.
Measurement of glycated serum protein is representative of the mean blood glucose levels over the preceding 2-3 weeks.
For in vitro diagnostic use only.
Jean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
10(k) Number. K023763
Fructosamine Calibrator
For calibration of the Fructosamine assay.
For in vitro diagnostic use only.
Fructosamine Controls (Level 1 and Level 3)
To monitor the performance of the Fructosamine assay.
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 (Optional format 1-2-96)