(60 days)
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Not Found
No
The summary describes a reagent set for a standard laboratory test and contains no mention of AI, ML, or related concepts.
No.
The product is a reagent set for the quantitative determination of fructosamine, intended for in vitro diagnostic use to evaluate glycemic control in diabetes, not for treating a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states, "This reagent set is intended for in vitro diagnostic use only," and describes its use for the "quantitative determination of fructosamine in human serum" for the "evaluation of glycemic control in diabetes," which are all diagnostic activities.
No
The device description explicitly states "Fructosamine Reagent Set, Fructosamine Calibrator and Fructosamine Controls," indicating it includes physical reagents and controls, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative determination of fructosamine in human serum" for the "evaluation of glycemic control in diabetes." This is a diagnostic purpose performed on a biological sample (serum) outside of the body.
- Setting and User: It's intended for use in a "diagnostic laboratory setting, by qualified laboratory technologists," which is typical for IVDs.
- Explicit Statement: The last sentence of the "Intended Use / Indications for Use" section directly states, "This reagent set is intended for in vitro diagnostic use only."
All of these points clearly indicate that this product is designed and intended for use as an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
This product is to be used in a diagnostic laboratory setting, by qualified laboratory technologists, for the quantitative determination of fructosamine in human serum. The determination of fructosamine is most commonly performed for the evaluation of glycemic control in diabetes. Fructosamine values provide an indication of glucose levels over the preceding 2-3 weeks. A higher fructosamine value indicates poorer glycemic control. This reagent set is intended for in vitro diagnostic use only.
Product codes
LCP, JJX
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
diagnostic laboratory setting, by qualified laboratory technologists
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
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)
Not Found
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human profiles or faces, stacked on top of each other, with flowing lines suggesting movement or connection.
DEC 2 1 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. William F. Walters, Jr. Vice President. Technical Operations Pointe Scientific, Inc. 1025 John A. Papalas Drive Lincoln Park, Michigan 48146
Re: K993590
Trade Name: Fructosamine Reagent Set, Fructosamine Calibrator and Fructosamine Controls
Regulatory Class: II Product Code: LCP, JIT Regulatory Class: I reserved Product Code: JJX Dated: October 20, 1999 Received: October 22, 1999
Dear Mr. Walters:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 Division of Clinical Laboratory Devices Office of Device Evaluation 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: Fructosamine Reagent Set, Fructosamine Calibrator and Fructosamine Controls
Indications for use:
This product is to be used in a diagnostic laboratory setting, by qualified laboratory technologists, for the quantitative determination of fructosamine in human serum. The determination of fructosamine is most commonly performed for the evaluation of glycemic control in diabetes. Fructosamine values provide an indication of glucose levels over the preceding 2-3 weeks. A higher fructosamine value indicates poorer glycemic control. This reagent set is intended for in vitro diagnostic use only.
Cawl C. Bensen for Jean Cooper DVM
(Division Sign-Off)
Division of Clinical Laboratory evices
510(k) Number K993590
(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)