FRUCTOSAMINE REAGENT SET, CALIBRATOR, AND CONTROL SET by POINTE SCIENTIFIC, INC.

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.

Device Description

Fructosamine Reagent Set, Fructosamine Calibrator and Fructosamine Controls

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a Fructosamine Reagent Set, Fructosamine Calibrator, and Fructosamine Controls. It acknowledges the substantial equivalence of the device to a legally marketed predicate device.

Crucially, this document is an FDA clearance letter and does not contain the actual study data, acceptance criteria, or performance metrics that would be submitted to the FDA as part of the 510(k) application.

Therefore, I cannot directly extract the specific information requested in your prompt based on the provided text. The letter only states that the device was found substantially equivalent to a predicate and the indications for use.

To answer your questions, I would need access to the full 510(k) submission (or at least the relevant sections detailing performance studies) that this letter refers to.

Here's what I can tell you based on the provided document, and what is missing:

Table of acceptance criteria and reported device performance: Not available in this document. The FDA letter grants clearance based on the determination of substantial equivalence, implying that the submitted performance data met the necessary criteria, but the criteria and results themselves are not detailed here.
Sample size used for the test set and the data provenance: Not available in this document. This information would be found in the performance studies submitted to the FDA.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/available in this document. This device is an in vitro diagnostic (IVD) for quantitative determination of fructosamine. Ground truth for such devices is typically established through a reference method or known concentration standards, not expert panel consensus as might be seen for imaging or subjective diagnostic aids. The letter does not detail the methods used to establish ground truth for the performance studies.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable/available in this document. Adjudication methods are typically used in studies where subjective interpretation is involved, such as medical imaging. For a quantitative IVD, the "ground truth" samples would have known reference values, not adjudicated interpretations.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is an in vitro diagnostic reagent set, not an AI-assisted diagnostic tool or an imaging device requiring human reader interpretation. No MRMC study would be performed for this type of device.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a reagent set for laboratory use, not an algorithm. Its performance is inherent to the chemical reaction and instrumentation.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not explicitly stated in this document. For an IVD like this, ground truth for performance studies would typically be established using:
- Reference methods with known accuracy and precision.
- Certified reference materials or calibrators with accurately assigned fructosamine concentrations.
- Clinical samples collected from patients with known glycemic status (often confirmed by other recognized methods like HbA1c or long-term glucose monitoring).
The sample size for the training set: Not applicable/available in this document. This device is a reagent set, not a machine learning algorithm that requires a "training set."
How the ground truth for the training set was established: Not applicable/available in this document. As it's not an AI/ML device, there's no "training set" in that context.

Summary

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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

K993590

510 (k) Number (if known): Unknown at this time

Device Name: Fructosamine Reagent Set, Fructosamine Calibrator and Fructosamine Controls

Indications for use:

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)

Over the Counter Use_

(Optional Format 1-2-96)

Regulation Number and Section

§ 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).