FRUCTOSAMINE, MODEL FR 106-01

K991246 · A.P. Total Care, Inc. · LCP · Dec 16, 1999 · Hematology

Device Facts

• Record ID: K991246
• Device Name: FRUCTOSAMINE, MODEL FR 106-01
• Applicant: A.P. Total Care, Inc.
• Product Code: LCP · Hematology
• Decision Date: Dec 16, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7470
• Device Class: Class 2

Indications for Use

The fructosamine reagent (R1), product No. FR10-01 is intended for Invitro Diagnostic use in the automated, quantitative determination of fructosamine in serum, or plasma.

Device Story

Fructosamine reagent (FR 106-01) used for quantitative determination of fructosamine in serum or plasma samples. Designed for use in automated clinical laboratory analyzers. Operates via chemical reaction to measure fructosamine levels, which serve as a marker for glycemic control. Intended for prescription use in clinical settings. Healthcare providers use quantitative results to assess patient metabolic status and monitor diabetes management. Benefits include providing objective data for clinical decision-making regarding patient glucose regulation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

In vitro diagnostic reagent for automated quantitative analysis. Chemical assay principle for fructosamine detection in serum/plasma. Designed for integration with automated clinical chemistry analyzers.

Indications for Use

Indicated for the automated, quantitative determination of fructosamine in human serum or plasma for in vitro diagnostic use.

Regulatory Classification

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.

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC I 6 1999

A.P. Total Care, Inc. c/o Mr. Luis P. Leon Catachem, Inc. 70 Hawley Avenue PO Box 6216 Bridgeport, Connecticut 06606

K991246 Re: Trade Name: Fructosamine, Model FR 106-01 Regulatory Class: II Product Code: LCP Dated: October 12, 1999 Received: October 15, 1999

Dear Mr. Leon:

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 (OS) 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 [phone].

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], or at its internet address "http://www.fda.gov/cdrlv/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

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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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ FRUCTOSAMINE Device Name:_

Indications For Use:

The fructosamine reagent (R1), product No. FR10-01 is intended for Invitro Diagnostic use in the automated, quantitative determination of fructosamine in serum, or plasma.

Dan Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K991246

(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)