GLYCACOR

K980888 · Exocell, Inc. · LCP · Aug 13, 1998 · Hematology

Device Facts

• Record ID: K980888
• Device Name: GLYCACOR
• Applicant: Exocell, Inc.
• Product Code: LCP · Hematology
• Decision Date: Aug 13, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7470
• Device Class: Class 2

Indications for Use

Enzyme linked Immunosorbent Assay (ELISA), non-radioactive, for determination of glycated LDL (low-density lipoprotein) in plasma

Device Story

Glycacor is an enzyme-linked immunosorbent assay (ELISA) kit; non-radioactive; used for quantitative determination of glycated LDL in human plasma. Device operates via standard ELISA laboratory procedures; utilizes specific binding to detect glycated LDL levels. Used in clinical laboratory settings by trained laboratory personnel. Output provides quantitative measurement of glycated LDL, assisting clinicians in assessing glycemic status or cardiovascular risk factors associated with protein glycation. Benefits include standardized, non-radioactive measurement of glycated LDL compared to traditional methods.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Enzyme-linked immunosorbent assay (ELISA) kit; non-radioactive; in vitro diagnostic reagent system. Designed for plasma sample analysis.

Indications for Use

Indicated for the determination of glycated LDL in human plasma samples. Intended for prescription 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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## AUG 1 3 1998

Margo P. Cohen, M.D. President Exocell, Inc. 3508 Market Street Suite 420 Philadelphia, Pennsylvania 19104

к980888/51 Re : Trade Name: Glycacor Requlatory Class: İI Product Code: LCP Dated: June 1, 1998 Received: June 4, 1998

Dear Dr. Cohen:

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 Requlations, 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 Reqister. 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.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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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.qov/cdrh/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): | K930888 |
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GLYCACOR Device Name:

Indications for Use:

IInzyme linked Immunosorbent Assay (ELISA), non-radioactive, for determination of glycated LDL (low-density lipoprotein) in plasma

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHIER PAGE IF NEED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use 1 (Per 21 CFR 801.109)

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Over-The-Counter Use

(Optional Format 1-2-96)

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number k-988888