SYNCHRON CX SYSTEMS GLUCOSE REAGENT (GLU)

K971467 · Carolina Liquid Chemistries Corp. · CFR · Jun 16, 1997 · Clinical Chemistry

Device Facts

• Record ID: K971467
• Device Name: SYNCHRON CX SYSTEMS GLUCOSE REAGENT (GLU)
• Applicant: Carolina Liquid Chemistries Corp.
• Product Code: CFR · Clinical Chemistry
• Decision Date: Jun 16, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Glucose Reagent is intended for the quantitative determination of serum glucose using the Beckman SYNCHRON CX Clinical Systems. The results are used in the diagnosis and treatment of diabetes mellitus, neonatal and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Device Story

Glucose Reagent is an in vitro diagnostic reagent for use with Beckman SYNCHRON CX Clinical Systems. It enables quantitative measurement of glucose levels in serum samples. The system processes samples to provide numerical glucose concentrations. Used in clinical laboratory settings by trained personnel. Results assist clinicians in diagnosing and managing diabetes mellitus, hypoglycemia, and pancreatic islet cell carcinoma. The device provides objective data to support clinical decision-making regarding metabolic status and glucose regulation.

Clinical Evidence

No clinical data provided; substantial equivalence is based on performance characteristics of the reagent for quantitative serum glucose determination.

Technological Characteristics

In vitro diagnostic reagent for use on Beckman SYNCHRON CX Clinical Systems. Quantitative enzymatic assay for serum glucose. Standard clinical chemistry reagent formulation.

Indications for Use

Indicated for quantitative determination of serum glucose in patients requiring diagnosis or treatment monitoring for diabetes mellitus, neonatal/idiopathic hypoglycemia, or pancreatic islet cell carcinoma. For prescription use only.

Regulatory Classification

Identification

A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Special Controls

*Classification.* Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 1 6 1997

Cynthia Shugart President Carolina Liquid Chemistries Corporation -----------451 West Lambert Road, Suite 207 Brea, California 92821

K971467 Re : SYNCHRON CX Systems Glucose Reagent (GLU) Requlatory Class: II Product Code: CFR Dated: April 17, 1997 Received: April 22, 1997

Dear Ms. Shugart:

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 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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

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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 Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory 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 requlations.

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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 requlation (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/cdrh/dsmamain.html".

Sincerely yours,
Steven Litman

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):__

Device Name: Glucose Reagent

Indications For Use:

Glucose Reagent is intended for the quantitative સ્ determination of serum glucose using the Beckman SYNCHRON CX Clinical Systems. The results are used in the diagnosis and treatment of diabetes mellitus, neonatal and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

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> Concurrence of CDRH, Office of Device Evaluation (ODE) On Sion-

Prescription Use_ Per 21 CFR 801.109

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Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

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