COAGUCHEK SYSTEM, COAGUCHEK SYSTEM FOR PROTHROMBIN TIME SELF TESTING

K974569 · Boehringer Mannheim Corp. · JPA · Jan 9, 1998 · Hematology

Device Facts

• Record ID: K974569
• Device Name: COAGUCHEK SYSTEM, COAGUCHEK SYSTEM FOR PROTHROMBIN TIME SELF TESTING
• Applicant: Boehringer Mannheim Corp.
• Product Code: JPA · Hematology
• Decision Date: Jan 9, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

Intended Use

The CoaguChek System for professional use is intended for quantitative prothrombin time (PT) testing in fresh capillary or venous whole blood by professional health care providers. The CoaguChek System for Patient Self Testing is intended for the quantitative prothrombin time (PT) testing in fresh capillary blood by selected and suitably trained patients or their caregivers on the prescription of the treating physician.

Device Story

CoaguChek System performs quantitative prothrombin time (PT) testing. Input: fresh capillary or venous whole blood. Operation: electrochemical measurement of coagulation time. Output: PT results displayed to user. Professional version used in clinical settings by healthcare providers; Patient Self Testing version used in home settings by trained patients/caregivers. Results assist in monitoring anticoagulant therapy; enables patient self-management of PT levels under physician supervision.

Clinical Evidence

No clinical data provided in the document.

Technological Characteristics

Electrochemical measurement system for prothrombin time (PT) testing. Designed for use with fresh capillary or venous whole blood. System includes two configurations: professional use and patient self-testing. Operates as an in vitro diagnostic device.

Indications for Use

Indicated for quantitative prothrombin time (PT) testing in fresh capillary or venous whole blood. Professional use version for healthcare providers; Patient Self Testing version for trained patients/caregivers via physician prescription.

Regulatory Classification

Identification

A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.

Special Controls

*Classification.* Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN - 9 1998

Mr. Richard Naples Director, Regulatory Affairs Boehringer Mannheim 9115 Haque Road 46250 Indianapolis, Indiana

RE : K974569 Trade Name: CoaguChek System (Professional Use) and CoaguChek PST (Patient Self Testing) Requlatory Class: II Product Code: JPA Dated: December 5, 1997 Received: December 8, 1997

Dear Mr. Naples:

We have reviewed your Section 510(k) notification of intent to market the CoaguChek System (Professional Use) and the CoaguChek PST (Patient Self Testing) devices under a single 510(k) number as referenced above and we have determined that these two devices are 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). Please note that the consolidation of these two devices under a single 510(k) number, K974569, does not change the fact that there are two separate and different intended uses for these devices, one for professional use and one for home use by prescription, and two different sets of quality control recommendations for the two devices. You may, therefore, market the devices, subject to the general controls The general controls provisions of provisions of the Act. the Act include requirements for annual registration, listing ... of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.

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Page 2 - Mr. Richard Naples

If your devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (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 regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your devices 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.

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), these devices 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 devices as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.

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Page 3 - Mr. Naples

If you desire specific advice for your devices 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 devices, 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 at [phone],or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html" .

Sincerely yours,

Steven Autman

Steven I. Gutman, MD,MBA Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page of of

510(k) Number (if known): K974569

Device Names: CoaguChek System for Professional Use and the CoaguChek System for Patient Self Testing

Indications For Use:

The CoaguChek System for professional use is intended for quantitative prothrombin time (PT) testing in fresh capillary or venous whole blood by professional health care providers. The CoaguChek System for Patient Self Testing is intended for the quantitative prothrombin time (PT) testing in fresh capillary blood by selected and suitably trained patients or their caregivers on the prescription of the treating physician.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Steven Autman

(Division Sign-Off) Division of Clinical Laboratory Devi NG745 510(k) Number.

Prescription Use X (Per 21 CFR 801.109) OR

Over-The-Counter Use