BIOCLOT APC SENSITIVITY

K983898 · Biopool Intl., Inc. · GGP · Jan 6, 1999 · Hematology

Device Facts

• Record ID: K983898
• Device Name: BIOCLOT APC SENSITIVITY
• Applicant: Biopool Intl., Inc.
• Product Code: GGP · Hematology
• Decision Date: Jan 6, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7290
• Device Class: Class 2

Intended Use

Bioclot® aPC Sensitivity is intended for the determination of resistance to activated protein C in human plasma using a clotting assay. Activated Protein C Resistance (aPC) is a hereditary defect which appears to play an important role in thrombophilia.

Device Story

Bioclot® aPC Sensitivity is an in vitro diagnostic reagent kit used to detect activated protein C (aPC) resistance in human plasma. The device functions as a clotting assay to identify a hereditary defect associated with thrombophilia. It is intended for professional use in clinical laboratory settings. The assay measures the clotting time of plasma samples in the presence and absence of activated protein C; a reduced anticoagulant response to aPC indicates aPC resistance. Healthcare providers use the resulting clotting time measurements to assess patient risk for thrombotic events. The device aids in the diagnosis of hereditary thrombophilia by identifying patients with this specific coagulation abnormality.

Clinical Evidence

No clinical data provided; device is an in vitro diagnostic reagent kit evaluated via bench-top clotting assay performance.

Technological Characteristics

In vitro diagnostic reagent kit for clotting-based coagulation analysis. Principle of operation involves measuring plasma clotting times to determine sensitivity to activated protein C. Designed for professional clinical laboratory use.

Indications for Use

Indicated for the determination of resistance to activated protein C (aPC) in human plasma via clotting assay to assess for hereditary thrombophilia.

Submission Summary (Full Text)

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## 6 1999 JAN

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Michael D. Bick, Ph.D. Chief Executive Officer Biopool International, Inc. 6025 Nicolle Street Ventura, California 93003

Re: K983898 Bioclot® aPC Sensitivity Kit Trade Name: Requlatory Class: II Product Code: GGP Dated: October 30, 1998 November 3, 1998 Received:

Dear Dr. Bick:

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 Requlation (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 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 regulations.

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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.gov/cdrh/dsma/dsmamain.html".

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Sincerely yours,

Steven Butman

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):

K983899

Device Name:

Bioclot® aPC Sensitivity

Indications for Use:

Bioclot® aPC Sensitivity is intended for the determination of resistance to activated protein C in human plasma using a clotting assay.

Activated Protein C Resistance (aPC) is a hereditary defect which appears to play an important role in thrombophilia.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Tetu E. Mafeni

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

Prescription Use レ (Per 21 CFR 801.109)

OR

Over-The-Counter Use ________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)