BIOCLOT APC SENSITIVITY by BIOPOOL INTL., INC.

I apologize, but the provided text from the FDA 510(k) approval letter for the Bioclot® aPC Sensitivity Kit does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving the device meets those criteria.

The document is a letter indicating substantial equivalence to a predicate device, allowing the kit to be marketed. It does not include:

A table of acceptance criteria or reported device performance.
Details about sample sizes for test or training sets, data provenance, or ground truth establishment.
Information on expert involvement, adjudication methods, or MRMC comparative effectiveness studies.
Results from standalone algorithm performance studies.

Therefore, I cannot fulfill your request based on the provided input.

Summary

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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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

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.

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

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)

Over-The-Counter Use ________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Regulation Number and Section

§ 864.7290 Factor deficiency test.

(a)
Identification. A factor deficiency test is a device used to diagnose specific coagulation defects, to monitor certain types of therapy, to detect coagulation inhibitors, and to detect a carrier state (a person carrying both a recessive gene for a coagulation factor deficiency such as hemophilia and the corresponding normal gene).(b)
Classification. Class II (performance standards).