CRYOCHECK PREKALLIKREIN DEFICIENT PLALSMA, MODEL FDPK10/10 (10 X 1.0 ML), FDPK10/25 (25 X 1.0ML)

K990296 · Precision Biologic · GJT · Mar 18, 1999 · Hematology

Device Facts

• Record ID: K990296
• Device Name: CRYOCHECK PREKALLIKREIN DEFICIENT PLALSMA, MODEL FDPK10/10 (10 X 1.0 ML), FDPK10/25 (25 X 1.0ML)
• Applicant: Precision Biologic
• Product Code: GJT · Hematology
• Decision Date: Mar 18, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7290
• Device Class: Class 2

Intended Use

Cryo Check™ Prekallikrein Deficient Plasma is human plasma deficient in the prekallikrein coagulation protein. It is recommended for use as a substrate in clot-based prekallikrein assays using the activated partial thromboplastin time (APTT).

Device Story

Cryo Check™ Prekallikrein Deficient Plasma is a human plasma-derived reagent used in clinical laboratories. It serves as a substrate in APTT-based clotting assays to quantify prekallikrein levels. By providing a plasma source specifically deficient in prekallikrein, the device allows clinicians to isolate and measure the patient's prekallikrein activity via the intrinsic coagulation pathway. The assay results assist in diagnosing prekallikrein deficiency, which may be associated with congenital or acquired hemostatic disorders. The device is intended for professional use in clinical laboratory settings.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Human plasma-derived reagent; deficient in prekallikrein protein; intended for use in clot-based APTT assays; in vitro diagnostic use.

Indications for Use

Indicated for use as a substrate in clot-based prekallikrein assays using the activated partial thromboplastin time (APTT) for the diagnosis of prekallikrein deficiency in patients with suspected congenital or acquired coagulation factor deficiencies.

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR 1 8 1999

Mr. Sandy Morrison Manager, Technical Operations Precision BioLogic Inc. 900 Windmill Road, Suite 100 Dartmouth, Nova Scotia Canada B3B 1P7

Re: K990296

Trade Name: Cryo | Check™ Prekallikrein Deficient Plasma Regulatory Class: II Product Code: GJT Dated: January 27, 1999 Received: January 28, 1999

Dear Mr. Morrison:

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 Regulations, 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 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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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 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".

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: _ K990in H

Device Name: Cryo Check™ Prekallikrein Deficient Plasma

## Indications for Use

Deficiencies in coagulation factors may have congenital or acquired etiologies and can compromise in vivo hemostasis. Prekallikrein or Fletcher factor, is a single chain polypeptide with a molecular weight of 85,000 and is necessary for normal coagulation of the "intrinsic coagulation pathway". Prekallikrein deficiency is commonly diagnosed in vitro through the use of the activated partial thromboplastin time (APTT), an intrinsic pathway screening assay and confirmed with a quantitative prekallikrein assay which is an APTT-based clotting assay.

Cryo Check™ Prekallikrein Deficient Plasma is human plasma deficient in the prekallikrein coagulation protein. It is recommended for use as a substrate in clot-based prekallikrein assays using the activated partial thromboplastin time (APTT).

Pete E. Masini

(Division Sion-Off) Oivision of Cinical Laboratory Devices 1990206 510(k) Number.

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