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

• K Number: K990296
• Device Name: CRYOCHECK PREKALLIKREIN DEFICIENT PLALSMA, MODEL FDPK10/10 (10 X 1.0 ML), FDPK10/25 (25 X 1.0ML)
• Manufacturer: PRECISION BIOLOGIC
• Date Cleared: 1999-03-18 ( 49 days)
• Product Code: GJT
• Regulation Number: 864.7290

Intended 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).

Device Description

Cryo Check™ Prekallikrein Deficient Plasma is human plasma deficient in the prekallikrein coagulation protein.

Predicate Devices

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Reference Devices

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AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a biological reagent (plasma) used in a laboratory assay and does not mention any computational or analytical components that would suggest the use of AI or ML.

Therapeutic

No
Explanation: This device is a diagnostic reagent used for in vitro testing to diagnose prekallikrein deficiency, not to treat a condition.

Diagnostic

No

This device is described as "human plasma deficient in the prekallikrein coagulation protein" and is recommended "for use as a substrate in clot-based prekallikrein assays." It is a reagent used in a diagnostic test, not a diagnostic device itself.

SaMD (Software as a Medical Device)

No

The device description clearly states that the device is "human plasma deficient in the prekallikrein coagulation protein," which is a biological material, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use clearly states that the device is used "as a substrate in clot-based prekallikrein assays using the activated partial thromboplastin time (APTT)." This describes a test performed in vitro (outside the body) on a biological sample (plasma) to aid in the diagnosis of prekallikrein deficiency.
• Device Description: The device is described as "human plasma deficient in the prekallikrein coagulation protein," which is a reagent used in a laboratory test.
• Context: The entire description revolves around laboratory testing for coagulation deficiencies.

Therefore, the Cryo Check™ Prekallikrein Deficient Plasma fits the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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).

Product codes

GJT

Device Description

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Mentions image processing

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Mentions AI, DNN, or ML

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Input Imaging Modality

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Anatomical Site

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Indicated Patient Age Range

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Intended User / Care Setting

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Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

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Summary of Performance Studies

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Key Metrics

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Predicate Device(s)

Not Found

Reference Device(s)

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Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with outstretched wings.

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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