CRYO CHECK INR VALIDATION SET

K971219 · Precision Biologicals, Inc. · GGN · Aug 29, 1997 · Hematology

Device Facts

• Record ID: K971219
• Device Name: CRYO CHECK INR VALIDATION SET
• Applicant: Precision Biologicals, Inc.
• Product Code: GGN · Hematology
• Decision Date: Aug 29, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

Indications for Use

CryoCheck INR Validation Set is indicated for use in monitoring the accuracy and control of oral anticoagulant therapy using the International Normalized Ratio (INR) on a variety of prothrombin time systems. CryoCheck INR Validation Set is not intended for use as calibration or reference plasma and should not be used for calibrating the local International Sensitivity Index (ISI) of commercial thromboplastins.

Device Story

CryoCheck INR Validation Set consists of well-characterized warfarinized human plasmas with system-specific INR assigned ranges. Used in clinical laboratories to monitor accuracy and control of oral anticoagulant therapy. Device provides external validation of PT system performance; helps mitigate variability in INR results across different commercial thromboplastins and automated coagulation analyzers. Not a calibrator; intended for quality control/validation purposes only. Healthcare providers use the output to verify the accuracy of patient INR testing, ensuring safe management of anticoagulant therapy.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Set of well-characterized warfarinized human plasmas. Formulated for use with various prothrombin time systems to validate INR reporting. Does not involve electronic components, software, or specific material standards.

Indications for Use

Indicated for monitoring accuracy and control of oral anticoagulant therapy (warfarin and related drugs) via INR on various prothrombin time systems. Not for use as calibration or reference plasma; not for calibrating local ISI of thromboplastins.

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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
2098 Gaither Road
Rockville MD 20850

Stephen L. Duff
Precision Biologicals
900 Windmill Road, #100
Dartmouth, Nova Scotia
Canada B3B 1P7

Re: K971219
Cryo Check™ INR Validation Set
Regulatory Class: II
Product Code: GGN
Dated: June 16, 1997
Received: June 19, 1997

Dear Mr. Duff:

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 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.

AUG 29 1997

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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/dsmamain.html".

Sincerely yours,

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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SENT BY: PRECISION BIOLOGICAL; 8-25-97 12:44; 902 468 642 => 301 5945940; #2/2

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510(k) Number (if known): not yet issued K# 971219

Device Name: CryoCheck INR Validation Set

Indications For Use: The Prothrombin Time (PT) was first described by Quick and is a common method of monitoring oral anticoagulant treatment in patients receiving warfarin and related drugs. The safety and efficacy of oral anticoagulant therapy is dependent on regular and appropriate laboratory monitoring of the PT test which measures the depression of clotting factors II, VII and X. In 1983 the World Health Organization (WHO) described a scheme for PT standardization based on the International Normalized Ratio (INR). The INR is defined as the Prothrombin Ratio (PR) of the patient raised to the power of the International Sensitivity Index (ISI) of the thromboplastin reagent in use such that INR=PR$^{ISI}$.

With the recent proliferation in both commercial thromboplastins and automated coagulation analyzers, the number of PT system combinations has increased significantly. This, in conjunction with the increasing prevalence of the INR reporting system, has resulted in a heightened awareness of variability in test results between laboratories reporting INR's.

CryoCheck INR Validation Set has been designed to enhance the effective monitoring of oral anticoagulant therapy by providing a set of well characterized warfarinized plasmas with system specific INR assigned ranges.

CryoCheck INR Validation Set is indicated for use in monitoring the accuracy and control of oral anticoagulant therapy using the International Normalized Ratio (INR) on a variety of prothrombin time systems. CryoCheck INR Validation Set is not intended for use as calibration or reference plasma and should not be used for calibrating the local International Sensitivity Index (ISI) of commercial thromboplastins.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ☑ (Per 21 CFR 801.109) OR Over-The-Counter Use ☐ (Optional Format 1-2-96)