CRYO CHECK APC RESISTANT PLASMA

K971222 · Precision Biologicals, Inc. · GGN · Aug 19, 1997 · Hematology

Device Facts

• Record ID: K971222
• Device Name: CRYO CHECK APC RESISTANT PLASMA
• Applicant: Precision Biologicals, Inc.
• Product Code: GGN · Hematology
• Decision Date: Aug 19, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

Intended Use

CryoCheck APC Resistant Plasma is indicated for use as a positive control in the clot based assessment of activated protein C resistance in citrated human plasma.

Device Story

CryoCheck APC Resistant Plasma functions as a positive control reagent for laboratory assays measuring activated protein C (APC) resistance. The device is used in clinical laboratory settings by trained technicians to validate the performance of clot-based coagulation assays. By providing a standardized sample with known resistance to APC, the product ensures the accuracy and reliability of patient testing for the factor V Leiden mutation, which is associated with familial thrombophilia and venous thrombosis. The output is a control result used to verify that the assay system is correctly identifying factor Va resistance to APC, thereby supporting clinical diagnostic decision-making regarding patient coagulation status.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

In vitro diagnostic reagent; lyophilized or liquid plasma-based control; contains factor V Leiden mutation (Arg506Gln); intended for use in clot-based coagulation assays; non-automated; no software or electronic components.

Indications for Use

Indicated for use as a positive control in the clot-based assessment of activated protein C (APC) resistance in citrated human plasma for patients being evaluated for familial thrombophilia or venous thrombosis risk associated with the factor V Leiden mutation.

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
AUG 19 1997

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

Re: K971222/S1
Trade Name: CRYOV CHECK™ APC RESISTANT PLASMA
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 requirement, 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 at [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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VRD

510(k) Number (if known): not yet issued

Device Name: CryoCheck APC Resistant Plasma

**Indications For Use:** Activated protein C (APC) is a serine protease with potent anticoagulant properties. During normal hemostasis, APC hinders clot formation through a mechanism of proteolytic inactivation of factors Va and VIIIa. Recently, a genetic single point mutation in the APC binding domain of the factor V gene, replacing Arg506 with Gln, was demonstrated to be both inherited and associated with familial thrombophilia. The resulting resistance of factor Va to activated protein C (APCR), often referred to as the factor $V_{\text{leiden}}$ mutation, is now recognized as a commonly inherited risk factor for venous thrombosis.

CryoCheck APC Resistant Plasma is indicated for use as a positive control in the clot based assessment of activated protein C resistance in citrated human plasma.

*[Handwritten signature]*
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number 97/222

(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)