CRYO CHECK FACTOR VII DEFICIENT PLASMA

• K Number: K971224
• Device Name: CRYO CHECK FACTOR VII DEFICIENT PLASMA
• Manufacturer: PRECISION BIOLOGICALS, INC.
• Date Cleared: 1997-07-17 ( 106 days)
• Product Code: GJT
• Regulation Number: 864.7290

Intended Use

CryoCheck Factor VII Deficient Plasma is human plasma deficient in the factor VII coagulation protein while having all other coagulation factors within normal limits. It is indicated for use to assess factor VII deficiencies in in vitro clot-based factor VII assays using the one stage prothrombin time.

Device Description

CryoCheck Factor VII Deficient Plasma is human plasma deficient in the factor VII coagulation protein while having all other coagulation factors within normal limits.

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 (deficient plasma) used in a standard laboratory assay. There is no mention of computational analysis, algorithms, or learning processes.

Therapeutic

No.
The device is an in vitro diagnostic reagent used to assess factor VII deficiencies in patient plasma, not to treat a medical condition.

Diagnostic

Yes

Explanation: The device is indicated for "assessing factor VII deficiencies in in vitro clot-based factor VII assays," which is an activity involved in diagnosing a condition.

SaMD (Software as a Medical Device)

No

The device is a biological reagent (human plasma) used in an in vitro diagnostic assay, not a software-only medical device.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use clearly states it is used "to assess factor VII deficiencies in in vitro clot-based factor VII assays". This indicates it is used to examine specimens from the human body in vitro (outside the body) to provide information for diagnostic purposes.
• Device Description: The description confirms it is "human plasma deficient in the factor VII coagulation protein". This is a reagent used in a laboratory setting for testing.
• Intended User / Care Setting: It is intended for use in "in vitro clot-based factor VII assays," which are laboratory tests.

All these points align with 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. Factor VII is a sinqle chain molecule with a molecular weight of 45,000 - 50, 000 and is important for extrinsic coagulation. Factor VII deficiency is commonly diagnosed in vitro through the used of a modified prothrombin time (PT) assay. When a patient sample is mixed with factor VII deficient plasma, the degree of correction of the PT is proportional to the level of Factor VII in the patient plasma.

CryoCheck Factor VII Deficient Plasma is human plasma deficient in the factor VII coagulation protein while having all other coagulation factors within normal limits. It is indicated for use to assess factor VII deficiencies in in vitro clot-based factor VII assays using the one stage prothrombin time.

Product codes

GJT

Device Description

CryoCheck Factor VII Deficient Plasma is human plasma deficient in the factor VII coagulation protein while having all other coagulation factors within normal limits.

Mentions image processing

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Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

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Anatomical Site

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Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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

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

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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

Not Found

Reference Device(s)

Not Found

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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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL 17 1997

Sandy Morrison Precision Biologicals 900 Windmill Road, #100 Dartmouth, Nova Scotia Canada B3B 1P7

Re : K971224 CryoCheck Factor VII Deficient Plasma Requlatory Class: II Product Code: GJT Dated: May 29, 1997 Received: June 2, 1997

Dear Ms. 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 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 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 requlation may result in regulatory In addition, FDA may publish further announcements action. 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 Requlations.

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Paqe 2

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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic 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 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 Litman

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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Page / of /

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

Device Name: CryoCheck Factor VII Deficient Plasma

Indications For Use: Deficiencies in coagulation factors may have congenital or acquired etiologies and can compromise in vivo hemostasis. Factor VII is a sinqle chain molecule with a molecular weight of 45,000 - 50, 000 and is important for extrinsic coagulation. Factor VII deficiency is commonly diagnosed in vitro through the used of a modified prothrombin time (PT) assay. When a patient sample is mixed with factor VII deficient plasma, the degree of correction of the PT is proportional to the level of Factor VII in the patient plasma.

CryoCheck Factor VII Deficient Plasma is human plasma deficient in the factor VII coagulation protein while having all other coagulation factors within normal limits. It is indicated for use to assess factor VII deficiencies in in vitro clot-based factor VII assays using the one stage prothrombin time.

(Division Sign-Off)
Division of Clinical Devices
510(k) Number:	K971224

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use (Optional Format 1-2-96)