CRYO CHECK FACTOR X DEFICIENT PLASMA

• K Number: K971227
• Device Name: CRYO CHECK FACTOR X DEFICIENT PLASMA
• Manufacturer: PRECISION BIOLOGICALS, INC.
• Date Cleared: 1997-07-18 ( 107 days)
• Product Code: GJT
• Regulation Number: 864.7290
• Type: Traditional
• Panel: Hematology
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

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

Device Description

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

AI/ML Overview

This document is a 510(k) clearance letter for the "CryoCheck Factor X Deficient Plasma" device. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the manner requested (i.e., with performance metrics like sensitivity, specificity, or accuracy compared to a ground truth).

The letter merely states that the FDA has determined the device is "substantially equivalent" to a legally marketed predicate device, allowing it to be marketed. The described "Indications For Use" explain how the device functions to assess factor X deficiencies but do not provide performance metrics or details of a study.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study results or effect size.
6. Standalone performance results.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document is a regulatory approval, not a scientific study report or clinical trial summary.

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 features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular fashion around the caduceus. The logo is black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

JUL 1 8 1997

K971227 Re : CryoCheck Factor X Deficient Plasma Regulatory 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, 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. ਰ 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 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 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 requlation (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 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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510(k) Number (if known): not yet issued

Device Name: CryoCheck Factor X Deficient Plasma

Indications For Use: Deficiencies in coagulation factors may have congenital or acquired etiologies and can compromise in vivo hemostasis. Factor X is a twochain molecule with a molecular weight of 59,000 and is important for both intrinsic and extrinsic coagulation. Factor X deficiency is commonly diagnosed in vitro through the used of a modified prothrombin time (PT) assay. When a patient sample is mixed with factor X deficient plasma, the degree of correction of the PT is proportional to the level of Factor X in the patient plasma.

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

(Division Sign-Off)
Division of Clinical Laboratory Zevices
510(k) Number K 971227

(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)	✓
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OR

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