CRYO CHECK FACTOR IX DEFICIENT PLASMA

K971226 · Precision Biologicals, Inc. · GJT · Jul 18, 1997 · Hematology

Device Facts

• Record ID: K971226
• Device Name: CRYO CHECK FACTOR IX DEFICIENT PLASMA
• Applicant: Precision Biologicals, Inc.
• Product Code: GJT · Hematology
• Decision Date: Jul 18, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7290
• Device Class: Class 2

Intended Use

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

Device Story

CryoCheck Factor IX Deficient Plasma is a human plasma-derived reagent used in clinical laboratories. It contains normal levels of all coagulation factors except Factor IX. In practice, a clinician or laboratory technician mixes a patient's plasma sample with the Factor IX Deficient Plasma. The device functions by allowing the degree of correction of the patient's APTT to be measured; this correction is proportional to the level of Factor IX present in the patient's sample. The output is a quantitative or semi-quantitative assessment of Factor IX activity, which aids in the diagnosis and monitoring of hemophilia B. The device is intended for professional use in a clinical laboratory setting.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Human plasma-derived reagent; deficient in Factor IX coagulation protein; normal levels of other coagulation factors; intended for use in in vitro clot-based APTT assays.

Indications for Use

Indicated for use in assessing Factor IX deficiencies (hemophilia B) in patients with congenital or acquired coagulation factor deficiencies via in vitro clot-based activated partial thromboplastin time (APTT) assays.

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

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

Re: K971226
CryoCheck Factor IX 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. 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.

JUL 18 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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DPR

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

Device Name: CryoCheck Factor IX Deficient Plasma

Indications For Use: Deficiencies in coagulation factors may have congenital or acquired etiologies and can compromise in vivo hemostasis. Factor IX is a single chain protein with a molecular weight of 54,000 and is necessary for intrinsic coagulation. Factor IX deficiency (hemophilia B) is commonly diagnosed in vitro through the use of a modified activated partial thromboplastin time (APTT) assay. When a patient sample is mixed with factor IX deficient plasma, the degree of correction of the APTT is proportional to the level of Factor IX in the patient plasma.

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


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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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