(49 days)
Deficiencies in coagulation factors may have congenital or acquired etiologies and can compromise in vivo hemostasis. Prekallikrein or Fletcher factor, is a single chain polypeptide with a molecular weight of 85,000 and is necessary for normal coagulation of the "intrinsic coagulation pathway". Prekallikrein deficiency is commonly diagnosed in vitro through the use of the activated partial thromboplastin time (APTT), an intrinsic pathway screening assay and confirmed with a quantitative prekallikrein assay which is an APTT-based clotting assay.
Cryo Check™ Prekallikrein Deficient Plasma is human plasma deficient in the prekallikrein coagulation protein. It is recommended for use as a substrate in clot-based prekallikrein assays using the activated partial thromboplastin time (APTT).
Cryo Check™ Prekallikrein Deficient Plasma is human plasma deficient in the prekallikrein coagulation protein.
I am sorry, but based on the limited information provided in the regulatory letter, I cannot describe the acceptance criteria or the study. The document is a 510(k) clearance letter from the FDA, which confirms that the "Cryo | Check™ Prekallikrein Deficient Plasma" device is substantially equivalent to a legally marketed predicate device.
This type of document does not typically contain the detailed information requested regarding acceptance criteria, study design, sample sizes, expert qualifications, adjudication methods, or specific performance metrics. The letter confirms clearance based on a prior submission, but the actual data and study details are not part of this public clearance announcement.
Therefore, I cannot provide the requested table or answer the specific questions about the study from the given text.
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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with outstretched wings.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 1 8 1999
Mr. Sandy Morrison Manager, Technical Operations Precision BioLogic Inc. 900 Windmill Road, Suite 100 Dartmouth, Nova Scotia Canada B3B 1P7
Re: K990296
Trade Name: Cryo | Check™ Prekallikrein Deficient Plasma Regulatory Class: II Product Code: GJT Dated: January 27, 1999 Received: January 28, 1999
Dear Mr. 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 legally marketed predicate 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.
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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 (770) 488-7655.
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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Sutman
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: _ K990in H
Device Name: Cryo Check™ Prekallikrein Deficient Plasma
Indications for Use
Deficiencies in coagulation factors may have congenital or acquired etiologies and can compromise in vivo hemostasis. Prekallikrein or Fletcher factor, is a single chain polypeptide with a molecular weight of 85,000 and is necessary for normal coagulation of the "intrinsic coagulation pathway". Prekallikrein deficiency is commonly diagnosed in vitro through the use of the activated partial thromboplastin time (APTT), an intrinsic pathway screening assay and confirmed with a quantitative prekallikrein assay which is an APTT-based clotting assay.
Cryo Check™ Prekallikrein Deficient Plasma is human plasma deficient in the prekallikrein coagulation protein. It is recommended for use as a substrate in clot-based prekallikrein assays using the activated partial thromboplastin time (APTT).
Pete E. Masini
(Division Sion-Off) Oivision of Cinical Laboratory Devices 1990206 510(k) Number.
Prescription
use
✓
§ 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).