(106 days)
CryoCheck Factor VIII Deficient Plasma is human plasma deficient in the factor VIII coagulation protein while having all other coagulation factors within normal limits. It is indicated for use to assess factor VIII deficiencies in in vitro clotbased factor VIII assays using the activated partial thromboplastin time.
CryoCheck Factor VIII Deficient Plasma is human plasma deficient in the factor VIII coagulation protein while having all other coagulation factors within normal limits.
The provided text is a 510(k) clearance letter from the FDA for a device called "CryoCheck Factor VIII Deficient Plasma." This document does not contain any information about acceptance criteria, device performance, study details, or ground truth establishment relevant to an AI/ML device.
The letter is a regulatory approval for an in vitro diagnostic product, not a software device, and primarily states that the device is substantially equivalent to existing devices. Therefore, I cannot extract the requested information regarding acceptance criteria, study details, or AI/ML specific metrics.
To provide the requested information, a different type of document, such as a clinical study report, a performance evaluation report, or a 510(k) summary for an AI/ML device, would be necessary.
{0}------------------------------------------------
Public Health Service
JUL 17 1997
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Sandy Morrison Precision Biologicals 900 Windmill Road, #100 Dartmouth, Nova Scotia Canada B3B 1P7
K971225 Re : CryoCheck Factor VIII 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, Drug, 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 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. ਜੋ 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 requlatory 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 Requlations.
{1}------------------------------------------------
Page 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 (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 requlation (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/dsmamain.html".
Sincerely yours,
Steven Gutman
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
{2}------------------------------------------------
Page of
510(k) Number (if known): not yet issued
Device Name: CryoCheck Factor VIII Deficient Plasma
Indications For Use: Deficiencies in coagulation factors may have congenital or acquired etiologies and can compromise in vivo hemostasis. Factor VIII is a trace protein which is present in vivo as a complex with von Willebrand factor and is necessary for intrinsic coagulation. Factor VIII deficiency (hemophilia A) is commonly diagnosed in vitro through the used of a modified activated partial thromboplastin time (APTT) assay. When a patient sample is mixed with factor VIII deficient plasma, the degree of correction of the APTT is proportional to the level of Factor VIII in the patient plasma.
CryoCheck Factor VIII Deficient Plasma is human plasma deficient in the factor VIII coagulation protein while having all other coagulation factors within normal limits. It is indicated for use to assess factor VIII deficiencies in in vitro clotbased factor VIII assays using the activated partial thromboplastin time.
(Division-Off)
Division of Chnical Laboratory devices
510(k) Nuraber971225
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Image /page/2/Figure/7 description: The image shows the concurrence of CDRH, Office of Device Evaluation (ODE). It indicates 'Prescription Use' (Per 21 CFR 801.109) is selected with a checkmark. It also shows 'OR' and 'Over-The-Counter Use' (Optional Format 1-2-96).
§ 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).