(91 days)
CASCADE™ Liquid Coagulation Control, Levels 1, 2, and 3 is a human plasma based quality control material intended for use in the clinical laboratory as a consistent tool of known concentration for monitoring the performance of coagulation assays (prothrombin time, activated partial thromboplastin time, and fibrinogen assays). The user can compare recovered values with expected ranges and is a means of assuring consistent performance of for use on the MLA 1600 analyzer.
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This document is a marketing clearance letter from the FDA for a medical device called "CASCADE™ Liquid Coagulation Control, Levels 1, 2, and 3". It does not contain information about the device's acceptance criteria, performance studies, or related details that would typically be found in a clinical study report or a 510(k) summary.
Therefore, I cannot provide the requested information. The document primarily focuses on the regulatory approval and classification of the device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with three intertwined snakes and a single wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 22 1999
Ms. Mary D. Thorsness Sr. Associate, Regulatory Affairs Medical Analysis Systems, Inc. Lincoln Technology Park 542 Flynn Road Camarillo, California 93012-8058
K992829 Re:
Trade Name: CASCADE™ Liquid Coagulation Control, Levels 1, 2, and 3 Regulatory Class: II Product Code: GGN Dated: August 19, 1999 Received: August 23, 1999
Dear Ms. Thorsness:
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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours.
Steven Butman
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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FDA request for amendment ● November 17, 1999 Coagulation Liquid Control Levels 1, 2, and 3
Statement of Indications for Use
CASCADE™ Liquid Coagulation Control, Levels 1, 2, and 3 is a human CASCADE - Elquilo ontrol material intended for use in the clinical laboratory plasma based quality bonne of known concentration for monitoring the as a consistent tool coagulation assays (prothrombin time, activated partial thromboplastin time, and fibrinogen assays). The user can compare recovered thiomboplastin time, and means of assuring consistent performance of values with expectod franges and is for use on the MLA 1600 analyzer.
Sue S. Mdin
ision Siansion of Clinical Laboratory Devi
Ruciphon ✓
§ 864.5425 Multipurpose system for in vitro coagulation studies.
(a)
Identification. A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.(b)
Classification. Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.