(30 days)
This product (The AvocetpT System Liquid Controls, Level 1 and Level 2) is used with the Avocetor in vitro diagnostic system to validate system performance. It is intended for use by health care professionals in assessing the functionality of the Avocetor System when monitoring patients who are on warfarin-type (coumarin) anticoagulation therapy.
AvocetpT System Liquid Controls, Level 1 and Level 2
The provided document is a 510(k) clearance letter from the FDA for the Avocet System Liquid Controls, Level 1 and 2. It indicates that the device has been found substantially equivalent to predicate devices. However, this document does not contain any information regarding acceptance criteria, study details, performance metrics, sample sizes, or ground truth establishment relevant to the device's efficacy or accuracy.
The letter primarily focuses on:
- The regulatory classification of the device.
- Indications for Use (which states it's for validating system performance of the Avocet System when monitoring patients on warfarin).
- Compliance with general controls and regulations.
- Contact information for further regulatory guidance.
Therefore, I cannot provide the requested information based solely on this document. There is no study data, acceptance criteria table, or performance metrics within these pages.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR 1 6 1998
Judith Blunt . Director of Requlatory Affairs and Quality Assurance Avocet Medical, Inc. 1696 Dell Avenue Campbell, California 95008
Re : K980982 Avoceton System Liquid Controls Level 1, 2 Requlatory Class: II Product Code: GGN, JPA Dated: March 16, 1998 Received: March 17, 1998
Dear Ms. Blunt:
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 reqistration, 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 Druq 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 requlations.
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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/dsmamain.html".
Sincerely yours,
Steven Bitman
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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Indication for Use Statement
510(k) number: netknown V<980982 Device Name:AvocetРт
Indications for Use:
This product (The AvocetpT System Liquid Controls, Level 1 and Level 2) is used with the Avocetor in vitro diagnostic system to validate system performance. It is intended for use by health care professionals in assessing the functionality of the Avocetor System when monitoring patients who are on warfarin-type (coumarin) anticoagulation therapy.
PLEASE DO NOT WRITE BELOW THIS LINE
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OR
Concurrence of
CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per21 CFR 801.109 Over-The-Counter Use (optional format 1-2-96
(Division Sign-Off)
Division of Clinical Laborator
510(k) Number. ces
§ 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.