(30 days)
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No
The summary describes liquid controls for a diagnostic system, which are used for calibration and validation, not for processing patient data or making diagnostic decisions using AI/ML. There are no mentions of AI, ML, image processing, or data analysis techniques typically associated with AI/ML in the provided text.
No
The device is described as controls for an in vitro diagnostic system to validate performance, not to directly treat a medical condition.
Yes
Explanation: The device is used with an "in vitro diagnostic system" and helps "validate system performance" when monitoring patients, indicating its role in assessing health conditions.
No
The device description and intended use clearly indicate a "System Liquid Controls" product, which are physical reagents used for in vitro diagnostic testing, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the product is used "with the Avocetor in vitro diagnostic system to validate system performance." It also mentions monitoring patients on anticoagulation therapy, which is a diagnostic process.
- Device Description: While the description itself doesn't explicitly say "IVD," the context of its use with an "in vitro diagnostic system" strongly indicates its nature.
- Mentions IVD: The intended use directly mentions "in vitro diagnostic system."
Therefore, based on the provided information, the AvocetpT System Liquid Controls, Level 1 and Level 2 are IVD controls used to validate the performance of an IVD system.
N/A
Intended Use / 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.
Product codes
GGN, JPA
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
health care professionals
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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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 stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.
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