(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.
§ 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.