(81 days)
The TAS analyzer with software version 4.0 is intended to be used with TAS test cards to monitor the hemostatic activity of whole blood and plasma samples. The TAS analyzer is a portable system designed to be used in non-laboratory testing environments by healthcare professionals. TAS test results are reported in quantitative units of measurement.
The TAS Analyzer with software version 4.0 provides a method of testing for coagulation parameters in samples of citrated or non-citrated blood or citrated plasma. The instrument is designed to be used with disposable test cards. The test cards are approximately the size of a credit card with a magnetic stripe on the back which is encoded with data including the test type and lot specific test parameters. The cards contain dried reagent which includes paramagnetic iron oxide particles in a small thin reaction chamber. When a sample is added to the test card, the reagent, particles, and sample mix. The instrument has a permanent magnet and an electromagnet which move the particles in the sample. The particle motion is monitored with a light source and detector. The electromagnet is energized repeatedly for half a second then turned off for half a second. When the electromagnet is on, the particles alian themselves with the magnetic field lines produced by the electromagnet. When the electromagnet is off, the particles align with the weaker field lines of the permanent magnet. As the sample clots, the motion of the particles is restrained. Software algorithms monitor the change in particle motion and determine features such as clotting time, lysis time, or other mathematically derived characteristics. These values are then reported to the user.
The software provides additional features to the operator such as optional operator identification codes, storage of 1000 test results, and a QC lockout mode which helps ensure that controls are performed. Most features are available to the user in one of two ways. Features which are intended for any operator to access are listed as options on the User menu. Features which are limited to supervisors are listed as options on the Supervisor menu. Access to the Supervisor menu is limited by a password.
This new software version adds new features such as Electronic Quality Control and improves some existing features. Many of the changes are minor modifications to the user interface. Other changes are more significant, providing the user with four new test types and a few new options.
A 510(k) will be filed for each of the new tests individually. In each case, the addition to the software of the capability to process the test does not allow the operator to perform the test without having the new test cards. The test cards for each of these tests will not be sold for human diagnostic or prognostic purposes until clearance has be granted by the FDA. This 510(k), which is for the new software version, does not address the clinical performance or efficacy of these new test cards.
The 4.0 software version has been developed under design control with the features verified and the design validated. The design, verification, and validation of the new and modified operator features in the 4.0 software version are covered in this submission.
The provided text does not contain acceptance criteria for device performance or any study details that would prove the device meets such criteria.
The document is a 510(k) summary for a software update (version 4.0) to a Thrombolytic Assessment System (TAS) Analyzer. The primary purpose of this submission is to demonstrate that the new software version is substantially equivalent to a previously cleared version (2.03) and that there are no new safety or effectiveness issues.
The document explicitly states:
- "This 510(k), which is for the new software version, does not address the clinical performance or efficacy of these new test cards." (Page 2)
- The software provides "additional features to the operator" and new test types, but the clinical performance or efficacy of these new tests are not addressed in this submission, as separate 510(k)s will be filed for each new test.
Therefore, I cannot extract the requested information from the provided text. The document focuses on demonstrating substantial equivalence based on software modifications and features, not on establishing or proving performance against specific acceptance criteria through a clinical or performance study for the device's diagnostic capabilities.
§ 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.