(77 days)
The STA Compact instrument is a fully automated laboratory analyzer designed to perform tests which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.
The STA Compact instrument is a fully automated laboratory analyzer designed to perform tests which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy. Once samples and test reagents are loaded onto the instrument, sample handling. reagent delivery, analysis and reporting of test results are performed automatically, making the STA Compact instrument a true walkaway system. A central processing unit controls instrument functions, including management of patient results, quality control, scheduling of instrument maintenance and workload organization. The instrument utilizes Diagnostica Stago (France) reagents, and is open to adaptation of other reagents currently available from third-party manufacturers. Barcoding of test reagents, calibrators and controls facilitates their use on the system and makes reagent management simple. Manual entry of reagent information enables the use of non-barcoded reagents. The instrument performs multiple test methodologies in random access (as selected by the user); these include clot-based tests and photometric assays at predetermined wavelengths.
The provided text describes a medical device, the STA Compact® Automated Multi-Parametric Analyzer, and asserts its substantial equivalence to a previously cleared device. However, it does not contain any information regarding specific acceptance criteria, study data, or performance metrics in the format requested.
Therefore, I cannot populate the table or answer the specific questions about sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details from the provided text.
The text focuses on:
- Device Function: An automated laboratory analyzer for coagulation tests.
- Automation: "True walkaway system" with automatic sample handling, reagent delivery, analysis, and reporting.
- Control: Central processing unit manages results, QC, maintenance, and workload.
- Reagents: Uses Diagnostica Stago (France) reagents, open to third-party reagents, barcoding for management.
- Test Methodologies: Clot-based and photometric assays in random access.
- Carryover: Very low (0.05%).
- Substantial Equivalence: Claimed to be substantially equivalent to the full-size STA® analyzer (K942117).
To provide the requested information, specific study reports detailing performance metrics and validation methodologies would be required.
§ 864.5400 Coagulation instrument.
(a)
Identification. A coagulation instrument is an automated or semiautomated device used to determine the onset of clot formation for in vitro coagulation studies.(b)
Classification. Class II (special controls). A fibrometer or coagulation timer intended for use with a coagulation instrument is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.