(63 days)
The ELECTRA 1800C is an in vitro diagnostic instrument which may be categorized as an automatic coagulation timer and photometric analyzer, for the performance of both coagulation and chromogenic testing. Coagulation testing capabilities of the proposed product include routine clotting tests such as prothrombin time (PT), activated partial thromboplastin time (APTT), factor assays, fibrinogen, and thrombin time. Chromogenic testing capabilities include tests such as Antithrombin III.
A detailed description of the device, including an explanation of how it functions and the basic scientific concepts, are described in the ELECTRA 1800C Operator's Manual, Chaper 1 - Getting Started ..
The provided 510(k) summary for the ELECTRA 1800C Automatic Coagulation Analyzer does not contain detailed information regarding acceptance criteria, study design, or performance metrics typically found in a clinical study report. The document primarily focuses on describing the device and its intended use, and establishing substantial equivalence to a predicate device (ELECTRA 1600C).
Therefore, it is not possible to complete the requested table and answer the specific questions about acceptance criteria, study design, and performance based solely on the provided text.
The 510(k) summary states:
- Device Description: Refers to the "ELECTRA 1800C Operator's Manual, Chapter 1 - Getting Started" for a detailed description of how it functions and basic scientific concepts. This manual is not provided.
- Device Comparison: "The proposed product , ELECTRA 1800C, is essentially equivalent in design to the ELECTRA 1600C " Automatic Coagulation Analyzer. Basic system technology remains unchanged. The sample mechanism has been modifed to allow for closed tube sampling. This modification has been included to limit operator exposure to bloodborne pathogens by eliminating standard practices such as removing tube stoppers for instrument sampling."
This type of documentation for a 510(k) submission, especially from 1996, often relies on demonstrating equivalence through design and minor modifications, rather than extensive new clinical studies with detailed performance metrics as might be required for novel devices or for AI/ML-based software as a medical device (SaMD) today. The focus here is on the physical and functional equivalence for a similar intended use, with an emphasis on a design modification for safety (closed tube sampling).
In summary, the provided document lacks the necessary information to address your specific questions about acceptance criteria and study details. To obtain this information, one would typically need access to the full 510(k) submission, including any performance data or validation studies submitted to the FDA at the time.
§ 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.