(431 days)
The i-STAT PT Control Level 1 (normal) and PT Control Level 2 (abnormal) are used for quality control of i-STAT PT cartridges on i-STAT handheld and wireless systems.
The i-STAT ACT Control Level 1 (normal) and ACT Control Level 2 (abnormal) are used for quality control of i-STAT ACT cartridges on i-STAT handheld and wireless systems.
Not Found
The provided document is a 510(k) premarket notification letter from the FDA to CLINIQA CORPORATION regarding their i-STAT PT Control and i-STAT ACT Control devices. This type of document declares substantial equivalence to a legally marketed predicate device, primarily focusing on regulatory compliance and the device's intended use (quality control for other in vitro diagnostic devices). It does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically found for a novel diagnostic device's performance claims.
Therefore, I cannot extract the requested information as it is not present in the provided text. The document is a regulatory approval letter, not a performance study report.
§ 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.