(204 days)
The SECQUIRE cell separator is designed for the safe and effective preparation of low volume platelet rich plasma, and platelet poor plasma at the point of care.
SECQUIRE Cell Separator
The provided text is a 510(k) premarket notification letter from the FDA to Smith Associates regarding the SECQUIRE Cell Separator. This document is a regulatory approval letter and does not contain information about acceptance criteria or the study data proving the device meets those criteria.
The letter states that the FDA has reviewed the 510(k) and determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed for its stated indications for use (preparation of low volume platelet rich plasma and platelet poor plasma at the point of care). However, it explicitly mentions a limitation: "The safety and effectiveness of this device for in vivo indications for use has not been established."
Therefore, based solely on the provided text, I cannot complete the requested table or answer the questions about acceptance criteria and study details. This information would typically be found in the 510(k) submission itself, including the detailed reports of performance studies, which are not part of this FDA clearance letter.
§ 862.2050 General purpose laboratory equipment labeled or promoted for a specific medical use.
(a)
Identification. General purpose laboratory equipment labeled or promoted for a specific medical use is a device that is intended to prepare or examine specimens from the human body and that is labeled or promoted for a specific medical use.(b)
Classification. Class I (general controls). The device is identified in paragraph (a) of this section and is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.