(21 days)
The SmartPReP2 Centrifuge System is intended to be used in the clinical laboratory or intraoperatively at point-of-care for the safe and rapid preparation of platelet poor plasma and platelet concentrate from a small sample of blood and for preparation of a cell concentrate from bone marrow.
The SmartPReP Centrifuge System is designed to be used in the clinical laboratory or intraoperatively at point-of-care for the safe and rapid preparation of platelet poor plasma and platelet concentrate from a small sample of blood.
Not Found
Unfortunately, the provided document is a 510(k) clearance letter from the FDA for a medical device (SmartPReP2 Centrifuge System and SmartPReP Centrifuge System).
This type of document primarily confirms that the device is substantially equivalent to a legally marketed predicate device and outlines regulatory compliance.
It does NOT contain the detailed information required to answer your specific questions regarding acceptance criteria, study design, expert involvement, and ground truth establishment.
The document focuses on:
- Device name and intended use.
- Regulatory classification.
- Reference to the predicate device.
- General regulatory requirements for the manufacturer.
To answer your questions, you would typically need to refer to a detailed study report, a scientific publication, or the actual 510(k) submission document itself (which often includes more detailed performance data and study summaries, though not always in the exact format you're looking for).
§ 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.