(100 days)
The GenesisCS Component Concentrating System is intended to be used in a clinical laboratory or intraoperatively at the point of care for the safe and rapid preparation of plasma and platelet concentrate from a small sample of blood and for a preparation of a cell concentrate from bone marrow. The safety and effectiveness of this device for in vivo indications for use has not been established.
Not Found
This document is a 510(k) premarket notification decision letter from the FDA for the GenesisCS Component Concentrating System. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.
Here's why and what's typically found in such documents when performance data is included:
- 510(k) Premarket Notification: This type of submission primarily demonstrates "substantial equivalence" to a legally marketed predicate device, rather than requiring extensive clinical trial data demonstrating novel safety and effectiveness.
- "Substantial Equivalence": The FDA determines if a new device is as safe and effective as a predicate device, often by comparing intended use, technological characteristics, and performance data if relevant differences exist. However, comprehensive performance studies with acceptance criteria are not always fully detailed in the publicly available decision letter itself, but rather in the submitted 510(k) summary or full submission.
- Missing Information: The provided text is a regulatory clearance letter. It clearly states, "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."
Therefore, I cannot provide the requested information based solely on the provided text. The document does not describe:
- A table of acceptance criteria or reported device performance.
- Sample sizes for a test set, data provenance, or details of retrospective/prospective studies.
- Number or qualifications of experts for ground truth establishment.
- Adjudication methods.
- MRMC comparative effectiveness studies or effect sizes.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
However, I can extract the following relevant information:
- Trade/Device Name: GenesisCS Component Concentrating System
- Regulation Number: 21 CFR 862.2050
- Regulation Name: General purpose laboratory equipment labeled or promoted for a specific medical use
- Regulatory Class: Class I
- Product Code: JQC
- Intended Use Statement: "The GenesisCS Component Concentrating System is intended to be used in a clinical laboratory or intraoperatively at the point of care for the safe and rapid preparation of plasma and platelet concentrate from a small sample of blood and for a preparation of a cell concentrate from bone marrow."
- Important Warning/Limitation: "The safety and effectiveness of this device for in vivo indications for use has not been established." This indicates that while the device is cleared for its stated in vitro laboratory preparation uses, it has not been proven safe or effective for direct use within a living organism.
§ 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.