(46 days)
Retic-Quinox is a whole blood reference control material designed to monitor the accuracy and precision of Coulter instruments equipped with reticulocye measuring capabilities using VCS technology.
Retic-Quinox is a reference control material designed to monitor the accuracy and precision of Coulter instruments capable of performing reticulocyte counts.
The provided text describes a 510(k) summary for the "Retic-Quinox Reticulocyte Control Mixture," a quality control device. However, the document does not contain explicit details about acceptance criteria, a specific study proving the device meets those criteria, or the methodology (sample size, expert qualifications, ground truth establishment, etc.) of such a study.
The document primarily focuses on:
- Device Description: Retic-Quinox is a reference control material for monitoring accuracy and precision of Coulter instruments performing reticulocyte counts.
- Predicate Device Comparison: It states that both Retic-Quinox and the predicate device (Retic-C) are in vitro diagnostic controls made of stabilized human red cells and a reticulocyte-like component in a buffered fluid. Both provide three levels for monitoring.
- Substantial Equivalence: The FDA's letter states that the device is "substantially equivalent" to legally marketed predicate devices, implying it has similar performance characteristics for its intended general use as a quality control.
Therefore, based solely on the provided text, the specific information requested in your prompt regarding acceptance criteria, a standalone study, and its detailed methodology cannot be extracted. The document confirms the device's regulatory classification and its substantial equivalence determination but does not include the detailed performance study report you've asked for.
If this information were available in a more comprehensive submission or study report, it would typically include a section detailing performance data against predefined acceptance criteria.
§ 864.8625 Hematology quality control mixture.
(a)
Identification. A hematology quality control mixture is a device used to ascertain the accuracy and precision of manual, semiautomated, and automated determinations of cell parameters such as white cell count (WBC), red cell count (RBC), platelet count (PLT), hemoglobin, hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC).(b)
Classification. Class II (special controls). Except when intended for use in blood components, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.