(77 days)
The intended use Certain® Hct is as a bi-level quality control material and CVM™ is a calibration verification material both for use with hematocrit analyzers.
The Chiron Certain Hct is a bi-level quality control material uniquely formulated to provide quality control values for hematocrit analyzers. There are two levels of Certain Hct each provided in 2.5 mL ampules. The product allows verfication of analyzer hematocrit performance within established ranges.
Chiron Calibration Vefication Material (CVM™) is formulated to verify the calibration of hematocrit analyzers. The product contains four levels of 2.5 mL ampules and is intended to assist laboratories in compliance with the requirements of calibration verification under CLIA.
This looks like a 510(k) premarket notification for a hematocrit quality control and calibration verification material, not a medical device in the typical sense of a diagnostic or therapeutic tool that relies on complex algorithms or human interpretation of images/data.
Therefore, many of the requested categories in your prompt (such as "number of experts," "adjudication method," "MRMC study," "standalone performance," "training set size") are not applicable to this type of product. The focus for this submission would be on the analytical performance of the control material itself, often demonstrated through precision, linearity, and stability studies.
Here's how I can address the applicable parts of your request based on the provided text:
Description of the Acceptance Criteria and Study:
The provided text K961807 is a "Summary of Safety and Effectiveness" for a quality control and calibration verification material for hematocrit analyzers. It describes the product (Certain® Hct and CVM™ Hct) and its intended use. However, the provided excerpt does not contain the specific acceptance criteria or the study details that demonstrate the device meets those criteria.
A typical 510(k) submission for a quality control material would include:
- Acceptance Criteria for Analytical Performance: This would likely involve specifications for parameters like:
- Precision/Reproducibility: How consistently the material yields the same Hct value over repeated measurements. (e.g., %CV
§ 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.