(21 days)
The CKMB CalPak is an in vitro diagnostic product used to calibrate the CKMB method on the Stratus® CS STAT fluorometric analyzer. This calibrator is a device intended to establish a point of reference that is used in the determination of CKMB values.
The CKMB CalPak is a liquid, buffered bovine protein matrix product with CKMB at an approximate concentration of 135 ng/mL. The CalPak is a plastic cartridge which contains the calibrator material in reagent wells. It is a single-use product.
The provided text is a 510(k) summary for the Dade Behring Stratus® CS CKMB CalPak. This document focuses on demonstrating substantial equivalence to an existing device, a common pathway for in vitro diagnostic products (IVDs). It explicitly states that the Stratus® CS CKMB CalPak is substantially equivalent to the Stratus® CKMB calibrator because "they are both intended to be used as calibrators for similar CKMB methods."
Therefore, the supplied document does not contain the information requested in the prompt, as it is a notification of intent to market and a declaration of substantial equivalence, not a study report detailing acceptance criteria and performance data for a novel device.
The prompt requests information typically found in a clinical validation study for a medical device (especially AI-powered ones), which is not applicable to a calibrator product seeking market clearance via substantial equivalence.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance: As a calibrator, its performance would be assessed against its ability to standardize a measurement, not by diagnostic metrics like sensitivity or specificity.
- Sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, or standalone performance: These are relevant to diagnostic or screening devices, not a calibrator.
- Type of ground truth: While calibrators have "true" values for their constituent components, this is part of their manufacturing specification, not a diagnostic ground truth established by experts or pathology.
- Training set details: This is a calibrator, not an algorithm that requires a training set.
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.