(9 days)
The Cardiac Marker Control Module is an assayed, bi-level control module containing analytes (CK-MB, myoglobin, and troponin I) associated with acute myocardial infarction (AMI). It is intended as an aid in monitoring day-to-day assay performance.
DPC's Cardiac Marker Control Module is an assayed, bi-level control intended for use with the IMMULITE CK-MB, IMMULITE Myoglobin, and IMMULITE Troponin I assays.
The provided text does not contain information about explicit acceptance criteria or a study proving the device meets them in the conventional sense of a clinical trial or performance study for an AI/CADe device.
This submission (K983971) is for a "Cardiac Marker Control Module," which is a quality control material, not a diagnostic device that directly interprets patient data. Therefore, the concept of "device performance" in terms of sensitivity, specificity, or reader improvement, as typically applied to AI-powered diagnostic tools, does not apply here.
The summary explicitly states: "Clinical Studies: Not applicable." This further confirms that no such studies were conducted or required for this type of device.
Instead, the submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, which is the standard for 510(k) clearances. Substantial equivalence for this type of product typically involves demonstrating that the control module behaves as expected for its intended purpose (monitoring assay performance) without presenting new safety or efficacy concerns compared to existing controls.
Therefore, the requested information cannot be extracted from this document as it pertains to a different type of medical device and regulatory submission.
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.