(63 days)
The NOD™ Chemistry Control is a two-level control set that is intended for in-vitro diagnostic use to monitor the precision of laboratory testing procedures for the analytes listed in the package insert (routine chemistries).
The NOD™ Chemistry Control is a two-level control set.
This document is a 510(k) premarket notification for a medical device called "NOD™ Chemistry Control." It indicates that the device has been found substantially equivalent to legally marketed predicate devices.
However, the provided text does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested in your prompt.
The document is a clearance letter from the FDA, confirming that Bioresource Technology, Inc. can market their NOD™ Chemistry Control. It specifies the regulation number, regulation name, regulatory class, and product code. The "Indications for Use" section states that the device is a two-level control set for in-vitro diagnostic use to monitor the precision of laboratory testing procedures for routine chemistries.
Therefore, I cannot fulfill your request for the specific details about acceptance criteria and the study that proves the device meets them based on the provided input.
§ 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.