(56 days)
Data-Trol A Abnormal Control serum is intended for monitoring the accuracy and precision of clinical chemistry test procedures. It is for in vitro diagnostic use only.
Data-Trol N Normal Control serum is intended for monitoring the accuracy and precision of clinical chemistry test procedures. It is for in vitro diagnostic use only.
Not Found
The provided text describes a 510(k) premarket notification for "Data-Trol A Abnormal Control Serum" and "Data-Trol N Normal Control Serum." This document is a clearance letter from the FDA, confirming that the devices are substantially equivalent to legally marketed predicate devices.
However, the document is a regulatory approval notice and does not contain the acceptance criteria, details of a study that proves the device meets acceptance criteria, or any of the specific information requested in points 1-9 of your prompt.
The FDA 510(k) process for these types of Class I devices often relies on demonstrating substantial equivalence to existing devices through comparative data (e.g., performance characteristics like accuracy and precision compared to a predicate) rather than requiring a detailed clinical study with the specifics you're asking for. For a quality control material, the "performance" typically refers to its ability to serve as a stable, known sample for monitoring laboratory test procedures.
To address your request, I would need a different type of document, such as a study report, validation protocol, or a more detailed technical submission from the manufacturer.
§ 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.