(28 days)
LiniCAL™ hsCRP Calibration Verifiers Levels A – E for the Dade BN™II Nephelometer is intended for use as an assayed quality control material for analysis.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA regarding a medical device called "LiniCAL™ hsCRP Calibration Verifiers Levels A – E for the Dade BN™II Nephelometer." This document does not contain information about acceptance criteria, study details, or performance data of the device.
The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."
This indicates that the FDA's approval is based on substantial equivalence to a predicate device, rather than a new study demonstrating performance against specific acceptance criteria.
Therefore, I cannot provide the requested information. The document is missing all points you asked for, including:
- A table of acceptance criteria and the reported device performance: Not present.
- Sample sized used for the test set and the data provenance: Not present.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
- Adjudication method for the test set: Not present.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not present.
- If a standalone performance study was done: Not present.
- The type of ground truth used: Not present.
- The sample size for the training set: Not present.
- How the ground truth for the training set was established: Not present.
§ 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.