(35 days)
The Elecsys C-Peptide CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the serum and plasma assay range established by the Elecsys C-Peptide reagent on the indicated Elecsys and cobas e immunoassay analyzers.
The Elecsys C-Peptide CalCheck 5 is a lyophilized product consisting of synthetic C-peptide in equine serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.
The provided text is related to a 510(k) submission for the "Elecsys C-Peptide CalCheck 5," a quality control material. However, the document does not contain any information about acceptance criteria or a study proving the device meets those criteria, nor does it include details about a clinical study, test set, ground truth, or training set mentioned in your request.
The document primarily focuses on:
- Administrative details: Submitter information, contact person, date prepared.
- Device identification: Proprietary name, common name, classification name, predicate device.
- Device description: Lyophilized product of synthetic C-peptide in equine serum matrix.
- Intended use: Assayed control for calibration verification and assay range verification for Elecsys C-Peptide reagent on Elecsys and cobas e immunoassay analyzers.
- Regulatory approval: FDA's 510(k) clearance letter, confirming substantial equivalence to a predicate device (K040157).
- Regulatory classification: Class I, reserved, product codes JJX.
Since the input text does not contain the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement, I cannot populate the table or answer the specific questions.
Therefore, I must state that the requested information is not available in the provided document.
§ 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.