Search Results

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.

Ask a specific question about this device