Search Results

The Special Protein Calibrator for the Dimension® clinical chemistry system is an in vitro diagnostic device intended to establish points of reference that are used in determination of human IgA, IgG, IgM, complement C3, complement C4, and Transferrin values.

The Dimension® Special Protein Calibrator is a liquid human serum-based product supplied as a kit of ten vials; two at each of five levels.

The provided text is a 510(k) summary for the Dade Behring Dimension® Special Protein Calibrator. This document describes a calibrator device and its comparison to a predicate device, rather than a study on a diagnostic device's performance. Therefore, most of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth is not applicable.

Here's an breakdown of the relevant and non-relevant sections based on your request:

1. A table of acceptance criteria and the reported device performance

• Not applicable as traditionally defined for a diagnostic device. This submission focuses on establishing substantial equivalence for a calibrator. The "performance" being demonstrated is that the calibrator functions comparably to a legally marketed predicate calibrator for its intended use, which is to calibrate specific assays. The document doesn't present specific performance metrics (like sensitivity, specificity, accuracy) for a diagnostic outcome.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable. There is no "test set" in the sense of patient samples being evaluated by an algorithm or device to generate a diagnostic output. This is a calibrator, and its equivalence is based on its intended use, analytes, matrix, form, volume, levels, and reference to a standard (IFCC, CRM 470).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. No ground truth for a test set is established by experts for this type of submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. No test set or adjudication method is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This is not a study involving human readers or AI.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This is a calibrator, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• Not applicable in the typical diagnostic sense. The "ground truth" for calibrators relates to their traceable reference standards. The document explicitly states the calibrator uses "IFCC, CRM 470" as a reference, which are international standards for protein measurements.

8. The sample size for the training set

• Not applicable. There is no training set mentioned for this product.

9. How the ground truth for the training set was established

• Not applicable. There is no training set mentioned.

Summary of the Acceptance Criteria and Study (as presented in the 510(k) context):

The "acceptance criteria" in this 510(k) submission are implicitly tied to demonstrating substantial equivalence to a predicate device. For a calibrator, this means showing that the new device is as safe and effective as the predicate and does not raise new questions of safety or effectiveness.

Table of Acceptance Criteria (based on substantial equivalence comparison):

Study Proving Device Meets Acceptance Criteria:

The "study" in this context is the comparison to a predicate device as presented in the "Summary of Safety and Effectiveness Information" section. The document explicitly states:

• "Both the Beckman CAL 1 and the Dimension® Special Protein Calibrator are intended as calibrators for C3, C4, Transferrin, IgG, IgA, and IgM methods." This addresses the primary functional sameness.
• The table systematically compares the two devices across key attributes (Intended Use, Analytes, Matrix, Form, Volume, Levels, Reference).
• Conclusion: "The Dimension® Special Protein Calibrator is substantially equivalent to the Beckman CAL 1 calibrator based on the comparison discussed above."

This form of demonstration, by detailed direct comparison to a legally marketed predicate device, is the standard method for establishing substantial equivalence for many Class I and Class II devices in 510(k) submissions where performance data from clinical studies are not typically required for calibrators. No specific clinical performance study measuring sensitivity, specificity, etc., was conducted or described in this submission, as the device's role is to ensure accurate calibration of other assays.

Ask a specific question about this device

The Dimension® Special Protein Calibrator is intended to be used to calibrate the Immunoglobulin G (IGG), Immunoglobulin A (IGA), and Immunoglobulin M (IGM) methods on the Dimension® clinical chemistry system.
The Special Protein Calibrator for the Dimension® Clinical Chemistry System is an in vitro diagnostic device intended for use in an in vitro test system to establish points of reference that are used in determination of values in the measurement of human substances.

The Dimension® Special Protein Calibrator is a liquid human serum-based product. The kit consists of ten vials; two at each of five levels.

The provided text is a 510(k) summary for a medical device (Dimension® Special Protein Calibrator). It focuses on establishing substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria.

Therefore, the document does not contain the information requested to fill out the table regarding acceptance criteria and a study proving the device meets those criteria.

Specifically:

• No acceptance criteria are mentioned. The document is focused on comparing the new calibrator to a predicate calibrator.
• No specific study results (performance, accuracy, precision, etc.) are reported for the Dimension® Special Protein Calibrator itself. The comparison is limited to intended use, analytes, matrix, form, volume, levels, and reference.
• There is no discussion of sample sizes, data provenance, expert panels, adjudication methods, MRMC studies, standalone performance, or ground truth establishment. These are all elements typically found in a study designed to demonstrate performance against set acceptance criteria, which is not what this 510(k) summary provides.

Ask a specific question about this device