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The Dimension® CSAE Cyclosporine Extended Range Calibrator is an in vitro diagnostic product intended to be used to calibrate the CSAE Cyclosporine Extended range method for the Dimension® clinical chemistry system and the Syva® Emit® 2000 Cyclosporine assay.

Device Description

The Dimension® CSAE Cyclosporine Extended Range Calibrator contains cyclosporine in a preserved whole blood hemolysate. The kit consists of 2 sets of the following: one vial of sample diluent (0.0 ng/ml of cyclosporine ) and one vial of levels 1 through 5. Target concentrations for the five calibrator levels are approximately 200, 400, 800, 1400 and 2000 ng/ml of cyclosporine.

Level 0 is included for dilution of over-range samples (>2000 ng/mL) in order to obtain results within the assay range; it is not used in calibration. Levels 1 thru 5 are used for calibration of the CSAE method.

AI/ML Overview

The provided text describes the Dimension® CSAE Cyclosporine Extended Range Calibrator (DC108A), a calibrator material used for the Syva® Emit® 2000 Cyclosporine assay and the Dimension® clinical chemistry system. The submission (K061503) concludes that the new device is substantially equivalent to a predicate device based on performance testing.

Here's an analysis of the acceptance criteria and study information provided, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical "acceptance criteria" for performance metrics like accuracy, precision, or detection limits typically associated with diagnostic devices. Instead, the performance characteristic described is stability, which is crucial for a calibrator material. The acceptance hinges on demonstrating that the new calibrator is "substantially equivalent" to its predicate device. This implies that the stability of the new device must be comparable to or meet the requirements that the predicate device satisfied for its clearance.

Performance Characteristic	Acceptance Criteria (Implied)	Reported Device Performance
Stability (Shelf Life)	Product stored at -15 to -25°C (recommended storage temperature) must not show significant analytical drift compared to product stored at -70°C (reference storage temperature) over the target shelf life of 12 months. This demonstrates dissociation of analytical system drift from calibrator drift.	The "Performance Characteristics" section implicitly states that studies will demonstrate that the calibrator meets its target shelf life of 12 months. The conclusion (`M. Comments on Substantial Equivalence/Conclusion`) states that "The performance testing according to the verification and validation test protocols demonstrate that the Dimension® CSAE Calibrator (DC108A) is substantially equivalent to the designated predicate device."
Traceability	Cyclosporine values in the calibrator should be traceable to a recognized standard (Novartis Pharmaceutical USP Grade CSA powder in this case) and verified by a definitive method.	Reference lot formulated using Novartis Pharmaceutical USP Grade CSA powder, diluted into whole blood hemolysate, and assigned by LC/MS/MS (a high-accuracy mass spectrometry method).
Value Assignment	New calibrator lots should be consistently assigned values that recover against a control calibrator lot and a frozen reference lot within acceptable limits. This ensures consistency between different production lots.	Cyclosporine stock solution prepared gravimetrically. Aliquots added to matrix to yield desired concentrations. Recovery of six levels verified against a control calibrator lot and a frozen reference lot.
Substantial Equivalence	The new device must demonstrate that it is as safe and effective as the predicate device and does not raise new questions of safety or effectiveness. This is the overarching "acceptance criterion" for 510(k) clearance.	Performance testing, including stability, traceability, and value assignment, demonstrated substantial equivalence to the predicate device (DC108).

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: For stability studies, three (3) lots of product were used. Each lot was tested at 14 different time points over 13 months. This is a prospective study design for real-time stability.
Data Provenance: Not explicitly stated, but given that Dade Behring Inc. is located in Newark, DE (USA), and the calibrator is manufactured in Glasgow, Delaware, it is highly likely that the data was generated in the USA and retrospectively analyzed for the submission, though the studies themselves were prospectively conducted over time (real-time stability).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable and not provided for this device submission. This device is a calibrator material, which means its "ground truth" (i.e., the true concentration of cyclosporine) is established through analytical chemistry methods, not expert human interpretation of medical images or clinical outcomes. The ground truth for calibrators is typically formed by:

Primary Reference Materials: Using highly pure, certified reference materials (e.g., Novartis Pharmaceutical USP Grade CSA powder).
Reference Methods: Using highly accurate and precise analytical methods (e.g., LC/MS/MS).

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where subjective human interpretation needs to be reconciled (e.g., radiologists interpreting images). For a chemical calibrator, the "ground truth" (target concentration) is determined analytically, not through human consensus.

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

This information is not applicable and not provided. This is a submission for a chemical calibrator, not a diagnostic imaging or AI-enabled device that would involve human readers or AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

This information is not applicable and not provided. This device is a chemical calibrator, and there is no algorithm or AI component involved. Its performance is evaluated through analytical testing.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the cyclosporine concentrations within the calibrator is established by:

Primary Reference Material: Novartis Pharmaceutical USP Grade CSA powder.
Definitive Analytical Method: LC/MS/MS (Liquid Chromatography-Mass Spectrometry/Mass Spectrometry). This is considered a highly accurate and precise method for quantifying drug concentrations, serving as the "gold standard" or definitive truth for chemical assays.
Gravimetric Procedures: For preparing stock solutions.

8. The Sample Size for the Training Set

This information is not applicable and not provided. Calibrators are not "trained" in the way an algorithm or AI model would be. Their formulation and value assignment are based on established chemical and analytical principles.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable and not provided for the reasons stated in point 8.

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