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The CHEM 3 CAL is an in vitro diagnostic product for the calibration of alcohol (ALC) and carbon dioxide (CO2) methods on the Dimension Vista" System.

CHEM 3 CAL is a multi-analyte, aqueous product containing ethyl alcohol and sodium carbonate. The kit consists of six vials, three vials of Calibrator A, and three vials of Calibrator B which are ready for use (no preparation is required). The volume per vial is 2.5 mL.

The provided submission is for a calibrator device, not an AI/ML diagnostic. Therefore, many of the requested fields are not applicable to this type of device. I will address the relevant sections based on the information provided in the 510(k) summary.

Here's an analysis of the Dimension Vista™ System Chemistry 3 Calibrator (CHEM 3 CAL - KC130) based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the sections that are not applicable to this device type:

• 2. Sample size used for the test set and the data provenance: For calibrators, "test sets" in the context of diagnostic accuracy are not applicable. The performance is assessed through stability studies and value assignment verification.
  • Stability Studies: Vials are opened/punctured on day zero and tested on days 1, 3, and 32 for open-vial stability. The number of replicates per time point for stability testing is not specified beyond "sufficient for multiple calibrations."
  • Bottle Value Assignment: N = 45 replicates per level were used for final bottle value assignment verification.
  • Data Provenance: Not explicitly stated, implied to be internal laboratory data generated by Dade Behring, Inc.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a calibrator concerns its inherent value and traceability to reference materials.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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 a calibrator, not an AI diagnostic device.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• 7. The type of ground truth used:
  • ALC (Alcohol): USP Grade Ethyl Alcohol.
  • CO2 (Carbon Dioxide): NIST SRM 351.
  • Bottle Value Assignment: Verification against previously approved Master Pools, which themselves are traced to the primary reference materials (USP and NIST SRM).
• 8. The sample size for the training set: Not applicable. This is not an AI/ML device.
• 9. How the ground truth for the training set was established: Not applicable.

Study That Proves the Device Meets Acceptance Criteria:

The 510(k) summary describes internal studies conducted by Dade Behring, Inc. to establish the performance characteristics of the Dimension Vista™ System Chemistry 3 Calibrator. These studies are designed to demonstrate the calibrator's suitability for its intended use and its substantial equivalence to predicate devices.

The key studies mentioned are:

1. Stability Studies: These studies evaluate the calibrator's stability over its proposed shelf life (12 months) and its stability after opening/puncturing (24 hours on-board, 30 days open vial in refrigerator). The acceptance criterion is a percent change less than or equal to 5%. The submission states that "Shelf-life stability (expiration) dating assignment at commercialization reflects the real-time data on file at Dade Behring, Inc.," indicating that internal data supports meeting these criteria. For open-vial stability, vials are tested on days 1, 3, and 32 versus freshly opened vials.

2. Traceability and Value Assignment Studies:

   • The calibrator's values for ALC are traceable to USP Grade Ethyl Alcohol, and for CO2 to NIST SRM 351. This establishes the fundamental accuracy of the calibrator's assigned values.
   • The "Bottle Value Assignment" process involves a multi-step verification process:
     • Preparation of carbon dioxide and alcohol reference materials.
     • Verification of "Master Pool" values against previously approved Master Pools.
     • Validation of "stock solution" values using instruments calibrated with approved Master Pools.
     • Final verification of commercial lot bottle values: "The final bottle values for each level of the commercial lot is assigned and verified using multiple instruments by testing N = 45 replicates per level." This extensive testing (N=45 replicates per level on multiple instruments) confirms that the assigned values for the commercial product are accurate and consistent within acceptable limits as determined by Dade Behring's internal quality standards.

In summary, the device meets its acceptance criteria through robust internal studies demonstrating its stability, traceability to recognized standards, and accurate value assignment through meticulous calibration and verification processes.

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