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Dimension Vista® Protein 1 Calibrator: PROT1 CAL is an in vitro diagnostic product for the calibration of the Dimension Vista" System for: a1-Acid Glycoprotein (A1AG) a1-Antitrypsin (A1AT) Bo-Microglobulin (B2MIC) C3 Complement (C3) C4 Complement (C4) Ceruloplasmin (CER) Haptoglobin (HAPT) Hemopexin (HPX) Homocysteine (HCYS) Immunoglobulin A (IGA) Immunoglobulin E (IGE) Immunoglobulin G (IGG) Immunoglobulin G Subclass 1 (IGG1) Immunoglobulin G Subclass 2 (IGG2) Immunoqlobulin G Subclass 3 (IGG3) Immunoglobulin G Subclass 4 (IGG4) lmmunoglobulin M (IGM) Prealbumin (PREALB) Retinol Binding Protein (RBP) soluble Transferrin Receptor (STFR) Transferrin (TRF)

Dimension Vista® Protein 1 Control L: PROT1 CON L is an assayed, low level, intralaboratory quality control for assessment of precision and analytical bias on the Dimension Vista® System in the quantitative determination of: a1-Acid Glycoprotein (A1AG) a1-Antitrypsin (A1AT) C3 Complement (C3) C4 Complement (C4) Ceruloplasmin (CER) Haptoglobin (HAPT) Hemopexin (HPX) Homocysteine (HCYS) Immunoglobulin A (IGA) Immunoglobulin E (IGE) Immunoglobulin G (IGG) Immunoglobulin G Subclass 1 (IGG1) Immunoglobulin G Subclass 2 (IGG2) Immunoglobulin G Subclass 3 (IGG3) Immunoglobulin G Subclass 4 (IGG4) Immunoglobulin M (IGM) Prealbumin (PREALB) Retinol Binding Protein (RBP) soluble Transferrin Receptor (STFR) Transferrin (TRF)

Dimension Vista® Protein 1 Control M and H: PROT1 CON M and PROT1 CON H are assayed, mid-level and high level respectively, intralaboratory quality controls for assessment of precision and analytical bias on the Dimension Vista System in the quantitative determination of: a1-Acid Glycoprotein (A1AG) a1-Antitrypsin (A1AT) B2-Microglobulin (B2MIC) C3 Complement (C3) C4 Complement (C4) Ceruloplasmin (CER) Haptoglobin (HAPT) Hemopexin (HPX) Homocysteine (HCYS) Immunoglobulin A (IGA) Immunoglobulin E (IGE) Immunoglobulin G (IGG) Immunoglobulin G Subclass 1 (IGG1) İmmunoglobulin G Subclass 2 (IGG2) Immunoglobulin G Subclass 3 (IGG3) Immunoglobulin G Subclass 4 (IGG4) Immunoqlobulin M (IGM) Prealbumin (PREALB) Retinol Binding Protein (RBP) soluble Transferrin Receptor (STFR) Transferrin (TRF)

Dimension Vista® Protein 1 Calibrator: Protein 1 Calibrator is a multi-analyte, liquid human serum based product containing: a - acid glycoprotein immunoglobulin G a - antitrypsin immunogiobulin G Subclass 1 B »- microalobulin immunoglobulin G Subclass 2 C3 complement immunoglobulin G Subclass 3 C4 complement immunoglobulin G Subclass 4 ceruloplasmin immunoqlobulin M haptoglobin prealbumin hemopexin retinol binding protein homocysteine soluble transferrin receptor immunoglobulin A transferrin immunoglobulin E

Dimension Vista® Protein 1 Control L: Protein 1 Control L is a multi-analyte, low level liquid human serum based product containing : a-acid glycoprotein a 1-antitrypsin C3 complement C4 complement ceruloplasmin haptoqlobin hemopexin homocysteine immunoglobulin A immunoglobulin E immunoqlobulin G immunoglobulin G Subclass 1 immunoglobulin G Subclass 2 immunoqlobulin G Subclass 3 immunoglobulin G Subclass 4 immunoglobulin M prealbumin retinol binding protein soluble transferrin receptor transferrin

Dimension Vista® Protein 1 Control M and H: Protein 1 Control M and H are multi-analyte, mid and high level respectively, liquid human serum based products containing : a1-acid glycoprotein a-antitrypsin B2-microglobulin C3 complement C4 complement ceruloplasmin haptoqlobin hemopexin homocysteine immunoglobulin A immunoglobulin E immunoglobulin G immunoqlobulin G Subclass 1 immunoglobulin G Subclass 2 immunoglobulin G Subclass 3 immunoglobulin G Subclass 4 immunoglobulin M prealbumin retinol binding protein soluble transferrin receptor transferrin

Dade Behring Inc. Dimension Vista™ Protein 1 Calibrator 1 and Dimension Vista™ Protein 1 Control 510(k) Notification

This document describes the 510(k) summary for the Dimension Vista® Protein 1 Calibrator and Dimension Vista® Protein 1 Control L, M, and H. These are in vitro diagnostic products used for the calibration and quality control of various protein assays on the Dimension Vista System. The summary focuses on the substantial equivalence to a previously marketed device (K063663), which was modified to include additional analytes.

1. Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria or detailed device performance metrics (e.g., precision, accuracy, linearity studies). Instead, it relies on the concept of "substantial equivalence" to a legally marketed predicate device. The primary claim of equivalence is that the modified devices (including hemopexin, immunoglobulin G subclasses 1-4, and retinol binding protein) are substantially equivalent in intended use to the current Dimension Vista Protein 1 Calibrator and Control L, M, and H (K063663).

The "reported device performance" is implicitly that the modified devices will perform comparably to the predicate devices for their stated intended uses (calibration and quality control) for all listed analytes.

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

The document does not provide details on specific sample sizes for a test set, nor does it mention the data provenance (e.g., country of origin, retrospective or prospective) for any performance studies. The submission focuses on the modifications to an existing device and claims substantial equivalence.

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

Not applicable. This type of information is generally relevant for devices that involve human interpretation or diagnostic capabilities. For a calibrator and control product, the "ground truth" would typically be established through analytical reference methods and certified reference materials, rather than expert consensus on a test set.

4. Adjudication Method for the Test Set:

Not applicable, as there is no mention of a test set requiring adjudication in the context of human interpretation.

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 device is a calibrator and control product for an automated in vitro diagnostic system, not an AI-based diagnostic tool that assists human readers.

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

Not applicable. This device is a component used with a larger automated system, not a standalone algorithm.

7. The Type of Ground Truth Used:

For a calibrator and control, the "ground truth" for the analytes within the product would be established by:

• Reference Methods: Highly accurate and precise analytical methods used to assign values to the constituents of the calibrator and control materials.
• Certified Reference Materials (CRMs): Materials with analytically established values traceable to international standards.
• Internal Validation and Characterization: Rigorous testing and characterization of the raw materials and final product to determine the concentration and stability of each analyte.

The document does not explicitly detail the specific ground truth methods for the initial predicate device (K063663) or for the newly added analytes in the modified device. However, given the nature of these products, it can be inferred that such analytical methods were employed.

8. The Sample Size for the Training Set:

Not explicitly stated. This information is typically relevant for machine learning or AI-based devices. For a calibrator and control product, a "training set" doesn't apply in the same way. The development and characterization of these products involve extensive analytical testing and formulation development.

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

Not explicitly stated, as the concept of a "training set" in the context of AI is not applicable here. The "ground truth" for the product itself (i.e., the known concentrations of the analytes within the calibrator and control materials) would have been established through the analytical methods mentioned in point 7.

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