Dimension Vista™ Protein 1 Calibrator: Protein 1 Calibrator is an in vitro diagnostic product for the calibration of the Immunoglobulin A (IGA), Immunoglobulin G (IGG) and Prealbumin / Transthyretin (PREALB) methods on the Dimension Vista™ System.

Dimension Vista™ Protein 1 Control L, M and H: Protein 1 Control L, M and H are for use as assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of Immunoglobulin A (IGA), Immunoglobulin G (IGG) and Prealbumin / Transthyretin (PREALB) on the Dimension Vista™ System.

Device Description

Dimension Vista™ Protein 1 Calibrator: Protein 1 Calibrator is a multi-analyte, liquid human serum based product containing Immunoqlobulin A. Immunoglobulin G and Prealbumin.

Dimension Vista™ Protein 1 Control L. M and H: Protein 1 Control L, M and H are multi-analyte, liquid human serum based products containing Immunoglobulin A, Immunoglobulin G and Prealbumin.

AI/ML Overview

The provided text is a 510(k) summary for the "Dimension Vista™ Protein 1 Calibrator" and "Dimension Vista™ Protein 1 Control L, M and H." This document describes the device, its intended use, and its substantial equivalence to a legally marketed predicate device.

Crucially, this type of 510(k) submission generally focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed study proving the device meets specific acceptance criteria in the way a clinical trial for a novel diagnostic might. For calibrators and controls, the primary "performance" is often related to their stability, accuracy in assigned values, and ability to perform as expected within the context of the assay they are designed for.

Therefore, many of the requested details like "acceptance criteria," "sample size," "ground truth establishment by experts," "adjudication methods," "MRMC studies," or "standalone performance" (as they would apply to a diagnostic or AI device) are not typically found or relevant in a 510(k) summary for a calibrator and control.

However, I can extract the information that is present:

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, explicit quantitative "acceptance criteria" and "reported device performance" in the context of a clinical performance study (e.g., sensitivity, specificity) are not provided for this device type within the summary. For calibrators and controls, the "performance" relates to their consistency, stability, and the accuracy of their assigned values relative to an established reference method. The summary simply states that the devices are "substantially equivalent" to the predicate, implying they perform similarly and meet the requirements for their intended use.

Criterion Type	Acceptance Criterion (Not explicitly stated in the 510(k) summary for this device type)	Reported Device Performance (Implied by substantial equivalence)
Intended Use	Device functions as a calibrator for IGA, IGG, and Prealbumin methods on the Dimension Vista™ System.	The device is "substantially equivalent in intended use" to the predicate, meaning it performs this function.
Intralaboratory Quality Control	Device functions as a quality control for assessment of precision and analytical bias for IGA, IGG, and Prealbumin on the Dimension Vista™ System.	The device is "substantially equivalent in intended use" to the predicate, meaning it performs this function.
Composition	Contains Immunoglobulin A, Immunoglobulin G, and Prealbumin (human serum-based).	Device described as "multi-analyte, liquid human serum based product containing Immunoqlobulin A. Immunoglobulin G and Prealbumin."
Safety	No new safety concerns compared to predicate.	Implied by FDA's substantial equivalence determination.
Effectiveness	Performs its intended function for calibration and quality control.	Implied by FDA's substantial equivalence determination.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not specified. For calibrators and controls, "test sets" in the context of clinical performance are not typically discussed in this manner for a 510(k) submission; rather, validation studies would focus on analytical performance (e.g., linearity, precision, stability).
Data Provenance: Not specified. The summary does not detail the origin of any data (e.g., country of origin, retrospective/prospective). Studies for these types of devices usually involve analytical testing conducted by the manufacturer.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. The concept of "experts establishing ground truth" for test sets is generally relevant for diagnostic devices that interpret complex clinical data (like medical images or pathology slides). For a calibrator or control, the "ground truth" would be the assigned analyte values, established through a rigorous analytical process, often traceable to reference materials, not expert consensus.

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

Not Applicable. Adjudication methods are used to resolve disagreements among multiple human readers interpreting data. This is not relevant to the validation of a calibrator or control.

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

No. This is a calibrator/control device, not an AI-based diagnostic tool. Therefore, MRMC comparative effectiveness studies comparing human readers with and without AI are not applicable.

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

Not Applicable. This device is a physical calibrator/control, not an algorithm.

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

For calibrators and controls, the "ground truth" refers to the assigned values for the analytes (Immunoglobulin A, Immunoglobulin G, and Prealbumin) within the calibrator and control materials. These values are typically established through highly accurate and precise analytical methods, often traceable to international reference materials or established reference measurement procedures, rather than expert consensus, pathology, or outcomes data. The summary does not detail the specific method for assigning these values, but this is the standard practice for such in-vitro diagnostic products.

8. The sample size for the training set

Not Applicable. This is a calibrator/control, not a machine learning model. Therefore, there is no "training set" in the context of AI development.

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

Not Applicable. As there is no training set for an AI model, this question is not relevant.

Summary

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510(k) Summary for Dimension Vista™ Protein 1 Calibrator Dimension Vista™ Protein 1 Control L, M and H

AUG - 7 2006

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

is: K062055

The assigned 510(k) number is:

1. Manufacturer's Name, Address, Telephone, and Contact Person, Date of Preparation:

Manufacturer:	Dade Behring Marburg GmbH
	Emil-von-Behring Str. 76
	D-35001
	Marburg, Germany

Contact Information: Dade Behring Inc. P.O. Box 6101 Newark, Delaware 19714-6101 Attn: Kathleen Dray-Lyons Tel: 781-826-4551 Fax: 781-826-2497
Preparation date: July 18, 2006
1. Device Name: Dimension Vista™ Protein 1 Calibrator Dimension Vista™ Protein 1 Control L Dimension Vista™ Protein 1 Control M Dimension Vista™ Protein 1 Control H

Classification:	Class II; Class I
Product Code:	JIX; JJY
Panel:	Clinical Chemistry (75)

3. ldentification of the Legally Marketed Device:

Dimension Vista™ Protein 1 Calibrator - K061338 Dimension Vista™ Protein 1 Control L- K061338 Dimension Vista™ Protein 1 Control M - K061338 Dimension Vista™ Protein 1 Control H - K061338

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

4. Device Description:

Dimension Vista™ Protein 1 Calibrator

Protein 1 Calibrator is a multi-analyte, liquid human serum based product containing Immunoqlobulin A. Immunoglobulin G and Prealbumin.

Dimension Vista™ Protein 1 Control L. M and H

Protein 1 Control L, M and H are multi-analyte, liquid human serum based products containing Immunoglobulin A, Immunoglobulin G and Prealbumin.

5. Device Intended Use:

Dimension Vista™ Protein 1 Calibrator

Protein Calibrator is an in vitro diagnostic product for the calibration of the Immunoglobulin A (IGA), Immunoglobulin G (IGG) and Prealbumin / Transthyretin (PREALB) methods on the Dimension Vista™ System.

Dimension Vista™ Protein 1 Control L, M and H

Protein 1 Control L, M and H are assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of Immunoglobulin A (IGA), Immunoglobulin G (IGG) and Prealbumin / Transthyretin (PREALB) on the Dimension Vista™ Šystem.

6. Medical device to which equivalence is claimed and comparison information:

The Dimension Vista™ Protein 1 Calibrator and Dimension Vista™ Protein 1 Control L, M and H (modified to include prealbumin) are substantially equivalent in intended use to the Dimension Vista™ Protein 1 Calibrator and Dimension Vista™ Protein 1 Control L, M and H (K061338).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Kathleen Dray-Lyons Manager, Regulatory Affairs and Compliance Dade Behring, Inc. Glasgow Site PO Box 6101, M/S 514 Newark, DE 19714-6101

AUG - 7 2006

K062055 Re:

Trade/Device Name: Dimension Vista™ Protein 1 Calibrator Dimension Vista™ Protein 1 Control L Dimension Vista™ Protein 1 Control M Dimension Vista™ Protein 1 Control H Regulation Number: 21 CFR§862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX, JJY Dated: July 18, 2006

Received: July 20, 2006

Dear Ms. Dray-Lyons:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Alberto G

Alberto Guticarez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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

Indications Statement

K062055

Device Name:

Dimension Vista™ Protein 1 Calibrator Dimension Vista™ Protein 1 Control L Dimension Vista™ Protein 1 Control M Dimension Vista™ Protein 1 Control H

Indications for Use:

Dimension Vista™ Protein 1 Calibrator

Protein 1 Calibrator is an in vitro diagnostic product for the calibration of the Immunoglobulin A (IGA), Immunoglobulin G (IGG) and Prealbumin / Transthyretin (PREALB) methods on the Dimension Vista™ System.

Dimension Vista™ Protein 1 Control L, M and H

Protein 1 Control L, M and H are for use as assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of Immunoglobulin A (IGA), Immunoglobulin G (IGG) and Prealbumin / Transthyretin (PREALB) on the Dimension Vista™ System.

Prescription Use × (Per 21 CFR 801 Subpart D) Over-The-Counter-Use (21 CFR 801)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

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CA.C.V.

Division Sign-Off Division Big
Office of in Vitmo Diagnostic Device Office tion and Safety

10(k) K 062055

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Regulation Number and Section

§ 862.1150 Calibrator.

(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.