Dimension Vista" APOAI Flex® reagent cartridge: The APOAI method is an in vitro diagnostic test for the quantitative determination of apolipoprotein A-1 in human serum, heparinized plasma or EDTA plasma on the Dimension Vista® System. Measurements of apolipoprotein A-I aid in the diagnosis and treatment of lipid disorders, various liver and renal diseases and in the assessment of risk for atherosclerosis and cardiovascular disease.

Dimension Vista™ APOB Flex® reagent cartridge: The APOB method is an in vitro diagnostic test for the quantitative determination of apolipoprotein B in human serum, heparinized plasma or EDTA plasma on the Dimension Vista® System. Measurements of apolipoprotien B aid in the diagnosis and treatment of lipid disorders, various liver and renal diseases and in the assessment of risk for atherosclerosis and cardiovascular disease.

Dimension Vista" Apolipoprotein Calibrator: The APO CAL is an in vitro diagnostic product for the calibration of the apolipoprotein A-I (APOAI) and apolipoprotein B (APOB) methods on the Dimension Vista® System.

Dimension Vista™ Apolipoprotein Control: APO CON is an assayed intralaboratory quality control for assessment of precision and analytical bias in determination of apolipoprotein A-I (APOAI) and apolipoprotein B (APOB) on the Dimension Vista® System.

Device Description

Dimension Vista™ APOAI and APOB Flex® reagent cartridges: Proteins contained in human body fluids form immune complexes in an immunochemical reaction with specific antibodies. These complexes scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the respective protein in the sample. The result is evaluated by comparison with a standard of known concentration.

Dimension Vista" Apolipoprotein Calibrator: APO CAL is a multi-analyte, lyophilized, human serum based product containing apolipoprotein A-I and apolipoprotein B.

Dimension Vista™ Apolipoprotein Control: APO CON is a multi-analyte, lyophilized, human serum based product containing apolipoprotein A-I and apolipoprotein B.

AI/ML Overview

The provided 510(k) summary describes the acceptance criteria and a study demonstrating the performance of the Dimension Vista™ APOAI and APOB Flex® reagent cartridges.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Dimension Vista™ APOAI and APOB assays are implicitly defined by their comparison to legally marketed predicate devices, specifically the Dade Behring N Antisera to Human Apo A-1 and Apo B assays on the BN ProSpec® System. The study aims to demonstrate "correlation and equivalent performance," and the reported objective metrics are high correlation coefficients (close to 1), slopes close to 1, and intercepts close to 0.

Assay	Performance Metric	Acceptance Criteria (Implicit)	Reported Device Performance
APOAI	Correlation Coefficient	High (e.g., >0.97)	0.997
APOAI	Slope	Close to 1 (e.g., 0.9-1.1)	1.007
APOAI	Intercept	Close to 0 (e.g., -0.1 to 0.1)	-0.038
APOB	Correlation Coefficient	High (e.g., >0.97)	0.995
APOB	Slope	Close to 1 (e.g., 0.9-1.1)	1.011
APOB	Intercept	Close to 0 (e.g., -0.1 to 0.1)	-0.004

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

Sample Size for Test Set:
- For APOAI: 72
- For APOB: 77
Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given the context of a 510(k) summary for a submission to the US FDA from a German manufacturer, it's likely the samples were collected and analyzed to support the submission, but specific details are not provided. The samples tested were human serum.

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

This information is not applicable to this type of device and study. The ground truth for this diagnostic device is established by the results produced by a legally marketed predicate device (the Dade Behring N Antisera assays on the BN ProSpec® System), not by human expert interpretation. The study is a method comparison study comparing a new device to an existing one.

4. Adjudication Method for the Test Set

This information is not applicable as the ground truth is established by a predicate device, not by expert consensus requiring adjudication.

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. This is a laboratory diagnostic device (an in vitro diagnostic test for apolipoproteins), not an AI-powered image analysis or clinical decision support tool involving human readers/interpreters. Therefore, MRMC studies and AI assistance effect sizes are irrelevant to this submission.

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

Yes, a standalone performance study was done. The study directly compares the performance of the new device (Dimension Vista™ APOAI and APOB assays) against the predicate device, operating independently. There is no human intervention mentioned as part of the primary measurement process for the device itself during the comparison.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth for this method comparison study is the results obtained from the legally marketed predicate device: Dade Behring N Antisera to Human Apo A-1 and Apo B assays on the BN ProSpec® System. This is considered a "reference method" comparison in the context of IVD submissions, rather than a true "ground truth" derived from an absolute standard like pathology or long-term outcomes data, which would be typical for validating clinical efficacy.

8. The Sample Size for the Training Set

The document does not provide information regarding a "training set" or its sample size. This is typical for in vitro diagnostic device submissions like this. The assays are based on established immunochemical principles, and the development process would involve internal optimization and validation, but not a "training set" in the machine learning sense to establish the core algorithm. The data presented is for validation testing.

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

Since no training set is described or relevant in the context of this 510(k) submission for an IVD reagent cartridge, the method for establishing its ground truth is not applicable and not provided.

Summary

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510(k) Summary for Dimension Vista" APOAl Flex® reagent cartridge

Dimension Vista" APOB Flex® reagent cartridge Dimension Vista™ Apolipoprotein Calibrator
Dimension Vista™ Apolipoprotein Control

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.

KO63608 The assigned 510(k) number is:

Manufacturer's Name, Address, Telephone, and Contact Person, Date of 1. Preparation:
- Manufacturer: Dade Behring Marburg GmbH Emil-von-Behring Str. 76 35041 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

February 6, 2007 Preparation date:

Dimension Vista™ APOAI Flex® reagent cartridge 2. Device Name: Dimension Vista™ APOB Flex® reagent cartridge Dimension Vista" Apolipoprotein Calibrator
Dimension Vista" Apolipoprotein Calibrator
Dimension Vista" Apolipoprotein Control
Classification: Class I; Class II; Class I (reserved) MSJ: JIX: JJY Product Code: Panel: Clinical Chemistry (75)

3. Identification of the Legally Marketed Device:

Dade Behring N Antisera to Human Apo A-1 - K860894 Dade Behring N Antisera to Human Apo B - K860894 Dade Behring Apolipoprotein Standard Serum - K041870 Dade Behring Apolipoprotein Control Serum CHD - K993310

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Device Description: 4.

Dimension Vista™ APOAI and APOB Flex® reagent cartridges:

Proteins contained in human body fluids form immune complexes in an immunochemical reaction with specific antibodies. These complexes scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the respective protein in the sample. The result is evaluated by comparison with a standard of known concentration.

Dimension Vista" Apolipoprotein Calibrator:

APO CAL is a multi-analyte, lyophilized, human serum based product containing apolipoprotein A-I and apolipoprotein B.

Dimension Vista™ Apolipoprotein Control:

APO CON is a multi-analyte, lyophilized, human serum based product containing apolipoprotein A-I and apolipoprotein B.

5. Device Intended Use:

Dimension Vista" APOAl Flex® reagent cartridge:

The APOAI method is an in vitro diagnostic test for the quantitative determination of apolipoprotein A-1 in human serum, heparinized plasma or EDTA plasma on the Dimension Vista® System. Measurements of apolipoprotein A-I aid in the diagnosis and treatment of lipid disorders, various liver and renal diseases and in the assessment of risk for atherosclerosis and cardiovascular disease.

Dimension Vista™ APOB Flex® reagent cartridge:

The APOB method is an in vitro diagnostic test for the quantitative determination of apolipoprotein B in human serum, heparinized plasma or EDTA plasma on the Dimension Vista® System. Measurements of apolipoprotien B aid in the diagnosis and treatment of lipid disorders, various liver and renal diseases and in the assessment of risk for atherosclerosis and cardiovascular disease.

Dimension Vista" Apolipoprotein Calibrator:

The APO CAL is an in vitro diagnostic product for the calibration of the apolipoprotein A-I (APOAI) and apolipoprotein B (APOB) methods on the Dimension Vista® System.

Dimension Vista™ Apolipoprotein Control:

APO CON is an assayed intralaboratory quality control for assessment of precision and analytical bias in determination of apolipoprotein A-I (APOAI) and apolipoprotein B (APOB) on the Dimension Vista® System.

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

Dimension Vista™ APOAI and APOB, like Dade Behring N Antisera to Human Apolipoprotein A-1 and Apolipoprotein B are in vitro diagnostic tests for the quantitative measurement of apolipoprotein A-1 and apolipoprotein B in human serum.

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Device Performance Characteristics: 7.

The Dimension Vista™ APOAI and APOB assays were compared to the Dade The Dimension The Human Apo A-1 and Apo B assays on the BN ProSpec® System by evaluating serum samples with concentrations ranging from 0.61 g/L to 5.10 g/L for APOA1 and 0.38 g/L to 3.81 g/L for APOB. Regression analyses of these results yielded the following equations.

Comparative Method	n	Slope	Intercept	CorrelationCoefficient
N Antisera to Human Apo A-1on the BN ProSpec®	72	1.007	-0.038	0.997
N Antisera to Human Apo Bon the BN ProSpec®	77	1.011	-0.004	0.995

Method Comparison Study

8. Conclusion:

These studies demonstrate correlation and equivalent performance between the Dade Behring N Antisera to Human Apo A-1 and Apo B assays and the Dimension Vista" APOAI and APOB assays.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread, rendered in a stylized, minimalist design.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Kathleen Dray-Lyons Dade Behring, Inc. P.O. Box 6101 Newark, DE 19714-6101 US

FEB 2 3 2007

Re: K063608

Trade/Device Name: Dimension Vista™ APOA1 Flex® reagent cartridge Dimension Vista™ APOB Flex® reagent cartridges Dimension Vista™Apolipoprotein Calibrator Dimension Vista™Apolipoprotein Control Regulation Number: 21 CFR 862.1475 Regulation Name: Lipoprotein test system

Regulatory Class: Class II Product Code: MSJ, JIX, JJY Dated: December 01, 2006 Received: December 04, 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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Page 2 -

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) 276-0490. 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jean M. Cooper, M.S., D.V.M.

Yean M. Cooper, M.S., D.V.M. 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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Indications Statement

Dimension Vista" APOAI Flex® reagent cartridge
Dimension Vista™ APOB Flex® reagent cartridge
Dimension Vista™ Apolipoprotein Calibrator Device Name: Dimension Vista™ Apolipoprotein Control

Indications for Use:

Dimension Vista" APOAI Flex® reagent cartridge:

The APOAI method is an in vitro diagnostic test for the quantitative determination of apolipoprotein A-I in human serum, heparinized plasma or EDTA plasma on the Dimension Vista® System. Measurements of apolipoprotein A-I aid in the diagnosis and treatment of lipid disorders, various liver and renal diseases and in the assessment of risk for atherosclerosis and cardiovascular disease.

Dimension Vista™ APOB Flex® reagent cartridge:

The APOB method is an in vitro diagnostic test for the quantitative determination of apolipoprotein B in human serum, heparinized plasma or EDTA plasma on the Dimension Vista System. Measurements of apolipoprotein B aid in the diagnosis and treatment of lipid disorders, various liver and renal diseases and in the assessment of risk for atherosclerosis and cardiovascular disease.

Dimension Vista™ Apolipoprotein Calibrator

Apolipoprotein Calibrator is an in vitro diagnostic product for the calibration of the Apolipoprotein A-I (APOAI) and Apolipoprotein B (APOB) methods on the Dimension Vista® System.

Dimension Vista™ Apolipoprotein Control

Apolipoprotein Control is an assayed intralaboratory quality control for assessment of precision and analytical bias in determination of apolipoprotein A-1 (APOAI) and apolipoprotein B (APOB) 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)

of the still Dingnostic Device

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Regulation Number and Section

§ 862.1475 Lipoprotein test system.

(a)
Identification. A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.