Dimension Vista™ MALB Flex® reagent cartridge: The MALB method is an in vitro diagnostic reagent for the quantitative determination of albumin in human urine on the Dimension Vista™ System. Measurement of albumin aids in the diagnosis of kidney and intestinal disease.
Dimension Vista™ Protein 3 Calibrator: Protein 3 Calibrator is an in vitro diagnostic product for the calibration of the Microalbumin (MALB) method on the Dimension Vista™ System.
Dimension Vista™ Protein 3 Control: Protein 3 Control is an assayed intralaboratory quality control for the assessment of precision and analytical bias in determination of Microalbumin (MALB) on the Dimension Vista™ System.

Device Description

Dimension Vista™ MALB Flex® reagent cartridge: Proteins contained in human urine 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 albumin in the sample. The result is evaluated by comparison with a standard of known concentration.
Dimension Vista™ Protein 3 Calibrator: PROT3 CAL is a lyophilized, polygeline based (with urinary proteins of human origin) product containing Albumin.
Dimension Vista™ Protein 3 Control: PROT3 CON is a lyophilized, polygeline and albumin based product containing albumin of human origin.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text describes a method comparison study between the Dimension Vista™ MALB Flex® reagent cartridge and a predicate device (Dade Behring N Antiserum to Human Albumin assay on the BN ProSpec® System). The acceptance criteria are implicitly based on the regression analysis results to demonstrate substantial equivalence.

Metric	Acceptance Criteria (Implicit)	Reported Device Performance (Dimension Vista™ MALB vs. Predicate)
Method Comparison	Regression analysis demonstrating substantial equivalence to the predicate device. The values of the slope, intercept, and correlation coefficient should indicate good agreement.	Slope: 0.922y-intercept: 2.1292r value: 0.9996

Note: The document only provides the regression analysis results as the performance characteristics. Explicit acceptance criteria (e.g., "slope within X range," "intercept within Y range," "r-value > Z") are not explicitly stated in the provided text. The regulatory body's approval of substantial equivalence (K061990) implies these results met their internal criteria for equivalence.

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

Sample Size: The number of urine samples used was 100.
Data Provenance: The text does not specify the country of origin of the data or whether it was retrospective or prospective. It only states "evaluating urine samples."

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

This type of study (method comparison for an in vitro diagnostic device for quantitative determination of albumin) does not typically involve expert readers or establishing ground truth through expert consensus. The "ground truth" in this context is established by the results from the legally marketed predicate device (Dade Behring N Antiserum to Human Albumin assay on the BN ProSpec® System).

4. Adjudication Method for the Test Set

Not applicable. As this is a method comparison study for an in vitro diagnostic device, there is no expert adjudication process in the way it would be applied for image-based diagnostics. The comparison is against the established results of a predicate device.

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 not an AI-assisted diagnostic device, nor is it an MRMC study. It is a comparison of an in vitro diagnostic reagent and system to a predicate device.

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

This refers to the performance of the Dimension Vista™ MALB assay system itself, which is a standalone automated in vitro diagnostic system. The study evaluates its performance independently, by comparing its results to a predicate device. It is not an AI algorithm, but a quantitative biochemical assay.

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

The "ground truth" in this context is the quantitative determination of albumin in human urine by the legally marketed predicate device, the Dade Behring N Antiserum to Human Albumin assay on the BN ProSpec® System.

8. The Sample Size for the Training Set

Not applicable. This device is an in vitro diagnostic reagent system, not a machine learning or AI model that requires a training set in the conventional sense. The "training" for such systems involves calibration and quality control, but not in the context of a dataset for model development.

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

Not applicable. As above, this is not an AI/ML device requiring a training set with established ground truth. The calibration and control materials (Dimension Vista™ Protein 3 Calibrator and Control) have known concentrations of albumin to ensure the system's accuracy and precision during routine use.

Summary

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510(k) Summary for Dimension Vista™ MALB Flex® reagent cartridge Dimension Vista™ Protein 3 Calibrator Dimension Vista™ Protein 3 Control

SEP 1 9 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.

Image /page/0/Picture/4 description: The image shows the text "The assigned 510(k) number is:" followed by the number K061990. The number is handwritten in black ink. The text is likely part of a document or form that requires the identification of a specific 510(k) number.

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 11, 2006

Dimension Vista™ Microalbumin Flex® reagent cartridge (MALB) 2. Device Name: Dimension Vista™ Protein 3 Calibrator Dimension Vista™ Protein 3 Control

Classification:	Class II; Class II; Class I
Product Code:	DCF; JIX; JJY
Panel:	Immunology (82) and Clinical Chemistry (75)

3. ldentification of the Legally Marketed Device:

Dade Behring N Antiserum to Human Albumin - K860894 Dade Behring N Protein Standard SL - K012470 Dade Behring N/T Protein Control LC - K991704

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4. Device Description:

Dimension Vista™ MALB Flex® reagent cartridge

Proteins contained in human urine 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 albumin in the sample. The result is evaluated by comparison with a standard of known concentration.

Dimension Vista™ Protein 3 Calibrator

PROT3 CAL is a lyophilized, polygeline based (with urinary proteins of human origin) product containing Albumin.

Dimension Vista™ Protein 3 Control

PROT3 CON is a lyophilized, polygeline and albumin based product containing albumin of human origin.

5. Device Intended Use:

Dimension Vista 1 MALB Flex® reagent cartridge:

The MALB method is an in vitro diagnostic reagent for the quantitative determination of albumin in human urine on the Dimension Vista™ System. Measurement of Albumin aids in the diagnosis of kidney and intestinal disease.

Dimension Vista™ Protein 3 Calibrator:

Protein 3 Calibrator is an in vitro diagnostic product for the calibration of the Microalbumin (MALB) method on the Dimension Vista " System.

Dimension Vista™ Protein 3 Control:

Protein 3 Control is an assayed intralaboratory quality control for the assessment of precision and analytical bias in determination of Microalbumin (MALB) on the Dimension Vista™ System.

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

The Dimension Vista™ MALB Flex reagent cartridge. Dimension Vista™ Protein 3 Calibrator and Dimension Vista™ Protein 3 Control are substantially equivalent to the Dade Behring N Antiserum to Human Albumin assay (K860894) assay, N Protein Standard SL (K012470) and N/T Protein Control LC (K991704), respectively. The Dimension Vista™ MALB assay, like the Dade Behring N Antiserum to Human Albumin assay is an in vitro diagnostic reagent for the quantitative measurement of Microalbumin (MALB) in human urine by means of particle enhanced immunonephelometry.

7. Device Performance Characteristics:

The Dimension Vista™ MALB assay was compared to the Dade Behring N Antiserum to Human Albumin assay on the BN ProSpec® System by evaluating urine samples with concentrations ranging from 5.87 to 332.74 mg/L. Regression analysis of these results yielded the following equation:

		1194199 VVIIIVMINVII WILL
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Method Comparison Study

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized caduceus, a symbol often associated with medicine and healthcare.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP 1 9 2006

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

K061990 Re:

Trade/Device Name: Dimension Vista™ MALB Flex® reagent cartridge Dimension Vista™ Protein 3 Calibrator Dimension Vista™ Protein 3 Control

Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: DCF, JIT, JJY Dated: July 11, 2006 Received: July 13, 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) 276-0484. 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 Gutierrez, 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™ MALB 510(k) Notification

Indications Statement

Dimension Vista™ MALB Flex® reagent cartridge Device Name: Dimension Vista™ Protein 3 Calibrator Dimension Vista™ Protein 3 Control

Indications for Use:

Dimension Vista™ MALB Flex® reagent cartridge:

The MALB method is an in vitro diagnostic reagent for the quantitative determination of albumin in human urine on the Dimension Vista™ System. Measurement of albumin aids in the diagnosis of kidney and intestinal disease.

Dimension Vista™ Protein 3 Calibrator:

Protein 3 Calibrator is an in vitro diagnostic product for the calibration of the Microalbumin (MALB) method on the Dimension Vista™ System.

Dimension Vista™ Protein 3 Control:

Protein 3 Control is an assayed intralaboratory quality control for the assessment of precision and analytical bias in determination of Microalbumin (MALB) 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)

CAC

Division Sign-Off

Office of In Vitro Diagnostic Device
Evaluation and Safety

510(k) K061990

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Regulation Number and Section

§ 866.5040 Albumin immunological test system.

(a)
Identification. An albumin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the albumin (a plasma protein) in serum and other body fluids. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases.(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 § 866.9.