Dimension Vista™ IGE Flex® reagent cartridge: The IGE method is an in vitro diagnostic test for the quantitative determination of Immunoglobulin E in human serum, heparinized plasma or EDTA plasma on the Dimension Vista® System. Measurements of IGE aid in the diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings.

Dimension Vista™ Protein 1 Calibrator: PROT1 CAL is an in vitro diagnostic product for the calibration of the C3 Complement (C3), C4 Complement (C4), Immunoglobulin A (IGA), Immunoglobulin E (IGE), Immunoglobulin G (IGG), Immunoglobulin M (IGM), and Prealbumin (PREALB) methods on the Dimension Vista® System.

Dimension Vista™ Protein 1 Control L. M and H: PROT1 CON L, M and H are assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of C3 Complement (C3), C4 Complement (C4), immunoglobulin A (IGA), immunoglobulin E (IGE), immunoglobulin G (IGG), immunoglobulin M (IGM), and prealbumin (PREALB) on the Dimension Vista® System.

Device Description

Dimension Vista™ IGE Flex® reagent cartridge: 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™ Protein 1 Calibrator: Protein 1 Calibrator is a multi-analyte, liquid, human serum based product containing C3 complement, C4 complement, immunoglobulin A (IGA), immunoglobulin E (IGE), immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin (PREALB).

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 C3 complement, C4 complement, immunoglobulin A (IGA), immunoglobulin E (IGE), immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin (PREALB).

AI/ML Overview

This submission describes the Dimension Vista™ IGE Flex® reagent cartridge, Dimension Vista™ Protein 1 Calibrator, and Dimension Vista™ Protein 1 Control L, M, and H for the quantitative determination of Immunoglobulin E (IgE). The study aimed to demonstrate equivalent performance to a legally marketed predicate device.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state pre-defined acceptance criteria in terms of specific thresholds for correlation coefficient, slope, or intercept. Instead, it implies that a strong correlation and "equivalent performance" between the new device and the predicate device would be considered acceptable. The reported performance is a regression analysis of the method comparison study.

Metric	Acceptance Criteria (Implied)	Reported Device Performance
Correlation (r)	Strong correlation to predicate (e.g., close to 1)	0.999
Slope (m)	Close to 1 (indicating proportional agreement)	1.041
Intercept (b)	Close to 0 (indicating negligible systematic bias)	0.151

Note: The document states, "These studies demonstrate correlation and equivalent performance between the Dade Behring N Latex IgE mono assay and the Dimension Vista " IGE assay." This statement, along with the high correlation coefficient, suggests the reported performance met the unstated equivalence criteria.

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

Sample Size for Test Set: 120 serum and plasma samples.
Data Provenance: The document does not explicitly state the country of origin. It indicates the samples were human serum and plasma. It doesn't specify if the data was retrospective or prospective, but method comparison studies are typically prospective or use banked retrospective samples to evaluate the new device against a predicate. Given the typical nature of device validation, it's likely these were distinct samples collected for the purpose of the comparison.

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

This type of in vitro diagnostic device (IVD) for quantitative measurement does not typically rely on "expert consensus" for ground truth in the same way an imaging or diagnostic AI model would.

Ground Truth Establishment: The "ground truth" for the test set was established by running the samples on the predicate device, the Dade Behring N Latex IgE mono assay on the BN ProSpec® System.
Number and Qualifications of Experts: Not applicable in the context of this type of quantitative IVD comparison. The performance of the predicate device serves as the reference, which has its own established accuracy and precision validated through previous studies.

4. Adjudication Method for the Test Set

Not applicable. The comparison involves quantitative measurements from two different analytical systems, not subjective interpretations requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Was an MRMC study done? No. This submission pertains to an in vitro diagnostic device for quantitative IgE measurement, which does not involve human readers interpreting cases or AI assistance in a diagnostic workflow. Therefore, an MRMC study is not relevant.
Effect size of human readers improve with AI vs without AI assistance: Not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Was a standalone study done? Yes, in essence. The method comparison study directly evaluated the Dimension Vista™ IGE assay (algorithm/device only) against the predicate device. The output is a numerical value, and there is no human-in-the-loop interpretation or intervention in generating this primary result.

7. The Type of Ground Truth Used

Type of Ground Truth: The ground truth for this comparison study was the quantitative IgE values obtained from the predicate device: the Dade Behring N Latex IgE mono assay on the BN ProSpec® System. This is a form of comparative reference measurement, where the established method (predicate) serves as the benchmark.

8. The Sample Size for the Training Set

Sample Size for Training Set: The document does not explicitly mention a "training set" in the context of machine learning. For IVDs, the development and calibration of the assay (reagents, calibrators, controls) are typically done through extensive internal studies (which would involve numerous samples for optimization, calibration curve generation, and verification of analytical performance characteristics like linearity, precision, etc.) before the final method comparison study. The 120 samples discussed in the method comparison are best considered a validation/test set for the final, developed assay.

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

Ground Truth Establishment for Training Set: Since a "training set" in the machine learning sense isn't explicitly described, the concept of ground truth for training would relate to the development and calibration of the assay itself. This would involve:
- Reference materials: Using internationally recognized IgE reference materials or purified IgE standards with known concentrations for calibrating the assay and defining the optimal reagent formulation and reaction conditions.
- Known samples: Running samples with previously established IgE concentrations (e.g., from other validated methods) to confirm the assay's ability to accurately measure them.
- Analytical studies: Performing studies to establish linearity, limit of detection, precision, and other analytical performance characteristics, where "ground truth" is defined by the expected behavior of the assay with controlled samples.

The document focuses on the final validation of the Dimension Vista™ IGE assay against a predicate, rather than the developmental steps involving "training."

Summary

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Dade Behring Inc. Dimension Vista™ IGE 510(k) Notification

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

FEB 1 5 2007

000104

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.

The assigned 510(k) number is: K063425

1. Manufacturer's Name, Address, Telephone, and Contact Person, Date of 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
Preparation date: November 9, 2006
Dimension Vista" IGE Flex® reagent cartridge
Dimension Vista" Protein 1 Calibral or
Dimension Vista " Protein 1 Controllor
Dimension Vista " Protein 1 Control II M
Dimension 2. Device Name:
Classification: Class II; Class II; Class I Product Code: DGC; JIX; JJY Panel: Immunology (82) and Clinical Chemistry (75)

ldentification of the Legally Marketed Device: 3.

Dade Behring N Latex IgE mono- K991787 Dade Behring N Protein Standard SL - K012470 Dade Behring N/T Protein Control SL - K012468

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Dade Behring Inc. Dimension Vista™ IGE 510(k) Notification

4. Device Description:

Dimension Vista" IGE Flex® reagent cartridge

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 " Protein 1 Calibrator

Protein 1 Calibrator is a multi-analyte, liquid, human serum based product containing C3 complement, C4 complement, immunoglobulin A (IGA), immunoglobulin E (IGE), immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin (PREALB).

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 C3 complement, C4 complement, immunoglobulin A (IGA), immunoglobulin E (IGE), immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin (PREALB).

5. Device Intended Use:

Dimension Vista™ IGE Flex® reagent cartridge:

The IGE method is an in vitro diagnostic test for the quantitative determination of Immunoglobulin E in human serum, heparinized plasma or EDTA plasma on the Dimension Vista System. Measurements of IGE aid in the diagnosis of the liated allergic disorders in conjunction with other clinical findings.

Dimension Vista™ Protein 1 Calibrator:

PROT1 CAL is an in vitro diagnostic product for the calibration of the C3 complement (C3), C4 complement (C4), Immunoglobulin A (IGA), Immunoglobulin E (IGE), immunoglobulin G (IGG), Immunoglobulin M (IGM) and Prealbumin (PREALB) methods on the Dimension Vista® System.

Dimension Vista™ Protein 1 Control L, M and H:

PROT1 CON L, M and H are assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of C3 Complement (C3), C4 Complement (C4), immunoglobulin A (IGA), immunoglobulin E (IGE), immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin (PREALB) on the Dimension Vistas System.

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

The Dimension Vista™ IGE assay, like the Dade Behring N Latex IgE mono assay is an in vitro diagnostic test for the quantitative measurement of Immunoglobulin E in human serum and plasma.

7. Device Performance Characteristics:

The Dimension Vista ™ IGE assay was compared to the Dade Behring N Latex IgE mono assay on the BN ProSpec® System by eveluating serum and plasma samples with concentrations ranging from 18.2 IU/mL to 1126.5 IU/mL. Regression analysis of these results yielded the following equation.

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1 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 1Method Comparison Study
			Intercept
N Latex IgE mono on theBN ProSpec®	120	1.041	0.151	0 999

Table 3

8. Conclusion:

These studies demonstrate correlation and equivalent performance between the Dade
Behring N Latex IgE mono assay and the Dimension Vista " IGE assay.

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Image /page/3/Picture/1 description: The image shows a circular seal or logo. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the top half of the circle. The bottom half of the circle contains a stylized image of an eagle or bird-like figure with flowing lines, possibly representing movement or flight.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Dade Behring Inc. c/o Ms. Kathleen Dray-Lyons Regulatory Affairs and Compliance Manager Glasgow Site P.O. Box 6101 Newark, DE 19714-6101

FEB 1 5 2007

Re: K063425

Trade/Device Name: Dimension Vista™ IgE Flex reagent cartridge 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 866.5510 Regulation Name: Immunoglobulin A, G, M, D and E Immunological Test System Regulatory Class: Class II Product Code: DGC, JIX, JJY Dated: January 10, 2007 Received: January 11, 2007

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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

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Page 2 -

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Robert H. Becker Jr.

Robert L. Becker, Jr., M.D., PH. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Dimension Vista™ IGF

Indications Statement

K063425

Device Name:

Dimension Vista™ IGE Flex® reagent cartridge Dimension Vista _ IGE Flex reagent ca
Dimension Vista _ Protein 1 Calibral L.
Dimension Vista _ Protein 1 Calibral L.
Dimension Vista _ Protein 1 Control M.
Dimension Vista Dimension Vista

Indications for Use:

Dimension Vista™ IGE Flex® reagent cartridge:

The IGE method is an in vitro diagnostic test for the quantitative determination of Immunoglobulin E in human serum, heparinized plasma or EDTA plasma on the Dimension Vista® System. Measurements of IGE aid in the diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings.

Dimension Vista™ Protein 1 Calibrator

PROT1 CAL is an in vitro diagnostic product for the calibration of the C3 Complement (C3), C4 Complement (C4), Immunoglobulin A (IGA), Immunoglobulin E (IGE), Immunoglobulin G (IGG), Immunoglobulin M (IGM), and Prealbumin (PREALB) methods on the Dimension Vista® System.

Dimension Vista™ Protein 1 Control L. M and H

PROT1 CON L, M and H are assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of C3 Complement (C3), C4 Complement (C4), immunoglobulin A (IGA), immunoglobulin E (IGE), immunoglobulin G (IGG), immunoglobulin M (IGM), and prealbumin (PREALB) on the Dimension Vista® System.

Prescription Use X (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)

maria In Che Division Sign-Off

Page 1 of

Division Sign-Off

W.L.N.I.A.L. R

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k)_________ Ko 63425

000065

Regulation Number and Section

§ 866.5510 Immunoglobulins A, G, M, D, and E immunological test system.

(a)
Identification. An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.(b)
Classification. Class II (performance standards).