The IgA method is an in vitro diagnostic test for the quantitative measurement of Immunoglobulin A in human serum and heparinized plasma on the Dimension Vista™ System. Measurements of IgA aid in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

PROT1 CAL is an in vitro diagnostic product for the calibration of Immunoglobulin A (IGA) and Immunoglobulin G (IGG) methods on the Dimension Vista™ System.

For use as an assayed intralaboratory quality control for assessment of precision and analytical bias in the determination of Immunoglobulin A (IGA) and Immunoglobulin G (IGG) on the Dimension Vista™ System.

Device Description

Dimension Vista™ IGA 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 calibrator of known concentration.

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

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

AI/ML Overview

Here's an analysis of the provided text regarding the Dimension Vista™ IGA Assay, focusing on acceptance criteria and the supporting study:

The provided text details a 510(k) summary for a new in vitro diagnostic device, the Dimension Vista™ IGA Flex® reagent cartridge, along with its associated calibrator and controls. It highlights the device's performance characteristics through a method comparison study.

Acceptance Criteria and Device Performance

The document does not explicitly state pre-defined "acceptance criteria" in a typical quantitative sense (e.g., minimum R-squared value, specific bias limits). Instead, it presents a "method comparison study" where the new device's performance is compared against a legally marketed predicate device. The implied acceptance is based on the regression analysis results demonstrating substantial equivalence.

Table of Acceptance Criteria (Implied) and Reported Device Performance

Performance Metric	Implied Acceptance Standard (from predicate device comparison)	Reported Device Performance (Dimension Vista™ vs. Predicate)
Number of Samples	(Not explicitly stated as a target, but 100 samples were used in the comparison study)	100 samples (50 serum, 50 plasma)
Slope	Close to 1.0	1.022
Y-intercept	Close to 0.0	-0.036
Correlation (R-value)	Close to 1.0 (indicating strong correlation)	0.998

The strong correlation (R-value of 0.998) and a slope close to 1.0 with a small y-intercept suggest that the Dimension Vista™ IGA assay performs similarly to the predicate device.

Study Details for Device Performance

The study described is a method comparison study intended to demonstrate substantial equivalence to a legally marketed predicate device.

Sample Size Used for the Test Set and Data Provenance:
- Sample Size: 100 samples (50 serum, 50 plasma).
- Data Provenance: Not specified regarding country of origin or whether it's retrospective or prospective. It states "human serum and heparinized plasma," implying they are clinical samples. Without further information, it's impossible to determine retrospectivity or prospectivity.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This information is not provided in the document. For in vitro diagnostic assays measuring specific analytes like IgA, "ground truth" is typically established by the reference method or the established predicate device's measurement, rather than expert consensus on interpretation. The predicate device (Dade Behring N Antisera to Human IgA on the BN ProSpec System) served as the comparator, representing the established "truth" for this comparison.
Adjudication Method for the Test Set:
- Not applicable as this is a quantitative measurement comparison study between two assays, not a subjective interpretation task requiring adjudication. The "truth" is derived from the predicate device's quantitative output.
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, an MRMC comparative effectiveness study was not conducted. This type of study is relevant for imaging or diagnostic interpretation tasks where human readers' performance is being evaluated, often with or without AI assistance. This document describes an in vitro diagnostic assay for quantitative measurement, which doesn't involve human 'readers' in an interpretive sense.
If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, effectively. The study described is a standalone performance evaluation of the Dimension Vista™ IGA assay. It compares the analytical output of the new automated assay system (Dimension Vista™ IGA) directly against the output of the predicate automated assay system (N Antisera to Human IgA on the BN ProSpec System). There is no human interpretation or human-in-the-loop component being evaluated in this performance study itself; it's comparing two automated measurement systems.
The Type of Ground Truth Used:
- The "ground truth" for this study was established by the measurement results from the legally marketed predicate device, the Dade Behring N Antisera to Human IgA assay run on the BN ProSpec System. This is a common practice for demonstrating substantial equivalence for in vitro diagnostic devices.
The Sample Size for the Training Set:
- This information is not provided in the document. The document describes a comparison study, which is typically a validation or test set rather than a training set as understood in machine learning. For an IVD assay, it would involve assay development and optimization, which would use various samples but not explicitly "training sets" in the AI sense.
How the Ground Truth for the Training Set was Established:
- This information is not provided as a "training set" is not explicitly mentioned or relevant in the context presented. The assay's development (optimization, reagent formulation, calibration) would have used reference materials and samples with known IgA concentrations, but these aren't typically termed a "training set" with established "ground truth" in the same way as for AI models.

Summary

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510(k) Summary for Dimension Vista™ IGA Assay

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: _ < 06 / 33 8

Manufacturer's Name, Address, Telephone, and Contact Person, Date of 1. Preparation:
- Dade Behring Inc. Manufacturer: P.O. Box 6101 Newark, Delaware 19714-6101 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 June 22, 2006 Preparation date: Dimension Vista™ IGA Flex® reagent cartridge 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 ﺍﻟﻤﺮﺍﺟﻊ

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

3. ldentification of the Legally Marketed Device:

Dade Behring N Antisera to Human IgA (K042735) Dade Behring N Protein Standard SL (K012470) Dade Behring N/T Protein Control SL (K012468)

4. Device Description:

Dimension Vista™ IGA 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 calibrator of known concentration.

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Dimension Vista™ Protein 1 Calibrator

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

Dimension Vista™ Protein 1 Controls L/M/H

Protein Controls L, M and H are multi-analyte, liquid human serum based product containing Immunoglobulin A and Immunoglobulin G.

5. Device Intended Use:

Dimension Vista™ IgA Flex® Reagent Cartridge:

Dimension Vista™ Protein 1 Calibrator:

The PROT1 CAL is an in vitro diagnostic product for the calibration of Immunoglobulin A (IGA) and Immunoglobulin G (IGG) methods on the Dimension Vista™ System.

Dimension Vista™ Protein 1 Control L/M/H:

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

The Dimension Vista™ IGA reagent cartridge, Dimension Vista™ Protein 1 Calibrator (K051087) and Dimension Vista™ Protein 1 Control L/M/H (K051087) are substantially equivalent to the Dade Behring N Antisera to Human IgA assay (K042735), N Protein Standard SL (K012470) and N/T Protein Control SL (K012468) respectively. The Dimension Vista™ IGA assay, like the N Antisera to Human IgA assay is an in vitro diagnostic reagent for the quantitative measurement of Immunoglobulin A in human serum and plasma.

7. Device Performance Characteristics:

The Dimension Vista™ IgA assay was compared to N Antiserum to Human IgA on the BN ProSpec System by evaluating 50 serum and 50 plasma samples with concentrations ranging from 0.276 to 6.864 g/L. Regression analysis of these results yielded the following equations:

Method Comparison Study

Dimension Vista™	100	1.022	-0.036	0.998

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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 and Human Services (HHS). The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted as a stylized design with flowing lines. The logo also includes the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" arranged in a circular pattern around the caduceus.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL - 6 2006

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

Re: K061338

Trade/Device Name: Dimension VISTA™ IgA Flex Reagent Cartridge Assay Dimension VISTA™ Protein 1 Calibrator Dimension VISTATM Protein 1 Control L, Control M and Control H Regulation Number: 21 CFR 866.5510 Regulation Name: Immunoglobulins A, G, M, D, E Immunological Test System Regulatory Class: Class II Product Code: CFN, JJY, JIX Dated: May 12, 2006 Received: May 15, 2006

Dear Ms. Dray-Lyons:

We have reviewed your Scction 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 Cosmelic 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. T'o 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 levice an be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition. FDA mey 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 requirements on the Acconnents 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

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systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Robert L. Becker, Jr., M.D., Ph.D. 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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Indications Statement

Device Name: Dimension Vista™ IGA Flex® reagent cartridge

Indications for Use: 1-061338

Dimension Vista™ IGA Flex® reagent cartridge:

Dimension Vista™ Protein 1 Calibrator:

PROT1 CAL is an in vitro diagnostic product for the calibration of Immunoglobulin A (IGA) and Immunoglobulin G (IGG) methods on the Dimension Vista™ System.

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

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)

Inara Chan
Motion Sign Off

vision Sign-Off

Thee of In Vitra Diagnostic evice Evaluation and a afety

510(k) K061338

(100013

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).