The IGG method is an in vitro diagnostic test for the quantitative measurement of immunoglobulin G in human serum, heparinized plasma and cerebrospinal fluid (CSF) on the Dimension Vista® System. Measurements of IgG 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 the Dimension Vista System for: a1-Acid Glycoprotein (A1AG), a1-Antitrypsin (A1AT), B2-Microglobulin (B2MIC), C3 Complement (C3), C4 Complement (C4), Ceruloplasmin (CER), Haptoglobin (HAPT), Hemopexin (HPX), Homocysteine (HCYS), Immunoglobulin A (IGA), Immunoglobulin E (IGE), Immunoglobulin G (IGG) [serum/plasma] and Immunoglobulin G (IGG-C) [cerebrospinal fluid], Immunoglobulin G Subclass 1 (IGG1), Immunoglobulin G Subclass 2 (IGG2), Immunoglobulin G Subclass 3 (IGG3), Immunoglobulin G Subclass 4 (IGG4), Immunoglobulin M (IGM), Prealbumin (PREALB), Retinol Binding Protein (RBP), soluble Transferrin Receptor (STFR), Transferrin (TRF).

PROT3 CON is an assayed, low level intralaboratory quality control for assessment of precision and analytical bias on the Dimension Vista® System in the determination of a1-Microglobulin (A1MIC), specialty Albumin (sALB), Immunoglobulin G (IGG -C) and Microalbumin (MALB). * For Cerebrospinal fluid (CSF)

Device Description

Dimension Vista® System Immunoglobulin G 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® System Protein 1 Calibrator: PROT1 CAL is a multi-analyte, liquid human serum based product containing: α₁-Acid Glycoprotein, α₁-Antitrypsin, β₂-Microglobulin, C3 Complement, C4 Complement, Ceruloplasmin, Haptoglobin, Hemopexin, Homocysteine, Immunoglobulin A, Immunoglobulin E, Immunoglobulin G, Immunoglobulin G Subclass 1, Immunoglobulin G Subclass 2, Immunoglobulin G Subclass 3, Immunoglobulin G Subclass 4, Immunoglobulin M, Prealbumin, Retinol Binding Protein, soluble Transferrin Receptor, Transferrin.

Dimension Vista® System Protein 3 Control: PROT3 CON is a multi-analyte, lyophilized, polygeline and rabbit albumin based product containing: a -Microglobulin, Immunoglobulin G, Albumin.

AI/ML Overview

The provided text is a 510(k) summary for the Dimension Vista® System Immunoglobulin G Flex® Reagent Cartridge, Dimension Vista® System Protein 1 Calibrator, and Dimension Vista® System Protein 3 Control. This document primarily focuses on demonstrating substantial equivalence to previously cleared devices for adding Cerebrospinal Fluid (CSF) as a sample matrix for IgG measurement. It does not contain specific acceptance criteria, performance data, or details of a comprehensive study as typically requested for AI/ML device evaluations.

Therefore, many of the requested items (sample size, data provenance, expert qualifications, adjudication methods, MRMC study, training set details) are not applicable or not available in this type of submission. This 510(k) is for an in-vitro diagnostic (IVD) test, which typically has different evaluation criteria and reporting compared to AI/ML devices for image analysis or other diagnostic tasks involving human readers.

However, I can extract the information that is present and indicate where information is missing based on the context of the document.

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in a quantitative table format or report performance against such criteria. Instead, it states that "The studies included in this submission demonstrate correlation to and equivalent performance between the predicate N Antisera to Human IGG for CSF sample matrix." This implies that the performance (likely accuracy, precision, and linearity for CSF samples) was deemed equivalent to the predicate, but the specific numerical values for performance or acceptance criteria are not provided.

Acceptance Criteria	Reported Device Performance
Not explicitly stated in quantitative terms.	"studies included in this submission demonstrate correlation to and equivalent performance between the predicate N Antisera to Human IGG for CSF sample matrix."
Implicitly, the performance for the expanded indications (CSF) must be equivalent to the predicate device.	Performance data for the CSF matrix extension is not provided in this summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the 510(k) summary. Given the nature of a 510(k) summary for an IVD test, such detailed study design specifics are often contained in the full 510(k) submission and not in the public summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable for this type of IVD device. The "ground truth" for a quantitative IVD test like this would typically involve reference methods, calibrator values, and quality control materials, not expert consensus on interpretations.

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

This information is not applicable for this type of IVD device. Adjudication methods are typically used in studies involving human readers or AI output where there can be discretionary interpretation.

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 for this type of IVD device. This is a laboratory diagnostic test for quantitative measurement of a marker, not an AI-assisted diagnostic tool for human readers interpreting images or complex data.

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

This information is not applicable in the context of an AI/ML algorithm. This device is an automated IVD test system. Its standalone performance is inherent to its function, but it's not an "algorithm only" in the way an AI model is, as it relies on reagent chemistry and instrument mechanics. The summary implies "standalone" performance was demonstrated through "correlation" and "equivalent performance" studies against a predicate device.

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

For a quantitative diagnostic assay of Immunoglobulin G in CSF, the ground truth would be established by:

Reference methods: Highly accurate and precise laboratory methods (e.g., nephelometry, turbidimetry, or potentially a gold standard method if available) used to determine true concentrations in samples.
Calibrators: Materials with known, assigned concentrations of the analyte (IgG) used to establish the measurement curve of the assay. The Dimension Vista® System Protein 1 Calibrator is mentioned for this purpose.
Quality Control materials: Materials with known, assigned ranges of analyte concentration used to monitor the assay's performance and ensure accuracy and precision. The Dimension Vista® System Protein 3 Control is mentioned for this purpose.

The summary itself does not detail how the ground truth for the specific 'studies' was established, but these are the general principles for such assays.

8. The sample size for the training set

This information is not applicable for this type of IVD device. The Dimension Vista® system and its reagents are based on established immunochemical principles (light scattering) and are calibrated, not "trained" in the machine learning sense. There is no training set in the context of AI/ML.

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

This information is not applicable for this type of IVD device, as there is no "training set" in the AI/ML sense. Calibration is performed using materials with established concentrations (as outlined in point 7).

Summary

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K073561

510 (k) Summary

This summary of 5109k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

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

FEB 26 2002

Manufacturer: Dade Behring Marburg GmbH Emil-von-Behring Str. 76 35041 Marburg, Germany

Contact Information: Helen M. Lee Dade Behring Inc. P.O. Box 6101 Newark, DE 19714-6101 302.631.8706 302.631.6299 (fax)

Date of Preparation: November 28, 2007

Name of Products: 2.

Dimension Vista® System IGG Flex® reagent cartridge Dimension Vista® System Protein 1 Calibrator Dimension Vista® System Protein 3 Control

3. Identification of the Legally marketed Device:

N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) K042735 Dimension Vista® System Immunoglobulin G Flex® reagent cartridge Dimension Vista® System Protein 1 Calibrator (K071980) Dimension Vista® System Protein 3 Control (K072435)

4. Device Descriptions:

Dimension Vista® System Immunoglobulin G 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.

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Dimension Vista® System Protein 1 Calibrator PROT1 CAL is a multi-analyte, liquid human serum based product containing:

α₁-Acid Glycoprotein	Immunoglobulin G
α₁-Antitrypsin	Immunoglobulin G Subclass 1
β₂-Microglobulin	Immunoglobulin G Subclass 2
C3 Complement	Immunoglobulin G Subclass 3
C4 Complement	Immunoglobulin G Subclass 4
Ceruloplasmin	Immunoglobulin M
Haptoglobin	Prealbumin
Hemopexin	Retinol Binding Protein
Homocysteine	soluble Transferrin Receptor
Immunoglobulin A	Transferrin
Immunoglobulin E

Dimension Vista® System Protein 3 Control PROT3 CON is a multi-analyte, lyophilized, polygeline and rabbit albumin based product containing:

a -Microglobulin Immunoglobulin G Albumin

Device Intended Uses: 5.

Dimension Vista Immunoglobulin G Flex reagent cartridge

The IGG method is an in vitro diagnostic test for the quantitative measurement of immunoglobulin G in human serum, heparinized plasma and cerebrospinal fluid (CSF) on the Dimension Vista System. Measurements of IgG aid in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

Dimension Vista® System Protein 1 Calibrator

PROT1 CAL is an in vitro diagnostic product for the calibration of the Dimension Vista System for:

a -Acid Glycoprotein (A1AG) Immunoglobulin G (IGG) [serum/plasma] and Immunoglobulin G (IGG-C) [cerebrospinal fluid] a -Antitrypsin (A1AT) Immunoglobulin G Subclass 1 (IGG1) B_-Microglobulin (B2MIC) Immunoglobulin G Subclass 2 (IGG2) C3 Complement (C3) Immunoglobulin G Subclass 3 (IGG3) C4 Complement (C4) Immunoglobulin G Subclass 4 (IGG4)

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Ceruloplasmin (CER) Haptoglobin (HAPT) Hemopexin (HPX) Homocysteine (HCYS) Immunoglobulin A (IGA) Immunoqlobulin E (IGE) Immunoqlobulin M (IGM) Prealbumin (PREALB) Retinol Binding Protein (RBP) soluble Transferrin Receptor (STFR) Transferrin (TRF)

Dimension Vista® System Protein 3 Control

PROT3 CON is an assayed quality control for the assessment of precision and analytical bias on the Dimension Vista System in quantitative determination of:

a -Microglobulin (A1MIC) Immunoglobulin G (IGG-C)* Microalbumin (MALB) specialty Albumin (sALB) *

For cerebrospinal fluid (CSF)

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

The N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) was determined to be substantially equivalent in 510(k) Premarket Notification K042735 and is the predicate for adding the CSF sample matrix to the Dimension Vista® IGG assay.

The current Dimension Vista® IGG Flex® reagent cartridge was originally determined to be substantially equivalent in 510(k) Premarket Notification K051087. The subsequent assay modifications are described in this submission. The changes include: adjustment of the measuring range: reagent stability (both on board and open well), as well as other minor changes to the IFU. The operating principle and reagent composition have not changed. For your convenience, the sections with changes have been underlined in the Draft Instructions for Use included in this submission.

Dimension Vista® Protein 1 Calibrator, modified to include IGG-C (IGG in CSF), is substantially equivalent in intended use to the current Dimension Vista® Protein 1 Calibrator (K071980). The modified Dimension Vista® Protein 1 Calibrator, like the current product, is intended to be used for the calibration of human protein assays on the Dimension Vista® System.

Dimension Vista® System Protein 3 Control modified to include IGG-C (IGG in CSF), is substantially equivalent in Intended Use to the current Dimension Vista® System Protein 3 Control (K072435). The modified Dimension Vista® System Protein 3 Control like the current product is intended to be used as an assayed intralaboratory quality control on the Dimension Vista® System.

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7. Conclusion:

The studies included in this submission demonstrate correlation to and equivalent performance between the predicate N Antisera to Human IGG for CSF sample matrix.

The modified Dimension Vista® System IGG assay, modified Dimension Vista® System Protein 1 The modified Dimension Vista® System Protein 3 Control are substantially equivalent to Callbrator and modified Dimender Vista Crossed upon the demonstrated correlation and the information above.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three lines representing the branches of government. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular pattern.

FEB 26 2000

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Dade Behring, Inc. c/o Ms. Helen M. Lee Regulatory Affairs and Compliance Manager P.O. Box 6101, MS514 Newark, DE 19714-6101

Re: K073561

Trade/Device Name: Dimension Vista® System Immunoglobulin G Flex® Reagent Cartridge Dimension Vista® System Protein 1 Calibrator Dimension Vista® System Protein 3 Control Regulation Number: 21 CFR 866.5510 Regulation Name: Immunoglobulins A, G, M, D, E immunological test system Regulatory Class: Class II Product Code: CFN, JIX, JJY Dated: February 18, 2008 Received: February 19, 2008

Dear Ms. Lee:

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 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

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Page 2 -

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). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 vours,

Robert H. Bockel

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 for Use Statement

510(k) Number (if known): 长۵ 735 /

Device Name:

Dimension Vista® System Immunoglobulin G Flex® Reagent cartridge

Indications for Use:

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)

Mana In Chan

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

53002 K073561

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Indications for Use Statement

510(k) Number (if known):

Device Name:

Dimension Vista® System Protein 1 Calibrator

Indications for Use:

PROT 1 CAL is an in vitro diagnostic product for the calibration of the Dimension Vista System for:

a1-Acid Glycoprotein (A1AG)

a1-Antitrypsin (A1AT) B2-Microglobulin (B2MIC) C3 Complement (C3) C4 Complement (C4) Ceruloplasmin (CER) Haptoglobin (HAPT) Hemopexin (HPX) Homocysteine (HCYS) Immunoglobulin A (IGA) Immunoglobulin E (IGE)

Immunoglobulin G (IGG) [serum/plasma] and Immunoglobulin G (IGG-C) [cerebrospinal fluid] Immunoglobulin G Subclass 1 (IGG1) Immunoglobulin G Subclass 2 (IGG2) Immunoglobulin G Subclass 3 (IGG3) Immunoglobulin G Subclass 4 (IGG4) Immunoglobulin M (IGM) Prealbumin (PREALB) Retinol Binding Protein (RBP) soluble Transferrin Receptor (STFR) Transferrin (TRF)

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)

ia m Chan

DIVISION: SIGN-OFF

Office of in Vitro Diagnostic Device Evaluation and Safety

a Ko73561

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Indications for Use Statement

Ko73561 510(k) Number (if known):

Device Name:

Dimension Vista® System Protein 3 Control

Indications for Use:

For Cerebrospinal fluid (CSF)

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)

Mana m Chan

Division Sign-Off

് Office of In Vitro Diagnostic Device Evaluation and Safety

5130 K073541

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).