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

Dimension Vista™ Protein 1 Calibrator: Protein 1 Calibrator is an in vitro diagnostic product for the calibration of the Immunoglobulin A (IGA), Immunoglobulin G (IGG) and Immunoglobulin M (IGM) methods on the Dimension Vista™ System.

Dimension Vista™ Protein 1 Control L, M and H: Protein 1 Control L, M and H are assayed intralaboratory quality controls for the assessment of precision and analytical bias in determination of Immunoglobulin A (IGA), Immunoglobulin G (IGG) and Immunoglobulin M (IGM) on the Dimension Vista™ System.

Device Description

Dimension Vista™ IGM 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 Immunoglobulin A, Immunoglobulin G, and Immunoglobulin M.

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 Immunoglobulin A, Immunoglobulin G, and Immunoglobulin M.

AI/ML Overview

The provided text describes a 510(k) summary for an in vitro diagnostic device, specifically the Dimension Vista™ IGM Flex® reagent cartridge, Dimension Vista™ Protein 1 Calibrator, and Dimension Vista™ Protein 1 Control L, M and H. This submission is for substantial equivalence to a predicate device for the quantitative measurement of Immunoglobulin M (IgM).

However, the document does not provide specific acceptance criteria or details of a study structured to prove the device meets those criteria in the format requested. The text focuses on the device description, intended use, and comparison to a legally marketed predicate device to establish substantial equivalence for regulatory purposes. It lacks the detailed performance study information typically found when proving a device meets specific acceptance criteria, especially for algorithm performance.

Therefore, many of the requested sections below cannot be fully populated from the provided text.

Here's what can be inferred or stated based on the given information:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance	Source in Document
(Not explicitly stated in the provided text)	Substantially equivalent to Dade Behring N Antisera to Human IgM assay (K042735), N Protein Standard SL (K012470) and N/T Protein Control SL (K012468).	Section 6, Paragraph 1

Explanation: The document establishes "substantial equivalence" as the primary criterion for regulatory clearance. It does not provide specific numerical or statistical acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds with confidence intervals) that a performance study would typically demonstrate. Instead, it claims equivalence to a predicate device which implies that its performance is comparable and acceptable for the intended use.

Study Details

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified in the provided text.
Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective/prospective). Studies for in-vitro diagnostics often involve clinical samples, but details are not given here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of Experts: Not applicable/Not specified. For in-vitro diagnostic assays measuring an analyte like IgM, the "ground truth" is typically established by reference methods or laboratory techniques, not by expert interpretation in the same way it would be for imaging diagnostics.
Qualifications of Experts: Not applicable/Not specified.

4. Adjudication method for the test set:

Not applicable/Not specified. As noted above, the "ground truth" for this type of device is typically established through analytical methods rather than expert 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:

MRMC Study: Not applicable. This device is an in-vitro diagnostic assay for quantitative measurement of Immunoglobulin M, not an AI-assisted diagnostic tool that human readers would interact with to improve interpretation of medical cases.
Effect Size: Not applicable.

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

The device itself (Dimension Vista™ IGM Flex® reagent cartridge) is a standalone diagnostic assay for quantitative measurement. Its performance is measured directly, without a human-in-the-loop component in the context of interpreting its primary output (a numerical concentration). The "algorithm" here refers to the chemical reaction and spectrophotometric measurement process, which operates independently to produce a result. The document does not detail specific "standalone performance" metrics (like accuracy, precision, linearity) typically reported for such devices, beyond the claim of substantial equivalence.

7. The type of ground truth used:

The "ground truth" for this type of in-vitro diagnostic device would typically be established by:
- Reference methods: Comparing the device's measurements to established, highly accurate laboratory methods for IgM quantification.
- Known concentration standards: Using samples with precisely known concentrations of IgM to assess accuracy and linearity.
- Clinical correlation: Demonstrating that the measured IgM levels correlate with clinical status or diagnosis as expected.
The provided text does not explicitly state which specific ground truth method was used in detail for their studies.

8. The sample size for the training set:

Not applicable/Not specified. This is a traditional in-vitro diagnostic device, not a machine learning model that requires a distinct "training set." The development of the assay involves optimization and validation, but not in the sense of training a neural network.

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

Not applicable. As this is not an AI/ML device requiring a training set, this question is not relevant in the context of the provided document.

Summary

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510(k) Summary for Dimension Vista™ IGM Flex® reagent cartridge Dimension Vista™ Protein 1 Calibrator Dimension Vista™ Protein 1 Control L, M and H

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: _______________________________________________________________________________________________________________________________________________

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: August 8, 2006

1. Device Name:
  Dimension Vista™ IGM 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

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

3. Identification of the Legally Marketed Device:

Dade Behring N Antisera to Human IgM - K042735 Dade Behring N Protein Standard SL - K012470 Dade Behring N/T Protein Control SL - K012468

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4. Device Description:

Dimension Vista™ IGM 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 Immunoglobulin A, Immunoglobulin G, and Immunoglobulin M.

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 Immunoglobulin A, Immunoglobulin G, and Immunoglobulin M.

5. Device Intended Use:

Dimension Vista™ IGM Flex® reagent cartridge:

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

Dimension Vista™ Protein 1 Calibrator:

Protein 1 Calibrator is an in vitro diagnostic product for the calibration of the Immunoglobulin A (IGA), Immunoglobulin G (IGG) and Immunoglobulin M (IGM) methods
on the Dimension Vista™ System.

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

Protein 1 Control L, M and H are assayed intralaboratory quality controls for the assessment of precision and analytical bias in determination of Immunoglobulin A (IGA), Immunoglobulin G (IGG) and Immunoglobulin M (IGM) on the Dimension Vista™ System.

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

The Dimension Vista™ IGM Flex® reagent cartridge, Dimension Vista™ Protein 1 Calibrator and Dimension Vista™ Protein 1 Control L, M and H are substantially equivalent to the the Dade Behring N Antisera to Human IgM assay (K042735), N Protein Standard SL (K012470) and N/T Protein Control SL (K012468), respectively. The Dimension Vista™ IGM assay, like Dade Behring N Antisera to Human IGM assay is an in vitro diagnostic test for the quantitative measurement of Immunoglobulin M in human serum and plasma by means of particle enhanced immunonephelometry.

7. Device Performance Characteristics:

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, emphasizing the department's name and national scope. The logo is presented in black and white, giving it a formal and official appearance.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

AUG 2 4 2006

Re: K061845

Trade/Device Name: Dimension Vista™ Immunoglobulin M Flex® Reagent Cartridee (IgM) Dimension Vista™ Protein 1 Calibrator Dimension Vista™ Protein 1 Control L Dimension Vista™ Protein 1 Control M Dimension VistaTM Protein 1 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, JIX, JJY Dated: June 28, 2006

Received: June 29, 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 cither 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 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 vours.

Tobe M. Bockerf

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

570(K) 061845

Device Name:

Dimension Vista™ IGM 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

Indications for Use:

Dimension Vista™ IGM Flex® reagent cartridge:

The IgM method is an in vitro diagnostic test for the quantitative measurement of Immunoglobulin M in human serum and heparinized plasma on the Dimension Vista 10 System. Measurements of IgM aid in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

Dimension Vista™ Protein 1 Calibrator

Protein 1 Calibrator is an in vitro diagnostic product for the calibration of the Immunoglobulin A (IGA), Immunoglobulin G (IGG) and Immunoglobulin M (IGM) methods on the Dimension Vista™ System.

Dimension Vista™ Protein 1 Control L, M and H

Protein 1 Control L. M and H are assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of Immunoglobulin A (IGA), Immunoglobulin G (IGG) and Immunoglobulin M (IGM)
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)

"marie M. Chen"

Page 1 of

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number 061845

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).