N Latex IgM is an in vitro diagnostic test for the quantitative determination of IgM in human cerebrospinal fluid (CSF) and in paired CSF/serum samples by means of particle-enhanced immunonephelometry using the BN™ Systems. The determination of IgM aids in the evaluation of the patient's immune system.

Device Description

Polystyrene latex particles coated with antibodies specific to human IgM are agglutinated when mixed with samples containing human IgM. These aggregates scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the relevant protein in the sample. The result is evaluated by comparison with a standard of known concentration.

AI/ML Overview

Here's an analysis of the N Latex IgM device's acceptance criteria and the study used to demonstrate its performance, based on the provided documents:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the N Latex IgM device appear to be tied to its correlation with a legally marketed predicate device (Beckman Coulter IMMAGE® Immunochemistry System Low Concentration Immunoglobulin M (IGMLC) assay). While specific numerical acceptance thresholds for slope, intercept, and correlation coefficient are not explicitly stated, the presented "Correlation" and "Method Comparison Studies" implicitly define the performance considered acceptable for demonstrating substantial equivalence. The reported device performance is as follows:

Parameter	Assay Type	Sample Type	Sample Size (n=)	Slope	Intercept	Correlation Coefficient
Correlation	N Latex IgM	CSF	24	1.04	-0.02	0.995
Correlation	N Latex IgM	Serum	50	0.91	+0.02	0.979
Correlation	N Latex IgM	CSF/Serum Ratio	24	1.03	-0.01	0.989

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

The "test set" for the correlation studies consists of the following sample sizes:

CSF: 24 samples
Serum: 50 samples
CSF/Serum Ratio: 24 samples

The documents do not specify the country of origin for the data or whether it was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the submitted documents. For in vitro diagnostic assays like N Latex IgM, "ground truth" is typically established by comparative analysis with a reference method or a legally marketed predicate device. The documents indicate that the predicate device (Beckman Coulter IMMAGE® IGMLC assay) served as the comparator, implying its results were used to establish the "truth" against which the N Latex IgM's performance was measured. However, there's no mention of human experts defining this "ground truth" in the context of this type of quantitative assay comparison.

4. Adjudication Method for the Test Set

Not applicable for this type of quantitative assay comparison. The "adjudication method" typically refers to how discrepancies in human expert interpretations (e.g., in medical image analysis) are resolved to establish a definitive ground truth. Here, the comparison is directly between the quantitative output of two diagnostic assays.

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

No. An MRMC study is not relevant for this device. MRMC studies are typically used to evaluate the impact of a new diagnostic method (like an AI algorithm) on human reader performance, often in image-based diagnostics. The N Latex IgM is an in vitro diagnostic reagent for quantitative measurement, and its performance is evaluated by direct comparison to another quantitative assay, not by human reader interpretation.

6. Standalone (Algorithm Only) Performance Study

Yes, in a sense. The reported "Correlation" and "Method Comparison Studies" represent the standalone performance of the N Latex IgM assay comparing its quantitative output directly with the quantitative output of the predicate device. There is no "human-in-the-loop" aspect to these measurements; it's the device's output itself being evaluated.

7. Type of Ground Truth Used

The "ground truth" for these studies was established by the results obtained from the legally marketed predicate device, the Beckman Coulter IMMAGE® Immunochemistry System Low Concentration Immunoglobulin M (IGMLC) assay (K993547). The assumption is that the predicate device provides accurate and established measurements of IgM, which then serve as the reference standard for the N Latex IgM device.

8. Sample Size for the Training Set

The documents make no mention of a "training set" in the context of machine learning or AI. This device is an immunoassay, not an AI/ML algorithm that requires training data. The "training" for the device would involve calibrating it according to manufacturer specifications, rather than using a data set to "teach" an algorithm.

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

Not applicable, as there is no "training set" in the AI/ML sense for this type of immunoassay.

Summary

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ade Behring Inc 510(k) Notification

AUG - 7 2003

510(k) Summary for N Latex IgM

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:

Contact Information:

Dade Behring Marburg GmbH Emil-von-Behring Str. 76 Marburg/Germany

Dade Behring Inc. Glasgow Site P.O. Box 6101 Newark, Delaware 19714 Attn: Kathleen Dray-Lyons Tel: 781-826-4551 Fax: 781-826-2497

Preparation date:

June 26, 2003

1. Device Name/ Classification:

N Latex IgM:	Immunologlobulin A, G, D and E immunological test
	system, Class II (866.5510)
Product Code:	81CFN

1. Identification of the Legally Marketed Device: Beckman Coulter IMMAGE® Immunochemistry System Low Concentration immunoglobulin M (IGMLC) assay (K993547)

4. Device Description:

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Dade Behring Inc. N Latex IgM 510(k) Notification

5. Device Intended Use:

In vitro diagnostic reagents for the quantitative determination of IgM in human cerebrospinal fluid (CSF) and in paired CSF/serum samples by means of particleenhanced immunonephelometry using the BN™ Systems. The determination of IgM aids in the evaluation of the patient's immune system.

Medical device to which equivalence is claimed and comparison information: 6. There are a number of in vitro diagnostic products in commercial distribution, which employ immunoassay techniques for the quantitative determination of IgM in human serum or CSF. One such product is the Beckman Coulter IMMAGE® Immunochemistry System Low Concentration Immunoglobulin M (IGMLC) Assay (K993547). The N Latex IgM is substantially equivalent in intended use and results obtained to the IMMAGE® IGMLC assay.

7. Device Performance Characteristics:

Correlation:

Assay	SampleType	(n=)	Slope	Intercept	CorrelationCoefficient
N Latex IgM	CSF	24	1.04	-0.02	0.995
N Latex IgM	Serum	50	0.91	+0.02	0.979
N Latex IgM	CSF/Serum Ratio	24	1.03	-0.01	0.989

Method Comparison Studies

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three curved lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Re:

AUG - 7 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Kathleen A. Dray-Lyons Manager. Regulatory Affairs and Compliance Dade Behring. Inc. Glasgow Site P.O. Box 6101 Newark, Delaware 19714

K032014 Trade/Device Name: N Latex IgM Regulation Number: 21 CFR & 866.5510 Regulation Name: Immunoglobulins A, G, M, D and E Immunological Test Regulatory Class: II Product Code: CFN Dated: June 26, 2003 Received: June 30, 2003

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. Iisting 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). 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.

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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 (301) 594-3084. 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/dsma/dsmamain.html.

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Dade Behring Inc. N Latex IqM 510(k) Notification

Indications Statement

【,】

Device Name: N Latex IgM

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use(Per 21 CFR 801.109)	✓
Over-The-Counter-Use(Optional Format 1-2-96)

J.P. Reeves for S. Bautista
Division Sign-Off
Office of In Vitro Diagnostic Device
Evaluation and Safety510(k).

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).