In vitro diagnostic reagents for the quantitative determination of immunoglobulins (IgG, IgA and IgM) in human serum, heparinized and EDTA plasma as well as IgG in human cerebrospinal fluid (CSF) using the BN™ Systems. Measurements of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

Device Description

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 relevant protein in the sample. The result is evaluated by comparison with a standard of known concentration.

AI/ML Overview

The provided information is for an In Vitro Diagnostic (IVD) device, not an AI/ML medical device. Therefore, many of the requested categories (e.g., number of experts for ground truth, adjudication methods, MRMC study, sample size for training set) are not applicable to the information contained within this 510(k) summary.

However, I can extract information related to acceptance criteria (often tied to performance characteristics) and the study details that demonstrate the device meets these criteria.

Here's an analysis of the provided text:

Acceptance Criteria and Reported Device Performance

The 510(k) summary for "N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)" describes performance characteristics based on method comparison studies. While explicit "acceptance criteria" (e.g., minimum correlation coefficient or acceptable bias range) are not stated in a tabular form, the equivalency claim to a legally marketed device (K860894) implies that the new device's performance should be comparable.

The device performance is reported in terms of correlation (r) and bias (y-intercept) from method comparison studies, comparing results obtained using the modified N Antisera with results obtained using the current N Antisera (K860894). The goal is to show substantial equivalence.

Analyte	Sample Type	Sample Size (n)	Correlation (r)	Bias (y-intercept)
IgG	Heparinized	49	0.969	0.155
IgG	EDTA	20	0.978	-0.102
IgA	Heparinized	49	1.003	-0.031
IgA	EDTA	20	0.947	0.014
IgM	Heparinized	49	0.988	0.001
IgM	EDTA	20	0.920	0.024

Implicit Acceptance Criteria: The reported correlation coefficients (all above 0.9) and low bias values indicate good agreement between the modified device and the predicate device, suggesting the performance is acceptable for substantial equivalence. For IVDs, strong correlation and minimal bias are standard expectations for method comparison studies to demonstrate equivalency.

Study Details

Sample sizes used for the test set and the data provenance:
- Test Set Sample Sizes:
  - IgG (Heparinized): 49 samples
  - IgG (EDTA): 20 samples
  - IgA (Heparinized): 49 samples
  - IgA (EDTA): 20 samples
  - IgM (Heparinized): 49 samples
  - IgM (EDTA): 20 samples
- Data Provenance: Not explicitly stated in the provided text (e.g., country of origin, retrospective/prospective). However, for IVD performance studies, samples are typically collected from a relevant patient population and tested prospectively or retrospectively.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is an IVD device measuring immunoglobulin concentrations. The "ground truth" for such devices is typically the result obtained from a reference method or a legally marketed predicate device. No human expert interpretation is involved in establishing the "ground truth" for quantitative analyte measurement in this context. Therefore, this question is not applicable.
Adjudication method for the test set:
- Not applicable as the "ground truth" is established by a quantitative assay, not by expert interpretation requiring adjudication.
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:
- Not applicable. This is an IVD assay, not an AI/ML-driven diagnostic imaging device requiring human reader interpretation or assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, this is a standalone IVD assay. Its performance is evaluated independently by comparing its results to a predicate device. There is no "human-in-the-loop" component in the operational analysis of this quantitative assay.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" (or reference standard) is the measurement obtained from the legally marketed predicate device (K860894), also "N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) assay" on the BN™ Systems. This is a comparison between two quantitative assays.
The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set. Performance is evaluated on test samples.
How the ground truth for the training set was established:
- Not applicable as there is no training set for this type of IVD device.

Summary

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510(k) Summary for N Antisera to Human Immunoglobulins (IgG, IgA, and 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: _______________________________________________________________________________________________________________________________________________

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

Manufacturer:

Dade Behring Marburg GmbH Emil-von-Behring Str. 76 D-35001 Marburg, Germany

Contact Information:

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

Preparation date:

September 30, 2004

1. Device Namel Classification: N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) Assay Class: Immunological Test System, Class II, 21 CFR 866.5510 Panel: Immunology Product Code: CFN

3. Identification of the Legally Marketed Device:

N Antisera to Human Immunoglobulins (IgG, IgA and IgM) - K860894

Device Description: 4.

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5. Device Intended Use:

In vitro diagnostic reagents for the quantitative determination of immunoglobulins (IgG, lgA and IgM) in human serum, heparinized and EDTA plasma as well as IgG in human cerebrospinal fluid (CSF) using the BN™ Systems.

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

The modified N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) assay is substantially equivalent to the N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) currently marketed (K860894). The modified N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) assay, like the current N Antisera to Human Immunoglobulins (IgG, lgA, and IgM) assay, is intended for the quantitative determination of immunoglobulins (IgG, IgA and IgM) by means of immunonephelometry on the BN™ Systems.

7. Device Performance Characteristics:

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lgG	Heparinized	49	0.969	0.155	0.993
	EDTA	20	0.978	-0.102	0.993
laA	Heparinized	49	1.003	-0.031	0.998
	EDTA	20	0.947	0.014	0.998
laM	Heparinized	49	0.988	0.001	0.994
	EDTA	20	0.920	0.024	0.994

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo is a circle with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread. The eagle is facing to the right and has a stylized design.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB 1 5 2005

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

Re: K042735

k042 133
Trade/Device Name: N Antisera to Human Immunoglobulins (IgG, IgA and IgM) Regulation Number: 21 CFR 866.5510 Regulation Name: Immunoglobulins A, G, M, D, E Immunological Test Systems Regulatory Class: Class II Product Code: CFN Dated: September 30, 2004 Received: October 1, 2004

Dear Ms. Dray-Lyons:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have leviewed your boother to the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce use stated in the eneround to regard date of the Medical Device Amendments, or to devices that prior to May 26, 1770, the onadances with the provisions of the Federal Food, Drug, and Cosmetic have been recuire and acceraroval of a premarket approval application (PMA). You may, Act (Act) that do not require apprect to the general controls provisions of the Act. The general therefore, matice the detrice, day of the manual registration, listing of devices, good controls provisions or allabeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your de vice to such additional controls. Existing major regulations affecting your device can be may be subject to sam adazine , 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 r reast of advisou that I be remination that your device complies with other requirements of the Act or that FDA mas made a decemination administered by other Federal agencies. You must comply with ally rederal statutes and regulations abut not limited to: registration and listing (21 CFR Part 807); an the Act 3 requirements, morading, sectice requirements as set forth in the quality labeling (21 CFR Part 807), good bart 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

comfor provisions (Sections 551 - 12 tresteting your device as described in your Section 510(k) I ins icter will anow you to objin maintaing of substantial equivalence of your device to legally

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Page 2

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 If you desire specific advice for your ac not to rease note the regulation entitled, comaci the Office of Comphance at (210) at Cetion" (21CFR Part 807.97). You may obtain other MISolanding of reference to promaibilities under the Act from the Division of Small general international on your responsibilities at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address

(501)445-0597 of at its intornet audioss
http://www.fda.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Robert Beckh.

Robert L. Becker, Jr., M.D., PhØ 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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Antisera to Human Immunoglobulins (IgG, IgA and IgM) Assay 510(k) Notification - Modification

Indications Statement

K042735

Device Name:

N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) Assay

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)

Maria Olan

Division Sign-Off

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K042753

000025

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).