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

Device Description

Polystyrene latex particles coated with specific antibodies to human IgA are agglutinated when mixed with samples containing IgA. The intensity of scattered light in the BN™ Systems depends on the IgA concentration in the sample. The concentration can therefore be determined by comparison with dilutions of a standard of known concentration.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the N Latex IgA device, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria (Implicit)	Reported Device Performance
Correlation with Predicate Device: The device should show strong correlation with the legally marketed predicate device (Beckman Coulter IMMAGE® Immunochemistry System IGALC assay) for quantitative determination of IgA in human CSF and serum samples.	Correlation (N Latex IgA vs. Predicate): - CSF (n=50): Slope = 1.008, Intercept = -0.324, Correlation Coefficient = 0.991 - Serum (n=50): Slope = 1.123, Intercept = -0.067, Correlation Coefficient = 0.992 - Serum/CSF Ratio (n=50): Slope = 0.910, Intercept = -0.146, Correlation Coefficient = 0.988

Note: The document explicitly states the N Latex IgA is "substantially equivalent in intended use and results obtained to the IMMAGE® IGALC assay." The provided "Device Performance Characteristics" table directly reports the correlation metrics (slope, intercept, and correlation coefficient) as evidence of this equivalence, implying these values met the internal acceptance criteria for demonstrating substantial equivalence. Excellent correlation coefficients (all above 0.98) and slopes close to 1.0, with small intercepts, typically indicate strong agreement between two measurement methods.

Study Details:

Sample size used for the test set and the data provenance:
- Sample Size:
  - CSF: 50 samples
  - Serum: 50 samples
  - Serum/CSF Ratio: 50 samples (presumably derived from the same CSF and Serum samples)
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The concept of "ground truth" established by experts is not applicable here as this is a quantitative diagnostic device comparing its performance to a predicate device.
- The "ground truth" in this context is the quantitative result obtained from the legally marketed predicate device (Beckman Coulter IMMAGE® Immunochemistry System IGALC assay).
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is a comparison between a new device and a predicate device, not an interpretation task requiring adjudication of expert opinions.
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. This is a study comparing a new diagnostic device's quantitative measurements to an existing predicate device, not an MRMC study involving human readers or AI assistance.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, this was a standalone performance evaluation. The N Latex IgA device (an in vitro diagnostic reagent system) was tested to determine its quantitative output for IgA, and these outputs were then correlated with results from a predicate device. There is no human-in-the-loop component described for the measurement process itself, although human operators would run the tests.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this study was the quantitative IgA measurements obtained from the legally marketed predicate device, the Beckman Coulter IMMAGE® Immunochemistry System Low Concentration Immunoglobulin A (IGALC) assay (K993549).
The sample size for the training set:
- Not applicable. This document describes a performance evaluation for regulatory submission, not the development or training of an algorithm in the machine learning sense. The device is a "particle-enhanced immunonephelometry system," which relies on biochemical reactions and optical detection, not a machine learning model that requires a training set.
How the ground truth for the training set was established:
- Not applicable, as there is no "training set" in the context of this type of diagnostic device.

Summary

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FEB 1 3 2003

510(k) Summary for N Latex IgA

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: _ K 0 2 4 0 3 8

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

Manufacturer:

Marburg/Germany

Contact Information:

Dade Behring Inc. Glasgow Site P.O. Box 6101 Newark, Delaware 19714 Attn: Kathleen Dray-Lvons Tel: 781.826.4551

Dade Behring Marburg GmbH

Emil-von-Behring Str. 76

Preparation date:

December 4, 2002

Device Name/ Classification: 2.

N Latex IgA:	Immunoglobulin A, G, M, D and E immunological test
	system, Class II (866.5510)
Product Code:	81 CZP

Identification of the Legally Marketed Device: 3.

Beckman Coulter IMMAGE® Immunochemistry System Low Concentration Immunoglobulin A (IGALC) assay (K993549)

4. Device Description:

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5. Device Intended Use:

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

1. Medical device to which equivalence is claimed and comparison information: There are a number of in vitro diagnostic products in commercial distribution, which employ immunoassay techniques for the quantitative determination IgA in human serum or CSF. One such product is the Beckman Coulter IMMAGE® Immunochemistry System IGALC assay (K993549). The N Latex igA is substantially equivalent in intended use and results obtained to the IMMAGE® IGALC assay. The N Latex IgA, like IMMAGE® IGALC assay is intended to be used for the quantitative determination of IgA in human serum or CSF.

7. Device Performance Characteristics:

Assay	Sample Type	(n=)	Slope	Intercept	Correlation Coefficient
N Latex IgA	CSF	50	1.008	-0.324	0.991
	Serum	50	1.123	-0.067	0.992
	Serum/CSF Ratio	50	0.910	-0.146	0.988

Correlation:

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

FEB 1 3 2003

Re: K024038

Trade/Device Name: N Latex IgA Regulation Number: 21 CFR & 866.5510 Regulation Name: Immunoglobulins A, G, M, D and E Immunological Test Regulatory Class: II Product Code: CZP Dated: January 29, 2003 Received: January 31, 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 (OS) 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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K024038 Indications Statement

Device Name: N Latex IgA

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)	J PReeves for J. Bautista
Division of Clinical Laboratory Devices

510(k) Number	K024038
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Prescription Use(Per 21 CFR 801.109)	Over-The-Counter-Use(Optional Format 1-2-96)
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000024

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).