The Immunoglobulin A assay is used for the quantitation of immunoglobulin A in human serum or plasma. Measurement of immunoglobulin A aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

Device Description

Immunoglobulin A is an in vitro diagnostic assay for the quantitative determination of immunoglobulin A in human serum or plasma. Antigen in the sample bonds to the specific antibody in the reagent, forming an immune complex. The immune complex causes an increase in light scattering, measured by reading turbidity at 700 nm, which correlates with the concentration of immunoglobulin A in the sample.

AI/ML Overview

This document describes the Abbott Laboratories Immunoglobulin A (IgA) assay, an in vitro diagnostic device. The study presented focuses on demonstrating substantial equivalence to a predicate device rather than setting new acceptance criteria based on novel clinical outcomes.

1. Table of Acceptance Criteria and Reported Device Performance

Performance Characteristic	Acceptance Criteria (from Predicate Device)	Reported Device Performance (IgA assay)
Correlation Coefficient	Not explicitly stated, but "acceptable correlation" to predicate.	0.9879 with K-ASSAY Immunoglobulin A assay
Slope	Not explicitly stated, but "acceptable correlation" to predicate.	1.006 with K-ASSAY Immunoglobulin A assay
Y-intercept	Not explicitly stated, but "acceptable correlation" to predicate.	-0.404 mg/dL with K-ASSAY Immunoglobulin A assay
Total %CV (Precision)	Not explicitly stated, but "precision studies were conducted... using two levels of control material."	Level 1/Panel 401: 1.5%Level 2/Panel 402: 2.4%
Assay Range	Not explicitly stated, but comparison is made.	0.566 to 797.44 mg/dL
Limit of Quantitation (Sensitivity)	Not explicitly stated, but comparison is made.	0.566 mg/dL

2. Sample Size and Data Provenance

The document does not specify the exact sample size used for the comparative performance studies (method comparison and precision studies). It mentions "two levels of control material" for precision studies, but not the number of replicates or runs for each. The data provenance is not explicitly stated (e.g., country of origin, retrospective or prospective), but it is implied to be from internal studies conducted by Abbott Laboratories for the purpose of this 510(k) submission.

3. Number of Experts and Qualifications

Not applicable. This is an in vitro diagnostic assay, and the ground truth is established through laboratory methods and comparison to a legally marketed predicate device, not through expert human review of images or clinical cases.

4. Adjudication Method

Not applicable. This is an in vitro diagnostic assay.

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

Not applicable. This is an in vitro diagnostic assay, not a medical imaging or diagnostic aid device that involves human readers.

6. Standalone Performance

Yes, a standalone performance was done. The IgA assay's performance characteristics (correlation, precision, assay range, sensitivity) were evaluated independently on the AEROSET™ System against the K-ASSAY® Immunoglobulin A assay run on the Hitachi® 717 Analyzer. This is a comparison of two analytical methods, effectively demonstrating the standalone performance of the new device relative to the predicate.

7. Type of Ground Truth Used

The ground truth for the comparative performance study was established by the K-ASSAY® Immunoglobulin A assay on the Hitachi® 717 Analyzer, which is the legally marketed predicate device. This is a form of comparative analytical performance against an established method.

8. Sample Size for the Training Set

Not applicable. This is a chemical assay, and the "training set" concept (as it pertains to machine learning algorithms) does not apply here. The device's performance is based on its inherent chemical and optical properties and established analytical protocols.

9. How Ground Truth for the Training Set Was Established

Not applicable for the same reason as point 8. The device operates based on established laboratory principles, not a learned algorithm from a training set. The performance is validated through comparison to a well-established and legally marketed predicate device.

Summary

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K983359

510(k) Summary

Submitter's Name/Address

Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038

NOV

4 1998

Contact Person Linda Morris Senior Regulatory Specialist MS 1-8 Regulatory Affairs (972) 518-6711 Fax (972) 753-3367

Date of Preparation of this Summary:	September 23, 1998
Device Trade or Proprietary Name:	IgA
Device Common/Usual Name or Classification Name:	Immunoglobulin A
Classification Number/Class:	Class II

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: K98.3359

Test Description:

Substantial Equivalence:

The Immunoglobulin A assay is substantially equivalent to the K-ASSA Y® Immunoglobulin A assay (K933971/S1) on the Hitachi® 717 Analyzer.

Immunoglobulin A 510(k) September 23, 1998 IgA 5 VI lwp

Section II Page 1

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Both assays yield similar Performance Characteristics. Similarities:

. Both assays are in vitro immunoassays.
Both assays can be used for the quantitative determination of . immunoglobulin A.
Both assays yield similar clinical results. .
Both assays are based on the light scattering properties of antigen-antibody . complexes.

Differences:

There is a difference between the assay range. .

Intended Use:

The Immunoglobulin A assay is used for the quantitation of immunoglobulin A in human serum or plasma.

Performance Characteristics:

Comparative performance studies were conducted using the AEROSET™ System. The Immunoglobulin A assay method comparison yielded acceptable correlation with the K-ASSAY Immunoglobulin A assay on the Hitachi 717 Analyzer. The correlation coefficient = 0.9879, slope = 1.006, and the Y-intercept = -0.404 mg/dL. Precision studies were conducted using the Immunoglobulin A assay. Within-run, between-run, and between-day studies were performed using two levels of control material. The total %CV for Level 1/Panel 401 is 1.5% and Level 2/Panel 402 is 2.4%. The Immunoglobulin A assay range is 0.566 to 797.44 mg/dL. The limit of quantitation (sensitivity) of the Immunoglobulin A assay is 0.566 mg/dL. These data demonstrate that the performance of the Immunoglobulin A assay is substantially equivalent to the performance of the K-ASSAY Immunoglobulin A assay on the Hitachi 717 Analyzer.

Section II Page 2

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Conclusion:

The Immunoglobulin A assay is substantially equivalent to the K-ASSAY Immunoglobulin A assay on the Hitachi 717 Analyzer as demonstrated by results obtained in the studies.

Immunoglobulin A 510(k) September 23, 1998
IgA_5_V1.lwp

Section II Page 3

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NOV

Ms. Linda Morris Senior Requlatory Specialist MS 1-8 Regulatory Affairs Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038

K983359 Re: Trade Name: IqA Regulatory Class: II Product Code: CZP Dated: September 23, 1998 Received: September 24, 1998

Dear Ms. Morris:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice reguirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obliqation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbrandinq by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 Butman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K98 3359

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

Peter E. Maher

al Laboratory De

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR Over-The-Counter Use (Per 21 CFR 801.109)

(Optional Format 1-2-96)

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Immunoglobulin A 510(k) September 23, 1998 lyA_5_V1.lwp

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).