The IGA Flex™ reagent cartridge for the Dimension® Clinical Chemistry System is an in vitro diagnostic device intended to quantitatively measure immunoglobulin A in serum and plasma.

Device Description

The IGA Flex™ reagent cartridge for the Dimension® clinical chemistry system is a quantitative, turbidimetric assay based on the precipitation of IgA by its polyclonal antibodies.a

IgA from serum or plasma reacts with its polyclonal antibodies to form an immunoprecipitate. Addition of polyethylene glycol accelerates the formation of the precipitate. Turbidity created by immunoprecipitation is measured as bichromatic endpoint measurements at 340 and 700 um. The increase in turbidity is proportional to the concentration of IgA and it is calculated from a five point calibration curve.

PEG IgA + Antibody ------------------------> IgA-Antibody Complex

a The antibody is manufactured by Dade Behring, Marburg, Germany

AI/ML Overview

The provided text describes a 510(k) submission for the IGA Flex™ Reagent Cartridge, comparing it to a predicate device. Here's a breakdown of the acceptance criteria and study information:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implied)	Reported Device Performance
Strong correlation with predicate device	Correlation Coefficient: 0.983
Good agreement in quantitative measurements	Slope: 0.96
Minimal bias compared to predicate device	Intercept: 3.4 mg/dL

Note: The document implies these criteria by presenting the results of the comparison study as evidence of substantial equivalence. Explicit acceptance criteria values (e.g., "correlation coefficient must be greater than 0.95") are not directly stated but are inferred from the conclusion of substantial equivalence based on these high values.

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

Sample Size (Test Set): 100 clinical patient samples
Data Provenance: The samples are referred to as "clinical patient samples," suggesting they were collected from patients, but the country of origin is not specified. The study is retrospective, as it involves a "split sample comparison" where existing samples would have been analyzed by both devices. It is also prospective relative to the device submission date of 1999.

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

This information is not provided in the document. The "ground truth" for this type of device (quantitative measurement of a biomarker) is typically established by the predicate device's measurement, which is considered a reference standard rather than expert consensus on individual cases.

4. Adjudication method for the test set

This information is not applicable and therefore not provided. Adjudication methods (e.g., 2+1, 3+1) are typically used in studies where human interpretation or consensus is required to establish ground truth or evaluate different interpretations, such as in image analysis or diagnostic assessments. For a quantitative immunoassay comparing a new device to a predicate, the comparison of numerical outputs doesn't involve adjudication in this sense.

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

This is not applicable. The device is an automated in vitro diagnostic system, not an AI-assisted diagnostic tool that requires human readers. Therefore, an MRMC study and analysis of human reader improvement with AI assistance are irrelevant to this submission.

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

Yes, a standalone performance study was done. The "split sample comparison" between the IGA Flex™ reagent cartridge and the Beckman Immunoglobulin A assay represents a direct comparison of the performance of the new device (algorithm/system) against an established method, without human intervention in the measurement process itself.

7. The type of ground truth used

The "ground truth" for the performance evaluation was the measurements obtained from the predicate device, the Beckman Array® Immunoglobulin A Method. In this context, the predicate device acts as the reference standard against which the new device's measurements are compared.

8. The sample size for the training set

This information is not provided in the document. For a traditional immunoassay device like this, there isn't typically a "training set" in the machine learning sense. Any initial assay development or calibration would rely on characterized samples or standards, but those details are not part of this summary.

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

This information is not provided and is largely not applicable in the typical sense for this type of device. If developmental samples were used, their "ground truth" would likely be based on established laboratory methods or certified reference materials, but these details are beyond the scope of this 510(k) summary.

Summary

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3/25/99

K990552

DADE BEHRING

DADE BEHRING INC. P.O. Box 6101 Newark, DE 19714

Summary of Safety and Effectiveness Information

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.

Submitter's Name:	Cathy P. CraftDade Behring Inc.P.O. Box 6101Newark, DE 19714-6101
Date of Preparation:	February 16, 1999
Name of Product:	IGA Flex™ Reagent Cartridge
FDA Classification Name:	Immunoglobulin A Test System
Predicate Device:	Beckman Array® Immunoglobulin A Method (K922273)

Device Description: The IGA Flex™ reagent cartridge for the Dimension® clinical chemistry system is a quantitative, turbidimetric assay based on the precipitation of IgA by its polyclonal antibodies.a

PEG IgA + Antibody ------------------------> IgA-Antibody Complex

a The antibody is manufactured by Dade Behring, Marburg, Germany

Intended Use: The IGA Flex™ reagent cartridge is used in the Dimension® clinical chemistry system to quantitatively measure immunoglobulin A (IgA) in serum and plasma.

Comparison to Predicate Device:

Item	IGA Flex™ Reagent Cartridge	Beckman Array® IgA
Sample Type	Serum and plasma	Serum
Methodology	Immunoprecipitation	Immunoprecipitation
Detection	Bichromatic endpoint(340 and 700 nm)(turbidimetry)	Nephelometry(405 nm)

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Comments on Substantial Equivalence:

Split sample comparison between the IGA Flex™ reagent cartridge and the Beckman Immunoglobulin A assay gave a correlation coefficient of 0.983, slope of 0.96, and an intercept of 3.4 mg/dL when tested with 100 clinical patient samples.

The IGA Flex™ reagent cartridge is substantially equivalent in principle and Conclusion: performance to the Beckman Immunoglobulin A Assay based on the split sample comparison discussed above.

Cathy P. Swift

Cathy P. Craft Regulatory Affairs and Compliance Manager Date: February 16, 1999

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MAR 2 5 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Cathy P. Craft Regulatory Affairs and Compliance Manager DADE Behring, Inc. Chemistry Group P.O. Box 6101 Route 896, Glasgow Bldg. 500 Newark, Delaware 19714-6101

Re: K990552

Trade Name: DIMENSION® Immunoglobulin IgA FLEX™ Reagent Cartridge Regulatory Class: II Product Code: CFQ Dated: February 18, 1999 Received: February 22, 1999

Dear Ms. Craft:

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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory 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 obligation 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 regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.

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 regulation entitled, "Misbranding 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 Putman

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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Indications For Use Statement

Device Name: IGA Flex™ Reagent Cartridge

Indications for Use:

The IGA Flex™ reagent cartridge for the Dimension® Clinical Chemistry System is an in vitro diagnostic device intended to quantitatively measure immunoglobulin A in serum and plasma.

Cathy P. Craft Regulatory Affairs and Compliance Manager

February 16, 1999

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Peter E. Mason

(Division Sign-Off) Division of Clinical Lab 510(k) Number

Prescription Use L (Per 21 CFR 801.109)

Over-the counter Use (Optional format 1-2-96)

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).