The IGG Flex™ reagent cartridge for the Dimension® clinical chemistry system is an in vitro diagnostic test intended to quantitatively measure immunoglobulin G (IgG) in serum and plasma.

Device Description

The IGG Flex™ reagent cartridge for the Dimension® clinical chemistry system is a quantitative, turbidimetric assay based on the precipitation of IgG by its polyclonal antibodies.a IgG 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 nm. The increase in turbidity is proportional to the concentration of IgG and it is calculated from a five point calibration curve.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the IGG Flex™ Reagent Cartridge, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Substantial equivalence to the predicate device (Beckman Array® Immunoglobulin G Method). This is primarily assessed through correlation of results.	Correlation Coefficient: 0.993 Slope: 1.00 Intercept: -12.8 mg/dL (These metrics demonstrate a very strong linear relationship and agreement between the IGG Flex™ and the predicate device, indicating substantial equivalence.)
Intended Use: Quantitatively measure immunoglobulin G (IgG) in human serum and plasma.	The device performed this function in the study, yielding quantitative IgG measurements comparable to the predicate device.
Methodology: Immunoprecipitation with Bichloromatic endpoint (340 and 700 nm) (turbidimetry).	The device successfully utilizes this methodology as described. Performance metrics (correlation, slope, intercept) indicate that this methodology is effective and comparable to the predicate's nephelometry.
Sample Type: Serum and plasma.	The study explicitly states that 111 clinical patient samples were used, implying the use of serum and/or plasma as per the device's intended use.

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

Sample Size for Test Set: 111 clinical patient samples.
Data Provenance: The text does not explicitly state the country of origin. It indicates "clinical patient samples," suggesting real-world patient data. The study is retrospective in nature, as it involves comparing the new device's measurements on existing "clinical patient samples" to a legally marketed predicate device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. For in vitro diagnostic (IVD) devices like this, the "ground truth" is typically established by measurements from a well-characterized, legally marketed predicate device, rather than direct expert interpretation of raw data. The predicate device's results serve as the reference.

4. Adjudication Method for the Test Set

This information is not applicable/provided as the study design is a direct comparison to a predicate device, not an interpretation-based task requiring expert adjudication. The comparison method involved running the same samples on both devices and analyzing the statistical correlation of the quantitative results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is more common for imaging devices where human readers interpret diagnostic images. The IGG Flex™ is an in vitro diagnostic reagent and system, and its performance is assessed through quantitative agreement (correlation) with a predicate device, not by human reader interpretation. Therefore, there is no effect size of how much human readers improve with AI vs without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in effect, a standalone performance study was done. The IGG Flex™ Reagent Cartridge, as an in vitro diagnostic assay on the Dimension® clinical chemistry system, operates as a standalone automated system. The reported performance (correlation, slope, intercept) reflects the direct output of this system compared to the predicate device, without direct human intervention in the result generation or interpretation for the comparison study itself. While humans operate the instruments, the "performance" here refers to the analytical capabilities of the assay and instrument combination.

7. The Type of Ground Truth Used

The "ground truth" for the comparative study was established by the measurements obtained from the legally marketed predicate device: the Beckman Array® Immunoglobulin G Method. The comparison was directly between the quantitative results of the IGG Flex™ system and the Beckman Array® system for the same patient samples.

8. The Sample Size for the Training Set

The document does not provide information about a specific "training set" or "training set sample size" for the IGG Flex™ reagent. This is typical for IVD assays. The development of such assays involves analytical validation, calibration, and optimization, which would use various samples, but these are not usually referred to as a "training set" in the same way machine learning algorithms are. The reported study focuses on clinical validation/comparison.

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

Since no specific "training set" is mentioned in the context of algorithm development (as it's not an AI/ML device), the concept of establishing ground truth for a training set in that sense is not applicable here. The ground truth for the reported study (comparison to predicate) was the Beckman Array® Immunoglobulin G Method results, as explained in point 7. For the initial development and calibration of the IGG Flex™ assay itself, ground truth would have been established through a combination of analytical methods, reference materials, and established laboratory practices to ensure accurate IgG quantification.

Summary

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3/25/99

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

K990551

DADE BEHRING

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:	IGG Flex™ Reagent Cartridge
FDA Classification Name:	Immunoglobulin G Test System
Predicate Device:	Beckman Array® Immunoglobulin G Method (K922273)

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

IgG 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 nm. The increase in turbidity is proportional to the concentration of IgG and it is calculated from a five point calibration curve.

PEG IgG + Antibody --------------------------> IgG-Antibody Complex

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

Intended Use: The IGG Flex® reagent cartridge is used in the Dimension® clinical chemistry system to quantitatively measure immunoglobulin G (IgG) in human serum and plasma.

Comparison to Predicate Device:

Item	IGG Flex™ Reagent Cartridge	Beckman Array® IgG
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 IGG Flex™ reagent cartridge and the Beckman Immunoglobulin G assay gave a correlation coefficient of 0.993, slope of 1.00, and an intercept of -12.8 mg/dL when tested with 111 clinical patient samples.

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

Cary PCraft
Cathy P. Craft

Regulatory Affairs and Compliance Manager Date: February 16, 1999

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The text is in all capital letters.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR 2 5 1999

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: K990551

Trade Name: DIMENSION® Immunoglobulin IgG FLEX™ Reagent Cartridge Regulatory Class: II Product Code: CFO Dated: February 16, 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 Sutman

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: IGG Flex™ Reagent Cartridge

Indications for Use:

The IGG Flex™ reagent cartridge for the Dimension® clinical chemistry system is an in vitro diagnostic test intended to quantitatively measure immunoglobulin G (IgG) 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)

Tetin E. Matson

1000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000

(Division Sign-Off Division of Clinical Laboratory De 510(k) Number

Prescription Use_1 (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).