The IGM Flex™ reagent cartridge for the Dimension® Clinical Chemistry System is an in vitro diagnostic test intended to quantitatively measure immunoglobulin M (IgM) in serum and plasma.

Device Description

The IGM Flex™ reagent cartridge for the Dimension® clinical chemistry system is a quantitative, turbidimetric assay based on the precipitation of IgM by its polyclonal antibodies. IgM 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 IgM and it is calculated from a five point calibration curve.

AI/ML Overview

Here's an analysis of the provided text, focusing on acceptance criteria and the study conducted for the IGM Flex™ Reagent Cartridge:

This submission is a 510(k) premarket notification for a medical device, which typically involves demonstrating substantial equivalence to a legally marketed predicate device rather than setting and proving specific acceptance criteria in the same way a novel device might establish clinical utility. For 510(k)s, the "acceptance criteria" are often implicitly tied to demonstrating comparable performance to the predicate.

Acceptance Criteria and Reported Device Performance

The core "acceptance criteria" for this 510(k) submission revolve around demonstrating substantial equivalence to the predicate device, the Beckman Array® Immunoglobulin M Method. This is primarily assessed through correlation between the new device and the predicate device.

Acceptance Criteria (Implied for Substantial Equivalence to Predicate)	Reported Device Performance (IGM Flex™ vs. Beckman Array®)
Strong correlation coefficient (close to 1)	0.943
Slope of regression analysis close to 1	0.88
Intercept of regression analysis close to 0	4.92 mg/dL

Interpretation: The reported performance metrics (correlation coefficient, slope, and intercept) are presented as evidence that the IGM Flex™ Reagent Cartridge is "substantially equivalent in principle and performance" to the predicate, thus meeting the implicit acceptance criteria for a 510(k) clearance.

Study Details

The study described is a split sample comparison between the IGM Flex™ Reagent Cartridge and the predicate Beckman Immunoglobulin M Assay.

Sample size used for the test set and the data provenance:
- Sample Size: 94 clinical patient samples.
- Data Provenance: Not explicitly stated, but it refers to "clinical patient samples," suggesting human samples. The country of origin for the data is not specified, and neither is whether it was retrospective or prospective.
Number of experts used to establish the ground truth for the test set and qualifications of those experts:
- Not applicable / Not explicitly stated. For this type of in vitro diagnostic device (IVD) comparison, the "ground truth" for the test set is established by the predicate device's measurement. The study aims to correlate the new device's readings with the predicate's readings, rather than establishing a gold standard through expert consensus.
Adjudication method for the test set:
- Not applicable. There was no human adjudication process involved in this direct comparison of quantitative measurements from two IVDs. The measurements from each device were compared statistically.
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 was a comparison of two in vitro diagnostic assays, not an AI-assisted human reader study.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in essence. Both devices (the IGM Flex™ cartridge on the Dimension® system and the Beckman Array® IgM method) operate as standalone automated analytical systems. The study compared the direct output of these two systems. There is no "human-in-the-loop" component for interpretation described.
The type of ground truth used:
- The "ground truth" in this comparative performance study is the measurements obtained from the legally marketed predicate device (Beckman Array® Immunoglobulin M Method). The new device's performance is gauged against this established method.
The sample size for the training set:
- Not applicable / Not explicitly stated. This device is an IVD reagent cartridge, not a machine learning algorithm that requires a "training set" in the computational sense. The data presented is for performance validation, not for algorithm training.
How the ground truth for the training set was established:
- Not applicable. As explained above, there isn't a "training set" for this type of device in the context of the provided information.

Summary

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K9208553

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

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

IgM 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 IgM and it is calculated from a five point calibration curve.

PEG IgM + Antibody ------------------------> IgM-Antibody Complex

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

Intended Use: The IgM Method is used in the Dimension® clinical chemistry system to quantitatively measure immunoglobulin M (IgM) in human serum.

Comparison to Predicate Device:

Item	IGM Flex™ Reagent Cartridge	Beckman Array® IgM
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 IGM Flex™ reagent cartridge and the Beckman Immunoglobulin M assay gave a correlation coefficient of 0.943, slope of 0.88, and an intercept of 4.92 mg/dL when tested with 94 clinical patient samples.

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

C-y PCmt

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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized abstract design of three human profiles facing right, stacked on top of each other. The profiles are rendered with thick, curved lines. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

MAR 2 2 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Cathy P. Craft Regulatory Affairs and Compliance Manager Dade Behring Inc. P.O. Box 6101 Newark, DE 19714-6101

Re: K990553 Trade Name: IgM™ Flex Reagent Cartridge Regulatory Class: II Product Code: CFQ Dated: February 16, 1999 February 22, 1999 Received:

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, Druq, 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 requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. this response to your premarket notification Please note: 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 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: IGM Flex™ Reagent Cartridge

Indications for Use:

The IGM Flex™ reagent cartridge for the Dimension® Clinical Chemistry System is an in vitro diagnostic test intended to quantitatively measure immunoglobulin M (IgM) 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) OR Over-the-counter Use Prescription Use (Per 21 CFR 801.109) (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).