IGALC reagent, when used in conjunction with IMMAGE® Immunochemistry Systems and Cerebrospinal Fluid Protein Calibrator, is intended for quantitative determination of Low Concentration Immunoglobulin A (IGALC) in human serum or cerebrospinal fluid (CSF) by rate nephelometry.

Device Description

The IMMAGE® Low Concentration Immunoglobulin A (IGALC) Reagent and Cerebrospinal Fluid Calibrator are designed for optimal performance on the IMMAGE® Immunochemistry Systems. It is intended for the quantitative determination of immunoglobulin A in serum and cerebrospinal fluid.

AI/ML Overview

The provided text describes a 510(k) submission for a medical device, which is primarily focused on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria with quantifiable metrics. The submission states that "Performance data from validation testing supports equivalency," but it does not provide the actual data, acceptance criteria, or a description of the study design in the provided text.

Therefore, many of the requested details cannot be extracted from the given input.

Here's a breakdown of what can and cannot be answered:

1. Table of acceptance criteria and the reported device performance:

Cannot be determined. The document states "Performance data from validation testing supports equivalency" but does not provide specific acceptance criteria (e.g., accuracy, precision targets) or the actual reported performance values for the device. The modification was "to reflect performance of the current reagent production processes," implying the performance itself was not significantly changed from the predicate.

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

Cannot be determined. The document does not provide any information about the sample size of the test set or the origin of the data.

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

Not applicable/Cannot be determined. This device is a diagnostic reagent for quantitative determination of Immunoglobulin A. The "ground truth" would typically be established by a reference method or known concentrations, not by expert interpretation in the way, for example, a radiology image would be. No information is provided about how the ground truth for any validation was established.

4. Adjudication method for the test set:

Not applicable/Cannot be determined. Similar to point 3, adjudication methods like 2+1 or 3+1 are typically used for subjective assessments (e.g., image interpretation) where multiple experts might disagree. This is not relevant to a quantitative chemical assay.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a reagent for an automated immunoassay system, not an AI-assisted diagnostic tool that human readers would interact with.

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

Not applicable. This device is a reagent kit used on an automated instrument. Its performance is inherently standalone in the sense that the instrument processes the sample without human interpretation of raw data, but it's not an "algorithm only" in the modern AI sense. The performance of the "device" (reagent and system together) is what's being evaluated.

7. The type of ground truth used:

Cannot be determined. While it would logically be against a reference method or known concentration standards for a quantitative assay, the document does not explicitly state the type of ground truth used for validation.

8. The sample size for the training set:

Not applicable/Cannot be determined. This device is a chemical reagent, not a machine learning model, so there isn't a "training set" in the computational sense. The "training" would refer to the development and optimization of the reagent formulation and assay parameters, but sample sizes for this are not provided.

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

Not applicable/Cannot be determined. As above, there is no "training set."

Summary of what can be extracted:

Device Name: IMMAGE® Systems Low Concentration Immunoglobulin A (IGALC) Reagent
Intended Use: Quantitative determination of Low Concentration Immunoglobulin A (IGALC) in human serum or cerebrospinal fluid (CSF) by rate nephelometry, when used with IMMAGE® Immunochemistry Systems and Cerebrospinal Fluid Protein Calibrator.
Modification: The serum methods comparison data has been modified to reflect performance of the current reagent production processes. All other performance parameters remain unchanged.
Equivalency Claim: Performance data from validation testing supports equivalency to the predicate device (IMMAGE Systems Low Concentration Immunoglobulin A Reagent, FDA 510(k) Number K993549).

The provided text is a 510(k) summary, which is typically a high-level overview. A full 510(k) submission would contain the detailed studies and data to support these claims, but that detailed information is not present in the given excerpt.

Summary

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K 060130

510(k) SUMMARY

1.0 Submitted By:

Annette Hellie Staff Regulatory Affairs Specialist Beckman Coulter, Inc. 200 S. Kraemer Blvd. W-110 Brea, CA 92822-8000 Telephone: (714) 993-8767 FAX: (714) 961-4234

2.0 Date Submitted

January 17, 2006

3.0 Device Name(s):

3.1 Proprietary Names IMMAGE Systems Low Concentration Immunoglobulin A Reagent
3.2 Classification Names Method, Nephelometric, Imunoglobulins (G, A, M) [865.5510]

4.0 Leqally Marketed Device

The IMMAGE Systems Low Concentration Immunoglobulin A Reagent substantial equivalence to the IMMAGE Systems Low claims -Concentration Immunoglobulin A Reagent currently in commercial distribution. (FDA 510(k) Number K993549)

5.0 Device Description

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6.0 Intended Use

IGALC reagent, when used in conjunction with IMMAGE® Immunochemistry Systems and Cerebrospinal Fluid Protein Calibrator, is intended for oyotation a ha e remination of Low Concentration Immunoglobulin A (IGALC) in human serum or cerebrospinal fluid (CSF) by rate nephelometry.

Comparison to the Predicate 7.0 (Description of the Modification to the Legally Marketed Device)

The IMMAGE Systems Low Concentration Immunoglobulin A reagent serum methods comparison data has been modified to reflect performance of the current reagent production processes. All other performance parameters remain unchanged.

8.0 Summary of Performance Data

Performance data from validation testing supports equivalency.

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Section 1: ADMINISTRATIVE INFORMATION

Submitted By: 1.0

Beckman Coulter, Inc. 200 S. Kraemer Blvd. W-110 Brea, CA 92822-8000

Primary Contact: Annette Hellie, Staff Regulatory Affairs Specialist Telephone: (714) 993-8767 FAX: (714) 961-4234 E-mail: athellie@beckman.com

Secondary Contact: Eri Hirumi, Staff Regulatory Affairs Specialist Telephone: (714) 961-4389 FAX: (714) 961-4234

2.0 Sponsor Address/FDA Registration Number

Beckman Coulter, Inc. 200 S. Kraemer Blvd. W-110 Brea, CA 92822-8000 Establishment Reqistration No. 2050012

Product Name/Classification Name and Number 3.0

Proprietary Names IMMAGE Systems Low Concentration Immunoglobulin A (IGALC) Reagent

Classification Names Method, Nephelometric, Imunoglobulins (G, A, M) [866.5510]

4.0 Device Classification

FDA has classified clinical chemistry test systems of this type into Class II

5.0 Section 514 Compliance

This Special 510(k): Device Modification submission is prepared pursuant to the FDA publication: The New 510(k) Paradigm: Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications -Issue Date: March 20, 1998

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB 1 3 2006

Beckman Coulter, Inc. c/o Ms Annette Hellie Regulatory Affairs 200 South Kraemer Blvd., W-110 Brea, CA 92822

Re: K060130

Trade/Device Name: IMMAGE Systems Low Concentration Immunoglobulin A (IGALC) Reagent Regulation Number: 21 CFR 866.5510 Regulation Name: Immunoglobulins A, G, M, D and E immunological systems Regulatory Class: Class II Product Code: CZP Dated: January 17, 2006 Received: January 18, 2006

Dear Ms. Hellie:

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, 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 (PMA), 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 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0484. 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/industry/support/index.html.

Sincerely yours,

Robert Z. Beckel

Robert L. Becker, Jr., M.D., Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

IMMAGE® Systems Low Concentration Device Name: Immunoglobulin A Reagent

Indications for Use:

INTENDED USE

CLINICAL SIGNIFICANCE

The concentration ratio of immunoglobulins in CSF and serum detects increased permeability of the blood-CSF barrier and intrathecal synthesis of immunoglobulins. The permeability of the blood-CSF barrier to plasma increases due to brain tumor, intracerebral hemorrhage, meningitis, encephalitis, and bacterial infections. The intrathecal synthesis of immunoglobulins is important in the diagnosis of diseases of the Central Nervous System (CNS).

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Page 1 of

Mana Chan

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K060130

Beckman Coulter, Inc., Special 510(k) Device Modification IMMAGE® Systems Low Concentration Immunoglobulin A Reagent File: IGALCserum 2005 s510k.doc, 1/06

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).