← Product Code [CZP](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZP) · K060130 # IMMAGE SYSTEMS LOW CONCENTRATION IMMUNOGLOBULIN A REAGENT (K060130) _Beckman Coulter, Inc. · CZP · Feb 13, 2006 · Immunology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZP/K060130 ## Device Facts - **Applicant:** Beckman Coulter, Inc. - **Product Code:** [CZP](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZP.md) - **Decision Date:** Feb 13, 2006 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 866.5510 - **Device Class:** Class 2 - **Review Panel:** Immunology ## Intended Use The Beckman Coulter Immunoglobulin A Low Concentration (IGALC) Reagent is intended for use on Beckman Coulter clinical chemistry analyzers for the quantitative determination of immunoglobulin A (IgA) in human serum. Measurement of immunoglobulin A is used in the diagnosis and treatment of IgA deficiency, myeloma, and other diseases involving immunoglobulins. ## Device Story Reagent kit for quantitative determination of low concentration Immunoglobulin A (IgA) in human serum or cerebrospinal fluid (CSF). Used on IMMAGE® Immunochemistry Systems; utilizes rate nephelometry principle. Input: patient serum or CSF samples. Output: quantitative IgA concentration. Used in clinical laboratory settings by trained personnel. Results assist clinicians in evaluating blood-CSF barrier permeability and detecting intrathecal immunoglobulin synthesis associated with CNS conditions like meningitis, encephalitis, and brain tumors. Modification involves updated reagent production processes; performance parameters remain equivalent to predicate. ## Clinical Evidence No clinical data provided. Substantial equivalence supported by bench testing, design control activities, and method comparison studies demonstrating performance consistency with the predicate device. ## Technological Characteristics In vitro diagnostic reagent for rate nephelometry. Used with IMMAGE® Immunochemistry Systems. Quantitative assay for IgA in serum and CSF. No specific materials of construction or software algorithm details provided beyond standard nephelometric measurement principles. ## Regulatory 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. ## Predicate Devices - IMMAGE Systems Low Concentration Immunoglobulin A Reagent ([K993549](/device/K993549.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ 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 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. {1}------------------------------------------------ ### 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. {2}------------------------------------------------ # 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 {3}------------------------------------------------ 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. {4}------------------------------------------------ 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 {5}------------------------------------------------ page 1 of 1 510(k) Number (if known): ### IMMAGE® Systems Low Concentration Device Name: Immunoglobulin A Reagent Indications for Use: ## INTENDED USE 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. ## 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 --- **Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZP/K060130](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZP/K060130) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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