Who is the manufacturer of OLYMPUS IGG REAGENT?

Olympus America, Inc. filed the 510(k) submission for OLYMPUS IGG REAGENT (K073490).

What is the FDA product code for OLYMPUS IGG REAGENT?

CFN. It is classified under 21 CFR 866.5510 as a Class 2 device in the Immunology panel.

What is the regulatory pathway for OLYMPUS IGG REAGENT?

510(k) clearance (submission type: Traditional).

What are the predicate devices for OLYMPUS IGG REAGENT?

Olympus IgG reagent (OSR6X45) (k951013); Roche Tina QUANT IgG Gen. 2 (k050113).

Who can help prepare an FDA 510(k) submission like OLYMPUS IGG REAGENT?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

OLYMPUS IGG REAGENT

K073490 · Olympus America, Inc. · CFN · Feb 11, 2008 · Immunology

Device Facts

Record ID	K073490
Device Name	OLYMPUS IGG REAGENT
Applicant	Olympus America, Inc.
Product Code	CFN · Immunology
Decision Date	Feb 11, 2008
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 866.5510
Device Class	Class 2

Intended Use

System reagent for the quantitative determination of IgG immunoglobulins in human serum, plasma and cerebrospinal fluid on OLYMPUS analyzers. For in vitro diagnostic use.

Device Story

Olympus IgG reagent (OSR6X172) is an immunoturbidimetric assay for quantitative IgG measurement. Input samples include human serum, plasma (Li-heparin or EDTA), and cerebrospinal fluid (CSF). The device utilizes goat anti-IgG antibodies to form insoluble immune complexes with IgG in the sample; these complexes scatter light. Olympus analyzers (AU400/400e, 600/640/640e, 2700/5400) measure the decrease in transmitted light intensity (absorbance increase) to quantify IgG concentration. The assay is performed in clinical laboratory settings by trained technicians. Results are used by clinicians to assess protein metabolism and immune function. The device provides automated dilution and measurement, facilitating diagnostic decision-making regarding infectious disease and metabolic status.

Clinical Evidence

No clinical trials were performed. Evidence consists of analytical bench testing, including precision (CLSI EP5-A2), linearity (CLSI EP6-A), limit of quantitation/detection (CLSI EP17-A), interference testing (CLSI EP7-A2), and method comparison studies (CLSI EP9-A2) against predicate devices. Precision studies (n=80) showed total CVs ranging from 1.51–4.66% for serum/plasma and 2.81–10.24% for CSF. Method comparison correlation coefficients (r) were ≥0.996.

Technological Characteristics

Quantitative immunoturbidimetric assay. Reagents: R1 (Tris buffer, polyethylene glycol 6000) and R2 (goat anti-IgG antiserum) with sodium azide preservative. Sensing principle: light scattering/absorbance measurement. Form factor: liquid, on-board refrigerated storage. Connectivity: integrated with Olympus AU-series analyzers. Calibration: multipoint, traceable to CRM 470. Stability: 90-day on-board reagent stability.

Indications for Use

Indicated for the quantitative determination of IgG immunoglobulins in human serum, plasma, and cerebrospinal fluid to aid in the diagnosis of abnormal protein metabolism and the body's inability to resist infectious agents. For use on Olympus analyzers.

Regulatory Classification

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

Olympus IgG reagent (OSR6X45) (k951013)
Roche Tina QUANT IgG Gen. 2 (k050113)

Related Devices

K073487 — OLYMPUS IGM REAGENT · Olympus America, Inc. · Feb 11, 2008
K965108 — SYNCHRON LX SYSTEMS IMMUNOGLOBULIN G/A/M REAGENT · Beckman Instruments, Inc. · Mar 6, 1997

Submission Summary (Full Text)

{0}------------------------------------------------ ## 510(k) Summary This summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. The assigned 510(k) number is: 3073490 | 1. Submitter name, address, contact | Olympus America Inc. 3500 Corporate Parkway Center Valley, PA 18034 | |-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | U.S. Telephone: | 469-230-0959 | | U.S. Fax: | 972-317-7861 | | Contact Person: | Stephanie G. Donnelly | | Date Prepared: | December 10, 2007 | | 2. Device name | | | Proprietary Name: | Olympus IgG Reagent (OSR6X172) | | Common Name: | IgG Reagent | | Classification Name: | IgG, Antigen, Antiserum, Control | | 3. Predicate device(s) | | | Serum/Plasma Applications | Olympus (OSR6145) IgG Reagent Submitted (K951013) | | CSF Application | Roche Tina-Quant IgG GEN.2 Submitted (K050113) | | 4. Device description | In this Olympus procedure: <ul><li>When a sample is mixed with R1 buffer and R2 antiserum solution, human IgG reacts specifically with anti-human IgG antibodies to yield insoluble aggregates.</li><li>Immune complexes formed in solution scatter light in proportion to their size, shape and concentration.</li><li>Turbidimeters measure the reduction of incidence light due to reflection, absorption or scatter.</li><li>In the Olympus procedure, the decrease in intensity of light transmitted (increase in absorbance) through particles suspended in solution is as a result of complexes formed during the antigen-antibody reaction.</li></ul> | | 5. Intended use | System reagent for the quantitative determination of IgG immunoglobulins in human serum, plasma and cerebrospinal fluid on OLYMPUS analyzers. For in vitro diagnostic use. | {1}------------------------------------------------ The following tables compare the new Olympus IgG (OSR6X172) reagent with the predicate devices outlined in point 3 above. ## Serum/Plasma Applications | Similarities | | | |---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------| | Item | Olympus IgG (OSR6X172) reagent | Predicate System | | Intended Use | System reagent for the quantitative determination of IgG immunoglobulins in human serum, plasma and cerebrospinal fluid on OLYMPUS analyzers. | System reagent for the quantitative determination of IgG immunoglobulins in human serum on OLYMPUS analyzers. | | Measurement | Quantitative | Same | | Instrument Required | Olympus AU400/400°, 600/640/640° and 2700/5400 | Same | | Reagent handling | Ready for use | Same | | Assay Methodology/Operating Principle | Immunoturbidimetric | Same | | Reagent storage form | Liquid On-board storage | Same | | Calibration | Olympus Serum Protein Multi- Calibrator (ODR3021) | Same | | Calibration Traceability | This method is traceable to the International Reference Preparation CRM 470 (US designation RPPHS lot 91/0619) | Same | | Antibody | Goat Anti-IgG antiserum | Same | | Expected Values | 635-1741 mg/dL | Same | | Reagent On Board Stability | Opened reagents are stable for 90 days when stored in the refrigerated compartment of the analyzer. | Same | | Calibration Frequency | 90 days | Same | | Differences | | | Item | Olympus IgG (OSR6X172) reagent | Predicate System | |---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|------------------------------------------------|------------------| | Item | Olympus IgG (OSR6X172) reagent | Predicate System | Assay Range | 75-3000 mg/dL | 75-3000 mg/dL | | Specimen Type | Serum, Li-heparin or EDTA plasma: and cerebrospinal fluid | Serum | LoQ | 75 mg/dL | Not specified | | Prozone Capacity | No high dose effect at IgG concentrations up to 30,000 mg/dL | Not specified | | | | | Precision | AU400/400e Sample Total CV% 1 2.18 2 2.29 3 3.43 AU600/640/640e Sample Total CV% 1 3.29 2 3.49 3 4.66 | AU400/400e Sample Total CV% 1 0.82 2 1.06 3 2.24 AU600 Sample Total CV% 1 2.50 2 1.54 3 1.92 | | | | | | AU640/640° Sample 1 2 | Total CV% 1.00 1.00 | AU2700/5400 Sample 1 2 3 | Total CV% 1.54 2.39 2.84 | | | | AU2700/5400 Sample 1 2 3 | Total CV% 1.51 1.87 2.03 | | | | | Method Comparison (Linear Regression) | Intercept Slope R2 n Range | 37.2 0.945 0.998 120 195-2986 mg/dL | Intercept Slope R2 n Range | -117 1.086 0.993 98 223-2633 mg/dL | | | Interfering Substances | AU400/400° Bilirubin: Interference less than 2% up to 40 mg/dL Bilirubin Hemolysate: Interference less than 3% up to 500 mg/dL Hemolysate Lipemia: Interference less than 3% up to 1000 mg/dL Intralipid RF: Interferences less than 7% up to 1200 IU/mL Not tested AU600/640/640° Bilirubin: Interference less than 3% up to 40 mg/dL Bilirubin Hemolysate: Interference less than 3% up to 500 mg/dL Hemolysate Lipemia: Interference less than 5% up to 1000 mg/dL Intralipid RF: Interferences less than 7% up to 1200 IU/mL Not tested AU2700/5400 Bilirubin: Interference less than 1% up to 40 mg/dL Bilirubin Hemolysate: Interference less than 3% up to 500 mg/dL Hemolysate Lipemia: Interference less than 2% up to 1000 mg/dL Intralipid RF: Interferences less than 7% up to 1200 IU/mL Not tested | AU400/400° Bilirubin: Interference less than 1% up to 40 mg/dL Bilirubin Hemolysis: Interference less than 2% up to 500 mg/dL Hemolysate Lipemia: Interference less than/10% up to 1000 mg/dL Intralipid. RF: Not Specified Ascorbic acid: Interference less than 1% up to 20 mg/dL Ascorbate AU600/640/640° Bilirubin: Interference less than 2% up to 40 mg/dL Bilirubin Hemolysis: Interference less than 2% up to 500 mg/dL Hemolysate Lipemia: Interference less than 3% up to 1000 mg/dL Intralipid. RF: Not Specified Ascorbic acid: Interference less than 2% up to 20 mg/dL Ascorbate AU2700/5400 Bilirubin: Interference less than 5% up to 40 mg/dL Bilirubin Hemolysis: Interference less than 3% up to 500 mg/dL Hemolysate Lipemia: Interference less than 3% up to 1000 mg/dL Intralipid. RF: Not Specified Ascorbic acid: Interference less than 3% up to 20 mg/dL Ascorbate | | | | ნ. {2}------------------------------------------------ {3}------------------------------------------------ ## CSF Application | Similarities | | | |---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------| | Item | Olympus IgG (OSR6X172) reagent | Predicate Systems | | Intended Use | System reagent for the quantitative determination of IgG immunoglobulins in human serum, plasma and cerebrospinal fluid on OLYMPUS analyzers. | In vitro test for the quantitative determination of IgG in human serum, plasma and cerebrospinal on Roche/Hitachi Cobas c systems. | | Measurement | Quantitative | Same | | Specimen Type | Serum, plasma: Li-heparin or EDTA and cerebrospinal fluid | Same | | Antibody | Goat Anti-IgG antiserum | Same | | Reagent handling | Ready for use | Same | | Assay Methodology/Operating Principle | Immunoturbidimetric | Same | | Reagent storage form | Liquid On -board storage | Same | | Calibration Traceability | CRM 470 | Same | | Calibration | Multi-point | Same | | Differences | | | |----------------------------|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------| | Item | Olympus IgG (OSR6X172) reagent | Predicate System | | Instrument Required | Olympus AU400/400°, 600/640/640° and 2700/5400 | Roche/Hitachi Cobas c systems. | | Expected Values | 15 – 20 y 3.5 mg/dL ± 2.0 mg/dL. 21 – 40 y 4.2 mg/dL ± 1.4 mg/dL. 41 – 60 y 4.7 mg/dL ± 1.0 mg/dL | 1-3 mg/dL | | Reagent On Board Stability | Opened reagents are stable for 90 days when stored in the refrigerated compartment of the analyzer. | Opened reagents are stable for 84 days when stored in the refrigerated compartment of the analyzer. | | Calibration | Olympus Serum Protein Mulit- Calibrator (ODR3021) | S1 H₂O S2 C.f.a.s. PUC | | Calibration Frequency | 2 Days | Not Specified | . | | Performance Characteristics | | | | |------------------|-------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|-------------------------| | Item | Olympus IgG (OSR6X172) reagent | | Predicate System | | | Assay Range | 2-50 mg/dL | | 0.4-20 mg/dL | | | LoQ | 2 mg/dL | | Not specified | | | Prozone Capacity | No high dose effect at IgG concentrations up to 6,000 mg/dL | | No high dose effect at IgG concentrations up to 100 mg/dL | | | Precision | AU400/400 e Sample 1 2 3 AU600/640/640e Sample 1 2 3 AU2700/5400 Sample 1 2 3 | Total CV% 9.82 4.08 3.61 Total CV% 9.53 3.67 2.81 Total CV% 10.24 6.29 3.83 | Sample 1 2 | Total CV% 2.1 1.1 | {4}------------------------------------------------ | | Intercept | -0.069 | Intercept | -0.17 | |---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|------------------------------------------------------------------------------------------------------------------------------------------|-----------------| | Method Comparison (Linear | Slope | 1.067 | Slope | 0.997 | | Regression) | R2 | 0.998 | R2 | 1.000 | | | Range | 2.0-42.9 mg/dL | Range | 1.07-18.6 mg/dL | | Interfering Substances | AU400/400e/600/640/640°/2700/5400 Bilirubin: Interference less than 10% up to 36 mg/dL Bilirubin Hemolysis: Interference less than 10% up to 500 mg/dL Hemolysate | | Bilirubin: Interference less than 10% up to 15 mg/dL Bilirubin Hemolysis: Interference less than 10% up to 200 mg/dL Hemolysate | | ****************************************************************************************************************************************************************************** {5}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/5/Picture/1 description: The image shows the seal of the Department of Health & Human Services. The seal features a stylized eagle with three lines representing its wings and body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. #### Public Health Service FEB 11 2008 Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Olympus America, Inc. c/o Ms. Stephanie Donnelly Regulatory Affairs/Quality Assurance Manager Olympus Life Science Research Europa GmbH Lismeehan, O, Callaghan's Mills Co. Claire, Ireland. Re: k073490 Trade/Device Name: Olympus IgG reagent Regulation Number: 21 CFR 866.5510 Regulation Name: Immunoglobulins A, G, M, D, E immunological test systems Regulatory Class: Class II Product Code: CFN Dated: December 11, 2007 Received: December 12, 2007 Dear Ms. Donnelly: 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). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The {6}------------------------------------------------ Page 2 - 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Robert H. Becker 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 {7}------------------------------------------------ ## Indication for Use # 510(k) Number (if known): KD73490 Device Name: The Olympus IgG reagent (OSR6X172). Indication For Use: System reagent for the quantitative determination of IgG immunoglobulins in human serum, plasma and cerebrospinal fluid on OLYMPUS analyzers. The measurement of IgG aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. For in vitro diagnostic use. Prescription Use (21 CFR Part 801 Subpart D) And/Or Over the Counter Use (21 CFR Part 801 Subpart C) ### (PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) Mana M. Aan Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K073490

OLYMPUS IGG REAGENT

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Device Story

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Technological Characteristics

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Submission Summary (Full Text)

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OLYMPUS IGG REAGENT

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Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

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Predicate Devices

Related Devices

Submission Summary (Full Text)

Panel 1

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