OLYMPUS IGA REAGENT

K073489 · Olympus America, Inc. · CFN · Feb 11, 2008 · Immunology

Device Facts

• Record ID: K073489
• Device Name: OLYMPUS IGA 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 IgA immunoglobulins in human serum and plasma on OLYMPUS analyzers. For in vitro diagnostic use.

Device Story

The Olympus IgA reagent (OSR6X171) is an in vitro diagnostic reagent used on Olympus AU400/400e, 600/640/640e, and 2700/5400 analyzers. The device utilizes an immunoturbidimetric principle: human IgA in patient serum or plasma samples reacts with goat anti-human IgA antibodies to form insoluble aggregates. These immune complexes scatter light; the analyzer measures the reduction in transmitted light intensity (increase in absorbance) to quantify IgA concentration. The system is operated by laboratory technicians in a clinical setting. Results are provided to clinicians to assist in diagnosing abnormal protein metabolism and immune system deficiencies. The device offers improved prozone capacity and expanded specimen types (serum, EDTA plasma, Li-Heparinized plasma) compared to the predicate.

Clinical Evidence

Bench testing only. Precision studies (n=80) across multiple platforms showed total CVs ranging from 1.50% to 4.01%. Linearity demonstrated from 10–700 mg/dL. Method comparison (n=111-115) against predicate showed high correlation (r=0.998-0.999). Matrix comparison (n=45) confirmed equivalence between serum and Li-heparin/EDTA plasma (r=0.999-1.000). Interference testing for bilirubin, lipids, hemoglobin, and RF showed acceptable performance.

Technological Characteristics

Immunoturbidimetric assay; liquid reagents (Tris buffer, PEG 6000, goat anti-IgA antiserum). Analyzers: Olympus AU series. Calibration: Olympus Serum Protein Multicalibrator (traceable to CRM 470). Measuring range: 10-700 mg/dL. On-board stability: 90 days. Sterilization: Not applicable (reagent).

Indications for Use

Indicated for the quantitative determination of IgA immunoglobulins in human serum and plasma to aid in the diagnosis of abnormal protein metabolism and the body’s lack of ability to resist infectious agents. For prescription use only.

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 IgA reagent (OSR6X44) (k951055)

Submission Summary (Full Text)

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## 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: KOJ3489

| 1. Submitter name, address, contact | Olympus America Inc.<br>3500 Corporate Parkway<br>Center Valley, PA 18034 |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | U.S. Telephone: [phone]<br>U.S. Fax: [phone] |
| | Contact Person: Stephanie G. Donnelly |
| | Date Prepared: December 10, 2007 |
| 2. Device name | Proprietary Name: Olympus IgA Reagent (OSR6X171) |
| | Common Name: IgA reagent |
| | Classification Name: IgA, Antigen, Antiserum, Control |
| 3. Predicate device | Reagent: Olympus (OSR6X44) IgA Reagent<br>Submitted K951055 |
| 4. Device description | In this Olympus procedure: <ul><li>When a sample is mixed with R1 buffer and R2 antiserum solution, human IgA reacts specifically with anti-human IgA 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 IgA immunoglobulins in human serum and plasma on OLYMPUS analyzers.<br>For in vitro diagnostic use. |

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6.

The following Tables compare the new Olympus IgA (OSR6X171)
reagent with the predicate devices outlined in point 3 above.

| Similarities | | |
|---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| Item | Olympus IgA (OSR6X171) reagent | Predicate System |
| Intended Use | System reagent for the quantitative<br>determination of IgA immunoglobulins in<br>human serum and plasma on Olympus<br>analyzers | System reagent for the quantitative<br>determination of IgA immunoglobulins in<br>human serum on Olympus analyzers |
| Measurement | Quantitative | Same |
| Instrument Required | Olympus AU400/400e, 600/640/640e and<br>2700/5400 | Same |
| Reagent handling | Ready for use | Same |
| Assay<br>Methodology/Operating<br>Principle | Immunoturbidimetric | Same |
| Reagent storage form | Liquid<br>On --board storage | Same |
| Calibrator | Olympus Serum Protein Mulit-Calibrator<br>(ODR3021) | Same |
| Calibration Traceability | This method is traceable to the International<br>Reference Preparation CRM 470 (US<br>designation RPPHS lot 91/0619) | Same |
| Antibody | Goat Anti-IgA antiserum | Same |
| Expected Values | 66-433 mg/dL | Same |
| Reagent On Board Stability | Opened reagents are stable for 90 days<br>when stored in the refrigerated<br>compartment of the analyzer. | Same |
| Differences | | |
| Item | Olympus IgA (OSR6X171) reagent | Predicate System |
| Specimen Type | Serum, EDTA Plasma and Li-Heparinized<br>Plasma | Serum |
| Calibration Frequency | 90 days | 7 days |

| Performance Characteristics | | | | |
|-----------------------------|--------------------------------|------------------|-------------|-----------|
| Item | Olympus IgA (OSR6X171) reagent | Predicate System | | |
| Precision | AU400/400e | AU400/400e | | |
| | Sample | Total CV% | Sample | Total CV% |
| | 1 | 2.43 | 1 | 1.53 |
| | 2 | 2.52 | 2 | 1.63 |
| | 3 | 2.95 | 3 | 1.26 |
| | AU600/640/640e | AU600 | | |
| | Sample | Total CV% | Sample | Total CV% |
| | 1 | 3.39 | 1 | 1.38 |
| | 2 | 3.85 | 2 | 1.08 |
| | 3 | 4.01 | 3 | 1.81 |
| | AU2700/5400 | AU640/640e | | |
| | Sample | Total CV% | Sample | Total CV% |
| | 1 | 1.50 | 1 | 1.8 |
| | 2 | 1.91 | 2 | 1.3 |
| | 3 | 1.83 | | |
| | | | AU2700/5400 | |
| | | | Sample | Total CV% |
| | | | 1 | 2.64 |
| | | | 2 | 2.05 |
| | | | 3 | 3.29 |

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| Assay Range | 10 to 700 mg/dL | 10 to 700 mg/dL |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| LoQ | 10 mg/dL | Not specified |
| Method Comparison<br>(Linear Regression) | Intercept 15.1 mg/dL<br>Slope 0.923<br>R2 0.999<br>N 111<br>Range 38-672 mg/dL | Intercept 1.3 mg/dL<br>Slope 0.957<br>R2 0.99<br>N 94<br>Range 54-660 mg/dL |
| Interfering Substances | AU400/400e<br>Bilirubin: Interference less than 2% up to<br>40 mg/dL Bilirubin<br>Hemolysate: Interference less than 1% up<br>to 500 mg/dL Hemolysate<br>Lipemia: Interference less than 10% up to<br>1000 mg/dL Intralipid<br>RF: Interferences less than 8% up to 600<br>IU/mL<br>Not tested | AU400/400e<br>Bilirubin: Interference less than 2% up to<br>40 mg/dL Bilirubin<br>Hemolysate: Interference less than 2%<br>up to 500 mg/dL Hemolysate<br>Lipemia: Interference less than 10% up<br>to 600 mg/dL Intralipid<br>Not Specified<br>Ascorbic Acid: Interferences less than<br>2% up to 20 mg/dL Ascorbate |
| | AU600/640/640e<br>Bilirubin: Interference less than 3% up to<br>40 mg/dL Bilirubin<br>Hemolysate: Interference less than 5% up<br>to 500 mg/dL Hemolysate<br>Lipemia: Interference less than 6% up to<br>1000 mg/dL Intralipid<br>RF: Interferences less than 8% up to 600<br>IU/mL<br>Not tested | AU600/640/640e<br>Bilirubin: Interference less than 5% up to<br>40 mg/dL Bilirubin<br>Hemolysate: Interference less than 2%<br>up to 500 mg/dL Hemolysate<br>Lipemia: Interference less than 7% up to<br>1000 mg/dL Intralipid<br>Not Specified<br>Ascorbic Acid: Interferences less than<br>2% up to 20 mg/dL Ascorbate |
| | AU2700/5400<br>Bilirubin: Interference less than 3% up to<br>40 mg/dL Bilirubin<br>Hemolysate: Interference less than 4% up<br>to 500 mg/dL Hemolysate<br>Lipemia: Interference less than 4% up to<br>1000 mg/dL Intralipid<br>RF: Interferences less than 4% up to 600<br>IU/mL<br>Not tested | AU2700/5400<br>Bilirubin: Interference less than 5% up to<br>40 mg/dL Bilirubin<br>Hemolysate: Interference less than 3%<br>up to 500 mg/dL Hemolysate<br>Lipemia: Interference less than 10% up<br>to 1000 mg/dL Intralipid<br>Not Specified<br>Ascorbic Acid: Interferences less than<br>3% up to 20 mg/dL Ascorbate |
| Prozone Capacity | No high dose effect at IgA concentrations<br>up to 10, 000 mg/dL | No high dose effect at IgA<br>concentrations up to 3,200 mg/dL |

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized graphic of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the graphic.

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: k073489

Trade/Device Name: Olympus IgA 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

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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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Robert H. Baker

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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## Indication for Use

510(k) Number (if known): K073489

Device Name: The Olympus IgA reagent (OSR6X171).

Indication For Use: System reagent for the quantitative determination of IgA immunoglobulins in human serum and plasma on OLYMPUS analyzers.

The spectrum of abnormalities in serum immunoglobulin concentrations is broad. Abnormal concentrations range from a virtual absence of one or more of the three major classes of immunoglobulin (IgG, IgA, and IgM) to polyclonal increases in one or more immunoglobulins. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

For in vitro diagnostic use.

V 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)

Maria M Chan

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K073489