OLYMPUS IGM REAGENT

K073487 · Olympus America, Inc. · CFN · Feb 11, 2008 · Immunology

Device Facts

• Record ID: K073487
• Device Name: OLYMPUS IGM 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 IgM immunoglobulins in human serum and plasma on OLYMPUS analyzers. For in vitro diagnostic use.

Device Story

Quantitative immunoturbidimetric assay for IgM measurement; utilizes R1 buffer (Tris, PEG 6000) and R2 (goat anti-IgM antiserum). Sample mixed with reagents; human IgM reacts with anti-IgM antibodies to form insoluble aggregates. Analyzer measures decrease in transmitted light intensity (absorbance increase) proportional to aggregate concentration. Used in clinical laboratories on Olympus AU400/400e, 600/640/640e, and 2700/5400 analyzers. Output is IgM concentration (mg/dL). Results aid clinicians in assessing protein metabolism and immune function. Supports serum and plasma (Li heparin/EDTA) matrices.

Clinical Evidence

Bench testing only. Precision studies (n=80) showed total %CV 2.60–4.08%. Linearity confirmed 20–500 mg/dL. LoQ <10 mg/dL; LoD ≤2 mg/dL. Interference testing (bilirubin, lipids, hemoglobin) showed ≤10% interference. Method comparison with predicate (n=107-110) showed slopes 0.978–1.027 and r=0.999–1.000. Matrix comparison (n=45) confirmed equivalence between serum and plasma (Li heparin/EDTA) with r=1.000.

Technological Characteristics

Immunoturbidimetric assay; liquid reagents (Tris buffer, PEG 6000, goat anti-IgM antiserum); sodium azide preservative. Measuring range 20-500 mg/dL. Traceable to CRM 470. On-board stability 90 days. Analyzers: Olympus AU series.

Indications for Use

Indicated for the quantitative determination of IgM 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 IgM reagent (OSR6X46) (k950900)

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.
1990 and 21 CC (CCC

| The assigned 510(k) number is: | K073486 |
|--------------------------------|---------|
|--------------------------------|---------|

| 1. Submitter name, address, contact | Olympus America Inc.<br>3500 Corporate Parkway<br>Center Valley, PA 18034 |
|-------------------------------------|---------------------------------------------------------------------------|
| U.S. Telephone: | 469-230-0959 |
| U.S. Fax: | 972-317-7861 |
| Contact Person: | Stephanie G. Donnelly |
| Date Prepared: | December 11, 2007 |

FEB 11 2008

| 2. Device name | |
|-----------------------|-------------------------------------------------------|
| Proprietary Name: | Olympus IgM reagent (OSR6X173) |
| Common Name: | IgM reagent |
| Classification Name: | IgM (mu chain specific), antigen, antiserum, control. |
| 3. Predicate device | |
| Reagent: | Olympus (OSR6X46) IgM Reagent Submitted K950900 |
| 4. Device description | In this Olympus procedure: |

- When a sample is mixed with R1 buffer and R2 antiserum solution, human IgM reacts specifically with anti-human IgM antibodies to yield insoluble aggregates.
- Immune complexes formed in solution scatter light in proportion to their size, shape and concentration.
- Turbidimeters measure the reduction of incidence light due to reflection, absorption or scatter.
- 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.

| 5. Intended use | System reagent for the quantitative determination of IgM immunoglobulins in human serum and plasma on OLYMPUS analyzers.<br>For <i>in vitro</i> diagnostic use. |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|

{1}------------------------------------------------

The following Tables compare the new Olympus IgM (OSR6X173) reagent
with the predicate device outlined in point 3 above.

| Similarities | | |
|---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| Item | Olympus IgM (OSR6X173) reagent | Predicate System |
| Intended Use | System reagent for the quantitative<br>determination of IgM immunoglobulins<br>in human serum and plasma on<br>OLYMPUS analyzers. | System reagent for the quantitative<br>determination of IgM immunoglobulins<br>in human serum on OLYMPUS<br>analyzers. |
| Instrument | Olympus AU400/400°, 600/640/640°<br>and 2700/5400 | Same |
| Measurement | Quantitative | Same |
| Reagent handling | Ready for use | Same |
| Assay<br>Methodology/Operating<br>Principle | Immunoturbidimetric | Same |
| Antibody | Goat anti-IgM antiserum | Same |
| Reagent storage form | Liquid<br>On-board storage | Same |
| On-Board Stability | 90 days | Same |
| Calibrator | Olympus Serum Protein Mulit-<br>Calibrator (ODR3021) | Same |
| Calibrator Traceability | This method is traceable to the<br>International Reference Preparation<br>CRM470 (US designation RPPHS lot<br>91/06/19) | Same |
| Calibration Frequency | 90 days | Same |
| Expected Values | 45-281 mg/dL | Same |
| | Differences | |
| Item | Olympus IgM (OSR6X173) reagent | Predicate System |
| Specimen Type | Serum and plasma: Li-heparin and<br>EDTA plasma | Serum |

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

| Item | Performance Characteristics<br>Olympus IgM (OSR6X173) reagent | Predicate System |
|-----------|---------------------------------------------------------------|----------------------|
| Precision | AU400/400e<br>Sample | AU400/400e<br>Sample |
| | 1<br>2<br>3 | 1<br>2<br>3 |
| | Total CV% | Total CV% |
| | 4.03<br>2.95<br>2.60 | 1.74<br>1.18<br>1.49 |
| | AU600/640/640e<br>Sample | AU600<br>Sample |
| | 1<br>2<br>3 | 1<br>2<br>3 |
| | Total CV% | Total CV% |
| | 3.44<br>3.29<br>4.08 | 2.16<br>1.48<br>1.35 |
| | | AU640/640e<br>Sample |
| | | 1<br>2 |
| | | Total CV% |
| | | 1.5<br>1.3 |

రి.

.

{2}------------------------------------------------

| | AU2700/5400 | AU2700/5400 |
|---------------------------|-------------------------------------------------------------------|----------------------------------------------------------------------|
| | Sample<br>Total CV% | Sample<br>Total CV% |
| | 3.79<br>1 | 1<br>2.49 |
| | 2<br>3.31 | 2<br>2.57 |
| Assay Range | 3<br>3.52<br>20-500 mg/dL | 3<br>3.07 |
| | Hook effect may occur with highly elevated | Same<br>Hook effect may occur with highly elevated |
| Prozone | IgM samples > 10, 000 mg/dL polyclonal | IgM samples > 3, 500 mg/dL polyclonal |
| | Slope<br>1.006 | Slope<br>0.968 |
| Method Comparison (Linear | Intercept<br>2.8 | Intercept<br>0.6 |
| Regression) | R<br>1.000 | R<br>0.998 |
| | N<br>107 | ക്ക<br>Z |
| Interfering Substances | 22-468 mg/dL<br>Range<br>AU400/4006 | Range<br>24-497 mg/dL<br>AU400/4008 |
| | Bilirubin: Interference less than 4% up to | Bilirubin: Interference less than 2% up to 40 |
| | 40 mg/dL Bilirubin | mg/dL Bilirubin |
| | Hemolysis: Interference less than 4% up to | Hemolysis: Interference less than 2% up to |
| | 500 mg/dL Hemolysate | 500 mg/dL Hemolysate |
| | Lipemia: Interference less than 10% up to | Lipemia: Interference less than 10% up to |
| | 300 mg/dL Intralipid | 300 mg/dL Intralipid |
| | | |
| | Not Tested | Ascorbic Acid: Interference less than 2% up<br>to 20 mg/dL Ascorbate |
| | | |
| | AU600/640/640° | AU600/640/640 |
| | Bilirubin: Interference less than 3% up to | Bilirubin: Interference less than 5% up to 40 |
| | 40 mg/dL Bilirubin | mg/dL Bilirubin |
| | Hemolysis: Interference less than 3% up to | Hemolysis: Interference less than 10% up to |
| | 500 mg/dL Hemolysate<br>Lipemia: Interference less than 10% up to | 500 mg/dL Hemolysate |
| | 300 mg/dL Intralipid | Lipemia: Interference less than 10% up to<br>400 mg/dL Intralipid |
| | | |
| | Not Tested | Ascorbic Acid: Interference less than 1% up |
| | | to 20 mg/dL Ascorbate |
| | | |
| | AU2700/5400 | AU2700/5400 |
| | Bilirubin: Interference less than 8% up to<br>40 mg/dL Bilirubin | Bilirubin: Interference less than 10% up to |
| | Hemolysis: Interference less than 3% up to | 40 mg/dL Bilirubin<br>Hemolysis: Interference less than 5% up to |
| | 500 mg/dL Hemolysate | 500 mg/dL Hemolysate |
| | Lipemia: Interference less than 10% up to | Lipemia: İnterference less than 10% up to |
| | 200 mg/dL. Intralipid | 400 mg/dL Intralipid |
| | | |
| | Not Tested | Ascorbic Acid: Interference less than 3% up |
| Function Sensitivity | < 20 mg/dL on AU400/4008 | to 20 mg/dL Ascorbate |
| | AU600/640/640° & AU2700/5400 | Not Specified |
| | | |
| | | |
| | | |
| | | |
| | | |
| | 大有力大发安安安安安安安安女女女女女女女 | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure embracing a sphere. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the emblem.

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: k073487

Trade/Device Name: Olympus IgM 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

{4}------------------------------------------------

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 [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 Becker J

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}------------------------------------------------

## Indication for Use

510(k) Number (if known):

Device Name: Olympus IgM reagent (OSR6X173)

Indication For Use: System reagent for the quantitative determination of IgM 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 (IgA, IgG, 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.

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 (OVD)

m cland

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

510(k) K073487