OLYMPUS D-DIMER REAGENT, MODEL OSR6X135, OLYMPUS D-DIMER CALIBRATOR, MODEL ODR3033, OLYMPUS D-DIMER CONTROL

K070453 · Olympus Life & Material Science Europa GmbH (Irish · GHH · Jun 11, 2007 · Hematology

Device Facts

• Record ID: K070453
• Device Name: OLYMPUS D-DIMER REAGENT, MODEL OSR6X135, OLYMPUS D-DIMER CALIBRATOR, MODEL ODR3033, OLYMPUS D-DIMER CONTROL
• Applicant: Olympus Life & Material Science Europa GmbH (Irish
• Product Code: GHH · Hematology
• Decision Date: Jun 11, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7320
• Device Class: Class 2

Intended Use

System reagent for the quantitative determination of D-Dimer in human plasma on OLYMPUS analyzers. Aid in detecting the presence and degree of intravascular coagulation and fibrinolysis, and in monitoring therapy for disseminated intravascular coagulation.

Device Story

Olympus D-Dimer test system consists of reagents, calibrators, and bi-level controls for use on automated clinical chemistry analyzers (AU400/400E, AU600/640/640E, AU2700, AU5400). Input: human plasma (citrate or lithium heparin). Principle: latex-enhanced immunoturbidimetric assay; monoclonal mouse anti-human D-dimer coated latex particles react with D-dimer fragments in sample; reaction forms aggregates causing decrease in transmitted light. Output: quantitative D-dimer concentration (µg FEU/mL). Used in clinical laboratory settings by trained technicians. Results assist clinicians in detecting intravascular coagulation/fibrinolysis and monitoring DIC therapy.

Clinical Evidence

Bench testing only. Precision assessed per CLSI EP5-A2 (n=80, CV <10%). Linearity established per CLSI EP6-P2 (0.15–8.00 µg FEU/mL). Analytical sensitivity (LOD) 0.15 µg FEU/mL. Interference testing showed no significant impact from bilirubin, hemolysis, lipemia, rheumatoid factor, or heparin. Method comparison with predicate (n=104, r=0.996). Matrix comparison (n=51) established conversion factor for heparinized samples. Reference range established using 151 healthy volunteers (0.01–0.5 µg FEU/mL).

Technological Characteristics

Latex-enhanced immunoturbidimetric assay. Reagents: monoclonal anti-human D-Dimer mouse antibodies on latex particles. Calibrators/Controls: human-origin, lyophilized or liquid. Analyzers: Olympus AU series (AU400/400e, 600/640/640e, 2700/5400). Energy source: optical (photometric absorbance). Connectivity: integrated with Olympus clinical chemistry analyzers. Storage: liquid/lyophilized.

Indications for Use

Indicated for quantitative determination of D-Dimer in human plasma to aid in detecting presence/degree of intravascular coagulation and fibrinolysis, and monitoring therapy for disseminated intravascular coagulation.

Predicate Devices

• Roche Tina-Quant® D-Dimer (K030740)
• Roche D-Dimer Calibrator (K002706)
• Roche D-Dimer Control I/II (K002706)

Submission Summary (Full Text)

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510(k) Summary

UN 1 2007

The assigned 510(k) number is: _ K070453 S

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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. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

| 1. Submitter name, address, contact | Olympus Life and<br>Material Science<br>Europa GmbH<br>Lismeehan,<br>O'Callaghan's Mills<br>Co. Clare, Ireland | |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| | U.S. Telephone:<br>U.S. Fax:<br>Telephone: | 469-230-0959<br>972-317-7861<br>011-353-65-683-1100 |
| | Contact Person: | Stephanie G. Schwartz |
| | Date Prepared: | April 25, 2007 |
| 2. Device name | Proprietary Name: | Olympus D-Dimer Reagent (OSR6x135)<br>Olympus D-Dimer Calibrator (ODR3033)<br>Olympus D-Dimer Control (ODC0029) |
| | Common Name: | D-Dimer Reagent, Calibrator and Control |
| | Classification Name: | Fibrinogen/fibrin degradation products<br>assay |
| 3. Predicate device | Reagent:<br>Calibrator<br>Control | Roche Tina-Quant® D-Dimer<br>Roche D-Dimer Calibrator<br>Roche D-Dimer Control I/II |
| | | Submitted (K030740 & K002706) |
| 4. Device description | In this Olympus procedure, the decrease in light intensity<br>transmitted (increase in absorbance) through particles suspended<br>in solution is as a result of complexes formed during the<br>immunological reaction between the D-Dimer of the patient serum<br>and the anti-human D-Dimer antibodies coated on the latex<br>particles | |
| 5. Intended use | System reagent for the quantitative determination of D-Dimer in<br>human plasma on Olympus analyzers | |
| | The Olympus D-Dimer Calibrator is designed to provide suitable<br>calibration levels for Olympus analyzers employing the immuno-<br>turbidimetric assays for D-Dimer determinations | |
| | The Olympus D-Dimer Control is a lyophilized human control.<br>These assayed controls are designed to monitor the accuracy and<br>precision of the quantitative Olympus D-Dimer reagents. | |

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#### 510(k) Summary

### The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________

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The following Tables compare the new Olympus D-Dimer Test
System with the Roche Tina-Quant® D-Dimer Test System.

| System with the Roche Tina-Quant ® D-Dimer Test System.<br>Similarities | | |
|------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Item | Olympus D-Dimer Test System | Predicate System |
| Intended Use | Reagent for the quantitative determination of D-Dimer in human plasma | Assay for quantitative determination of D-Dimer in human plasma |
| Traceability | Another Commercially available assay | Same |
| Measurement | Quantitative | Same |
| Specimen Type | Citrate and Lithium Heparin Plasma | Same |
| Assay Methodology | Latex enhanced Immunoturbidimetric | Same |
| Antibody | Monoclonal anti human D-Dimer mouse antibodies | Same |
| Solid Phase | Latex Particle | Same |
| Reagent storage form | Liquid<br>On-board storage | Same |
| Reagent Handling | R1 Ready for use<br>R2: Mix before placing on instrument and at weekly intervals thereafter | Same |
| Calibrator and Control<br>Constituents | Single | Same |
| Calibrator and Control<br>Material | Human Origin | Same |
| Calibrator Storage form | Calibrator 1 : Liquid ready to use<br>Calibrator 2 : Lyophilized Powder | Same |
| Calibration | 6 points | Same |
| Quality Controls | 2 Levels | Same |
| Control Storage Form | Lyophilized Powder | Same |
| Expected Values | < 0.5 µg FEU/mL | Same |
| Differences | | |
| Item | Olympus D-Dimer Test System | Predicate System |
| Instrument required | Olympus AU400/400e, 600/640/640e<br>and 2700/5400 | Roche/Hitachi analyzers.<br>Calibrator and control can also be used<br>with Roche Cobas Integra analyzers. |
| Intended Use | System reagent for the quantitative<br>determination of D-Dimer in human<br>plasma on OLYMPUS analyzers | Immunoturbidimetric assay for the in<br>vitro quantitative determination of fibrin<br>degradation products including D-<br>Dimer and X-oligomers in human<br>plasma on Roche automated clinical<br>chemistry analyzers. |
| Traceability/Standardization | Traceable to an in-house Master<br>Calibrator and aligned with another<br>commercially available test system | The Roche Tina-Quant® D-Dimer<br>method was calibrated against the<br>Asserachrom D-Dimer method |
| Reagent On Board Stability | 30 days on board | 28 Days on board |
| Calibrator Open Vial<br>Stability | • 1 day @ 15 - 25°C<br>• 28 days @ 2 - 8°C<br>• 30 days @ -20°C | 1 day @ 15 -25°C |
| Control Open vial Stability | • 1 day @ 15 - 25°C<br>• 28 days @ 2 - 8°C<br>• 30 days @ -20°C | • 1 day @ 15 - 25°C<br>• 14 days @ 2 - 8°C |
| Calibration Stability | 30 days | Not Specified |
| Performance Characteristics | | |
| Item | Olympus D-Dimer Test System | Predicate System |
| Precision | AU400/400e<br>Sample Total CV%<br>1 9.44<br>2 7.99<br>3 2.48<br><br>AU600/640/640e<br>Sample Total CV%<br>1 9.14<br>2 7.95<br>3 3.02<br><br>AU2700/5400<br>Sample Total CV%<br>1 8.17<br>2 4.44<br>3 2.52 | Sample Total CV%<br>1 6.5<br>2 8.3<br>3 3.2 |
| Assay Range | 0.15 - 8.00 µg FEU/mL | 0.15 - 9.0 µg FEU/mL |
| Analytical Sensitivity | 0.08 µg FEU/mL | 0.04 µg FEU/mL |
| Method Comparison (Linear<br>Regression) | Intercept 0.079<br>Slope 1.010<br>R2 0.996<br>Range 0.28-7.53 µg FEU/mL | Intercept 0.06<br>Slope 0.87<br>R2 0.755<br>Range 0.08-4.55 µg FEU/mL |
| Interfering Substances | AU400/400e, 600/640/640e &<br>2700/5400<br>Interference less than 10%<br><br>• Bilirubin: up to 40 mg/dL Bilirubin<br>• Hemolysis: up to 500 mg/dL Hemolysate<br><br>• Rheumatoid Factor: up to 100IU/mL<br>• Heparin: up to 1.5 IU/mL<br><br>AU400/400e & 600/640/640e<br>Interference less than 10%<br><br>• Lipemia: up to 1000 mg/dL Intralipid<br><br>2700/5400<br>Interference less than 10%<br><br>• Lipemia: up to 700 mg/dL Intralipid | Roche Analyzers<br>within ± 10% of initial value<br><br>• Bilirubin up to 20 mg/dL Bilirubin<br>• Hemolysis: up to 500 mg/dL Hemoglobin<br><br>• Rheumatoid Factor: < 100 IU/mL<br>• Heparin: < 1.5 IU/mL<br><br>• Lipemia: up to 1500 mg/dL<br>Triglyceride Concentration |

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### 510(k) Summary

## The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________

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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 features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle. The logo is black and white and appears to be a scanned image.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Stephanie Schwartz Olympus Life & Material Science Europa GMBH c/o Olympus America, Inc. 3131 West Royal Lane Irving, Texas 75063

JUN 1 1 2007

Re: k070453

Trade/Device Name: Olympus D-Dimer Reagent, Olympus D-Dimer Calibrator, Olympus D-Dimer Control Regulation Number: 21 CFR 864.7320 Regulation Name: Fibrinogen/fibrin degradation products assay Regulatory Class: Class II Product Code: GHH Dated: April 25, 2007 Received: April 30, 2007

Dear Ms. Schwartz:

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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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

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Page 2 - Stephanie Schwartz

CFR Part 807); labeling (21 CFR Parts 801 and 809); and 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 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" (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 [phone] or [phone], or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Robert L. Becker, Jr., MD, PhD

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

Enclosure

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# Indications for Use

510(k) Number (if known): K070453

Device Name:

Olympus D-Dimer Test System

Indications for Use:

System reagent for the quantitative determination of D-Dimer in human plasma on OLYMPUS analyzers.

Aid in detecting the presence and degree of intravascular coagulation and fibrinolysis, and in monitoring therapy for disseminated intravascular coagulation.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign Off
Josephine Bautista

Office of In Vitro Diagnostic Device Evaluation and Safety

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510(k) K070453