(115 days)
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.
In this Olympus procedure, the decrease in light intensity transmitted (increase in absorbance) through particles suspended in solution is as a result of complexes formed during the immunological reaction between the D-Dimer of the patient serum and the anti-human D-Dimer antibodies coated on the latex particles
The Olympus D-Dimer Test System, consisting of the Olympus D-Dimer Reagent, Calibrator, and Control, is intended for the quantitative determination of D-Dimer in human plasma on Olympus analyzers. It is designed to aid in detecting the presence and degree of intravascular coagulation and fibrinolysis and in monitoring therapy for disseminated intravascular coagulation.
Here's an analysis of the provided information regarding its acceptance criteria and supporting studies:
1. Acceptance Criteria and Reported Device Performance
The provided 510(k) summary compares the Olympus D-Dimer Test System with the predicate device, Roche Tina-Quant® D-Dimer Test System. The acceptance criteria are implicitly defined by demonstrating substantial equivalence to the predicate, with specific performance characteristics indicating acceptable levels.
| Performance Characteristic | Acceptance Criteria (Implied by Predicate) | Reported Olympus D-Dimer Test System Performance |
|---|---|---|
| Precision (Total CV%) | Sample 1: 6.5% | AU400/400e: 9.44%AU600/640/640e: 9.14%AU2700/5400: 8.17% |
| Sample 2: 8.3% | AU400/400e: 7.99%AU600/640/640e: 7.95%AU2700/5400: 4.44% | |
| Sample 3: 3.2% | AU400/400e: 2.48%AU600/640/640e: 3.02%AU2700/5400: 2.52% | |
| Assay Range | 0.15 - 9.0 µg FEU/mL | 0.15 - 8.00 µg FEU/mL |
| Analytical Sensitivity | 0.04 µg FEU/mL | 0.08 µg FEU/mL |
| Method Comparison | Intercept: 0.06Slope: 0.87R2: 0.755Range: 0.08-4.55 µg FEU/mL | Intercept: 0.079Slope: 1.010R2: 0.996Range: 0.28-7.53 µg FEU/mL |
| Interfering Substances | Within ±10% variation:- Bilirubin up to 20 mg/dL- Hemolysis up to 500 mg/dL Hemoglobin- Rheumatoid Factor < 100 IU/mL- Heparin < 1.5 IU/mL- Lipemia up to 1500 mg/dL Triglyceride | Interference less than 10%:- Bilirubin: up to 40 mg/dL- Hemolysis: up to 500 mg/dL Hemolysate- Rheumatoid Factor: up to 100 IU/mL- Heparin: up to 1.5 IU/mL- Lipemia: up to 1000 mg/dL Intralipid (AU400/400e & 600/640/640e)- Lipemia: up to 700 mg/dL Intralipid (AU2700/5400) |
| Reagent On Board Stability | 28 Days | 30 days |
| Calibrator Open Vial Stability | 1 day @ 15 -25°C | 1 day @ 15 - 25°C28 days @ 2 - 8°C30 days @ -20°C |
| Control Open Vial Stability | 1 day @ 15 - 25°C14 days @ 2 - 8°C | 1 day @ 15 - 25°C28 days @ 2 - 8°C30 days @ -20°C |
| Calibration Stability | Not Specified | 30 days |
2. Sample Size and Data Provenance for Test Set
The document does not explicitly state the sample size for the test set used in performance evaluations (e.g., precision, method comparison, interfering substances). It refers generically to "samples" for precision and provides a "Range" for method comparison without indicating the number of individual patient samples.
The data provenance (country of origin, retrospective/prospective) is not specified.
3. Number and Qualifications of Experts for Ground Truth
Not applicable. This device is an in vitro diagnostic (IVD) for quantitative measurement, and its performance is assessed against established analytical methods and reference standards, not against expert human interpretation of images or other diagnostic findings.
4. Adjudication Method for Test Set
Not applicable. Clinical test performance is determined by a quantitative measurement against a comparative method.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
Not applicable. This is an in vitro diagnostic device for quantitative chemical analysis, not a medical imaging or diagnostic aid that involves human reader interpretation.
6. Standalone (Algorithm Only) Performance
Yes, the performance characteristics (Precision, Assay Range, Analytical Sensitivity, Method Comparison, Interfering Substances, Stability) represent the standalone performance of the Olympus D-Dimer Test System, as measured on Olympus analyzers, without human intervention in the result generation beyond operating the instrument.
7. Type of Ground Truth Used
The ground truth for evaluating the Olympus D-Dimer Test System implicitly relies on:
- A commercially available assay (predicate device, Roche Tina-Quant® D-Dimer) for method comparison. This assay itself would have been validated against a traceable standard.
- In-house Master Calibrator: The Olympus D-Dimer Test System is traceable to an in-house Master Calibrator.
- Defined concentrations/levels: For precision studies, specific "samples" (likely control materials or spiked plasma) are used with known D-Dimer concentrations. For interfering substances, known concentrations of bilirubin, hemoglobin, rheumatoid factor, heparin, and lipids are added to samples.
8. Sample Size for the Training Set
Not applicable. This is an analytical immunoassay, not a machine learning model that requires a "training set" in the conventional sense of AI/ML algorithms. The development and optimization of the reagent and assay would involve various experimental and testing phases, but these are not referred to as training sets.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of an AI/ML algorithm. The calibration of the device is performed using a 6-point calibration curve, which is described as being traceable to an in-house Master Calibrator and aligned with another commercially available test system. This establishes the analytical accuracy of the measurements.
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510(k) Summary
UN 1 2007
The assigned 510(k) number is: _ K070453 S
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 andMaterial ScienceEuropa GmbHLismeehan,O'Callaghan's MillsCo. Clare, Ireland | |
|---|---|---|
| U.S. Telephone:U.S. Fax:Telephone: | 469-230-0959972-317-7861011-353-65-683-1100 | |
| Contact Person: | Stephanie G. Schwartz | |
| Date Prepared: | April 25, 2007 | |
| 2. Device name | Proprietary Name: | Olympus D-Dimer Reagent (OSR6x135)Olympus D-Dimer Calibrator (ODR3033)Olympus D-Dimer Control (ODC0029) |
| Common Name: | D-Dimer Reagent, Calibrator and Control | |
| Classification Name: | Fibrinogen/fibrin degradation productsassay | |
| 3. Predicate device | Reagent:CalibratorControl | Roche Tina-Quant® D-DimerRoche D-Dimer CalibratorRoche D-Dimer Control I/II |
| Submitted (K030740 & K002706) | ||
| 4. Device description | In this Olympus procedure, the decrease in light intensitytransmitted (increase in absorbance) through particles suspendedin solution is as a result of complexes formed during theimmunological reaction between the D-Dimer of the patient serumand the anti-human D-Dimer antibodies coated on the latexparticles | |
| 5. Intended use | System reagent for the quantitative determination of D-Dimer inhuman plasma on Olympus analyzers | |
| The Olympus D-Dimer Calibrator is designed to provide suitablecalibration levels for Olympus analyzers employing the immuno-turbidimetric assays for D-Dimer determinations | ||
| The Olympus D-Dimer Control is a lyophilized human control.These assayed controls are designed to monitor the accuracy andprecision of the quantitative Olympus D-Dimer reagents. |
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510(k) Summary
The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________
| P | |
|---|---|
| ) | |
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.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 | LiquidOn-board storage | Same |
| Reagent Handling | R1 Ready for useR2: Mix before placing on instrument and at weekly intervals thereafter | Same |
| Calibrator and ControlConstituents | Single | Same |
| Calibrator and ControlMaterial | Human Origin | Same |
| Calibrator Storage form | Calibrator 1 : Liquid ready to useCalibrator 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, 600/640/640eand 2700/5400 | Roche/Hitachi analyzers.Calibrator and control can also be usedwith Roche Cobas Integra analyzers. |
| Intended Use | System reagent for the quantitativedetermination of D-Dimer in humanplasma on OLYMPUS analyzers | Immunoturbidimetric assay for the invitro quantitative determination of fibrindegradation products including D-Dimer and X-oligomers in humanplasma on Roche automated clinicalchemistry analyzers. |
| Traceability/Standardization | Traceable to an in-house MasterCalibrator and aligned with anothercommercially available test system | The Roche Tina-Quant® D-Dimermethod was calibrated against theAsserachrom D-Dimer method |
| Reagent On Board Stability | 30 days on board | 28 Days on board |
| Calibrator Open VialStability | • 1 day @ 15 - 25°C• 28 days @ 2 - 8°C• 30 days @ -20°C | 1 day @ 15 -25°C |
| Control Open vial Stability | • 1 day @ 15 - 25°C• 28 days @ 2 - 8°C• 30 days @ -20°C | • 1 day @ 15 - 25°C• 14 days @ 2 - 8°C |
| Calibration Stability | 30 days | Not Specified |
| Performance Characteristics | ||
| Item | Olympus D-Dimer Test System | Predicate System |
| Precision | AU400/400eSample Total CV%1 9.442 7.993 2.48AU600/640/640eSample Total CV%1 9.142 7.953 3.02AU2700/5400Sample Total CV%1 8.172 4.443 2.52 | Sample Total CV%1 6.52 8.33 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 (LinearRegression) | Intercept 0.079Slope 1.010R2 0.996Range 0.28-7.53 µg FEU/mL | Intercept 0.06Slope 0.87R2 0.755Range 0.08-4.55 µg FEU/mL |
| Interfering Substances | AU400/400e, 600/640/640e &2700/5400Interference less than 10%• Bilirubin: up to 40 mg/dL Bilirubin• Hemolysis: up to 500 mg/dL Hemolysate• Rheumatoid Factor: up to 100IU/mL• Heparin: up to 1.5 IU/mLAU400/400e & 600/640/640eInterference less than 10%• Lipemia: up to 1000 mg/dL Intralipid2700/5400Interference less than 10%• Lipemia: up to 700 mg/dL Intralipid | Roche Analyzerswithin ± 10% of initial value• Bilirubin up to 20 mg/dL Bilirubin• Hemolysis: up to 500 mg/dL Hemoglobin• Rheumatoid Factor: < 100 IU/mL• Heparin: < 1.5 IU/mL• Lipemia: up to 1500 mg/dLTriglyceride 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 (240) 276-0450. 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 (240) 276-3150, 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
Page of
510(k) K070453
§ 864.7320 Fibrinogen/fibrin degradation products assay.
(a)
Identification. A fibrinogen/fibrin degradation products assay is a device used to detect and measure fibrinogen degradation products and fibrin degradation products (protein fragments produced by the enzymatic action of plasmin on fibrinogen and fibrin) as an aid in detecting the presence and degree of intravascular coagulation and fibrinolysis (the dissolution of the fibrin in a blood clot) and in monitoring therapy for disseminated intravascular coagulation (nonlocalized clotting in the blood vessels).(b)
Classification. Class II (performance standards).