(115 days)
Roche Tina-Quant® D-Dimer, Roche D-Dimer Calibrator, Roche D-Dimer Control I/II
No
The device description details a standard immunological reaction and photometric measurement, with no mention of AI/ML algorithms for analysis or interpretation.
No
The device is intended for diagnostic purposes (detection and monitoring of a condition), not for treating or preventing a disease.
Yes
This device aids in detecting the presence and degree of intravascular coagulation and fibrinolysis, which is a diagnostic function, and is used on human plasma to determine D-Dimer levels to provide information about a patient's health status.
No
The device description clearly indicates it is a system reagent used with an analyzer, describing a chemical reaction involving latex particles and antibodies, which are physical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "System reagent for the quantitative determination of D-Dimer in human plasma". This indicates the device is used to test a sample taken from the human body (plasma) in vitro (outside the body) to obtain diagnostic information (quantitative determination of D-Dimer).
- Device Description: The description details an "immunological reaction between the D-Dimer of the patient serum and the anti-human D-Dimer antibodies coated on the latex particles". This describes a laboratory test performed on a biological sample.
- Aid in Diagnosis/Monitoring: The intended use also mentions aiding in "detecting the presence and degree of intravascular coagulation and fibrinolysis, and in monitoring therapy for disseminated intravascular coagulation." This clearly links the test results to diagnostic and monitoring purposes for medical conditions.
All these points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
GHH
Device Description
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Precision:
AU400/400e:
Sample 1: Total CV% 9.44
Sample 2: Total CV% 7.99
Sample 3: Total CV% 2.48
AU600/640/640e:
Sample 1: Total CV% 9.14
Sample 2: Total CV% 7.95
Sample 3: Total CV% 3.02
AU2700/5400:
Sample 1: Total CV% 8.17
Sample 2: Total CV% 4.44
Sample 3: Total CV% 2.52
Assay Range: 0.15 - 8.00 µg FEU/mL
Analytical Sensitivity: 0.08 µg FEU/mL
Method Comparison (Linear Regression):
Intercept 0.079
Slope 1.010
R2 0.996
Range 0.28-7.53 µg FEU/mL
Interfering Substances (Interference less than 10%):
AU400/400e, 600/640/640e & 2700/5400:
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/mL
AU400/400e & 600/640/640e:
Lipemia: up to 1000 mg/dL Intralipid
2700/5400:
Lipemia: up to 700 mg/dL Intralipid
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Roche Tina-Quant® D-Dimer, Roche D-Dimer Calibrator, Roche D-Dimer Control I/II
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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 and
Material Science
Europa GmbH
Lismeehan,
O'Callaghan's Mills
Co. Clare, Ireland | |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| | U.S. Telephone:
U.S. Fax:
Telephone: | 469-230-0959
972-317-7861
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)
Olympus D-Dimer Calibrator (ODR3033)
Olympus D-Dimer Control (ODC0029) |
| | Common Name: | D-Dimer Reagent, Calibrator and Control |
| | Classification Name: | Fibrinogen/fibrin degradation products
assay |
| 3. Predicate device | Reagent:
Calibrator
Control | Roche Tina-Quant® D-Dimer
Roche D-Dimer Calibrator
Roche D-Dimer Control I/II |
| | | Submitted (K030740 & K002706) |
| 4. Device description | 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 | |
| 5. Intended use | System reagent for the quantitative determination of D-Dimer in
human plasma on Olympus analyzers | |
| | The Olympus D-Dimer Calibrator is designed to provide suitable
calibration 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 and
precision of the quantitative Olympus D-Dimer reagents. | |
1
510(k) Summary
The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________
| P | |
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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.
| 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 | |
| On-board storage | Same | |
| Reagent Handling | R1 Ready for use | |
| R2: Mix before placing on instrument and at weekly intervals thereafter | Same | |
| Calibrator and Control | ||
| Constituents | Single | Same |
| Calibrator and Control | ||
| Material | Human Origin | Same |
| Calibrator Storage form | Calibrator 1 : Liquid ready to use | |
| Calibrator 2 : Lyophilized Powder | Same | |
| Calibration | 6 points | Same |
| Quality Controls | 2 Levels | Same |
| Control Storage Form | Lyophilized Powder | Same |
| Expected Values |