(225 days)
No
The device description details a standard immunoturbidimetric assay based on antigen/antibody reactions and turbidity measurements, with no mention of AI or ML components.
No
This device is an in vitro diagnostic (IVD) device used for the quantitative determination of fibrin degradation products, specifically D-Dimer and X-oligomers, to aid in the exclusion of deep vein thrombosis (DVT) and pulmonary embolism (PE). It does not directly treat or alleviate a medical condition.
Yes
The device "Tina-Quant® D-Dimer test system" is intended for the quantitative determination of fibrin degradation products, specifically to exclude deep vein thrombosis (DVT) and pulmonary embolism (PE) in conjunction with clinical probability assessment. This directly indicates its use in diagnosing or ruling out medical conditions.
No
The device description clearly outlines a laboratory-based immunoturbidimetric assay involving physical reagents (latex particles, antibodies) and a turbidimetric measurement, indicating it is a hardware-based in vitro diagnostic device, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states "For the in vitro quantitative determination of fibrin degradation products including D-Dimer and X-oligomers." The term "in vitro" is a key indicator of an IVD, meaning the test is performed outside of the living body, typically on biological samples.
- Device Description: The description details an "immunoturbidimetric assay" that uses "Latex particles...coated with monoclonal antibodies" to measure substances in "samples containing D-dimer." This describes a laboratory test performed on a biological sample.
- Clinical Performance Studies: The performance studies describe testing on "outpatients with suspected DVT" and "outpatients with suspected PE," using the device to analyze biological samples (implied to be blood or plasma, as D-dimer is measured in these).
- Predicate Devices: The listed predicate devices (K030740 Tina-quant® D-Dimer Test System and K040822 Biomerieux Vidas ® D-Dimer Exclusion Assay) are also IVD devices used for D-dimer testing.
All of these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
For Roche/Hitachi Immunoturbidimetric assay for the in vitro quantitative determination of fibrin degradation products including D-Dimer and X-oligomers. In conjunction with a non-high clinical probability assessment, a normal (3) or non-high (
§ 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
11
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Ka2203
| Introduction | According to the requirements of 21 CFR 807.92, the following information
provides sufficient detail to understand the basis for a determination of
substantial equivalence. |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter
name, address,
contact | Roche Diagnostics Corporation
9115 Hague Road
Indianapolis, IN 46250
(317) 521 - 3723
Contact Person: Theresa Ambrose Bush
Date Prepared: Nov 3, 2006 |
| Device Name | Proprietary name: Tina-Quant D-Dimer Test System on Roche Hitachi and
COBAS Integra Analyzers
Common name: D-Dimer Test System
Classification name: Fibrinogen/Fibrin Degradation Products Assay |
| Description | The Tina-Quant® D-Dimer test system is an immunoturbidimetric assay for
the in vitro quantitative determination of fibrin degradation products
including D-Dimer and X-oligomers. Latex particles of uniform size are
coated with monoclonal antibodies (F(ab')2 fragments) to the D-Dimer
epitope. The antigen/antibody complexes produced by the addition of
samples containing D-dimer lead to an increase in the turbidity of the test
reactants, which can be determined turbidimetrically. The calibrator is D-
Dimer calibrator and the recommended control material is D-dimer Control
I/II. |
| Intended use | for the in vitro quantitative determination of fibrin degradation products
including D-Dimer and X-oligomers. In conjunction with a non-high clinical
probability assessment, a normal (3) or non-high (