(22 days)
Not Found
No
The description details a standard immunoturbidimetric assay based on antigen/antibody complex formation and turbidity measurement, with no mention of AI or ML algorithms for data analysis or interpretation.
No
The device is described as an "immunoturbidimetric assay for the in vitro quantitative determination of fibrin degradation products," which is a diagnostic test, not a therapeutic intervention.
Yes
The device is used for the "in vitro quantitative determination of fibrin degradation products including D-Dimer and X-oligomers in plasma," which provides information for diagnosing conditions related to blood clotting.
No
The device description clearly states it is an "immunoturbidimetric assay" and involves "latex particles" and "antigen/antibody complexes," indicating a physical, in vitro diagnostic test, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" explicitly states "Immunoturbidimetric assay for the in vitro quantitative determination of fibrin degradation products... in plasma." The phrase "in vitro" is the key indicator that this device is used to test samples taken from the body, rather than being used directly on or in the body.
- Device Description: The description details a laboratory assay that analyzes a biological sample (plasma) using chemical and immunological reactions to measure a specific substance (fibrin degradation products). This is characteristic of an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
Immunoturbidimetric assay for the in vitro quantitative determination of fibrin degradation products including D-Dimer and X-oligomers in plasma.
Product codes (comma separated list FDA assigned to the subject device)
GHH
Device Description
The Tina-quant® D-Dimer Test system is a particle enhanced immunoturbidimetric assay. Latex particles are coated with monoclonal antibodies to the D-Dimer epitope. The antigen/antibody complexes produced by the addition of samples containing D-Dimer lead to an increase in turbidity.
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)
Not Found
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.
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.
Not Found
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 - Tina-quant® D-Dimer Test System
APR 0 1 2003
| 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 Rd
Indianapolis IN 46250
(317) 521-3831 |
| | Contact person: Sherri L. Coenen |
| | Date prepared: March 7, 2003 |
| Device Name | Proprietary name: Tina-quant® D-Dimer Test System |
| | Common name: D-Dimer Test System |
| | Classification name: Fibrinogen/Fibrin Degradation Products Assay |
| Device
description | The Tina-quant® D-Dimer Test system is a particle enhanced
immunoturbidimetric assay. Latex particles are coated with monoclonal
antibodies to the D-Dimer epitope. The antigen/antibody complexes produced
by the addition of samples containing D-Dimer lead to an increase in
turbidity. |
| Intended use | Immunoturbidimetric assay for the in vitro quantitative determination of
fibrin degradation products including D-Dimer and X-oligomers in plasma. |
| Predicate
Device | We claim substantial equivalence to the currently marketed Tina-quant® D-
Dimer Test System. (K002706 and K011143). |
1
510(k) Summary - COBAS Integra Creatinine plus ver.2,
continued
The following table describes the similarities and differences between the Reagent Summary Tina-quant® D-Dimer Test System and the predicate device.
| Topic | Tina-quant® D-dimer
on Roche Hitachi
(K002706) | Tina-quant® D-dimer
on COBAS Integra
(K011143) | Tina-quant® D-dimer
(Modified Device) |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|
| Intended Use | Immunoturbidimetric
assay for the in vitro
quantitative
determination of fibrin
degradation products
including D-Dimer and
X-oligomers. | The cassette COBAS
Integra Tina-quant® D-
Dimer contains an in
vitro diagnostic reagent
system intended for use
on COBAS Integra
systems for the
quantitative
immunological
determination of fibrin
degradation products (D-
Dimer and X-oligomers)
in plasma | Same |
| Method | Particle enhanced
Immunoturbidimetric | Same | Same |
| Sample type | Citrated plasma | Same | Citrated plasma
Li-heparin plasma |
| Measuring
range | 0.15 - 9.0 µg FEU/ml | Same | Same |
| Expected
values |