|IVD – In Vitro Diagnostic||MDD – Medical Device Directive|
|EU Directive 98/79/EC||Directive 93/42/EEC|
|List A ve B devices off list.||Class I, Is, Im, IIa, IIb , III|
|Special symbol IVD required.||Special symbol required CE (CE 2195).|
|Not allowed clinical use.||Approved for clinical use.|
|No test required biocompatibility.||Complete required biocompatibility. (ISO 10993)|
|No clinical assessment.||Clinical evaluation required. (MEDDEV 2.7.1)|
As it is expressed on the table that the IVD Tubes do not require any clinical evaluation process and they are not tested in the frame of biocompatibility. For this reason, IVD tubes are prohibited from clinical applications. T-LAB PRP Kit is CE marked of Class IIb according to European Commission’s MEDDEV 93/42/EEC, Classification Document Annex IX with the Rule 3 that requires clinical evaluation and biocompatibility tests that leads the permission of clinical applications.
T-LAB PRP Kit is not a Blood Storage Tube or Blood Seperation kit unlike the many other products. The requirements of CE Class IIb has been acquired.
Unfortunately, some IVD tubes are marketed as PRP products. IVD tubes’ intended use are diagnoses outside the human body. The section of the catalogues of these tubes express that “do not inject to humans” .
According to 93/42/EEC directive Annex IX and MEDDEV guidance document Classification of the Medical Devices MEDDEV 2.4/1 Rev 9, June 2010, expresses on Rule 3: Non-Invasive devices that modify biological or chemical composition of blood, body-liquids or other liquids intended for infusion into the body are in Class IIb.
T-LAB PRP Kit has Class IIb medical device certificate.
There are various products in the market sold as PRP tubes or collection of products along with PRP Tubes. As many of them are not certified to be used on PRP procedures, also some of tubes have certificate as “Blood Storage Tube” or “Blood Seperation Kit”. But, T-LAB PRP Kit is equipped with every necessary equipments to be used on PRP Procedures.
Blood Storage Tubes and Blood Seperation Kits do not include any anticoagulant. So, instructions lead the user to collect anticoagulant from outer sources that eliminates the standardization of anticoagulant quality and the possibility of choosing the wrong anticoagulant. T-LAB PRP Kit does not let the user to change the anticoagulant or have the risk of misusage of anticoagulant.
Due to strong centrifugal force, the clump formation of the platelets can occur. Re-suspension of the platelets helps to homogenize the platelets in the plasma milieu.
Cell-Cell interaction determines that the platelets’ role to become proaggregator and interact with the other cells around the microenviroment. Publications have shown that the PRP+RBC in collagen-induced activation leads ADP and ATP synthesis fivefold-sevenfold in comparison to PRP alone
Some kits have gel in the tubes. During centrifugation, gel keeps RBCs under the gel. But RBCs are bigger molecular structures than platelets and during the centrifugational movement of the cells, RBCs collect many Platelets under the gel along with RBCs. Also, it is a risk that the gel may be allergen. In some cases, there may be some risks to collect the gel inside the tubes and re-inject to patients. Due to those risks, T-LAB PRP Tubes do not include gel.