| 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 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.
01
Injectable
T-LAB PRP Kit is not a Blood Storage Tube or Blood Separation kit unlike the many other products. The requirements of CE Class IIb has been acquired.
02
Does not include Ficoll and not an IVD Tube
Unfortunately, some IVD tubes are marketed as PRP products. IVD tubes’ intended use are diagnoses outside the human body.
03
CE Class IIb Certificate
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.
04
Not a Tube, a PRP Kit.
There are various products in the market sold as PRP tubes. Many of them are not certified to be used on PRP procedures, also some of the tubes have certificate as “Blood Storage Tube” or “Blood Separation Kit”. But, T-LAB PRP Kit is equipped with every necessary equipments to be used on PRP Procedures.
05
Includes Anticoagulant
Blood Storage Tubes and Blood Separation Kits do not include any anticoagulant. So, instructions lead the user to collect anticoagulant from outer sources that eliminates the standardisation of anticoagulant quality and possibility of choosing the wrong anticoagulant. T-LAB PRP Kit does not let the user to change the anticoagulant and minimise the risk of misusage of anticoagulant.
06
Re-suspension mechanism
Due to strong centrifugal force, the clump formation of the platelets can occur. Re-suspension of the platelets helps to homogenise the platelets in the plasma milieu.
07
Cell-Cell Interaction
Cell-Cell interaction determines that the platelets’ role to become pro aggregator and interact with the other cells around the micro-enviroment. Publications have shown that the PRP+RBC in collagen-induced activation leads ADP and ATP synthesis fivefold-sevenfold in comparison to PRP alone.
08
No Gel in the PRP Tubes
Some kits have gel in the tubes. As we know RBCs are bigger in size than platelets and during centrifugation movement of the cells, RBCs collect many Platelets under the gel. 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.