PRP Kit Selection Guide for Clinics: What Should You Look For?
Author: Clinimate Medikal (corporate content)
· Updated:
PRP (platelet-rich plasma) is used in dermatology, orthopedics, hair transplantation and medical aesthetics. This article is not clinical guidance; it is a procurement guide to the information you should request from the manufacturer when buying a PRP kit.
What is in a PRP kit?
PRP is platelet-rich plasma obtained from the patient's own blood by centrifugation. A kit contains the blood collection tube, the anticoagulant and, in most products, a separator gel that separates platelets from red cells. For example, the tubes described in Regen Lab's FDA 510(k) summary are evacuated glass tubes containing a thixotropic separator gel with a sodium citrate anticoagulant above the gel; up to 10 mL of blood is collected per tube, and the centrifuge settings are given in the instructions for use.
How the literature classifies platelet concentrates
Platelet concentrates are divided into four families by leukocyte and fibrin content: P-PRP (pure PRP), L-PRP (leukocyte-rich PRP), P-PRF and L-PRF. The paper proposing this classification stresses that each preparation method yields a different product and that efficacy remains debated. The PAW classification used in orthopedics is based on platelet count, activation method and the presence of white cells; the same paper notes that preparation protocols vary widely between authors.
Which type to use for which application is a clinical decision. On the purchasing side, the task is to make sure the manufacturer's documents clearly state which product the kit produces.
Comparison table before requesting quotes
| Criterion | What to request from the manufacturer | Why it matters |
|---|---|---|
| Product type | The type of concentrate the kit produces (P-PRP or L-PRP) | Classification is based on leukocyte and fibrin content |
| Platelet concentration | Concentration and recovery data declared in the instructions for use (IFU) | Preparation protocols differ widely between products |
| Tube contents | Anticoagulant type and separator gel details | Determines separation after centrifugation and the handling steps |
| Blood volume | Blood collected per tube | Determines how many tubes each application needs |
| Centrifuge protocol | g-force (RCF) and time in the IFU | Shows compatibility with your existing centrifuge |
| Regulatory | CE marking, ISO 13485 certificate, ÜTS registration; FDA 510(k) for the US | Required documents for sale and inspection in Turkey |
Purchasing checklist
- Request the current instructions for use (IFU) and check that the centrifuge settings can be run on your device.
- Request the CE certificate, ISO 13485 certificate and ÜTS registration with the quote.
- Have the kit contents (tube, blood collection set, transfer syringe) itemized.
- Check the expiry date and the storage conditions on the packaging.
- Share your monthly application count; unit cost should be calculated per set.
FDA "clearance", not "approval"
In the US, PRP preparation systems can reach the market through a 510(k); Regen Lab's system above is one example. FDA does not "approve" a device this way: it finds the device substantially equivalent to a legally marketed device and "clears" it for sale. For sale in Turkey, the CE marking and ÜTS registration are what count; an FDA 510(k) can be considered additional information.
Cost analysis
When evaluating PRP kit cost, look not only at the unit price but at the total cost per application:
- Kit price
- Centrifuge investment (one-time)
- Application consumables
- Labor cost
Unit costs drop significantly with bulk purchases. An annual contract is advantageous for clinics performing 20+ applications per month.
At Clinimate, we supply CE-certified PRP kits, centrifuges and application supplies. Contact us for a package quote tailored to your clinic.
Frequently asked questions
How do you compare the platelet concentration of PRP kits?
Rather than a single general threshold, request the concentration and recovery data each kit declares in its instructions for use. The literature notes that preparation protocols vary widely between products.
What is the difference between L-PRP and P-PRP?
The classification is based on leukocyte content: L-PRP is leukocyte-rich, P-PRP is leukocyte-poor (pure) PRP. Which type to use for which application is a clinical decision; the manufacturer's documents should state which type the kit produces.
What does an FDA-approved PRP kit mean?
In the US, PRP systems can reach the market through a 510(k). FDA does not approve a device this way; it finds it substantially equivalent to a marketed device and clears it for sale. Sale in Turkey requires CE marking and ÜTS registration.
Sources
Technical details are based on the manufacturer documents and official sources below. For exact values for a given product, the product's instructions for use (IFU) and technical data sheet apply.
- Dohan Ehrenfest DM, Rasmusson L, Albrektsson T. Classification of platelet concentrates: from pure platelet-rich plasma (P-PRP) to leucocyte- and platelet-rich fibrin (L-PRF). Trends Biotechnol. 2009;27(3):158-67 — PubMed
- DeLong JM, Russell RP, Mazzocca AD. Platelet-rich plasma: the PAW classification system. Arthroscopy. 2012;28(7):998-1009 — PubMed
- 510(k) Summary: RegenBMC (RegenKit-THT-BMC) — RegenLab USA / FDA
- Premarket Notification 510(k) — U.S. Food and Drug Administration (FDA)
Related products and procurement
- PRP Kit
PRP kit supply, PRP tubes, centrifuge-compatible sets and application consumables for hair transplant centers, medical aesthetic clinics, dermatology clinics and orthopedic applications.
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