What to ask about claims for a machine that prepares your blood

What to ask about the blood mixture

Ask how many platelets and white blood cells the finished mixture holds. White blood cells help your body fight germs. For joints, research often uses mixtures with fewer white cells. Tendon research often uses more. No direct study has proved one amount is better for every person.

The centrifuge is the machine that spins your blood into layers. It works like a washer spin cycle separating water from clothes. After the spin, the clinician keeps the blood layer chosen for your care.

More platelets or more white cells isn't always better. The clinic needs to explain why its mixture fits your sore area.

What to ask during the clinic visit

At the visit, name the hurting body part and what your doctor called the problem. Explain the first day you noticed the ache and the tasks that became hard. Then show your medicines and earlier X-ray report.

PRP may be offered at QC Kinetix as a regenerative treatment, meaning its material comes from you. Have the clinician name the blood mixture planned for the sore tissue. Learn which activities are safe later and whom to call with trouble.

Before deciding, get the sore tissue, blood mixture, and follow-up steps in common words.

What to do when the answer stays vague

Clearance means a government agency has checked whether a machine may be sold for its stated use. That agency keeps a public entry about the decision. The entry covers the machine and its stated use. It isn't evidence that PRP will ease your soreness.

Ask the clinic to show the government entry behind its claim. Then ask for a common-word account of what the entry says. Research about one body part may not fit a different body part.

An official-sounding claim shouldn't hurry you. Pause when the clinic can't explain the machine, blood mixture, and reason for using both.

Sources

1. The devices used to spin PRP at the point of care are cleared by FDA as clinical centrifuges, product code JQC, a Class I device under 21 CFR 862.2050 - for example the Biomet GPS Platelet Separation Kit (K030555, cleared 2003) and the Harvest SmartPrep2 / SmartPrep Platelet Concentration System (K103340, cleared 2010). That clearance covers the equipment that separates blood. It is not an FDA approval of platelet-rich plasma as a treatment for osteoarthritis, tendinopathy or any other orthopedic condition, and copy must never blur the two.

   U.S. Food and Drug Administration (Center for Devices and Radiological Health) — 510(k) Premarket Notification database and Product Classification: JQC, Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use, 21 CFR 862.2050. FDA accessdata (CDRH device databases), 2003.

2. FDA states verbatim of stem cell, stromal vascular fraction, umbilical cord blood, Wharton's jelly, amniotic fluid and exosome products: 'None of these products have been approved for the treatment of any orthopedic condition, such as osteoarthritis, tendonitis, disc disease, tennis elbow, back pain, hip pain, knee pain, neck pain, or shoulder pain.' The only FDA-approved stem cell products in the United States are blood-forming cells from umbilical cord blood, approved only for disorders of blood production, and there are no FDA-approved exosome products. PRP is a different product from all of these and the categories must not be blurred in either direction.

   U.S. Food and Drug Administration — Consumer Alert on Regenerative Medicine Products Including Stem Cells and Exosomes. FDA (Center for Biologics Evaluation and Research), 2020.

3. The Cochrane review of STEM CELL injections for knee osteoarthritis concluded that on low-certainty evidence they may slightly improve pain and function, with uncertainty about effects on quality of life, treatment success and structural progression, and uncertainty about safety. This matters on a PRP site because 'stem cell therapy' is routinely used as a marketing label for PRP; they are different products with different evidence and PRP must never be described as a stem cell treatment.

   Whittle SL, Johnston RV, McDonald S, et al. — Stem cell injections for osteoarthritis of the knee. Cochrane Database of Systematic Reviews, 2025. DOI: 10.1002/14651858.CD013342.pub2.

4. A technical and biological review screened 1379 studies and identified 50 commercial PRP preparation systems in three technical categories (tubes, syringes, bags). Sufficient biological characterisation was available for only 14 of those 50 systems. Comparing the 36 characterised preparations across the seven existing PRP classifications revealed 'a large heterogeneity among the available current PRP commercial systems' and showed the classifications themselves differ in how well they discriminate between preparations.

   Magalon J, Brandin T, Francois P, et al. — Technical and biological review of authorized medical devices for platelets-rich plasma preparation in the field of regenerative medicine. Platelets, 2021. DOI: 10.1080/09537104.2020.1832653.