We import and characterise a research-use-only blood-collection device — measuring it against an approved reference method, sample by sample, until the dataset is complete enough to stand on its own. This track produces validation evidence and a CE-readiness file. It does not produce results for anyone's chart.
RUO collection-device validation only. Not a CE-marked clinical blood-test device, not a home test kit, and never the source of a clinical report. Clinical reports come solely from approved clinic and lab routes via LabBridge.
Starter proves the method, Pro powers a parallel comparison study, and the CE-readiness programme assembles the regulatory file. Each is sold by Peppies Device R&D SIA and ships RUO devices with validation templates — no peptides, no blood panels.
Validation is arithmetic before it is evidence. Every plan resolves to a real device count, every draw runs beside an approved method, and every rejection is recorded. The output is a quality file — not a verdict.
You commit to a number of validation events and the samples drawn at each. Fifty devices is a method check; two hundred and fifty runs a powered study. The device count is the product of the two — agreed up front, not estimated later.
Each RUO draw runs in parallel with an approved reference collection. We measure agreement, bias and limits against the method that already holds — never the device judged against itself.
Time-to-analysis, temperature and handling are logged for every sample. Stability windows are measured, not assumed, so the dataset reflects how the device behaves outside a perfect bench.
Hemolysis, underfill, clotting, mislabelling — rejections are counted and categorised, never quietly dropped. The failure rate is part of the result and travels with the data.
Protocols, raw data, comparison statistics and rejection logs assemble into a single quality file — the evidence a notified body, lab partner or CE route expects. We build the file; certification stays with the bodies that grant it.
A completed dataset is a starting position for a CE route — it is not certification, not a clearance, and not permission to report patient results. The device stays validation-only unless a CE route or an accepting clinic/lab adopts a valid route.
The boundaries below are load-bearing. They are the reason this track can exist alongside research supply and clinical reporting without blurring into either.
Need clinical blood reports? Those are generated only from an approved clinic or lab collection route — never from this device.