510(k) Report

FDA applicant

Progenika Biopharma S.A., A Grifols Company

Derio, ES4 decisions2017–20220 recalls

FDA records 4 decisions for Progenika Biopharma S.A., A Grifols Company (Derio, ES) from 2017 to 2022: 4 510(k) clearances. Most are in product codes PZH (Serpina1 Variant Detection System) and PTA (Genetic Variant Detection And Health Risk…). Its devices cite 4 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, immunology panel, where it files most

How often FDA has decided Progenika Biopharma S.A., A Grifols Company’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2017: 12019: 12021: 12022: 1
2017high 1 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Progenika Biopharma S.A., A Grifols Company by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • PZHSerpina1 Variant Detection System3decisions
  • PTAGenetic Variant Detection And Health Risk Assessment System1decision

Whose devices does it build on?

Its devices cite 4 predicates; 2 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K192858A1AT Genotyping TestProgenika Biopharma S.A., A Grifols Company · 20191cites it
  • K171868A1AT Genotyping TestProgenika Biopharma S.A., A Grifols Company · 20171cites it

What has FDA decided for it lately?

  • K221420AlphaID™ At Home Genetic Health Risk ServiceProgenika Biopharma S.A., A Grifols Company · 2022
  • K211115A1AT Genotyping TestProgenika Biopharma S.A., A Grifols Company · 2021
  • K192858A1AT Genotyping TestProgenika Biopharma S.A., A Grifols Company · 2019
  • K171868A1AT Genotyping TestProgenika Biopharma S.A., A Grifols Company · 2017

All 4 as Progenika Biopharma S.A., A Grifols Company →