510(k) Report

FDA applicant

Biokit, S.A.

Barcelona, ES23 decisions2005–20258 recalls

FDA records 23 decisions for Biokit, S.A. (Barcelona, ES) from 2005 to 2025: 23 510(k) clearances. Most are in product codes JIT (Calibrator, Secondary) and CDZ (Radioimmunoassay, Testosterones And…). Its devices cite 23 predicates, 4 of them its own earlier devices. 8 recalls are linked to its devices.

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

FIG. A — Illustration, clinical chemistry panel, where it files most

How often FDA has decided Biokit, S.A.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2007: 42008: 32011: 12013: 22016: 12018: 22023: 22024: 22025: 1
2007high 4 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2021

2010: 12012: 12014: 22017: 12019: 22021: 1
2007high 2 (2014) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Biokit, S.A. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Biokit, S.A.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • JITCalibrator, Secondary2decisions
  • CDZRadioimmunoassay, Testosterones And Dihydrotestosterone2decisions
  • JZGSystem, Test, Beta-2-Microglobulin Immunological2decisions
  • LEHRadioimmunoassay, Vancomycin2decisions
  • DGCIge, Antigen, Antiserum, Control2decisions
  • MXJEnzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-12decisions

Also: MYF (2), MRG (1), LGS (1), DEM (1), KXT (1), DFC (1).

Whose devices does it build on?

Its devices cite 23 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 9 times; 4 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K110619Architect 25-OH Vitamin D 100T, Vitamin D 500T, Vitamin D Calibrators, Vitamin D ControlsBiokit, S.A. · 20113cite it
  • K060818Architect SHBG Reagent Kit, Architect SHBG Calibrator Kit, and Architect SHBG Control Kit with Models…Biokit, S.A. · 20072cite it
  • K072036Architect Ivancomycin Reagents and Architect Ivancomycin Calibrators, Models: 1P30-25 and 1P30-01Biokit, S.A. · 20081cites it
  • K050487Quantia LA (a)Biokit, S.A. · 20051cites it
  • K050493Quantia IgeBiokit, S.A. · 20051cites it
  • K063232Architect Intact PTH Reagents, Calibrators (a-F) and Controls (Low, Medium, High), Models 8K25-20, 8K25-25…Biokit, S.A. · 20071cites it

What has FDA decided for it lately?

  • K243575ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG ControlsBiokit, S.A. · 2025
  • K233606ADVIA Centaur EBV-VCA IgMBiokit, S.A. · 2024
  • K233605ADVIA Centaur EBV-EBNA IgGBiokit, S.A. · 2024
  • K213987ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG ControlsBiokit, S.A. · 2023
  • K214068Quantia IgEBiokit, S.A. · 2023
  • K181333ADVIA Centaur Herpes-1 IgGBiokit, S.A. · 2018
  • K181334ADVIA Centaur Herpes-2 IgGBiokit, S.A. · 20181 recall
  • K152185Architect SHBGBiokit, S.A. · 2016

All 23 as Biokit, S.A. →

What has been recalled?

8 recalls linked to its devices; the latest:

  • K181334Enzyme linked immunosorbent assay, for herpes simplex virus, hsv-2Feb 8, 2021Class II
  • K063232ARCHITECT Intact PTH Calibrators - Product Usage: The ARCHITECT Intact PTH Calibrators…Apr 9, 2019Class III
  • K063232ARCHITECT Intact PTH Controls - Product Usage: The ARCHITECT Intact PTH Calibrators are…Apr 9, 2019Class III
  • K060818ARCHITECT SHBG Reagent The ARCHITECT SHBG assay is a chemiluminescent microparticle…Apr 18, 2017Class II
  • K063232ARCHITECT Intact PTH Controls consists of 3 x 1 Bottle (8.0 mL each) of PTH (synthetic…Feb 12, 2014Class II
  • K063232ARCHITECT Intact PTH Calibrators consists of 6 bottles (4.0 mL each). Calibrator A…Feb 12, 2014Class II

Other applicant names beginning “Biokit”

FDA records each applicant name separately; these may or may not be the same firm.

Biokit USA, Inc. 16