510(k) Report

FDA applicant

Ucp Biosciences, Inc.

San Jose, CA14 decisions2005–20160 recalls

FDA records 14 decisions for Ucp Biosciences, Inc. (San Jose, CA) from 2005 to 2016: 14 510(k) clearances. Most are in product codes DKZ (Enzyme Immunoassay, Amphetamine) and LFG (Radioimmunoassay, Tricyclic Antidepressant Drugs). Its devices cite 8 predicates, 6 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, clinical toxicology panel, where it files most

How often FDA has decided Ucp Biosciences, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2007: 12009: 12010: 12011: 12012: 12013: 42014: 12015: 12016: 1
2007high 4 (2013) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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

See the 510(k) Report

Which product codes does it file in?

  • DKZEnzyme Immunoassay, Amphetamine9decisions
  • LFGRadioimmunoassay, Tricyclic Antidepressant Drugs2decisions
  • LCXKit, Test, Pregnancy, Hcg, Over The Counter1decision
  • DJGEnzyme Immunoassay, Opiates1decision
  • DISEnzyme Immunoassay, Barbiturate1decision

Whose devices does it build on?

Its devices cite 8 predicates; 6 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 11 times; 6 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.

  • K091588Ucp Home Drug Screening TestsUcp Biosciences, Inc. · 20094cite it
  • K130463Ucp Home Drug Screening Test; Cards, CupsUcp Biosciences, Inc. · 20132cite it
  • K132812Ucp Multi-Drug Test Key CupsUcp Biosciences, Inc. · 20142cite it
  • K050540Ucp Rapid Drug Screening TestsUcp Biosciences, Inc. · 20051cites it
  • K131811Ucp Compact Drug Test Cards, Ucp Compact Drug Test CupsUcp Biosciences, Inc. · 20131cites it
  • K110515Ucp Drug Screening Test CupsUcp Biosciences, Inc. · 20111cites it

What has FDA decided for it lately?

  • K152908Ucp Compact Drug TestsUcp Biosciences, Inc. · 2016
  • K151213UCP Drug Test Mini CupsUcp Biosciences, Inc. · 2015
  • K132812Ucp Multi-Drug Test Key CupsUcp Biosciences, Inc. · 2014
  • K131236Ucp Pregnancy Cassette Test, Dip/Card Strip, Home Pregnancy Cassette Test, Midstream Test and Dip/Card StripUcp Biosciences, Inc. · 2013
  • K131811Ucp Compact Drug Test Cards, Ucp Compact Drug Test CupsUcp Biosciences, Inc. · 2013
  • K130463Ucp Home Drug Screening Test; Cards, CupsUcp Biosciences, Inc. · 2013
  • K123863Ucp Compact Drug Test Cards, Ucp Compact Drug Test CupsUcp Biosciences, Inc. · 2013
  • K122419Ucp Home Drug Screening Test CupsUcp Biosciences, Inc. · 2012

All 14 as Ucp Biosciences, Inc. →