510(k) Report

FDA applicant

Third Wave Technologies, Inc.

Madison, WI2 decisions2005–20081 recall

FDA records 2 decisions for Third Wave Technologies, Inc. (Madison, WI) from 2005 to 2008: 2 510(k) clearances. Most are in product codes NTI (Drug Metabolizing Enzyme Genotyping Systems) and NUA (System, Cystic Fibrosis Transmembrane…). Its devices cite 2 predicates, 0 of them its own earlier devices. 1 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 Third Wave Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2016

2016: 1
2007high 1 (2016) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Third Wave Technologies, 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?

  • NTIDrug Metabolizing Enzyme Genotyping Systems1decision
  • NUASystem, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 0 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.

  • K051824Invader UGT1A1 Molecular AssayThird Wave Technologies, Inc. · 20051cites it
  • K063787Inplex CF Molecular TestThird Wave Technologies, Inc. · 20081cites it

What has FDA decided for it lately?

  • K063787Inplex CF Molecular TestThird Wave Technologies, Inc. · 20081 recall
  • K051824Invader UGT1A1 Molecular AssayThird Wave Technologies, Inc. · 2005

All 2 as Third Wave Technologies, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K063787Hologic InPlex CF Molecular Test (IVD); Catalog Number: 95-432.Mar 31, 2016Class II