510(k) Report

FDA applicant

OraSure Technologies, Inc.

Bethlehem, PA31 decisions1996–201913 recalls

FDA records 31 decisions for OraSure Technologies, Inc. (Bethlehem, PA) from 1996 to 2019: 29 510(k) clearances, 1 De Novo grant and 1 original PMA approval. Most are in product codes GEH (Unit, Cryosurgical, Accessories) and DIO (Enzyme Immunoassay, Cocaine And Cocaine…). Its devices cite 12 predicates, 3 of them its own earlier devices. 13 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 toxicology panel, where it files most

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

FDA decisions per year

1in 2019

2010: 12019: 1
2007high 1 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2021

2008: 42016: 22017: 12020: 52021: 1
2007high 5 (2020) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like OraSure 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?

  • GEHUnit, Cryosurgical, Accessories6decisions
  • DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites4decisions
  • MKUEnzyme Immunoassay, Nicotine And Nicotine Metabolites3decisions
  • JXMEnzyme Immunoassay, Benzodiazepine2decisions
  • LDJEnzyme Immunoassay, Cannabinoids2decisions
  • LCMEnzyme Immunoassay, Phencyclidine2decisions

Also: DIS (2), DKZ (2), DJG (2), DJR (1), LAF (1), CFR (1).

Whose devices does it build on?

Its devices cite 12 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 42 times; 3 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.

  • K023487Histofreezer Wart Removal System or Other Proprietary NameOraSure Technologies, Inc. · 20037cite it
  • K981341STC Opiates Micro-Plate Eia (Orasure Application)OraSure Technologies, Inc. · 19985cite it
  • K992918STC Amphetamine-Specific Intercept Micro-Plate Eia, Model 1103IOraSure Technologies, Inc. · 20004cite it
  • K972481Auto-Lyte Cotinine EiaOraSure Technologies, Inc. · 19973cite it
  • K990877Histofreezer DeviceOraSure Technologies, Inc. · 19993cite it
  • K993208STC Methamphetamine Intercept Micro-Plate Eia, Model 1104IOraSure Technologies, Inc. · 20003cite it

What has FDA decided for it lately?

  • DEN190025OraQuick Ebola Rapid Antigen TestOraSure Technologies, Inc. · 2019
  • P080027Oraquick HCV Rapid Antibody TestOraSure Technologies, Inc. · 20101 recall
  • K060859Compound W Freeze Off Wart Removal SystemOraSure Technologies, Inc. · 2006
  • K023487Histofreezer Wart Removal System or Other Proprietary NameOraSure Technologies, Inc. · 20033 recalls
  • K013882Oti Benzodiazepines Intercept Micro-Plate Eia Model #1110IOraSure Technologies, Inc. · 20022 recalls
  • K020371Uplink Test SystemOraSure Technologies, Inc. · 2002
  • K011057Intercept Oral Fluid Drug Test Oral Specimen Collection Device, Model 503-XXXXOraSure Technologies, Inc. · 2001
  • K002375STC Cannabinoids Intercept Micro-Plate Eia, Model 1118IOraSure Technologies, Inc. · 20014 recalls

All 31 as OraSure Technologies, Inc. →

What has been recalled?

13 recalls linked to its devices; the latest:

  • K993208Methamphetamine Intercept Microplate kit EIA - IVD qualitative determination of…Feb 5, 2021Class III
  • K023487Personelle OTC Skin Tag Remover, Canada Catalog Number: 1001-0314 - Product Usage…Jul 15, 2020Class III
  • K023487Pointts sistema de ellmlnact!;o de verrugas OTC - Brazil Catalog Number: 1001-0280 -…Jul 15, 2020Class III
  • K023487CVS Advanced Wart Remover Kit, Catalog Number: 1001-0407 - Product Usage: indicated for…Jul 15, 2020Class III
  • K013882Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 5plate Matrix Oral…Jul 13, 2020Class III
  • K013882Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 2 plate Matrix…Jul 13, 2020Class III