OraSure Technologies, Inc.: FDA filings under this applicant name
FDA lists 29 510(k) clearances under the applicant name “OraSure Technologies, Inc.” (first 1996, latest 2006), plus 1 PMA and 1 De Novo decisions, across 15 product codes in 4 review panels. Median 510(k) review time under this name: 111 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEH | Unit, Cryosurgical, Accessories | 6 | 6 |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 4 | 4 |
| MKU | Enzyme Immunoassay, Nicotine And Nicotine Metabolites | 3 | 3 |
| DIS | Enzyme Immunoassay, Barbiturate | 2 | 2 |
| DJG | Enzyme Immunoassay, Opiates | 2 | 2 |
| DKZ | Enzyme Immunoassay, Amphetamine | 2 | 2 |
| JXM | Enzyme Immunoassay, Benzodiazepine | 2 | 2 |
| LCM | Enzyme Immunoassay, Phencyclidine | 2 | 2 |
| LDJ | Enzyme Immunoassay, Cannabinoids | 2 | 2 |
| CFR | Hexokinase, Glucose | 1 | 1 |
Plus 5 more product codes.
Review panels
Most recent OraSure Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K060859 | COMPOUND W FREEZE OFF WART REMOVAL SYSTEM | GEH | 2006-07-18 | 112 |
| K023487 | HISTOFREEZER WART REMOVAL SYSTEM OR OTHER PROPRIETARY NAME | GEH | 2003-03-20 | 154 |
| K013882 | OTI BENZODIAZEPINES INTERCEPT MICRO-PLATE EIA MODEL #1110I | JXM | 2002-04-17 | 145 |
| K020371 | UPLINK TEST SYSTEM | DJG | 2002-04-03 | 58 |
| K011057 | INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE, MODEL 503-XXXX | PJD | 2001-06-06 | 61 |
| K002375 | STC CANNABINOIDS INTERCEPT MICRO-PLATE EIA, MODEL 1118I | LDJ | 2001-01-26 | 175 |
| K001976 | STC BARBITURATES INTERCEPT MICRO-PLATE EIA, MODEL 1108I | DIS | 2000-12-06 | 160 |
| K002010 | STC METHADONE INTERCEPT MICRO-PLATE EIA, MODEL 11421 | DJR | 2000-11-29 | 149 |
| K000399 | STC PCP INTERCEPT MICRO-PLATE EIA, MODEL 11541 | LCM | 2000-05-15 | 98 |
| K001197 | COCAINE METABOLITE INTERCEPT MICRO-PLATE EIA | DIO | 2000-05-11 | 30 |
19 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN190025 | De Novo | Device To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens | 2019-10-10 |
| P080027 | PMA | ORAQUICK HCV RAPID ANTIBODY TEST | 2010-06-25 |
Recalls
14 product recalls in 9 recall events; 0 initiated in the last five years. Most recent: 2021-02-05.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
SEC filings
ORASURE TECHNOLOGIES INC (OSUR): EDGAR filings, CIK 1116463. An SEC registrant with the same name, matched by name only.
Frequently asked questions
How many FDA 510(k) clearances are listed under OraSure Technologies, Inc.?
FDA lists 29 510(k) clearances under the applicant name “OraSure Technologies, Inc.” (first 1996, latest 2006), plus 1 PMA and 1 De Novo decisions, across 15 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by OraSure Technologies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name OraSure Technologies, Inc. is 111 days.
Which FDA product codes appear under OraSure Technologies, Inc.?
The most frequent FDA product codes under this applicant name are GEH (Unit, Cryosurgical, Accessories, 6); DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites, 4); MKU (Enzyme Immunoassay, Nicotine And Nicotine Metabolites, 3).
Next steps
- See all 29 OraSure Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEH, OraSure Technologies, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.