Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
OraSure Technologies, Inc. — Predicate Candidate Screening
30 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
112 daysmedian FDA review time
189 days90th percentile
30clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| DEN190025 | OraQuick Ebola Rapid Antigen Test | OraSure Technologies, Inc. | 2019-10-10 | 150 | 0 |
| K060859 | COMPOUND W FREEZE OFF WART REMOVAL SYSTEM | OraSure Technologies, Inc. | 2006-07-18 | 112 | 0 |
| K023487 | HISTOFREEZER WART REMOVAL SYSTEM OR OTHER PROPRIETARY NAME | OraSure Technologies, Inc. | 2003-03-20 | 154 | 0 |
| K013882 | OTI BENZODIAZEPINES INTERCEPT MICRO-PLATE EIA MODEL #1110I | OraSure Technologies, Inc. | 2002-04-17 | 145 | 0 |
| K020371 | UPLINK TEST SYSTEM | OraSure Technologies, Inc. | 2002-04-03 | 58 | 0 |
| K011057 | INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVI | OraSure Technologies, Inc. | 2001-06-06 | 61 | 0 |
| K002375 | STC CANNABINOIDS INTERCEPT MICRO-PLATE EIA, MODEL 1118I | OraSure Technologies, Inc. | 2001-01-26 | 175 | 4 |
| K001976 | STC BARBITURATES INTERCEPT MICRO-PLATE EIA, MODEL 1108I | OraSure Technologies, Inc. | 2000-12-06 | 160 | 1 |
| K002010 | STC METHADONE INTERCEPT MICRO-PLATE EIA, MODEL 11421 | OraSure Technologies, Inc. | 2000-11-29 | 149 | 0 |
| K000399 | STC PCP INTERCEPT MICRO-PLATE EIA, MODEL 11541 | OraSure Technologies, Inc. | 2000-05-15 | 98 | 0 |
| K001197 | COCAINE METABOLITE INTERCEPT MICRO-PLATE EIA | OraSure Technologies, Inc. | 2000-05-11 | 30 | 0 |
| K993208 | STC METHAMPHETAMINE INTERCEPT MICRO-PLATE EIA, MODEL 1104I | OraSure Technologies, Inc. | 2000-04-03 | 192 | 0 |
| K992918 | STC AMPHETAMINE-SPECIFIC INTERCEPT MICRO-PLATE EIA, MODEL 11 | OraSure Technologies, Inc. | 2000-04-03 | 217 | 0 |
| K990877 | HISTOFREEZER DEVICE | OraSure Technologies, Inc. | 1999-06-14 | 90 | 0 |
| K982759 | AUTO-LYTE COCAINE METABOLITE EIA, MODEL # 1222U | OraSure Technologies, Inc. | 1998-11-20 | 106 | 0 |
| K982745 | AUTO-LYTE BARBITURATES EIA | OraSure Technologies, Inc. | 1998-11-18 | 104 | 0 |
| K982831 | AUTO-LYTE BENZODIAZEPINES EIA MODEL NUMBER 1210U | OraSure Technologies, Inc. | 1998-11-12 | 93 | 0 |
| K982801 | AUTO-LYTE PCP EIA, MODEL #1254U | OraSure Technologies, Inc. | 1998-11-04 | 86 | 0 |
| K982358 | HISTOFREEZER DEVICE | OraSure Technologies, Inc. | 1998-10-02 | 88 | 0 |
| K982061 | STC COCAINE METABOLITE MICRO-PLATE EIA (ORASURE DEVICE) | OraSure Technologies, Inc. | 1998-08-25 | 82 | 0 |
| K980739 | HISTOFREEZER/ 17% SALICYLIC ACID-VERRUCA PLANTARIS | OraSure Technologies, Inc. | 1998-05-26 | 90 | 0 |
| K981341 | STC OPIATES MICRO-PLATE EIA (ORASURE APPLICATION) | OraSure Technologies, Inc. | 1998-05-22 | 39 | 0 |
| K974534 | MICRO-PLATE COTININE EIA | OraSure Technologies, Inc. | 1998-05-18 | 167 | 0 |
| K974234 | MICRO-PLATE COTININE EIA | OraSure Technologies, Inc. | 1998-05-14 | 183 | 0 |
| K973750 | STC CANNABINOIDS MICRO-PLATE EIA | OraSure Technologies, Inc. | 1998-02-13 | 135 | 0 |
| K972989 | STC METHAMPHETAMINE MICRO-PLATE EIA | OraSure Technologies, Inc. | 1998-01-28 | 169 | 0 |
| K973651 | STC COCAINE METABOLITE MICRO-PLATE EIA | OraSure Technologies, Inc. | 1998-01-02 | 99 | 0 |
| K972481 | AUTO-LYTE COTININE EIA | OraSure Technologies, Inc. | 1997-10-21 | 111 | 0 |
| K971392 | HISTOFREEZER VERRUCA PLANA | OraSure Technologies, Inc. | 1997-10-21 | 189 | 0 |
| K962435 | STC AUTO-LYTE URINARY GLUCOSE ASSAY | OraSure Technologies, Inc. | 1996-12-26 | 185 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda