INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE, MODEL 503-XXXX
FDA 510(k) clearance K011057 · decided 2001-06-06
Clearance details
- K-number
- K011057
- Device name
- INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE, MODEL 503-XXXX
- Applicant
- OraSure Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-04-06
- Decision date
- 2001-06-06
- Days to decision
- 61 days
- Clearance type
- Traditional
- Product code
- PJD
- Device class
- 2
- Regulation number
- 862.1675
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Bethlehem, PA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Quantisal™ Oral Fluid Collection Device (K232898) | Immunalysis Corporation | 2023-11-21 |
| Quantisal™ II Oral Fluid Collection Device (K223781) | Immunalysis Corporation | 2023-07-28 |
| Quantisal Oral Fluid Collection Device (K200801) | Immunalysis Corporation | 2020-07-28 |
| Quantisal II Oral Fluid Collection Device (K183048) | Immunalysis Corporation | 2019-07-29 |
| ORAL-EZE ORAL FLUID COLLECTION SYSTEM (K984361) | Osborn Laboratories, Inc. | 1999-01-13 |
| EPISCREEN ORAL SPECIMEN COLLECTION DEVICE (K973395) | Epitope, Inc. | 1998-02-13 |
| EPISCREEN (K970357) | Epitope, Inc. | 1997-03-10 |
| SALIVA SAMPLER (K942435) | Saliva Diagnostic Systems, Inc. | 1995-08-21 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| OraQuick HCV Rapid Antibody Test (P080027/S039) | OraSure Technologies, Inc. | 2021-04-20 |
| OraQuick HCV Rapid Antibody Test (P080027/S038) | OraSure Technologies, Inc. | 2021-02-25 |
| OraQuick HCV Rapid Antibody Test (P080027/S037) | OraSure Technologies, Inc. | 2020-10-16 |
| OraQuick HCV Rapid Antibody Test (P080027/S035) | OraSure Technologies, Inc. | 2019-09-11 |
| OraQuick HCV Rapid Antibody Test (P080027/S034) | OraSure Technologies, Inc. | 2018-12-06 |
| OraQuick HCV Rapid Antibody Test (P080027/S033) | OraSure Technologies, Inc. | 2018-04-12 |
| OraQuick HCV Rapid Antibody Test (P080027/S032) | OraSure Technologies, Inc. | 2018-02-01 |
| OraQuick HCV Rapid Antibody Test (P080027/S031) | OraSure Technologies, Inc. | 2018-01-03 |