PJD · Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device
Clinical Chemistry · 21 CFR 862.1675 · Class 2
Overview
| Product Code | PJD |
|---|---|
| Device Name | Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device |
| Regulation | 21 CFR 862.1675 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
Identification
A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.
Classification Rationale
Class II.
Recent Cleared Devices (9 of 9)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K232898 | Quantisal Oral Fluid Collection Device | Immunalysis Corporation | Nov 21, 2023 | SESE |
| K223781 | Quantisal II Oral Fluid Collection Device | Immunalysis Corporation | Jul 28, 2023 | SESE |
| K200801 | Quantisal Oral Fluid Collection Device | Immunalysis Corporation | Jul 28, 2020 | SESE |
| K183048 | Quantisal II Oral Fluid Collection Device | Immunalysis Corporation | Jul 29, 2019 | SESE |
| K011057 | INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE, MODEL 503-XXXX | OraSure Technologies, Inc. | Jun 6, 2001 | SESE |
| K984361 | ORAL-EZE ORAL FLUID COLLECTION SYSTEM | Osborn Laboratories, Inc. | Jan 13, 1999 | SESE |
| K973395 | EPISCREEN ORAL SPECIMEN COLLECTION DEVICE | Epitope, Inc. | Feb 13, 1998 | SESE |
| K970357 | EPISCREEN | Epitope, Inc. | Mar 10, 1997 | SESE |
| K942435 | SALIVA SAMPLER | Saliva Diagnostic Systems, Inc. | Aug 21, 1995 | SESE |
Top Applicants
- Immunalysis Corporation — 4 clearances
- Epitope, Inc. — 2 clearances
- OraSure Technologies, Inc. — 1 clearance
- Osborn Laboratories, Inc. — 1 clearance
- Saliva Diagnostic Systems, Inc. — 1 clearance
