JTW · System, Transport, Aerobic
Microbiology · 21 CFR 866.2900 · Class 1
Overview
| Product Code | JTW |
|---|---|
| Device Name | System, Transport, Aerobic |
| Regulation | 21 CFR 866.2900 |
| Device Class | Class 1 |
| Review Panel | Microbiology |
| 3rd-Party Reviewable | Yes |
Identification
A microbiological specimen collection and transport device is a specimen collecting chamber intended for medical purposes to preserve the viability or integrity of microorganisms in specimens during storage of specimens after their collection and during their transport from the collecting area to the laboratory. The device may be labeled or otherwise represented as sterile. The device aids in the diagnosis of disease caused by pathogenic microorganisms.
Classification Rationale
Class I (general controls). The device, when solely intended for use in the collection of concentrated parasites from specimens and transport, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.
Recent Cleared Devices (20 of 43)
Showing 20 most recent of 43 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K121039 | COPAN MSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM | Copan Flock Technologies | May 25, 2012 | SESE |
| K061301 | COPAN LIQUID AMIES ELUTION SWAB (ESWAB) COLLECTION AND TRANSPORT SYSTEM | Copan Diagnostics, Inc. | Jun 23, 2006 | SESE |
| K022874 | GEN-PROBE APTIMA COMBO 2 ASSAY | Gen-Probe, Inc. | Sep 17, 2002 | SESE |
| K013819 | URINE COLLECTION, PRESERVATION AND TRANSPORT SYSTEM | Sierra Diagnostic, LLC | Feb 28, 2002 | SESE |
| K993161 | COPAN EASY-SWAB COLLECTION AND TRANSPORT SYSTEM | Copan Diagnostics, Inc. | Nov 9, 1999 | SESE |
| K983244 | SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES(ADDITION OF MEROPENEM) | Trek Diagnostic Systems, Inc. | Nov 30, 1998 | SESE |
| K961148 | CEFEPIME DISPANS-O-DISC (CEFEPLIME - 30MCG) | Difco Laboratories, Inc. | Apr 26, 1996 | SESE |
| K934894 | CULTURESWAB TRANSPORT SYSTEM | Difco Laboratories, Inc. | Feb 22, 1994 | SESE |
| K904773 | P AND T MEDIUM | Gibson Laboratories, Inc. | Dec 4, 1990 | SESE |
| K895187 | FDL, INC.'S TRANSPORT SYSTEM | Fairleigh Dickinson Laboratories, Inc. | Oct 24, 1989 | SESE |
| K882580 | MECHANICAL CHANGE IN IN-VITRO MICRO DEVICE | Precision Dynamics Corp. | Jul 8, 1988 | SESE |
| K872325 | GONOSTAT FEMALE SPECIMEN COLLECTION & TRANSPORT | Technology Management & Marketing, Inc. | Aug 12, 1987 | SESE |
| K872326 | GONOSTAT MALE SPECIMEN COLLECTION & TRANSPORT | Technology Management & Marketing, Inc. | Aug 11, 1987 | SESE |
| K843359 | URINE TRANSPORT KIT | Applied Polytechnology, Inc. | Sep 27, 1984 | SESE |
| K843341 | GONO-PAK W/THAYER-MARTIN AGAR/GONO-PAK | Bd Becton Dickinson Vacutainer Systems Preanalytic | Sep 27, 1984 | SESE |
| K843173 | CELL-MATICS VIRAL TRANSPORT PACK | Difco Laboratories, Inc. | Sep 6, 1984 | SESE |
| K840719 | BAKTERIETTE-VI-PAK | Great Lakes Intl. | Apr 4, 1984 | SESE |
| K840991 | PRESERV BUFFERED GLYCEROL SALINE | Preventive Diagnostics Corp. | Mar 23, 1984 | SESE |
| K840990 | PRESERV CARY BLAIR TRANSPORT PACK | Preventive Diagnostics Corp. | Mar 23, 1984 | SESE |
| K840968 | PRESERV TRANSPORT & CULTURE PACK | Preventive Diagnostics Corp. | Mar 23, 1984 | SESE |
Top Applicants
- Precision Dynamics Corp. — 9 clearances
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 5 clearances
- Difco Laboratories, Inc. — 3 clearances
- Preventive Diagnostics Corp. — 3 clearances
- Biolog, Inc. — 2 clearances
