KDT · Container, Specimen Mailer And Storage, Sterile
Pathology · 21 CFR 864.3250 · Class 1
Overview
| Product Code | KDT |
|---|---|
| Device Name | Container, Specimen Mailer And Storage, Sterile |
| Regulation | 21 CFR 864.3250 |
| Device Class | Class 1 |
| Review Panel | Pathology |
Identification
A specimen transport and storage container, which may be empty or prefilled, is a device intended to contain biological specimens, body waste, or body exudate during storage and transport in order that the matter contained therein can be destroyed or used effectively for diagnostic examination. If prefilled, the device contains a fixative solution or other general purpose reagent to preserve the condition of a biological specimen added to the container. This section does not apply to specimen transport and storage containers that are intended for use as part of an over-the-counter test sample collection system for drugs of abuse testing.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 864.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (12 of 12)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K873593 | BIOSURE SPECIMEN COLLECTION CONTAINER | Biosure, Inc. | Nov 25, 1987 | SESE |
| K862665 | NOVACYTE-U | Xsirius Medical, Inc. | Sep 4, 1986 | SESE |
| K834579 | BIOSPAL 2400S | Hospal Medical Corp. | Feb 4, 1984 | SESE |
| K834412 | PRESERV PVA FIXATIVE 15ML-FORMALIN PK | Preventive Diagnostics Corp. | Jan 13, 1984 | SESE |
| K833660 | PRESERV PVA FIXATIVE -MALIN PACK | Preventive Diagnostics Corp. | Nov 28, 1983 | SESE |
| K823773 | PROVIAL II #006-010-0201 | Dynatech Corp. | Jan 21, 1983 | SESE |
| K822870 | STOOL-COLLECTION/PRESERVATION KIT | American Scientific Products | Nov 1, 1982 | SESE |
| K821621 | PREGNOPOST | M.M. Wolfred, Ph.D. | Jul 21, 1982 | SESE |
| K820246 | PREFILLED SPECIMEN CONTAINER | Sage Products, Inc. | Feb 18, 1982 | SESE |
| K811793 | FIX-RIGHT 90ML & 180 ML PREFILLED CONT | Richard-Allan Medical Ind., Inc. | Jul 31, 1981 | SESE |
| K800946 | URINARY CATHETER SAMPLING KIT | Sage Products, Inc. | Jun 20, 1980 | SESE |
| K770071 | PINLOCK CONTAINER | Perkins Mfg. Co. | Feb 24, 1977 | SESE |
Top Applicants
- Preventive Diagnostics Corp. — 2 clearances
- Sage Products, Inc. — 2 clearances
- American Scientific Products — 1 clearance
- Biosure, Inc. — 1 clearance
- Dynatech Corp. — 1 clearance
