GMZ · Antigens, All Types, Escherichia Coli
Microbiology · 21 CFR 866.3255 · Class 1
Overview
| Product Code | GMZ |
|---|---|
| Device Name | Antigens, All Types, Escherichia Coli |
| Regulation | 21 CFR 866.3255 |
| Device Class | Class 1 |
| Review Panel | Microbiology |
Identification
Escherichia coli serological reagents are devices that consist of antigens and antisera used in serological tests to identify Escherichia coli from cultured isolates derived from clinical specimens. Additionally, some of these reagents consist of Escherichia coli antisera conjugated with a fluorescent dye used to identify Escherichia coli directly from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by this bacterium belonging to the genus Escherichia, and provides epidemiological information on diseases caused by this microorganism. Although Escherichia coli constitutes the greater part of the microorganisms found in the intestinal tract in humans and is usually nonpathogenic, those strains which are pathogenic may cause urinary tract infections or epidemic diarrheal disease, especially in children.
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 the limitations in § 866.9.
Recent Cleared Devices (14 of 14)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K222829 | Curian® Shiga Toxin | Meridian Bioscience, Inc. | Apr 17, 2023 | SESE |
| K121411 | SHIGA TOXIN CHEK | Techlab Inc., Corporate Research Center | Oct 2, 2012 | SESE |
| K121364 | SHIGA TOXIN QUIK CHEK | Techlab Inc., Corporate Research Center | Oct 2, 2012 | SESE |
| K062546 | IMMUNOCARD STAT! EHEC, MODEL 751630 | Meridian Bioscience, Inc. | Feb 14, 2007 | SESE |
| K061889 | BIOSTAR OIA SHIGATOX | Inverness Medical-Biostar, Inc. | Dec 12, 2006 | SESE |
| K023599 | IMMUNOCARD STAT! E. COLI O157 PLUS | Meridian Bioscience, Inc. | Jan 3, 2003 | SESE |
| K990263 | IMMUNOCARD STAT! E. COLI O157:H7 | Meridian Diagnostics, Inc. | Aug 9, 1999 | SESE |
| K980507 | PROSPECT SHIGA TOXIN MICROPLATE ASSAY | Alexon - Trend, Inc. | Apr 23, 1998 | SESE |
| K973457 | CHROMALEX E. COLI 0157 LATEX TEST SYSTEM, PROD. NO. 800 | Shared Systems, Inc. | Jan 2, 1998 | SESE |
| K971663 | WELLCOLEX E.COLI O157:H7 | Murex Biotech , Ltd. | Dec 30, 1997 | SESE |
| K972156 | QUIX RAPID E. COLI O157 STRIP TEST | Guardian Scientific, Corp. | Oct 16, 1997 | SESE |
| K942705 | E. COLI 0157 ELISA STOOL ASSAY | Lmd Laboratories | Sep 27, 1995 | SESE |
| K944421 | E.COLI 0157 LATEX TEST | Pro-Lab Diagnostics | Dec 15, 1994 | SESE |
| K884513 | PF TEST | Medi-Tech, Inc. | Feb 3, 1989 | SESE |
Top Applicants
- Meridian Bioscience, Inc. — 3 clearances
- Techlab Inc., Corporate Research Center — 2 clearances
- Alexon - Trend, Inc. — 1 clearance
- Guardian Scientific, Corp. — 1 clearance
- Inverness Medical-Biostar, Inc. — 1 clearance
