Browse hierarchy: [Microbiology (MI)](/submissions/MI) → [Subpart D — Serological Reagents](/submissions/MI/subpart-d%E2%80%94serological-reagents) → [21 CFR 866.3255](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3255) → GNA — Antisera, All Types, Escherichia Coli

# GNA · Antisera, All Types, Escherichia Coli

_Microbiology · 21 CFR 866.3255 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GNA

## Overview

- **Product Code:** GNA
- **Device Name:** Antisera, All Types, Escherichia Coli
- **Regulation:** [21 CFR 866.3255](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3255)
- **Device Class:** 1
- **Review Panel:** [Microbiology](/submissions/MI)

## 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 (12 of 12)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K071799](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GNA/K071799.md) | MODIFICATION TO BIOSTAR OIA SHIGATOX | Iverness Medical Professional Diagnostics | Oct 2, 2007 | SESE |
| [K031367](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GNA/K031367.md) | DUOPATH VEROTOXINS GLISA TEST | Emd Chemicals, Inc. | Jan 23, 2004 | SESE |
| [K993401](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GNA/K993401.md) | DRYSPOT E.COLI 0157 KIT | Oxoid , Ltd. | Feb 28, 2000 | SESE |
| [K981734](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GNA/K981734.md) | VTEC-RPLA SEIKEN | Denka Seiken'S | Sep 22, 1998 | SESE |
| [K962028](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GNA/K962028.md) | WELLCOLEX E-COLI OI57 ZC60 | Murex Diagnostics, Inc. | Nov 1, 1996 | SESE |
| [K953362](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GNA/K953362.md) | PREMIER EHEC | Meridian Diagnostics, Inc. | Nov 14, 1995 | SESE |
| [K950167](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GNA/K950167.md) | PREMIER EHEC | Meridian Diagnostics, Inc. | Apr 14, 1995 | SESE |
| [K933457](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GNA/K933457.md) | RIM E.COLI 0157:H7 LATEX TEST | Remel Co. | Apr 20, 1994 | SESE |
| [K903714](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GNA/K903714.md) | E. COLI 0157 LATEX TEST | Pro-Lab, Inc. | Jan 24, 1991 | SESE |
| [K884026](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GNA/K884026.md) | ESCHERICHIA COLI 0157 LATEX AGGLUTINATION TEST KIT | Oxoid U.S.A., Inc. | Feb 3, 1989 | SESE |
| [K874288](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GNA/K874288.md) | PHADEBACT ETEC-LT TEST | Pharmacia, Inc. | Sep 2, 1988 | SESE |
| [K855234](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GNA/K855234.md) | DIAGNOSTIC REAGENT VET-RPLA | Oxoid U.S.A., Inc. | Nov 4, 1986 | SESE |

## Top Applicants

- Meridian Diagnostics, Inc. — 2 clearances
- Oxoid U.S.A., Inc. — 2 clearances
- Denka Seiken'S — 1 clearance
- Emd Chemicals, Inc. — 1 clearance
- Iverness Medical Professional Diagnostics — 1 clearance

---

**Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GNA](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GNA)

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