Browse hierarchy: [Microbiology (MI)](/submissions/MI) → [Subpart B — Diagnostic Devices](/submissions/MI/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 866.1640](/submissions/MI/subpart-b%E2%80%94diagnostic-devices/866.1640) → MYI — System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies

# MYI · System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies

_Microbiology · 21 CFR 866.1640 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/MYI

## Overview

- **Product Code:** MYI
- **Device Name:** System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies
- **Regulation:** [21 CFR 866.1640](/submissions/MI/subpart-b%E2%80%94diagnostic-devices/866.1640)
- **Device Class:** 2
- **Review Panel:** [Microbiology](/submissions/MI)
- **3rd-party reviewable:** yes

## Identification

An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (10 of 10)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K140619](https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/MYI/K140619.md) | MECA XPRESSFISH | Advandx, Inc. | Oct 10, 2014 | SESE |
| [K133851](https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/MYI/K133851.md) | ALERE PBP2A SA/CONS CULTURE COLONY TEST | Alere Scarborough, Inc. | Sep 3, 2014 | SESE |
| [K121905](https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/MYI/K121905.md) | ALERE PBP2A TEST | Alere Scarborough, Inc. | Jul 26, 2012 | SESE |
| [K090301](https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/MYI/K090301.md) | BINAXNOW PBP2A TEST, MODEL 890-000 | Binax, Inc. | Apr 14, 2010 | SESE |
| [K091766](https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/MYI/K091766.md) | CLEARVIEW EXACT PBP2A TEST, MODEL 891-000 | Binax, Inc. | Feb 24, 2010 | SESE |
| [K062864](https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/MYI/K062864.md) | MASTALEX -MRSA, MODEL RST501 | Mast Group , Ltd. | Oct 18, 2006 | SESE |
| [K011710](https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/MYI/K011710.md) | OXOID PBP2 1 LATEX AGGLUTINATION TEST | Oxoid , Ltd. | Apr 2, 2002 | SESE |
| [K011400](https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/MYI/K011400.md) | MRSA-SCREEN | Denka Seiken'S | Mar 27, 2002 | SESE |
| [K010858](https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/MYI/K010858.md) | VELOGENE GENOMIC IDENTIFICATION ASSAY FOR MRSA WITH ONE-STEP DETECTION | Id Biomedical Corp. | May 24, 2001 | SESE |
| [K990640](https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/MYI/K990640.md) | VELOGENE RAPID MRSA IDENTIFICATION ASSAY | Id Biomedical Corp. | Jul 9, 1999 | SESE |

## Top Applicants

- Alere Scarborough, Inc. — 2 clearances
- Binax, Inc. — 2 clearances
- Id Biomedical Corp. — 2 clearances
- Advandx, Inc. — 1 clearance
- Denka Seiken'S — 1 clearance

---

**Source:** [https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/MYI](https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/MYI)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com