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) → PTJ — Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates

# PTJ · Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates

_Microbiology · 21 CFR 866.1640 · Class 2_

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

## Overview

- **Product Code:** PTJ
- **Device Name:** Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates
- **Regulation:** [21 CFR 866.1640](/submissions/MI/subpart-b%E2%80%94diagnostic-devices/866.1640)
- **Device Class:** 2
- **Review Panel:** [Microbiology](/submissions/MI)

## 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 (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K243499](https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/PTJ/K243499.md) | NG-Test® CTX-M MULTI | Ng Biotech | Jun 4, 2025 | SESE |
| [K191889](https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/PTJ/K191889.md) | NG-Test CARBA 5 | Ng Biotech | Oct 2, 2019 | SESE |
| [K162385](https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/PTJ/K162385.md) | RAPIDEC CARBA NP | Biomerieux S.A. | Apr 27, 2017 | SESE |

## Top Applicants

- Ng Biotech — 2 clearances
- Biomerieux S.A. — 1 clearance

---

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

**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