← Product Code [LTT](/productcode/LTT) · K962150

# DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS (K962150)

_Dade Intl., Inc. · LTT · Aug 16, 1996 · Microbiology · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K962150

## Device Facts

- **Applicant:** Dade Intl., Inc.
- **Product Code:** [LTT](/productcode/LTT.md)
- **Decision Date:** Aug 16, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.1640
- **Device Class:** Class 2
- **Review Panel:** Microbiology

## Indications for Use

To determine antimicrobial agent susceptibility

## Device Story

MicroScan® Dried Gram-Negative and Gram-Positive MIC/Combo Panels used in clinical microbiology laboratories to determine minimum inhibitory concentrations (MIC) of Cefepime. Panels contain dehydrated antimicrobial agents; inoculated with bacterial isolates using various methods (Turbidity, Log, Stationary, Prompt). Panels incubated and read via autoScan-4® or WalkAway® instruments. Output provides MIC values to guide antibiotic therapy selection. Benefits include standardized, reproducible susceptibility testing for patient infection management.

## Clinical Evidence

Bench testing only. External evaluations compared dried Cefepime panels against NCCLS frozen reference panels using fresh/stock efficacy isolates and stock challenge strains. Gram-negative panels: 98.6% Essential Agreement. Gram-positive panels: 95.9% Essential Agreement. Reproducibility testing performed across multiple inoculum methods (Turbidity, Log, Stationary, Prompt) and instruments (autoScan-4, WalkAway). Quality control performance acceptable.

## Technological Characteristics

Dried microdilution panels containing antimicrobial agents. Compatible with autoScan-4® and WalkAway® automated reading instruments. Supports multiple inoculum methods: Turbidity, Log, Stationary, and Prompt.

## Regulatory 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.

## Predicate Devices

- NCCLS Frozen Cefepime Reference Panels

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [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/).

{0}

DADE
K962150
Attachment A - 510(k) SUMMARY
DADE INTERNATIONAL
MicroScan Inc
1584 Enterprise Boulevard
West Sacramento, CA 95691
916.372.1900

## 510(k) Submission Information:

|  Device Manufacturer: | Dade MicroScan Inc.  |
| --- | --- |
|  Contact name: | Sharolyn Lentsch, Sr. Regulatory Affairs Administrator  |
|  Fax: | 916-374-3144  |
|  Date prepared: | May 31, 1996  |
|  Product Name: | Microdilution Minimum Inhibitory Concentration (MIC) Panels  |
|  Trade Name: | MicroScan® Dried Gram-Negative and Gram-Positive MIC/Combo Panels  |
|  Intended Use: | To determine antimicrobial agent susceptibility  |
|  510(k) Notification: | New antimicrobial - Cefepime  |
|  Predicate device: | NCCLS Frozen Cefepime Reference Panels  |

## 510(k) Summary:

The proposed MicroScan® Dried Gram-Negative and Gram-Positive MIC/Combo Panel with Cefepime demonstrated substantially equivalent performance when compared with an NCCLS frozen Cefepime Reference Panel, as defined in the FDA DRAFT document "Review Criteria for Assessment of Antimicrobial Susceptibility Devices" (dated May 31, 1991).

The Premarket Notification (510[k]) presents data in support of the new antimicrobial, Cefepime, for the MicroScan® Dried Gram-negative and Gram-positive MIC/Combo Panels.

Both the gram-negative and gram-positive external evaluations were conducted with fresh and stock Efficacy isolates and stock Challenge strains. The external evaluations were designed to confirm the acceptability of the proposed Dried Cefepime panels by comparing their performance with an NCCLS frozen Cefepime Reference panel.

The Dried gram-negative Cefepime panel demonstrated acceptable performance with an overall Essential Agreement of 98.6% when compared with the frozen Cefepime Reference panel. The Dried gram-positive Cefepime panel demonstrated acceptable performance with an overall Essential Agreement of 95.9% when compared with the frozen Cefepime Reference panel.

Inoculum and instrument reproducibility testing was conducted; both the gram-negative and the gram-positive Dried Cefepime panels demonstrated acceptable reproducibility and precision, regardless of which inoculum method (i.e., Turbidity, Log, Stationary, and Prompt), or instrument (autoScan-4® and WalkAway®) was used.

Quality Control performance was acceptable for both the gram-negative and the gram-positive Dried Cefepime panels.

510k-sum.doc
Page 248

---

**Source:** [https://fda-staging.innolitics.com/device/K962150](https://fda-staging.innolitics.com/device/K962150)

**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