MICROSCAN RAPID GRAM-NEGATIVE INDENTIFICATION TYPE 3 PANEL

K961042 · Dade Microscan, Inc. · LRH · May 30, 1996 · Microbiology

Device Facts

• Record ID: K961042
• Device Name: MICROSCAN RAPID GRAM-NEGATIVE INDENTIFICATION TYPE 3 PANEL
• Applicant: Dade Microscan, Inc.
• Product Code: LRH · Microbiology
• Decision Date: May 30, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.2660
• Device Class: Class 1

Indications for Use

Rapid identification of non-fastidious aerobic and facultatively anaerobic gram-negative bacilli from human clinical specimens

Device Story

MicroScan Rapid Gram-Negative Identification Type 3 Panel is a diagnostic test for identifying gram-negative bacilli. Device utilizes biochemical test wells to analyze bacterial isolates from human clinical specimens. Principle of operation involves biochemical reactions within the panel wells to produce identification results. Used in clinical laboratories by trained personnel. Output consists of bacterial identification at the species level. Results assist clinicians in identifying pathogens to guide treatment decisions. Benefits include rapid turnaround time for identification compared to conventional methods.

Clinical Evidence

Efficacy testing performed at two external sites using 405 fresh and stock gram-negative isolates. Comparison against API 20E system and conventional tube methodologies showed 97.1% (393/405) agreement at the species level. Reproducibility testing across three sites (two external, one internal) using 15 stock isolates showed >95% agreement. Quality control testing performed with eight strains and a saline blank; user QC recommendations align with NCCLS Document M7-A3.

Technological Characteristics

Microbiological identification panel containing biochemical test wells. Operates via biochemical reaction principles. Designed for use with non-fastidious aerobic and facultatively anaerobic gram-negative bacilli. Quality control procedures follow NCCLS Document M7-A3 standards.

Indications for Use

Indicated for the rapid identification of non-fastidious aerobic and facultatively anaerobic gram-negative bacilli from human clinical specimens.

Regulatory Classification

Identification

A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.

Predicate Devices

• MicroScan® Rapid Gram-Negative Identification Type 2 Panel
• API 20E System

Submission Summary (Full Text)

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DADE
510(k) Summary - Attachment 1 Page 1 of 2
K961042
MAY 30 1996
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 28, 1996 |
| Product Name: | Microbiological Identification System |
| Trade Name: | MicroScan® Rapid Gram-Negative Identification Type 3 Panel |
| Intended Use: | Rapid identification of non-fastidious aerobic and facultatively anaerobic gram-negative bacilli from human clinical specimens |
| 510(k) Notification: | Modified Device Request |
| Predicate devices: | MicroScan® Rapid Gram-Negative Identification Type 2 Panel API 20E System |

# 510(k) Summary:

The proposed MicroScan® Rapid Gram-Negative Identification Panel (referred to as the MicroScan RNID Type 3 panel) is substantially equivalent in intended use, technology, and methodology to the current MicroScan® Rapid Gram-Negative Identification Type 2 Panel and is substantially equivalent to the API 20E System with regard to performance.

The Premarket Notification (510[k]) presents data in support of a formulation modification for the current MicroScan® Rapid Gram-Negative Identification Type 2 Panel and requests a release to market for the modified device (i.e., the MicroScan® Rapid Gram-Negative Identification Type 3 Panel).

Efficacy testing was conducted with a total of 405 fresh and stock gram-negative isolates at two (2) external sites. MicroScan® Rapid Gram-Negative Identification Type 3 Panel identifications were compared with API 20E System identifications. Isolates meeting a pre-defined criteria were either repeated and/or were arbitrated using conventional tube methodologies. Overall the MicroScan RNID Type 3 panel demonstrated a combined final agreement (percent agreement at the species level, high and low probabilities) of 97.1% (393/405) when compared with API 20E System identifications supplemented with conventional tube methodologies. There was only one (1) Very Rare Biotype (VRB) result.

Reproducibility testing with the MicroScan® Rapid Gram-Negative Identification Type 3 Panel (RNID) was comprised of 15 stock isolates tested at two (2) external sites and at MicroScan. Reproducibility was evaluated using individual biochemical test results, biotype frequencies, and overall identification performance. Overall the MicroScan RNID Type 3 panel gave results which were > 95% in agreement with expected results.

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510(k) Summary - Attachment 1 Page 2 of 2

Dade MicroScan Inc.
May 28, 1996
MicroScan® Rapid Gram-Negative Identification Type 3 Panel

Quality control (QC) testing with the MicroScan® Rapid Gram-Negative Identification Type 3 Panel (RNID) was conducted with eight (8) strains and a saline blank. Quality control (QC) testing was performed on the API 20E System at the clinical trial sites according to the API 20E procedure manual. The QC performance was acceptable for both systems during the clinical trial. The four (4) strains recommended for routine user (customer) QC for the MicroScan RNID Type 3 panel provide adequate coverage to verify that the panel is performing as expected during routine use (e.g., > 95% agreement). User QC recommendations fulfill the requirements for user QC as described by NCCLS Document M7-A3 (Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically, Ed.3; Approved Standard. Pennsylvania, NCCLS, December 1993).

We therefore believe that the MicroScan® Rapid Gram-Negative Identification Type 3 Panel (RNID) gives appropriate rapid identifications with non-fustidious aerobic and facultatively anaerobic gram-negative bacilli from human clinical specimens.

510K-SUM.DOC
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