GRAM NEGATIVE IDENTIFICATION PLUS CARD

K962609 · Biomerieux Vitek, Inc. · LRH · Aug 30, 1996 · Microbiology

Device Facts

• Record ID: K962609
• Device Name: GRAM NEGATIVE IDENTIFICATION PLUS CARD
• Applicant: Biomerieux Vitek, Inc.
• Product Code: LRH · Microbiology
• Decision Date: Aug 30, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.2660
• Device Class: Class 1

Indications for Use

The Vitek GNI+ Card is intended to be used in conjunction with the Vitek System for the automated identification of microorganism of the family Enterobacteriaceae. In addition, a select group of glucose non-fermenting gram-negative bacteria, and members of the family Vibrionaceae can be identified. In addition to the organisms currently claimed with the GNI Card, the GNI+ Card has added the following 13 new organism claims: Aeromanas veronii biovar veronii, Budvicia aquatica, Burkholdenia mallei, CDC Group EO-2, Chromobacterium violaceum, Edwardsiella hoshinae, Klebsiella ornithinolytica, Moellerella wisconsensis, Rahnella aquatilis, Shigella boydii/flexneri, Sphingobacterium spiritivorum, Sphingobacterium thalpophilum, Yokenella regensburgei (Koserella trabulsi).

Device Story

GNI+ Card consists of plastic card with 30 wells containing 28 dehydrated biochemical broths, negative control, and growth control. Used with Vitek System; saline suspension of pure culture isolated from patient specimen rehydrates broths. System performs biochemical tests; photometrically reads reactivity biopatterns. Incubation time 2-12 hours. Automated Vitek System analyzes patterns to identify microorganisms. Used in clinical laboratories; operated by laboratory technicians. Output provides organism identification; assists clinicians in diagnosing bacterial infections.

Clinical Evidence

Bench and clinical testing performed. Database development used 2974 well-characterized strains (96.9% correct identification). Clinical trials at three sites compared GNI+ to GNI card. Challenge set of 106 organisms showed 94.7% correct identification. Routine clinical isolates (n=130+) and stock collections tested. Overall correlation between GNI+ and GNI was 97.4%. Discrepancies resolved using API 20E, API NFT, or conventional biochemical methods.

Technological Characteristics

Plastic card with 30 wells; 28 dehydrated biochemical broths, negative control, growth control. Sensing principle: photometric reading of biochemical reactivity biopatterns. Energy source: automated Vitek System. Connectivity: integrated with Vitek System. Software: rule-based analysis of biopatterns.

Indications for Use

Indicated for automated identification of Enterobacteriaceae, select glucose non-fermenting gram-negative bacteria, and Vibrionaceae from pure culture patient 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

• Gram Negative Identification (GNI) Card

Reference Devices

• API 20E
• API NFT

Submission Summary (Full Text)

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K962609

# 510(k) Summary Statement

AUG 30 1996

| Company Name: | bioMérieux Vitek, Inc.
595 Anglum Drive
Hazelwood, MO 63042 |
| --- | --- |
| Contact Person: | David K Broadway
Phone: [phone]
Fax: [phone] |
| Date Prepared: | May 30, 1996 |
| Device Name: | Gram Negative Identification Plus (GNI+) Card |
| Classification | Automated Microorganism Differentiation
and Identification Device
Class I |
| Substantial Equivalence Claim: | bioMérieux Vitek, Inc.
Gram Negative Identification (GNI) Card |

## Device Description:

The GNI+ Card consists of a plastic card with thirty wells that contain 28 dehydrated biochemical broths, one negative control broth and one growth control broth. The broths are re-hydrated with a saline suspension of a pure culture isolated from a patient specimen. The GNI+ Card performs a variety of conventional and non-conventional biochemical tests that are based on established biochemical methods. Organism identification usually requires between 2-12 hours of incubation on the automated Vitek System.

## Intended Use:

The Vitek GNI+ Card is intended to be used in conjunction with the Vitek System for the automated identification of microorganism of the family Enterobacteriaceae. In addition, a select group of glucose non-fermenting gram-negative bacteria, and members of the family Vibrionaceae can be identified. In addition to the organisms currently claimed with the GNI Card, the GNI+ Card has added the following 13 new organism claims:

- Aeromanas veronii biovar veronii
- Budvicia aquatica
- Burkholdenia mallei
- CDC Group EO-2
- Chromobacterium violaceum
- Edwardsiella hoshinae
- Klebsiella ornithinolytica
- Moellerella wisconsensis
- Rahnella aquatilis
- Shigella boydii/flexneri
- Sphingobacterium spiritivorum
- Sphingobacterium thalpophilum
- Yokenella regensburgei (Koserella trabulsi)

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# Technological Characteristics

The GNI + Card maintains the same technological characteristics as GNI, i.e., conventional and nonconventional biochemical tests that are selectively metabolized by bacteria, resulting in reactivity biopatterns that may be photometrically read and analyzed by the automated Vitek System.

# Non Clinical Development Trials

A panel of 2974 strains were used to develop the GNI + database. These organisms were well characterized, having been previously previously identified by the GNI Card, API strips and/or conventional biochemicals. The GNI + Card correctly identified 96.9% of the tests run.

# Clinical Trials

Three clinical sites conducted the trials.

# Trial Design

The performance claims of the GNI+ card were validated by directly comparing to the current Vitek GNI Card. Discrepancies between the GNI+ and the current GNI were resolved by the API 20E (fermenters) or the API NFT (non-fermenters). Further discrepancies and also any sample that was identified by the GNI+ card as a species not claimed by the reference methodology(ies) was confirmed with conventional biochemical testing.

A panel of 106 challenge organisms bioMérieux Vitek which cover the range of the GNI+ card's performance claims, were tested. The challenge organisms were different isolates than those used to develop the database. Extremely rare or pathogenic organisms were excluded from this challenge set. A minimum of 130 routine clinical isolates were tested. These isolates were from fresh patient cultures as they were randomly submitted to the laboratory. Thirty to fifty isolates from the investigator's stock collection were tested in addition to the 130 clinical isolates. The GNI+ Card identified the challenge set provided by bioMérieux Vitek correctly 94.7% of the time. Overall correlation of GNI+ compared to GNI was 97.4%.

# Software Testing

GNI+ software analysis rules were tested extensively in-house and were also run at the clinical trial sites. A detailed protocol was established to challenge the performance of the GNI+ card based on the software specification. This software was designed, validated and tested according to established written procedures.

# Safety and Effectiveness Issues

The GNI+ data validates that the performance characteristics are reproducible, safe and effective. No adverse discrepancies were noted in the comparison studies. When used according to the package insert directions, the GNI+ Card will perform as claimed.

# Conclusions

The modifications to the database in order to incorporate the 13 new strains does not affect the safety or effectiveness of the GNI+ card, as demonstrated by the data included in this premarket notification. Overall correlation of GNI+ compared to GNI was 97.4%.