VITEK GRAM POSITIVE IDENTIFICATION CARD (GPI)

K952095 · Biomerieux Vitek, Inc. · LQL · Mar 12, 1996 · Microbiology

Device Facts

• Record ID: K952095
• Device Name: VITEK GRAM POSITIVE IDENTIFICATION CARD (GPI)
• Applicant: Biomerieux Vitek, Inc.
• Product Code: LQL · Microbiology
• Decision Date: Mar 12, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.2660
• Device Class: Class 1

Intended Use

The VITEK® Gram Positive Identification Card containing new claims for the identification of Enterococcus casseliflavus, Enterococcus gallinarum, Enterococcus hirae is intended for use in conjunction with the Vitek® System for the automated identification of clinically significant streptococci, staphylococci, and a selected group of Gram positive bacilli.

Device Story

Vitek GPI Card used with Vitek System for automated identification of Gram-positive bacteria; system processes biochemical reactions on card to identify species; software update adds Enterococcus casseliflavus, Enterococcus gallinarum, and Enterococcus hirae to existing identification database; used in clinical microbiology laboratories; results assist clinicians in identifying pathogens for diagnostic purposes.

Clinical Evidence

Clinical correlation studies on enterococcal isolates showed 96.7% correct genus identification and 91.1% correct species identification after repeat/supplemental testing; 3.3% mis-identification rate; equivalency study showed 99.8% agreement between new and current software for non-enterococcal isolates.

Technological Characteristics

Vitek GPI Card; automated biochemical identification system; software-based identification logic; updated database for specific Enterococcus species.

Indications for Use

Indicated for automated identification of clinically significant streptococci, staphylococci, and selected Gram-positive bacilli, including Enterococcus casseliflavus, Enterococcus gallinarum, and Enterococcus hirae.

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.

Submission Summary (Full Text)

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bioMérieux

MAR 12 1996

# Summary of Safety and Effectiveness Information for the Enterococcus spp. claims added to the Vitek® GPI Card

The VITEK® Gram Positive Identification Card containing new claims for the identification of *Enterococcus casseliflavus*, *Enterococcus gallinarum*, *Enterococcus hirae* is intended for use in conjunction with the Vitek® System for the automated identification of clinically significant streptococci, staphylococci, and a selected group of Gram positive bacilli.

Safety and effectiveness issues for the new software which contains the three additional species claims for *Enterococcus* for the bioMérieux Vitek GPI include the following considerations:

- The study was designed to validate the addition of six new species of enterococcus to the bioMérieux Vitek, Inc. GPI software. After clinical testing was performed it was determined that the addition of *Enterococcus malodoratus*, *Enterococcus raffinosus* and *Enterococcus mundtii* did not improve the software. Not only was the testing on these organisms irreproducible, the react file lines affected the accuracy of the *Enterococcus faecium* call. *Enterococcus malodoratus* is not a clinical isolate and the other two species have little clinical utility, therefore it was determined to limit the FDA submission data to *Enterococcus casseliflavus*, *Enterococcus gallinarum* and *Enterococcus hirae*.

- Performance characteristics: Performance of the GPI Card remains the same utilizing the new software compared to the current software as documented by clinical testing. The addition of three new enterococcal species does not affect the performance of the GPI card.

- Reproducibility: The new software reproducibly identifies specified gram-positive organisms.

- The Correlation Studies on enterococcal isolates gave a correct genus call 96.7% of the time after repeat and supplemental testing. Of these, 91.1% also correctly identified to the species level. Mis-identifications occurred at 3.3%.

- Performance of the GPI Card for non-enterococcal isolates remains the same utilizing the new software compared to the current software. The addition of three new enterococcal species does not affect the performance of the GPI Card as documented by clinical testing. In the Equivalency Study, the overall agreement of identification between the new software and the current software occurred at 99.8%.

bioMérieux Vitek, Inc.

595 Anglum Drive, Hazelwood, Missouri 63042-2395, USA

Phone: [phone] Fax: [phone]

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bioMérieux

# Summary of Safety and Effectiveness Information for the Enterococcus spp. claims added to the Vitek® GPI Card

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- Validation of software design: The software Certification Statement attests to our adherence to design, validation and testing procedures, and that release of this software takes place only when these written criteria are met.

When used within the context of the package insert, the new software containing the new Enterococcus species will perform as claimed. Additional information may be found in the package insert and technical bulletin.