VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST

K122514 · Nanosphere, Inc. · PAM · Sep 19, 2012 · Microbiology

Device Facts

• Record ID: K122514
• Device Name: VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST
• Applicant: Nanosphere, Inc.
• Product Code: PAM · Microbiology
• Decision Date: Sep 19, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3365
• Device Class: Class 2

Indications for Use

The Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) performed using the sample-to-result Verigene System is a qualitative, multiplexed in vitro diagnostic test for the simultaneous detection and identification of potentially pathogenic gram-positive bacteria which may cause bloodstream infection (BSI). BC-GP is performed directly on blood culture bottles identified as positive by a continuous monitoring blood culture system and which contain gram-positive bacteria. BC-GP detects and identifies the following bacterial genera and species: Staphylococcus spp., Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunensis, Enterococcus faecalis, Enterococcus faecium, Streptococcus spp., Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus anginosus group, and Listeria spp. In addition, BC-GP detects the mecA resistance marker, inferring mecA-mediated methicillin resistance, and the vanA and vanB resistance markers, inferring vanA/vanB-mediated vancomycin resistance. In mixed growth, BC-GP does not specifically attribute van-mediated vancomycin resistance to either E. faecalis or E. faecium, or mecA-mediated methicillin resistance to either S. aureus or S. epidermidis. BC-GP is indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial bloodstream infections; however, is not to be used to monitor these infections. Sub-culturing of positive blood cultures is necessary to recover organisms for susceptibility testing, identification of organisms not detected by BC-GP, differentiation of mixed growth, association of antimicrobial resistance marker genes to a specific organism, or for epidemiological typing.

Device Story

The Verigene System is a bench-top molecular diagnostics workstation for clinical laboratories. It processes positive blood culture bottles to identify gram-positive bacteria and resistance markers. The system uses disposable test cartridges for automated nucleic acid extraction, target hybridization, and gold nanoparticle probe-based detection. The Verigene Reader images light scatter from silver-enhanced gold nanoparticle aggregates on a microarray to determine the presence or absence of specific DNA sequences. Results are provided to clinicians to aid in the diagnosis of bloodstream infections, enabling faster identification of pathogens compared to traditional culture methods. The device does not replace sub-culturing for susceptibility testing or mixed growth differentiation.

Clinical Evidence

Bench testing only. Analytical studies evaluated the performance of the BC-GP test with six additional blood culture bottle types (Becton-Dickinson and bioMérieux brands) across three automated culture systems. Testing confirmed acceptable performance for the detection of representative strains of S. aureus, S. epidermidis, E. faecium, S. pneumoniae, and L. monocytogenes. No new clinical studies were required as clinical performance data from the predicate (K113450) remains applicable.

Technological Characteristics

Molecular assay using microarray format with capture and mediator oligonucleotides. Detection via gold nanoparticle probes with silver enhancement. Automated sample-to-result processing on the Verigene System (Processor SP and Reader). Connectivity via barcode scanner for specimen ID. Software-based decision algorithm for result interpretation. Class II device.

Indications for Use

Indicated for patients with suspected bacterial bloodstream infections (BSI). Used on positive blood culture bottles containing gram-positive bacteria to identify specific pathogens (Staphylococcus spp., S. aureus, S. epidermidis, S. lugdunensis, Enterococcus faecalis, E. faecium, Streptococcus spp., S. pneumoniae, S. pyogenes, S. agalactiae, S. anginosus group, Listeria spp.) and resistance markers (mecA, vanA, vanB). Not for infection monitoring.

Regulatory Classification

Identification

A multiplex nucleic acid assay for identification of microorganisms and resistance markers from positive blood cultures is a qualitative in vitro device intended to simultaneously detect and identify microorganism nucleic acids from blood cultures that test positive by Gram stain or other microbiological stains. The device detects specific nucleic acid sequences for microorganism identification as well as for antimicrobial resistance. This device aids in the diagnosis of bloodstream infections when used in conjunction with other clinical and laboratory findings. However, the device does not replace traditional methods for culture and susceptibility testing.

Special Controls

In combination with the general controls of the FD&C Act, the Verigene® Gram Positive Blood Culture Nucleic Acid Test is subject to the following special controls: The special controls for the BC-GP Assay are contained in the guideline document entitled "Class II Special Controls Guideline: Multiplex Nucleic Acid Assay for Identification of Microorganisms and Resistance Markers from Positive Blood Cultures."

*Classification.* Class II (special controls). The special control for this device is FDA's guideline document entitled “Class II Special Controls Guideline: Multiplex Nucleic Acid Assay for Identification of Microorganisms and Resistance Markers from Positive Blood Cultures.” For availability of the guideline document, see § 866.1(e).

Submission Summary (Full Text)

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Decision Summary, k122514

This 510(k) was reviewed under OIVD’s Pilot Triage Program. This program represents an internal workload management tool intended to reduce internal FDA review resources for 510(k) applications that are of good quality upon receipt by FDA.

The information in the 510(k) is complete and supports a substantial equivalence (SE) determination. Please refer to the applicant’s 510(k) summary for a summary of the information that supports this SE determination.