VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST— 510(k) K122514

Clearance details

Applicant

Nanosphere, Inc.

Product code

Code PAM

Device class

Class 2

Regulation

21 CFR 866.3365

Advisory panel

Microbiology

Date received

2012-08-17

Decision date

2012-09-19

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Northbrook, IL, US

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• K143653 — Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex)2015-09-04
• K140083 — VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST ( EP)2014-06-20
• K132843 — VERIGENE GRAM NEGATIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GN)2014-01-08
• K123197 — VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF)2012-12-05
• K120466 — VERIGENE CYP2C19 NUCLEIC ACID TES (2C19)2012-11-06

Death

6

Malfunction

598

Total

604

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-2533-2024 — Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid TestClass II·Ongoing·Luminex Corporation·20240620
• Z-0500-2024 — Luminex VERIGENE BC-GP Utility Tray (5-Pack Carrier), Gram-Positive Blood Culture Nucleic Acid Test, REF 20-011-018, a component of the Luminex VERIGENE BC-GP Utility Kit, REF 20-012-018, containing 20 tests.Class II·Ongoing·Luminex Corporation·20231107
• Z-2007-2021 — Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) Model Number: 20-006-018Class II·Ongoing·Luminex Corporation·20201030
• Z-2775-2020 — Verigene Processor SP with assay: Luminex, VERIGENE Gram-Positive Blood Culture Nucleic Acid Test,BC-GP, IVD - Product Usage: utilizes a single-use disposable test consumables and a self-contained Verigene Test Cartridge for each sample tested.Class II·Terminated·Luminex Corporation·20200615
• Z-0822-2019 — Vergene Amplification Tray - 700uL, BC-GP REF 20-011-018 The Verigene(R) 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.Class III·Terminated·Luminex Corporation·20181226
• Z-0445-2019 — VERIGENE Blood Culture Gram-Positive Nucleic Acid Kits (packaged as five-pack carriers) Product Usage: In vitro diagnostic test for the simultaneous detection and identification of potentially pathogenic gram-positive bacteria.Class II·Terminated·Luminex Corporation·20180914
• Z-2683-2014 — The Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-UP) 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-UP is performed directly on blood culture bottles identified as positive by a continuous monitoring blood culture system and which contain gram-positive bacteria. BC-UP 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-UP detects the mnecA resistance marker, inferring mecA-mediated, methicillin resistance, and the vanA and vanB resistance markers, inferring vanA/vanB-mediated vancomycin resistance. In mixed growth, BC-UP 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-UP 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-UP, differentiation of mixed growth, association of antimicrobial resistance marker genes to a specific organism, or for epidemiological typing.Class II·Terminated·Nanosphere, Inc.·20131010
• Z-2735-2014 — Verigene BC-GP Kit (Catalog number 20-005-018); 1) 20 Verigene BC-GP Test Cartridges; are qualitative multiplexed in vitro diagnostic tests for simultaneous detection and identification of selected gram-positive (BC-GP) and gram-negative (BC-GN) bacteria and resistance markers.Class II·Terminated·Nanosphere, Inc.·20130617

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K122514.