K Number

Device Name

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

Manufacturer

NANOSPHERE, INC

Date Cleared

2012-09-19

(33 days)

Product Code

PAM

Regulation Number

866.3365

Intended 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 continuousmonitoring 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 mecAmediated 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 Description

The Verigene® Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) is a molecular assay which relies on detection of specific nucleic acid targets in a microarray format. For each of the bacterial nucleic acid sequences detected by the BC-GP test. Capture and Mediator olizonucleotides are utilized for gold nanoparticle probe-based endpoint detection. The Canture oligonucleotides bind to a specific portion of the nucleic acid target and are themselves bound onto a substrate in the microarray. The Mediator oligonucleotides bind to a different portion of the same nucleic acid target and allow binding of a gold nanoparticle probe to a portion complementary to a gold nanoparticle probe. Specific silver enhancement of the bound gold nanoparticle probes at the capture sites results in gold-silver aggregates that scatter light with high efficiency. The BC-GP test is performed on the Verigene System, a "sample-to-result", fully automated, bench-top molecular diagnostics workstation. The Verigene System consists of two components: the Verigene Reader and the Verigene Processor SP. The BC-GP test utilizes single-use disposable test consumables and a self-contained Verigene Test Cartridge for each sample tested. For the BC-GP test, the Verigene System allows automated nucleic acid extraction from grampositive bacteria-containing blood culture specimens and target detection of bacteria-specific DNA. The Reader is the Verigene System's user interface, which serves as the central control unit for all aspects of test processing and results generation. The Reader's graphical user interface guides the user through test processing and test results using a barcode scanner. The user inserts the Test Cartridge into the Verigene Processor SP, which executes the test procedure, automating the steps of ( ) Sample Preparation - Cell lysis and magnetic bead-bacterial DNA isolation from blood culture samples and (2) Hybridization - Detection and identification of bacterialspecific DNA in a microarray format by using gold nanoparticle probe-based technology. After test processing is complete, to obtain the test results the user removes the Test Cartridge from the Processor SP, removes the reagent pack from the substrate holder, and inserts the substrate holder into the Reader for analysis. Light scatter from the capture spots is imaged by the Reader and intensities from the microarray spots are used to make decisions regarding the presence (Detected) or absence (Not Detected) of a bacterial nucleic acid sequence/analyte.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K113450

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description details a molecular assay based on nucleic acid detection and microarray analysis, with no mention of AI or ML algorithms for data interpretation or decision-making. The decision-making process is described as based on light scatter intensities from microarray spots.

Therapeutic

No
This device is an in vitro diagnostic test used to detect and identify bacteria and resistance markers, aiding in the diagnosis of bacterial bloodstream infections. It does not provide therapy or treatment.

Diagnostic

Yes

The device is explicitly described in the "Intended Use / Indications for Use" section as 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)." It further states it is "indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial bloodstream infections."

SaMD (Software as a Medical Device)

The device description clearly outlines hardware components: the Verigene Reader and the Verigene Processor SP, which are integral to the test's operation. The software runs on and controls these hardware components.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

The "Intended Use / Indications for Use" section explicitly states: "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)."

This statement directly identifies the device as an in vitro diagnostic test.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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 mecAmediated 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.

Product codes (comma separated list FDA assigned to the subject device)

PAM

Device Description

The BC-GP test is performed on the Verigene System, a "sample-to-result", fully automated, bench-top molecular diagnostics workstation. The Verigene System consists of two components: the Verigene Reader and the Verigene Processor SP. The BC-GP test utilizes single-use disposable test consumables and a self-contained Verigene Test Cartridge for each sample tested. For the BC-GP test, the Verigene System allows automated nucleic acid extraction from grampositive bacteria-containing blood culture specimens and target detection of bacteria-specific DNA.

The Reader is the Verigene System's user interface, which serves as the central control unit for all aspects of test processing and results generation. The Reader's graphical user interface guides the user through test processing and test results using a barcode scanner. The user inserts the Test Cartridge into the Verigene Processor SP, which executes the test procedure, automating the steps of ( ) Sample Preparation - Cell lysis and magnetic bead-bacterial DNA isolation from blood culture samples and (2) Hybridization - Detection and identification of bacterialspecific DNA in a microarray format by using gold nanoparticle probe-based technology.

After test processing is complete, to obtain the test results the user removes the Test Cartridge from the Processor SP, removes the reagent pack from the substrate holder, and inserts the substrate holder into the Reader for analysis. Light scatter from the capture spots is imaged by the Reader and intensities from the microarray spots are used to make decisions regarding the presence (Detected) or absence (Not Detected) of a bacterial nucleic acid sequence/analyte.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Bloodstream

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Analytical studies performed to support the expanded intended use/indications of the test are described in part & below. The full analytical and clinical performance data establishing the performance characteristics of the BC-GP test was completed in support of K113450 and remain unchanged for the device as modified under this 510(k).

Analytical Testing of Additional Culture Bottles:
The BC-GP analytical and clinical validations used to support K113450 were performed primarily with two types of aerobic blood culture bottles, BACTEC™ Plus Aerobic/F (Becton-Dickinson) and BacT/ALERT FA FAN® (bioMérieux). The suitability of five additional blood culture bottles for use with BC-GP, including BACTEC™ Standard/10 Aerobic/F, BACTEC™ Peds Plus™/F, BacT/ALERT SA Standard Aerobic, BacT/ALERT PF Pediatric FAN, and BACTEC™ Plus Anaerobic/F bottles was also demonstrated in an analytical interference study described in K113450.

To support the expanded intended use of the BC-GP test, a new study was performed to evaluate additional culture bottles and a third automated culture system. Six bottles types were tested, including the BACTEC Standard Anaerobic/F, BACTEC Lytic/10 Anaerobic/F, BacT/ALERT SN Anaerobic, BacT/ALERT FN FAN Anaerobic, as well as the VersaTREK REDOX 1 EZ Draw Aerobic® and VersaTREK REDOX 2 EZ Draw Anaerobic® bottles used on the VersaTREK® system.

To evaluate performance of these six additional bottles types, representative strains of S. aureus (methicillin resistant), S. epidermidis (methicillin-resistant), E. faecium (vancomycin-resistant), S. pneumoniae, and L. monocytogenes were inoculated into seven replicates of each blood culture bottle type, grown until "bottle positivity" and tested with BC-GP. All of the six bottle types demonstrated acceptable performance, with the expected targets detected for all tests performed with two exceptions: a) two of twenty-one replicates of MRSE in BACTEC Lytic/10 Anaerobic/F bottles were positive for Staphylococcus spp. but negative for S. epidermidis and mecA, and b) one replicate of Listeria monocytogenes in a VersaTREK REDOX 2 EZ DRAW/Anaerobic (Trek N) bottle detected Staphylococcus spo. in addition to the Listeria spp. target. Product labeling includes information regarding detection of MRSE in BACTEC Lytic/10 Anaerobic/F bottles and the potential cross-reactivity of Listeria species with BC-GP Staphylococcus species probes.

Therefore, in total analytical testing demonstrated acceptable performance of thirteen blood culture bottle typeswith the BC-GP test.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K113450

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 866.3365 Multiplex nucleic acid assay for identification of microorganisms and resistance markers from positive blood cultures.

(a)
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.(b)
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).

Summary

Image /page/0/Picture/0 description: The image shows the word "Nanosphere" in a bold, sans-serif font. To the left of the word is a circular logo that is divided into two halves. The left half is solid black, while the right half is filled with diagonal lines. The logo and the word "Nanosphere" are aligned horizontally.

510(k) Summary

19 200

The Summary for this 510(k) submission is submitted in accordance with the requirements of SMDA 1900 and CFR 807.92

510(k) Number:

K122514 Verigene® Gram-Positive Blood Culture Nucleic Acid Test (BC-GP)

Summary Preparation Date:

September 17, 2012

Submitted by:

Nanosphere, Inc. 4088 Commercial Avenue Northbrook, IL 60062 Phone: 847-400-9000 Fax: 847-400-9199

Contact:

Mark Del Vecchio Vice President, Regulatory Affairs

Proprietary Names:

For the instrument:

Verigene® System

For the assay:

Verigene® Gram-Positive Blood Culture Nucleic Acid Test (BC-GP)

Common Names:

For the instrument:

Bench-top molecular diagnostics workstation

For the assay:

Rapid gram-positive blood culture assay Multiplex gram-positive blood culture assay

Purpose for Submission:

To expand the intended use/indications for use of the test for the non-specific use of commercially-available blood culture bottles.

Measurand:

Bacterial-specific nucleic acid sequences of 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, and resistance markers mecA, vanA, and vanB.

Type of Test:

Qualitative, multiplexed test for the detection of specific nucleic acid targets in a microarrav format using capture and mediator oligonucleotides for gold nanoparticle probe-based endpoint detection.

Applicant:

Nanosphere, Inc.

Regulatory Information:

1. Regulation section:
  21 CFR 866.3365 - Multiplex Nucleic Acid Assay for Identification of Microorganisms and Resistance Markers from Positive Blood Cultures
1. Classification:
  Class II
1. Product code:
  PAM
1. Panel:
  Microbiology (83)

Intended Use:

1. Intended use(s):
  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 continuousmonitoring 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 pvogenes. 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 mecAmediated methicillin resistance to either S. aureus or S. epidermidis.

1. Indication(s) 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 continuousmonitoring 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/vanBmediated vancomycin resistance. In mixed growth, BC-GP does not specifically attribute van-mediated vancomycin resistance to either E. faecalis or E. faecium, or mecAmediated methicillin resistance to either S. aureus or S. epidermidis.

1. Special conditions for use statement(s):
  Prescription use only
1. Special instrument requirements:
  Performed using the sample-to-result Verigene System

Device Description:

Substantial Equivalence Information:

1. Predicate device name(s):
  Verigene® Gram-Positive Blood Culture Nucleic Acid Test (BC-GP)
1. Predicate 510(k) number(s):
  K113450

3. Comparison with predicate:

Similarities
Item	Device	Predicate
Intended Use (General)	Qualitative, multiplexed in vitro diagnostic test for the simultaneous detection and identification of potentially pathogenic gram-positive bacteria which may cause bloodstream infection (BSI).	Same
Test Cartridge	Disposable single-use, multi-chambered fluidic cartridge.	Same
Nucleic Acid Target	Staphylococcus:
tuf, gyrB, hsp60, mecA, sodA
Enterococcus:
hsp60, vanA, vanB
Streptococcus :
tuf, hsp60, gyrB
Listeria sp.:
tuf	Same
Sample Prep	Automated DNA extraction	Same
Quality control	Internal procedural/instrument quality controls; Internal Negative Control, Sample processing control, external positive and negative assay controls	Same
Interpretation of Results	Diagnostic Software/Decision Algorithm	Same

Differences
Item	Device	Predicate
Intended Use
(Sample type)	Analysis of positive blood
culture bottles (unspecified)
which contain gram-positive
bacteria.	Analysis of positive blood
cultures using BACTEC
PlusTM Aerobic/F and
BacT/ALERT FA FAN®
Aerobic blood culture bottles,
which contain gram-positive
bacteria.

Standard/Guidance Document Referenced (if applicable):

Not applicable

Test Principle:

The Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) is a qualitative, multiplexed molecular assay which relies on detection of specific nucleic acid targets in a microarray format. Bacterial DNA from the organisms present in a positive blood culture media specimen is extracted, fragmented and denatured. This fragmented, single-stranded bacterial DNA hybridizes to complementary sequence-specific DNA oligonucleotides. known as capture oligonucleotides, arrayed on the surface of a substrate. A second oligonucleotide with two sequence domains, called a mediator oligonucleotide, then hybridizes to the captured bacterial DNA. In addition to a sequence complementary to the bacterial DNA target, the mediator oligonucleotide contains a sequence domain complementary to a common oligonucleotide probe that is bound to gold nanoparticles. After washing away any DNA not affixed to the captures, the common probe is exposed to the microarray where it hybridizes to any captured mediator/target complexes. Presence of the silver-enhanced gold nanoparticle probes at a particular location on the substrate is determined optically with the Verigene Reader. The relative density of probes at each set of captures on the substrate is then translated into a signal intensity which is used to assess the presence or absence of captured DNA from a target organism.

Performance Characteristics (if/when applicable):

1. Analytical performance:
- a. Precision/Reproducibility: Refer to K113450
- . b. Linearity/assay reportable range: Not applicable
- Traceability, Stability, Expected values (controls, calibrators, or methods): C. Refer to K113450
- d. Detection limit: Refer to K113450
- e. Analytical specificity: Refer to K113450
- Assay cut-off: f. Refer to K113450

g. Analytical Testing of Additional Culture Bottles

The BC-GP analytical and clinical validations used to support K113450 were performed primarily with two types of aerobic blood culture bottles, BACTEC™ Plus Aerobic/F (Becton-Dickinson) and BacT/ALERT FA FAN® (bioMérieux). The suitability of five additional blood culture bottles for use with BC-GP, including BACTEC™ Standard/10 Aerobic/F, BACTEC™ Peds Plus™/F, BacT/ALERT SA Standard Aerobic, BacT/ALERT PF Pediatric FAN, and BACTEC™ Plus Anaerobic/F bottles was also demonstrated in an analytical interference study described in K113450.

Therefore, in total analytical testing demonstrated acceptable performance of thirteen blood culture bottle typeswith the BC-GP test.

1. Comparison studies:
- a. Method comparison with predicate device: Refer to K113450
- b. Matrix comparison: Not applicable
1. Clinical studies:
- a. Clinical Sensitivity: Not applicable

Clinical specificity: b. Not applicable
Other clinical supportive data (when a. and b. are not applicable): C. Not applicable
1. Clinical cut-off:

Not applicable

1. Expected values/Reference range: Not applicable

Instrument Name:

Nanosphere Verigene® System (Verigene Processor SP and Verigene Reader)

System Descriptions:

1. Modes of Operation:
  The Verigene System operates in a random access mode, with fully automated 'sample to result' performance. A single Verigene Reader can independently control up to thirtytwo Verigene Processor SP units.
1. Software:
  FDA has reviewed applicant's Hazard Analysis and software development processes for this line of product types:

X Yes or No

1. Specimen Identification:
  Specimens are labeled with a Barcode. The Processor SP and Reader detect the specimen ID and the assay results are printed with this specimen identifier.
1. Specimen Sampling and Handling:
  Automated Verigene System
1. Calibration:
  Not required
1. Quality Control:
  A series of internal controls, used in conjunction with procedural checks, monitors instrument functionality, performance, fluidics, reagent integrity, and result determination, based on a pre-defined decision algorithm.

For external controls, known culture-confirmed blood culture specimens positive for each

of the BC-GP test panel organisms may be tested routinely as defined by the user's laboratory's standard operating procedures on a rotating basis using 3-4 smaller groups of organisms, and/or under the following circumstances:

. Instrument installation, test validation, and when troubleshooting is necessary
. During performance verification for receipt of a new set/lot of consumables;
. When the integrity of consumables or the device is in question.

Frozen aliquots of blood cultures containing these organisms may be used for this purpose.

All external quality control requirements and testing should be performed in conformance with local, state, and federal regulations or accreditation organizations as applicable and should follow the user's laboratory's standard quality control procedures.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Nanosphere, Inc. c/o Mark Del Vecchio VP of Regulatory Affairs and Quality 4088 Commercial Avenue Northbrook, IL 60062

SEP 19 2012

Re: K122514

Trade/Device Name: Verigene® Gram Positive Blood Culture Nucleic Acid Test (BC-GP) Regulation Number: 21 CFR 866.3365 Regulation Name: Multiplex Nucleic Acid Assay for Identification of Microorganisms and Resistance Markers from Positive Blood Cultures Regulatory Class: Class II Product Code: PAM Dated: August 15, 2012 Received: August 17, 2012

Dear Mr. Del Vecchio:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of

Page 2 - Mr. Mark Del Vecchio

medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office

of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sayutty

Sally A. Hojvat, M.Sc., Ph.D Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

Verigene® Gram Positive Blood Culture (BC-GP) Nucleic Acid Test Traditional 510(k) Pre-Market Notification- Expanded Indications K122514

Indications for Use Statement

K122514 510(k) Number (if known):

Device Name: Verigene® Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) on the Verigene® System

The Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) performed using the sample-toresult 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.	Streptococcus spp.	Enterococcus faecalis
Staphylococcus aureus	Streptococcus pneumoniae	Enterococcus faecium
Staphylococcus epidermidis	Streptococcus pyogenes
Staphylococcus lugdunensis	Streptococcus agalactiae	Listeria spp.
	Streptococcus anginosus group

In addition, BC-GP detects the mecA resistance marker, inferring mecA-mediated methicillin resistance, and the vanA and vanB resistance markers, inferring vanAlvanB-mediated vancomycin resistance. In mixed growth. BC-GP does not specifically attribute van-mediated vancomycin resistance to either E. faecalis or E. faccium, 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. Subculturing 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.

Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

and/or

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Eualdi A. Cook

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety Nanosphere, Inc.

510(k) K122514

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