VITEK® 2 Streptococcus Moxifloxacin is designed for antimicrobial susceptibility testing of Streptococcus species and is intended for use with the VITEK® 2 and VITEK® 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK® 2 Streptococcus Moxifloxacin is a quantitative test. Moxifloxacin has been shown to be active against most isolates of the microorganisms listed below, according to the FDA label for this antimicrobial.

Active in vitro and in clinical infections
Streptococcus anginosus
Streptococcus constellatus
Streptococcus pneumoniae (including multi-drug resistant isolates [MDRSP]*)
Streptococcus pyogenes

*MDRSP. Multi-drug resistant Streptococcus pneumoniae includes isolates previously known as PRSP (Penicillin resistant S. pneumoniae), and are isolates resistant to two or more of the following antibiotics: penicillin (MIC) ≥2 mcg/mL). 2nd generation cephalosporins (for example, cefuroxime), macrolides. tetracyclines, and trimethoprim/sulfamethoxazole.

The following in vitro data are available. but their clinical significance is unknown.

Gram-positive bacteria
Streptococcus agalactiae
Streptococcus viridans group

The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus spp., and clinically significant yeast.

Device Description

The VITEK® 2 AST card is essentially a miniaturized, abbreviated and automated version of the doubling dilution technique for determining the minimum inhibitory concentration (MIC). Each VITEK® 2 AST card contains 64 wells. A control well which only contains microbiological culture media is resident on all cards. The remaining wells contain premeasured portions of a specific antibiotic combined with culture media. The bacterial or yeast isolate to be tested is diluted to a standardized concentration with 0.45 - 0.5% saline before being used to rehydrate the antimicrobial medium within the card. The VITEK® 2 System automatically fills, seals and places the card into the incubator/reader. The VITEK® 2 Compact has a manual filling, sealing and loading operation. The VITEK® 2 Systems monitor the growth of each well in the card over a defined period of time. At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antibiotic test contained on the card.

The VITEK® 2 AST-ST Moxifloxacin for Streptococcus species has the following concentrations in the card: 0.5. 1, 4 and 8 µg/ml (equivalent standard method concentration by efficacy in µg/mL). The MIC result range for the VITEK 2 card is ≤ 0.06 -> 4 µg/mL.

AI/ML Overview

Here's an analysis of the acceptance criteria and study details for the VITEK® 2 AST-ST Moxifloxacin device, based on the provided text:

Acceptance Criteria and Device Performance for VITEK® 2 AST-ST Moxifloxacin

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for antimicrobial susceptibility testing devices are typically defined by regulatory bodies and guidance documents (e.g., FDA, CLSI) and are based on various performance metrics like Essential Agreement (EA), Category Agreement (CA), and the rates of major (maj), very major (vmj), and minor (min) discrepancies. The provided document details the performance in these categories. While explicit numerical "acceptance criteria" are not listed as such, the observed performance is presented in comparison to the expected standards for such devices.

Metric	Acceptance Criteria (Implied by Regulatory Standards)	Reported Device Performance (VITEK® 2 Auto Dilution, Combined Clinical & Challenge)	Reported Device Performance (VITEK® 2 Manual Dilution, Challenge)	Reported Device Performance (VITEK® 2 Compact Manual Dilution, Challenge)
Essential Agreement (EA)	Typically ≥ 90% (often > 90-95%)	93.5%	95.6%	95.6%
Evaluable Essential Agreement (Eval EA)	Typically ≥ 90% (often > 90-95%)	94.0%	95.6%	95.6%
Category Agreement (CA)	Typically ≥ 90% (often > 90-95%)	99.5%	99.4%	98.7%
Very Major Discrepancies (#vmj)	≤ 1.5% (or 0-1)	0	0	0
Major Discrepancies (#maj)	≤ 3.0% (or 0-1)	0	0	0
Minor Discrepancies (#min)	≤ 7.0-10%	6 (0.5%)	1	2
Reproducibility (Best Case)	Typically > 95%	100% (VITEK® 2 Auto Dilution)	99.3% (VITEK® 2 Compact Manual Dilution)	99.3% (VITEK® 2 Compact Manual Dilution)
Reproducibility (Worst Case)	Typically > 95%	100% (VITEK® 2 Auto Dilution)	99.3% (VITEK® 2 Compact Manual Dilution)	99.3% (VITEK® 2 Compact Manual Dilution)

Note: The specific numerical acceptance criteria for EA, CA, and discrepancy rates are often derived from FDA guidance documents and CLSI standards. The reported performance clearly demonstrates that the device meets or exceeds typical expectations for these metrics. The text notes "acceptable results" for the VITEK® 2 Compact, reinforcing that the performance aligns with regulatory requirements.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set:
- Clinical Isolates: 941 viable clinical isolates (out of 951 tested, with 10 failing to grow).
- Challenge Isolates: 159 isolates.
- Combined (Clinical + Challenge): 1100 isolates.
Data Provenance: The study was conducted at three external clinical sites. The isolates included both clinical specimens (majority of the 951) and stock isolates (229 of the 951 clinical isolates, indicating a mix of prospective clinical collection and possibly retrospective stock isolates for diversity). No specific country of origin is mentioned, but "external clinical sites" typically refers to institutions within the country where the submission is made (USA in this context, given the FDA submission). The nature of the clinical and challenge isolates suggests a mix of retrospective (stock) and prospective (fresh clinical) data types.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The ground truth for the test set was established using the CLSI approved broth microdilution reference method. This is a standardized laboratory procedure, not typically relying on individual "experts" for ground truth determination in the same way, for example, image interpretation would. The expertise comes from adherence to the CLSI protocol for performing the reference method. Therefore, the concept of "number of experts" and their "qualifications" for establishing ground truth in this context is not applicable in the traditional sense of human consensus.

4. Adjudication Method for the Test Set

The adjudication method is not explicitly described as a specific consensus process (like 2+1 or 3+1). Instead, the performance of the VITEK® 2 system is compared directly against the CLSI broth microdilution reference method, which serves as the gold standard. Discrepancies (vmj, maj, min errors) are identified and quantified based on this comparison. The decision-making process for these discrepancies would likely follow predefined internal bioMérieux quality control protocols and regulatory guidelines for AST device validation, rather than expert adjudication of each discordant result.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study comparing human readers with and without AI assistance was performed. This device is an Automated Antimicrobial Susceptibility Testing (AST) system, meaning it replaces manual subjective interpretation of susceptibility rather than assisting human readers. Its effectiveness is measured by its agreement with a standardized reference method (broth microdilution), not by human-in-the-loop performance.

6. Standalone Performance Study (Algorithm Only)

Yes, a standalone performance study was done. The entire performance evaluation (Essential Agreement, Category Agreement, and discrepancy rates) directly measures the algorithm's output (MIC values and interpretive categories S/I/R) against the reference method's output. The VITEK® 2 system is an automated device, and its reported performance is its standalone (algorithm only) performance. The results for the VITEK® 2 Auto Dilution, VITEK® 2 Manual Dilution, and VITEK® 2 Compact Manual Dilution all represent standalone device performance.

7. Type of Ground Truth Used

The ground truth used was the Clinical and Laboratory Standards Institute (CLSI) approved broth microdilution testing conditions (reference method) for determining Minimum Inhibitory Concentration (MIC). This is a well-established and universally accepted laboratory method for antimicrobial susceptibility testing.

8. Sample Size for the Training Set

The document does not explicitly state the sample size for the training set. The provided data pertains to validation testing of the device's performance. For FDA 510(k) submissions of AST devices, the focus is on the performance against a defined test set. Information on internal training data used during the development of the VITEK® 2's interpretive algorithm is typically considered proprietary and not included in such summaries.

9. How the Ground Truth for the Training Set Was Established

As with the training set size, the document does not specify how the ground truth for the training set was established. However, it is highly probable that the ground truth for any internal training data would also have been established using comprehensive reference methods, similar or identical to the CLSI broth microdilution method used for the validation test set, to ensure accurate algorithm development. This is standard practice in the development of in vitro diagnostic devices.

Summary

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K132573

SEP 1 3 2013

Image /page/0/Picture/1 description: The image shows the logo for bioMerieux. The logo consists of a black circle with a vertical line through it, with the left side of the circle having horizontal lines. The text "BIOMERIEUX" is written in a sans-serif font below the circle.

510(k) SUMMARY

VITEK® 2 AST-ST Moxifloxacin

510(k) Submission Information:

Submitter's Name:	bioMérieux, Inc.
Address:	595 Anglum RoadHazelwood, MO 63042
Contact Person:	Nathan HardestyStaff Regulatory Affairs Specialist
Phone Number:	314-731-8666
Fax Number:	314-731-8689
Date of Preparation:	September 10, 2013

A. 510(k) Number:

K132573

B. Purpose for Submission:

Substantial equivalence determination for the addition of Moxifloxacin to the VITEK® 2 and VITEK® 2 Compact Antimicrobial Susceptibility Test (AST) Systems for the testing of Streptococcus species.

C. Measurand:

VITEK® 2 AST-ST Moxifloxacin concentrations of 0.5, 1, 4 and 8 µg/ml. The MIC result range of the card is ≤ 0.06 -> 4 µg/mL.

D. Type of Test:

The minimum inhibitory concentration (MIC) is determined using a quantitative growth based detection algorithm according to a predetermined growth threshold.

E. Applicant:

bioMérieux, Inc.

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F. Proprietary and Established Names:

VITEK" 2 Streptococcus Moxifloxacin VITEK® 2 AST-ST Moxifloxacin

G. Regulatory Information:

Product Code	Classification	Regulation Section	Panel
LONSystem, Test, Automated,AntimicrobialSusceptibility, ShortIncubation	Class II	21 CFR 866.1645Short-TermAntimicrobialSusceptibility TestSystem	83Microbiology

H. Intended Use:

l. Intended use:

VITEK 2 Strentococcus Moxifloxacin is designed for antimicrobial susceptibility testing of Streptococcus species and is intended for use with the VITEK® 2 and VITEK® 2 Compact Systems as a laboratory aid in determination of in vitro susceptibility to antimicrobial agents. VITEK® 2 Streptococcus Moxifloxacin is a quantitative test. Moxifloxacin has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial.

Active in vitro and in clinical infections

Streptococcus anginosus Streptococcus constellatus Streptococcus pneumoniae (including multi-drug resistant isolates [MDRSP]*) Streptococcus pyogenes

*MDRSP. Multi-drug resistant Streptococcus pneumoniae includes isolates previously known as PRSP (Penicillin resistant S. pneumoniae), and are isolates resistant to two or more of the following antibiotics: penicillin (MIC) ≥2 mcg/mL), 2nd generation cephalosporins (for example, cefuroxime), macrolides, tetracyclines, and trimethoprim/sulfamethoxazole.

The following in vitro data are available, but their clinical significance is unknown.

Gram-positive bacteria Streptococcus agalactiae Streptococcus viridans group

1. Indication(s) for use:

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Active in vitro and in clinical infections

Streptococcus anginosus Streptococcus constellatus Streptococcus pneumoniae (including multi-drug resistant isolates |MDRSP]*) Streptococcus pyogenes

The following in vitro data are available. but their clinical significance is unknown.

Gram-positive bacteria Streptococcus agalactiae Streptococcus viridans group

1. Special conditions for use statement(s):
  For prescription use only.
1. Special instrument requirements:
  For use with the VITEK® 2 and VITEK® 2 Compact Systems.

I. Device Description:

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culture media. The bacterial or yeast isolate to be tested is diluted to a standardized concentration with 0.45 - 0.5% saline before being used to rehydrate the antimicrobial medium within the card. The VITEK® 2 System automatically fills, seals and places the card into the incubator/reader. The VITEK® 2 Compact has a manual filling, sealing and loading operation. The VITEK® 2 Systems monitor the growth of each well in the card over a defined period of time. At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antibiotic test contained on the card.

VITEK® 2AST-ST	Equivalent Standard Method Concentrationby Efficacy in µg/mL	MIC Ranges and FDACategories*MIC in µg/mL:
		S	I	R
Moxifloxacin	0.5, 1, 4, and 8	≤ 1	2	≥ 4

The MIC ranges, interpretive criteria and equivalent concentrations are as follows:

S = Susceptible; 1 = Intermediate; R = Resistant

J. Substantial Equivalence Information:

1. Predicate device name(s):
  VITEK® 2 AST-ST Cefotaxime
1. Predicate K number(s):
  K121863

3. Comparison with predicate:

Similarities
Item	Device	Predicate
Intended Use	Determining quantitativeantimicrobial susceptibility forStreptococcus species	Same
Inoculation and testorganism	Isolated colonies ofStreptococcus species	Same
Instrument	Test are run on both theVITEK® 2 and VITEK® 2Compact Systems	Same
Test Card	VITEK® 2 card format with	Same

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Similarities
Item	Device	Predicate
	base broth
Test Method	Automated quantitativeantimicrobial susceptibility testto determine the in vitrosusceptibility of Streptococcusspecies	Same

Differences
Item	Device	Predicate
Antibiotic	Moxifloxacin-specificconcentrations	Cefotaxime -specificconcentrations
Reading algorithm	Unique to Moxifloxacin	Unique to Cefotaxime
Test organisms	Streptococcus anginosus,Streptococcus constellatus,Streptococcus pneumoniae (includingmulti-drug resistant isolates[MDRSP]), Streptococcus pyogenes,Streptococcus agalactiae,Streptococcus viridans group.	Streptococcus pneumoniae,Streptococcus pyogenes(Group A beta-hemolyticstreptococci), Streptococcusspp.

K. Standard/Guidance Document Referenced (if applicable):

Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Guida nceDocuments/ucm071462.pdf

Clinical and Laboratory Standards Institute (CLSI) M07-A8: *Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically. Approved Standard -8th Edition". Januarv. 2009.

CLSI M100-S21, "Performance Standards for Antimicrobial Susceptibility Testing -Twenty-first Informational Supplement", January. 2011.

L. Test Principle:

Automated growth based detection using attenuation of light measured by an optical scanner. The optics used in the VITEK 2 Systems use visible light to directly measure organism growth. Optical readings are based on an initial read of a well before significant growth has begun. Light transmittance sampling at a defined interval of time for the well measures organism growth by how much light is prevented from going through the well. The VITEK®2 Systems monitor the growth of each well in the card over a defined period of time. An interpretive call is made between 4 and 16 hours for a "rapid" read but in some instances may be extended to 18 hours for GN and GP cards, up to 24 hours for some Streptococcus species, or up

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36 hours for some yeast species. At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antibiotic on the card.

The VITEK® 2 AST-ST Moxifloxacin for Streptococcus species has the following concentrations in the card: 0.5. 1. 4. and 8 ug/ml (equivalent standard method concentration by efficacy in µg/ml). The MIC result range for the VITEK® 2 card is < 0.06 -> 4 µg/mL.

M. Performance Characteristics (if/when applicable):

1. Analytical performance:
- a. Precision/Reproducibility:

A reproducibility study was conducted at three external clinical sites. Two isolates of Streptococcus pneumoniae, two isolates of Streptococcus agalactiae, and six isolates of viridans group streptococci (i.e. three Streptococcus sobrinus, one Streptococcus infamtarius ssp. coli, and two Streptococcus downer) were tested at each site and testing with the VITEK® 2 AST-ST Moxifloxacin card was performed in triplicate over three days, resulting in a total of 270 test results. The study included both auto and manual dilution methods for the VITEK® 2 and manual dilution only for the VITEK® 2 Compact, since the VITEK® 2 Compact system does not have functionality to support automatic dilutions to inoculate the cards. For the sake of reproducibility calculations, off-scale values are handled in two ways: "best case" and "worst case" scenarios. Best case calculation for reproducibility assumes the off-scale result is within one well from the mode MIC value. Worst case calculation for reproducibility assuming the off-scale result is greater than one well from the mode MIC value.

The overall reproducibility was > 95% with +/- one dilution observation for the VITEK® 2 and the VITEK® 2 Compact system. Results were as follows:

VITEK(R) System	Inoculation Method	Best Case	Worst Case
VITEK(R) 2	Auto Dilution	100%	100%
VITEK(R) 2 Compact	Manual Dilution	99.3%	99.3%

h. Linearity/assay reportable range:
Not applicable
c. Traceability, Stability, Expected values (controls, calibrators, or methods):

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The recommended Streptococcus pneumoniae QC organism was tested on every test occasion with the reference method and the VITEK® 2 System. The reference method QC results were in range for every day tested. The VITEK® 2 was tested a sufficient number of times to demonstrate that the system can produce OC results in the recommended range.

Quality Control was performed during the studies using both the auto and manual methods of diluting the organisms on the VITEK® 2 System. Results demonstrated that both methods were comparable. Quality Control Results with the VITEK® 2 System for AST-ST Moxifloxacin were as follows:

Organism	Moxifloxacin Concentration (µg/mL)	Auto Dilution		Manual Dilution
		Reference	VITEK® 2	Reference	VITEK® 2
Streptococcus pneumoniaeATCC 49619Acceptable MIC range:0.06-0.25 µg/mL	0.016
	0.03		1
	0.06*	140		58
	0.12*	62	203	46	104
	0.25*
	0.5*
	1*
	2*
	4*
	8

VITEK® 2 Card Result Range is ≤ 0.06 -> 4 ug/mL.

Results for VITEK® 2 AST-ST Moxifloxacin were within the expected OC results range > 95% of the time for both the automatic and manual dilution options of the VITEK® 2.

A similar OC study was conducted to evaluate the VITEK® 2 Compact, a secondary option. at three sites and the results were within the expected QC ranges as shown in the table below.

Organism	MoxifloxacinConcentration(µg/mL)	Manual DilutionReference	VITEK® 2
Streptococcus pneumoniae ATCC 49619Acceptable MIC range:0.06-0.25 µg/mL	0.0160.030.060.120.250.51*	5944	1021

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------	200 100tt	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Bearing11
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	----------------		11

VITEK® Card Result Range is ≤ 0.06 -> 4 µg/ml.

Inoculum density control was monitored using the DensiCHEK™ Plus instrument. The DensiCHEK™ Plus controls were standardized daily with all results recorded and in the expected range.

d. Detection limit:
Not applicable.

e. Analytical specificity:

Not applicable.

f. Assay cut-off:
Not applicable
1. Comparison studies:
  The reference method follows the CLSI approved broth microdilution testing conditions.

Medium:	Cation-adjusted Mueller-Hinton broth (CAMHB) supplemented with 5% lysed horse blood
Inoculum:	Direct colony suspension
Incubation:	35 °C; ambient air; 20-24 hours

Method comparison with predicate device: u.

Performance was established through a clinical study conducted at three external study sites. A total of 951 clinical isolates were tested by the VITEK® 2 AST-ST Moxifloxacin card on the VITEK® 2 System. The majority of the isolates were recovered from clinical specimens. Two hundred twenty-nine of the 951 clinical isolates (24.1%) were stock isolates. Ten of the isolates failed to grow in the VITEK® 2 card giving a no growth rate of 1.1% (10/951). Therefore, the total number of viable clinical isolates evaluated was 941.

Testing of the clinical isolates was performed using the automated method of inoculation and the challenge organisms were tested with both the manual and automatic dilution methods. Each isolate was tested by VITEK® 2 AST-ST Moxifloxacin and the CLSI broth microdilution reference method. The inoculum was prepared with direct colony suspensions. A comparison was

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provided to the reference method with the agreement shown in the following tables.

There is only one set of Moxifloxacin breakpoints [≤ 1 (S). 2 (I). ≥ 4 (R)] for Streptococcus pneumoniae and Streptococcus spp. in the FDA drug label. The performance data were analyzed using the FDA breakpoints. A summary of the combined clinical and challenge data for the auto dilution method is shown in the table below.

VITEK® 2Auto	Total	EAN	EA%	EvalEATot	EvalEAN	EvalEA%	CAN	CA%	#R	#min
CLINICAL	941	878	93.3	917	860	93.8	936	99.5	9	5
CHALLENGE	159	151	95.0	158	150	94.9	158	99.4	0	1
COMBINED(CLINICALANDCHALLENGE)	1100	1029	93.5	1075	1010	94.0	1094	99.5	9	6

Auto Dilution (VITEK® 2)

EA-Essential Agreement CA-Category Agreement #R-number of resistant isolates maj-major discrepancies vmi-very major discrepancies min-minor discrepancies

Essential agreement (EA) is when the VITER® 2 panels agree with the broth microdilution reference results exactly or within one doubling dilution of the reference method. Category agreement (CA) is when the VITEK® 2 panel result interpretation agrees exactly with the broth microdilution reference panel result interpretation. Evaluable (Eval EA) is when the MIC result is on-scale for both the VITEK® 2 and the reference method and have on-scale EA.

For the combined Streptococcus species and S. pneumoniae. 6 (0.5%) minor categorical errors were observed, with a total EA of 93.5%, evaluable EA of 94.0%, and a CA of 99.5%. The clinical study demonstrated a trend, which was one doubling dilution higher when compared to the reference method. Of the 1100 Streptococci. 9 isolates of the Streptococcus viridans group were resistant with no very major errors. The MDRSP were evaluated in the challenge study. The combined clinical and challenge set included 295 S. pneumoniae, 256 S. pyogenes, 260 S. agalactiae and 269 viridans streptococci group, in addition to 12 S. anginosus and 8 S. constellatus.

The challenge set of 159 isolates was also tested against a manual dilution method on the VITEK® 2. A summary of VITEK® 2 manual dilution data is shown in the table below.

VITEK® 2Manual	Total	EAN	EA%	EvalEATot	EvalEAN	EvalEA%	CAN	CA%	#R	#vmj	#maj	#min
CHALLENGE	159	152	95.6	158	151	95.6	158	99.4	0	0	0	1

Manual Dilution (VITEK® 2) - Challenge

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Performance of the VITEK® 2 Compact was evaluated as a secondary procedural option. The evaluation was conducted using the same 159 challenge isolates that were tested on the VITEK® 2 system. VITEK® 2 Compact comparison testing against the reference method is shown in the table below.

Manual Dilution (VITEK® 2 Compact) - Challenge

VITEK(R) 2CompactManual	Total	EAN	EA%	EvalEATot	EvalEAN	EvalEA%	CAN	CA%	#R	#vmj	#maj	#min
CHALLENGE	159	152	95.6	158	151	95.6	157	98.7	0	0	0	2

The performance of the VITEK® 2 Compact, a secondary option, was evaluated in the reproducibility, QC, and challenge studies with acceptable results.

b. Matrix comparison:
Not Applicable
1. Clinical Studies:
- a. Clinical Sensitivity:

Not Applicable

b. Clinical specificity:
Not Applicable
c. Other clinical supportive data (when a. and b. are not applicable):
Not Applicable
1. Clinical cut-off:
  Not Applicable
1. Expected values/Reference range:
  Streptococcus species and S. pneumoniae: ≤ 1 (S), 2 (I), ≥ 4 (R)

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Image /page/10/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus has a staff with a snake winding around it, and a pair of wings at the top.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - W1 166-GMP Silver Spring, MD 20993-0002

September 13, 2013

bioMéricux, Inc. c/o Mr. Nathan Hardesty Staff Regulatory Affairs Specialist 595 Anglum Road Hazelwood. MO. 63042

Re: K132573

Trade/Device Name: VITEK"2 AST-ST Moxifloxacin (≤ 0.06- ≥4pg/mL) Regulation Number: 21 CFR $866.1645 Regulation Name: Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility System Regulatory Class: II Product Code: LON Dated: August 13, 2013 Received: August 16, 2013

Dear Mr. Hardesty:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you. however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21. Parts 800 to 898. In addition. FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA is 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 medical device-related adverse events) (21 CFR 803): good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

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Page 2-Mr. Hardesty

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact 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/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Sally A Hojvat -S

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

Enclosure

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Indications for Use

510(k) Number : K132573

Device Name: VITEK® 2 AST-ST Moxifloxacin ( ≤ 0.06 -> 4 µg/mL )

Indications For Use:

VITEK® 2 Streptococcus Moxifloxacin is designed for antimicrobial susceptibility testing of Streptococcus species and is intended for use with the VITEK® 2 and VITEK® 2 Compact Systems as a laboratory ald in the determination of in vitro susceptibility to antimicrobial agents. VITEK® 2 Streptococcus Moxifloxacin is a quantitative test. Moxifloxacin has been shown to be active against most isolates of the microorganisms listed below, according to the FDA label for this antimicrobial.

Active in vitro and in clinical infections Streptococcus anginosus Streptococcus constellatus Streptococcus pneumoniae (including multi-drug resistant isolates (MDRSP)") Streptococcus pyogenes

*MDRSP, Multi-drug resistant Streptococcus pneumoniae includes isolates previously known as PRSP (Penicillin resistant S. pneumoniae), and are isolates resistant to two or more of the following antibiotics: penicillin (MIC) ≥2 mcg/mL), 2nd generation cephalosporins (for example, cefuroxime), macrolides, tetracyclines, and trimethoprim/sulfamethoxazole.

The following in vitro data are available, but their clinical significance is unknown.

Gram-positive bacteria Streptococcus agalactiae Streptococcus viridans group

The VITEK 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus spp. and clinically significant yeast.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Regulation Number and Section

§ 866.1645 Fully automated short-term incubation cycle antimicrobial susceptibility system.

(a)
Identification. A fully automated short-term incubation cycle antimicrobial susceptibility system is a device that incorporates concentrations of antimicrobial agents into a system for the purpose of determining in vitro susceptibility of bacterial pathogens isolated from clinical specimens. Test results obtained from short-term (less than 16 hours) incubation are used to determine the antimicrobial agent of choice to treat bacterial diseases.(b)
Classification. Class II (special controls). The special control for this device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA.”