VITEK® 2 AST - ST Cefotaxime is designed for antimicrobial susceptibility testing of Streptococcus species. VITEK® 2 AST - ST Cefotaxime is a quantitative test 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. Cefotaxime has been shown to be active against most strains of the microorganism listed below, according to the FDA label for this antimicrobial.

Active in vitro and in clinical infections: Streptococcus pneumoniae. Streptococcus pyogenes (Group A betahemolytic streptococci), Streptococcus spp.

The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 and VITEK 2 Compact 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 agalactiae, and S. pneumoniae.

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 contained on the card.

The VITEK® 2 AST - ST Cefotaxime for Streptococcus species has the following concentrations in the card: 0.25, 0.5, 1, and 2 ug/ml (equivalent standard method concentration by efficacy in uq/ml). The MIC result range for the VITEK 2 card is ≤ 0.125 ~ ≥ 8 µg/ml.

AI/ML Overview

The provided document describes the VITEK® 2 AST - ST Cefotaxime, an antimicrobial susceptibility test system for Streptococcus species. Below is a summary of the acceptance criteria and the study that proves the device meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The device's performance is assessed through Essential Agreement (EA), Evaluable Essential Agreement (Eval EA), Category Agreement (CA), and the rates of major (maj), very major (vmj), and minor (min) discrepancies, against a reference broth microdilution method. While explicit numerical acceptance criteria for each metric are not stated in the provided text, the implied acceptance is based on "high agreement" and low error rates, consistent with guidance documents for AST systems. Typical acceptance criteria for AST systems are often >90% for EA and CA, and low rates for major (<3%), very major (<1.5-2%), and minor errors. The study demonstrates the device meets these expectations.

VITEK® 2 AST - ST Cefotaxime Performance Summary (Combined Clinical and Challenge Data)

Organism Group (Breakpoint)	EA Total	EA %	Eval EA Total	Eval EA %	CA %	#R	#maj	#min
S. pneumoniae (non-meningitis) (Auto Dilution)	351	98.6	118	96.6	89.7	23	1	35
S. pneumoniae (meningitis) (Auto Dilution)	351	98.6	118	96.6	89.5	54	2	35
S. pyogenes (Auto Dilution)	310	100	0	N/A	100	0	0	0
All Streptococcus species including S. pneumoniae (meningitis) (Auto Dilution)	1623	99.0	243	97.1	96.5	81	3	54

Reproducibility (Best Case / Worst Case)

VITEK® System	Inoculation Method	Best Case	Worst Case
VITEK® 2	Auto Dilution	100%	100%
	Manual	100%	100%
VITEK® 2 Compact	Manual	100%	100%

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

Test Set Sample Size:
- Clinical Isolates: 1425 isolates for VITEK® 2 AST - ST Cefotaxime with the VITEK® 2 System (1416 viable after removing failed growths).
  - Specifically, 301 clinical isolates of Streptococcus pneumoniae.
- Stock Isolates: 465 of the 1425 clinical isolates (32.6%) were stock isolates. For S. pneumoniae, 151 of 301 clinical isolates (50.2%) were stock isolates.
- Challenge Set: 207 isolates (Streptococcus species) and 50 isolates of Streptococcus pneumoniae.
Data Provenance: Retrospective (stock isolates) and Prospective (recently recovered clinical specimens). The study was conducted at four external clinical sites, but specific country of origin is not mentioned.

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

The ground truth was established using the CLSI broth microdilution reference method. This is an established laboratory standard method, and its execution implicitly relies on qualified laboratory personnel, though no specific number or qualification of "experts" is explicitly stated beyond adherence to the CLSI standard.

4. Adjudication Method for the Test Set

Not applicable. The ground truth was established by comparison to a single, accepted reference method (CLSI broth microdilution). There was no panel of experts adjudicating discrepancies; performance was directly compared to the reference.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, this was not an MRMC comparative effectiveness study in the context of human reader performance. This study evaluated an automated antimicrobial susceptibility test system against a reference laboratory method, not human interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the performance study directly assessed the VITEK® 2 AST - ST Cefotaxime system (algorithm only) against the CLSI broth microdilution reference method. The VITEK® 2 system is an automated device designed to determine MIC values and interpretive categories autonomously once inoculated and loaded.

7. The Type of Ground Truth Used

The ground truth was established using the CLSI broth microdilution reference method, which is an established laboratory standard for antimicrobial susceptibility testing.

8. The Sample Size for the Training Set

The document does not explicitly state the sample size for a "training set." This type of device (an AST system) typically relies on extensive historical data and established microbiological principles for its underlying algorithms, rather than a distinct, separate "training set" in the machine learning sense often discussed for image analysis. The "reading algorithm" for Cefotaxime is unique to that antibiotic, suggesting it's tuned based on known growth kinetics and concentration-response relationships rather than a discrete training set like a diagnostic AI.

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

Given that a specific "training set" is not detailed, the ground truth for establishing the algorithms would likely be based on:

Extensive historical microbiological data on bacterial growth, antibiotic effects, and MIC definitions.
Correlation with established reference methods (like broth microdilution) during the development and validation of the VITEK® 2 system's underlying technology and specific antibiotic panels.
CLSI and FDA interpretive criteria, which define the susceptible, intermediate, and resistant categories based on clinical and microbiological data.

Summary

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1863

510(k) SUMMARY

AUG 16 2012

VITEK® 2 AST- ST Cefotaxime

510(k) Submission Information:

Submitter's Name:	bioMérieux, Inc.
Address:	100 Rodolphe StreetDurham, NC 27712
Contact Person:	Elizabeth (Betty) LandonStaff Regulatory Affairs Specialist
Phone Number:	919-620-2329
Fax Number:	919-620-2548
Date of Preparation:	June 25, 2012

A. 510(k) Number:

K121863

B. Purpose for Submission:

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

C. Measurand:

Cefotaxime concentrations of 0.25, 0.5, 1, and 2 µg/ml. The MIC result range of the card is ≤ 0.125 -- ≥ 8 µg/ml.

D. Type of Test:

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

E. Applicant:

bioMérieux, Inc.

F. Proprietary and Established Names:

VITEK® 2 AST - ST Cefotaxime

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G. Requlatory Information:

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H. Intended Use:

1. Intended use:

Active in vitro and in clinical infections: Streptococcus pneumoniae. Streptococcus pyogenes (Group A betahemolytic streptococci), Streptococcus spp.

1. Indication(s) for use:
  VITEK® 2 AST - ST Cefotaxime is designed for antimicrobial susceptibility testing of Streptococcus species. VITEK® 2 AST - ST Cefotaxime is a quantitative test 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. Cefotaxime has been shown to be active against most strains of the microorganism listed below, according to the FDA label for this antimicrobial.

Active in vitro and in clinical infections:

Streptococcus pneumoniae. Streptococcus pyogenes (Group A betahemolytic streptococci), Streptococcus spp.

1. Special conditions for use statement(s):
  For prescription use only.

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4. Special instrument requirements:

For use with the VITEK® 2 and VITEK® 2 Compact Systems.

I. Device Description:

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

VITEK® 2AST- ST	EquivalentStandard MethodConcentration byEfficacy in µg/ml	Organism(Infection)	MIC Ranges andFDA/CLSI Categories*MIC in µg/ml:
			S	I	R
Cefotaxime	0.25, 0.5, 1, and2	S. pneumoniae(non-meningitis)CLSI	≤ 1	2	≥ 4
		S. pneumoniae(meningitis)FDA	≤ 0.5	1	≥ 2
		StreptococcusSpeciesFDA	≤ 0.5	1	≥ 2

S = Susceptible; I = Intermediate; R = Resistant

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J. Substantial Equivalence Information:

1. Predicate device name(s):
  VITEK® 2 AST - GP Amoxicillin for S. pneumoniae
1. Predicate K number(s):
  K063597
1. Comparison with predicate:

Item	Device	Predicate
Intended Use	Determining quantitative and qualitative susceptibility to antimicrobial agents	Same
Inoculation and test organism	Isolated colonies of Streptococcus pneumoniae	Same
Instrument	Test are run on both the VITEK® 2 and VITEK® 2 Compact Systems	Same
Test Card	VITEK® 2 card, including base broth	Same
Test Method	Automated quantitative Antimicrobial susceptibility test to determine the in vitro susceptibility of Streptococcus pneumoniae	Same

Differences
Item	Device	Predicate
Antibiotic	Cefotaxime-specificconcentrations	Amoxicillin-specificconcentrations
Reading algorithm	Unique to Cefotaxime	Unique to Amoxicillin
Test organisms	Streptococcus pyogenes(Group A beta-hemolyticstreptococci), andStreptococcus spp. inaddition to S. pneumoniae	S. pneumoniae

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

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

. 4

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http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidanc e/GuidanceDocuments/ucm071462.pdf

Clinical and Laboratory Standards Institute (CLSI) Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically. Approved Standard -8th Edition, Document M7-A8.

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

L. Test Principle:

Automated growth based detection using attenuation of light measured by an optical scanner. The optics used in the systems use visible light to directly measure organism growth. Transmittance optics are based on an initial light reading of a well before significant growth has begun. Periodic light transmittance samplings of the same well measure organism growth by how much light is prevented from going through the well. The VITEK® 2 System monitors 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 may be extended to 18 hours in some instances. 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 Cefotaxime for Streptococcus species has the following concentrations in the card: 0.25, 0.5, 1, and 2 µg/ml (equivalent standard method concentration by efficacy in ug/ml). The MIC result range for the VITEK® 2 card is ≤ 0.125 - ≥ 8 µg/ml.

M. Performance Characteristics (if/when applicable):

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

A reproducibility study was conducted at three external clinical sites. Nine isolates of Streptococcus pneumoniae and one isolate of Streptococcus mitis were tested at each site and testing was performed in triplicate over three days with the VITEK® 2 AST - ST Cefotaxime card resulting in a total of 270 test results. The testing was performed using both the manual dilution method and the automated dilution method. Testing was conducted on the VITEK® 2 instrument.

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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. Only Manual Dilution testing was conducted since the VITEK® 2 Compact system does not have a functionality to support automatic dilution to inoculate the card. Results were as follows:

VITEK® System	InoculationMethod	Best Case	Worst Case
VITEK® 2	Auto Dilution	100%	100%
	Manual	100%	100%
VITEK® 2 Compact	Manual	100%	100%

b. Linearity/assay reportable range:
Not applicable
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
The recommended Streptococcus pneumonia 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 demonstratethat the system can produce QC results in the recommended range.

Quality Control was performed during the studies using both the Autodilution and the manual method of diluting the organisms on the VITEK® 2 System. Results demonstrated that methods were comparable.

Quality Control Results with the VITEK® 2 System for Cefotaxime were as follows:

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Organism	CefotaximeConcentration(µg/ml)	Auto Dilution		Manual Dilution
		Reference	VITEK® 2	Reference	VITEK® 2
StreptococcuspneumoniaATCC 49619	0.016	1		1
	0.03
	0.06	128		126
	0.12*	53	182	52	178
Acceptable MICrange:0.06-0.25 (FDA)	0.25*
	0.5*				1
	1*
	2*
	4*
	8*

VITEK® Card Result Range is ≤ 0.125 - ≥ 8.

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

A similar QC study was conducted to evaluate the VITEK® 2 Compact System. Results were within the expected FDA QC ranges. Quality Control results for the VITEK® 2 System using either inoculation dilution method demonstrated that the VITEK® 2 System could produce the expected quality control results.

Inoculum density control was monitored using the DensiChek2 instrument. This was standardized weekly 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.

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2. Comparison studies:

a. Method comparison with predicate device:

Performance was established through a clinical study which was conducted at four external study sites. A total of 1425 clinical isolates were tested by VITEK® 2 AST - ST Cefotaxime with the VITEK® 2 System. The majority of the isolates were recently recovered from clinical specimens. Four hundred sixty-five of the 1425 clinical isolates tested were stock isolates (32.6%). Nine of the isolates failed to grow in the VITEK® card giving a no growth rate of 0.6% (9/1425). Therefore, the total number of viable clinical isolates evaluated was 1416.

A total of 301 clinical isolates of Streptococcus pneumoniae were tested and the performance data was analyzed using the meningitis and non-meningitis breakpoints for Cefotaxime. None of the isolates failed to grow in the VITEK® 2 AST card. One hundred fifty one of the 301 clinical isolates tested were stock isolates (50.2%).

A challenge set consisting of 207 isolates (Streptococcus species) and 50 isolates for Streptococcus pneumonia (non-meningitis breakpoint) was also evaluated with VITEK® 2 AST - ST Cefotaxime at one external site. The challenge set was tested with both of the VITEK® 2 System card inoculation

options, automatic dilution and manual dilution.

Testing of clinical isolates was performed using the automated method of inoculation and the challenge organisms were tested with both the manual dilution and automatic dilution. Each isolate was tested by the VITEK® 2 AST - ST Cefotaxime and the CLSI broth microdilution reference method. The inoculum was prepared with direct colony suspension. A comparison was provided to the reference method with the agreement shown in the following tables.

There is only one set of breakpoints [≤ 0.5 (S), 1 (I), ≥ 2 (R)] for Streptococcus spp in the FDA drug label for Cefotaxime. The performance data for Streptococcus species and S. pneumoniae were analyzed using the FDA breakpoints for Streptococcus spp.

Another analysis was conducted using CLSI breakpoints for S. pneumoniae. As stated in CLSI M100-S22, Vol 32, No. 3, January 2012, Performance Standards for Antimicrobial Susceptibility Testing; Twenty-Second Informational Supplement, CLSI breakpoints for S. pneumoniae meningitis are the same as FDA breakpoints for

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Streptococcus species [≤ 0.5 (S), 1 (I), ≥ 2 (R)]. Therefore, the clinical trial performance data was analyzed by combining Streptococcus species and the CLSI S. pneumoniae meningitis breakpoint. Because the CLSI breakpoints the S. pneumoniae non-meningitis ([≤ 1 (S), 2 (I), ≥ 4 (R)] are different, this performance data is presented separately.

A summary of the data is shown in the tables that follow.

OrganismGroup	EATot	EAN	EA%	EvalEATot	EvalEAN	EvalEA%	CAN	CA%	#R	#vmj	#maj	#min
Streptococcus pneumoniae (non-meningitis breakpoint)
CLINICAL	301	296	98.3	83	79	95.2	270	89.7	6	0	1	30
CHALLENGE	50	50	100	35	35	100	45	90.0	17	0	0	5
COMBINED(CLINICALANDCHALLENGE)	351	346	98.6	118	114	96.6	315	89.7	23	0	1	35
Streptococcus pneumoniae (meningitis breakpoint)
CLINICAL	301	296	98.3	83	79	95.2	270	89.7	29	0	2	29
CHALLENGE	50	50	100	35	35	100	44	88.0	25	0	0	6
COMBINED(CLINICALANDCHALLENGE)	351	346	98.6	118	114	96.6	314	89.5	54	0	2	35
Streptococcus pyogenes
CLINICAL	260	260	100	0	0	N/A	260	100	0	0	0	0
CHALLENGE	50	50	100	0	0	N/A	50	100	0	0	0	0
COMBINED(CLINICALANDCHALLENGE)	310	310	100	0	0	N/A	310	100	0	0	0	0
All Streptococcus species including S. pneumoniae (meningitis breakpoint)
CLINICAL	1416	1400	98.9	188	181	96.3	1367	96.5	50	0	3	46
CHALLENGE	207	207	100	55	55	100	199	96.1	31	0	0	8
COMBINED(CLINICALANDCHALLENGE)	1623	1607	99.0	243	236	97.1	1566	96.5	81	0	3	54

Auto Dilution (S. pneumonia and Streptococcus species)

EA-Essential Agreement: CA-Category Agreement; maj-major discrepancies vmj-very major discrepancies; min-minor discrepancies

Essential agreement (EA) is when the VITEK® 2 panels agree with the reference test panel 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 reference panel result interpretation. Evaluable (EA) is when the MIC result is on scale for both the VITEK® 2 and the reference and have on-scale EA.

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For the non-meningitis breakpoint for S. pneumoniae, 35 (10%) minor categorical errors were seen along with one maior error. A high agreement was observed with a total EA of 98.6%, evaluable EA of 96.6%, and a CA of 89.7%. Of 351 total isolates of S. pneumoniae, 23 isolates were considered resistant based on the Cefotaxime breakpoint for non-meningitis, but no very major errors occurred.

For the meningitis breakpoint for S. pneumoniae, 35 (10%) minor categorical errors were seen along with two major errors. A high agreement was observed with a total EA of 98.6%, evaluable EA of 96.6%, and a CA of 89.5%. Of 351 total isolates of S. pneumoniae, 54 isolates were considered resistant based on the Cefotaxime breakpoint for non-meningitis, but no very major errors occurred.

For combined Streptococci species and S. pneumoniae (meningitis breakpoint). 54 (3.3%) minor categorical errors were seen along with three major errors. A high agreement was observed with a total EA of 99.0%, evaluable EA of 97.1%, and a CA of 96.5%. Of 1623 total isolates of Streptococci, 81 isolates were considered resistant based on the Cefotaxime breakpoints of [≤ 0.5(S), 1 (I) . ≥ 2(R)], but no very major errors occurred.

OrganismGroup(breakpoint)	EATot	EAN	EA%	EvalEATot	EvalEAN	EvalEA%	CAN	CA%	#R	#vmj	#maj	#min
Streptococcus pneumoniae (non-meningitis breakpoint)
CHALLENGE(non-meningitis)	50	50	100	33	33	100	46	92.0	17	0	0	4
Streptococcus pneumoniae (meningitis breakpoint)
CHALLENGE(meningitis)	50	50	100	33	33	100	45	90.0	25	0	0	5
All Streptococcus species including S. pneumoniae (meningitis breakpoint)
CHALLENGE	207	207	100	53	53	100	200	96.6	31	0	0	7

Manual Dilution (VITEK® 2) - Challenge

Performance of the VITEK® 2 Compact was evaluated as a secondary procedural option. The evaluation was conducted using the same 207 isolates (Streptococcus species), and 50 isolates of Streptococcus pneumoniae challenge set tested in the VITEK® 2 system.

A comparison was provided to the reference method with the following agreement as shown here:

1 0

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OrganismGroup(breakpoint)	EATot	EAN	EA%	EvalEATot	EvalEAN	EvalEA%	CAN	CA%	#R	#vmj	#maj	#min
Streptococcus pneumoniae (non-meningitis breakpoint)
CHALLENGE(non-meningitis)	50	50	100	34	34	100	44	88.0	17	0	0	6
Streptococcus pneumoniae (meningitis breakpoint)
CHALLENGE(meningitis)	50	50	100	34	34	100	43	86.0	25	0	0	7
All Streptococcus species including S. pneumoniae (meningitis breakpoint)
CHALLENGE	207	205	99.0	50	49	98.0	196	94.7	31	0	0	11

Manual Dilution (VITEK® 2 Compact) - Challenge

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:
  The interpretive criteria and QC ranges are as recommended in the approved drug label. S. pneumoniae (non-meningitis) was also analyzed using CLSI interpretive criteria.

FDA: Streptococcus species and S. pneumoniae (meningitis): ≤ 0.5 (S), 1 (l), ≥ 2 (R)

CLSI: S. pneumoniae (non-meningitis): ≤ 1(S), 2 (I), ≥ 4 (R)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/11/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is in black and white and appears to be a scanned or digital representation.

Public Health Service

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

bioMérieux, Inc. c/o Elizabeth Landon Staff Regulatory Affairs Specialist 100 Rodolphe Street Durham, NC 27712

AUG 16 2012

Re: K121863

Trade Name: VITEK®2 AST- ST Cefotaxime Regulation Number: 21 CFR §866.1645 Regulation Name: Fully automated short-term incubation cycle antimicrobial susceptibility system. Regulatory Class: Class II Product Code: LON Dated: June 25, 2012 Received: July 13, 2012

Dear Ms. Landon:

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 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'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 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

{12}------------------------------------------------

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 Part 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,

Soy aitar

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

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Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

K121863

Device Name: VITEK® 2 AST - ST Cefotaxime ( ≤ 0.125 - ≥ 8 µg/ml )

Indications For Use:

VITEK® 2 AST - ST Cefotaxime is designed for antimicrobial susceptibility testing of Streptococcus species. VITEK 2 AST - ST Cefotaxime is a quantitative test 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. Cefotaxime has been shown to be active against most strains of the microorganism listed below, according to the FDA label for this antimicrobial.

Active in vitro and in clinical infections

Streptococcus pneumoniae, Streptococcus pyogenes (Group A beta-hemolytic streptococi), Streptococcus spp.

The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 and VITEK 2 Compact 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 agalactiae, and S. pneumoniae.

Prescription Use (Part 21 CFR 801 Subpart D) 1 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 Diagnostic Devices (OIVD)

Eualdi h. Poole

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K121863

Page 1 of 1

Page 7 of 575

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.”