VITEK® 2 Gram Negative Ceftriaxone is designed for antimicrobial susceptibility testing of Gram-negative bacilli. VITEK® 2 Gram Negative Ceftriaxone 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. Ceftriaxone 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 clinical infections:
Escherichia coli
Enterobacter aerogenes
Klebsiella pneumoniae
Proteus mirabilis
Klebsiella oxytoca
Serratia marcescens

In vitro data available but clinical significance is unknown:
Citrobacter freundii
Citrobacter koseri (formerly Citrobacter diversus)
Providencia species (including Providencia rettgeri)
Shigella species
Salmonella species (including Salmonella typhi)

The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 System 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., S. pneumoniae, and clinically significant yeast.

Device Description

The VITEK® 2 AST Cards are essentially miniaturized versions of the doubling dilution technique for determining the minimum inhibitory concentration (MIC) microdilution methodology.

The isolate to be tested is diluted to a standardized concentration in 0.45 - 0.50% saline before being used to rehydrate the antimicrobial medium within the card. The VITEK® 2 automatically fills, seals and places the card into the incubator/reader. The VITEK® 2 Compact has a manual filling and sealing operation. The VITEK® 2 monitors the growth of each well in the card over a defined period of time (up to 18 hours). At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antimicrobial contained on the card.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the VITEK® 2 Gram Negative Ceftriaxone device, as extracted from the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance (%)
Overall Essential Agreement (EA)	97.5%
Overall Category Agreement (CA)	99.0%

Note: The document states that a performance limitation will be taken for Proteus vulgaris.

Study Information

2. Sample size used for the test set and the data provenance:

Test Set Size: Not explicitly stated as a single number. The study utilized "fresh and stock clinical isolates, as well as a set of challenge strains."
Data Provenance: Not explicitly stated (e.g., country of origin). The study involved "clinical isolates" and a "retrospective" study design can be inferred as "stock clinical isolates" were used.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not specified. However, the external evaluation compared the device's performance directly against the CLSI broth microdilution reference method, which serves as the gold standard for antimicrobial susceptibility testing. This implies the CLSI method itself is the 'adjudication' or 'ground truth' establishment.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No, an MRMC comparative effectiveness study was not done. This device is an automated antimicrobial susceptibility testing system, not an AI-assisted diagnostic tool designed to improve human reader performance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Yes, a standalone performance study was done. The VITEK® 2 system is an automated device, and the study evaluated its performance (algorithm only) compared to the reference method.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The ground truth used was the CLSI broth microdilution reference method incubated at 16 - 20 hours. This is a laboratory-based gold standard for determining Minimum Inhibitory Concentration (MIC) values.

8. The sample size for the training set:

Not explicitly mentioned. The document primarily focuses on the external evaluation (test set).

9. How the ground truth for the training set was established:

Not explicitly mentioned. Assuming standard practices for such devices, the training data would likely also have been established using a recognized reference method like CLSI broth microdilution.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 12, 2017

BIOMERIEUX, INC. KAREN RUSSELL STAFF REGULATORY AFFAIRS SPECIALIST 595 ANGLUM ROAD HAZELWOOD MO 63042

Re: K161217

Trade/Device Name: VITEK 2 Gram Negative Ceftriaxone (<0.25 ->64 u/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: December 22, 2016 Received: December 23, 2016

Dear Ms. Russell:

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. 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'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 (OS) 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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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education 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" (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 Industry and Consumer Education 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,

Ribhi Shawar -A

For Uwe Scherf, 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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DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration
Indications for Use	VITEK® 2 AST-GN CeftriaxoneTraditional 510(k) SubmissionK161217.AINNForm Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See PRA Statement below.
510(k) Number (if known)	K161217
Device Name	VITEK® 2 Gram Negative Ceftriaxone(≤0.25-≥64 µg/mL)
Indications for Use (Describe)	VITEK® 2 Gram Negative Ceftriaxone is designed for antimicrobial susceptibility testing of Gram-negative bacilli.VITEK® 2 Gram Negative Ceftriaxone is a quantitative test intended for use with the VITEK® 2 and VITEK® 2Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. Ceftriaxonehas 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 clinical infections:
	Escherichia coli
	Enterobacter aerogenes
	Klebsiella pneumoniae
	Proteus mirabilis
	Klebsiella oxytoca
	Serratia marcescens
In vitro data available but clinical significance is unknown:
	Citrobacter freundii
	Citrobacter koseri (formerly Citrobacter diversus)
	Providencia species (including Providencia rettgeri)
	Shigella species
	Salmonella species (including Salmonella typhi)
	The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 System for theautomated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobicgram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus spp., S. pneumoniae, and clinicallysignificant yeast.
Type of Use (Select one or both, as applicable)
	Prescription Use (Part 21 CFR 801 Subpart D)
	Over-The-Counter Use (21 CFR 801 Subpart C)

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VITEK® 2 AST-GN Ceftriaxone: Section 028. 510(k) Summary

A. 510(k) Submission Information:

Submitter's Name:	bioMérieux, Inc.
Address:	595 Anglum RoadHazelwood, MO 63042
Contact Person:	Karen RussellStaff Regulatory Affairs Specialist
Phone Number:	314-731-8639
Fax Number:	314-731-8689
Date of Preparation:	December 2, 2016

B. Device Name:

Formal/Trade Name:	VITEK® 2 Gram Negative Ceftriaxone(≤0.25 – ≥64 µg/mL)
Classification Name:	21 CFR 866.1645Fully Automated Short-Term Incubation CycleAntimicrobial Susceptibility System
Product Code	LON
Common Name:	VITEK® 2 AST-GN Ceftriaxone

C. Predicate Device: VITEK®2 AST-GN Doxycycline (K121546)

D. 510(k) Summary:

Active in vitro and clinical infections: Enterobacter aerogenes Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae Proteus mirabilis

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Serratia marcescens

In vitro data available but clinical significance is unknown: Citrobacter koseri (formerly Citrobacter diversus) Citrobacter freundii Shigella species Providencia species (including Providencia rettgeri) Salmonella species (including Salmonella typhi)

The antimicrobial presented in VITEK® 2 AST-GN Cards is in concentrations equivalent by efficacy to standard method concentrations in mcg/ml. The VITEK® 2 AST Cards are essentially miniaturized versions of the doubling dilution technique for determining the minimum inhibitory concentration (MIC) microdilution methodology.

VITEK® 2 AST-GN Ceftriaxone demonstrated substantially equivalent performance when compared with the CLSI broth microdilution reference method, as defined in the FDA Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA. Issued August 28, 2009.

The Premarket Notification (510[k]) presents data in support of VITEK® 2 AST-GN Ceftriaxone.

An external evaluation was conducted with fresh and stock clinical isolates, as well as a set of challenge strains. The external evaluations were designed to confirm the acceptability of VITEK® 2 AST-GN Ceftriaxone by comparing its performance with the CLSI broth microdilution reference method incubated at 16 - 20 hrs. The data is representative of performance on both the VITEK® 2 and VITEK® 2 Compact instrument platforms. VITEK® 2 AST-GN Ceftriaxone demonstrated acceptable performance of 97.5% overall Essential Agreement and 99.0% overall Category Agreement with the reference method. A performance limitation will be taken for Proteus vulgaris. Reproducibility and Quality Control demonstrated acceptable results.

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.”