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 agalactiae, and S. pneumoniae.

VITEK 2 Gram Positive Ertapenem is designed for antimicrobial susceptibility testing of Staphylococcus aureus (methicillin susceptible strains only), and Streptococcus agalactiae. VITEK 2 Gram Positive Ertapenem is a qualitative test. It is intended for use with the VITEK 2 System as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents.

Device Description

The VITEK 2 AST Cards are essentially miniaturized versions of the doubling rily n technique for determining the minimum inhibitory concentration (MIC) microdilution methodology. The bacterial isolate to be tested is diluted to a standardized concentration in 0.45% 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 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 antibiotic contained on the card.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the VITEK® 2 Gram Positive Ertapenem device, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria (NCCLS reference agar dilution method)	Reported Device Performance
90.0% Overall Category Agreement	Acceptable results

Note: The specific numerical performance for "Overall Category Agreement" is not explicitly stated as a percentage in the document, only that it demonstrated "acceptable results." The criteria is mentioned as "90.0% Overall Category Agreement" but the actual performance against this criteria is not given numerically, only that it was "acceptable."

Study Details

2. Sample sizes used for the test set and data provenance

Test Set: Not explicitly stated how many clinical isolates and stock challenge strains were used. The document mentions "fresh and stock clinical isolates and stock challenge strains."
Data Provenance: Not explicitly stated (e.g., country of origin). The document mentions "external evaluations" which implies multi-site, but locations are not specified. The study used both prospective ("fresh clinical isolates") and retrospective ("stock clinical isolates and stock challenge strains") data.

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

Not specified in the provided text.

4. Adjudication method for the test set

Not specified in the provided text. The text only mentions "comparison with the NCCLS agar dilution reference method" as the ground truth.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC study was not done. This device is an automated antimicrobial susceptibility testing system, not a device requiring human interpretation for its primary output.

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

Yes, this was a standalone study. The VITEK® 2 system is an automated device designed to produce direct results (MIC values and interpretive category results) without human intervention in the interpretation of the susceptibility itself. The study compared the device's automated results against a reference method.

7. The type of ground truth used

Expert Consensus: Not explicitly stated.
Pathology: Not applicable for an antimicrobial susceptibility test.
Outcomes Data: Not applicable for an antimicrobial susceptibility test.
Reference Method: The ground truth was established by the NCCLS reference agar dilution method. This is an established laboratory standard for determining antimicrobial susceptibility.

8. The sample size for the training set

The document does not explicitly mention a separate "training set" or its size. The study describes "testing of Staphylococcus aureus (methicillin susceptible strains only), and Streptococcus agalactiae" using clinical and challenge strains. It is implied that the system's underlying algorithm was previously developed and validated, and this submission focuses on the performance of a new drug/organism combination on an existing system.

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

As no explicit "training set" is described for this submission, the method for establishing its ground truth is not detailed in the provided text. For automated susceptibility testing systems, the ground truth for developing and calibrating the algorithms would typically also be established using recognized reference methods like the NCCLS agar dilution method.

Summary

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K050076

Image /page/0/Picture/1 description: The image shows the date "FEB 1 8 2005" on the left side. To the right of the date is the word "BIOMERIEUX". There is a black circle with a line through it above the word "BIOMERIEUX".

510(k) SUMMARY

VITEK® 2 Gram Positive Ertapenem

510(k) Submission Information:

Submitter's Name:	bioMérieux, Inc.
Address:	595 Anglum RoadHazelwood, MO 63042
Contact Person:	Jolyn TenlladoRegulatory Affairs Specialist
Phone Number:	314-731-8386
Fax Number:	314-731-8689
Date of Preparation:	January 7, 2005
Device Name:
Formal/Trade Name:	VITEK® 2 Gram Positive Ertapenem (≤ 0.5 - ≥ 8 µg/ml)
Classification Name:	Fully Automated Short-Term Incubation CycleAntimicrobial Susceptibility Device, 21CFR 866.1645
Common Name:	VITEK 2 AST-GP Ertapenem
Predicate Device:	VITEK 2 Gram Positive Susceptibility Test forGatifloxacin (K032788)

D. 510(k) Summary:

்.

VITEK® 2 Gram Positive Ertapenem is designed for antimicrobial susceptibility testing of Staphylococcus aureus (methicillin susceptible strains only), and Streptococcus agalactiae. It is intended for use with the VITEK 2 System as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. The antimicrobial presented in VITEK 2 AST 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 rily n technique for determining the minimum inhibitory concentration (MIC) microdilution methodology

The bacterial isolate to be tested is diluted to a standardized concentration in 0.45% 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 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 antibiotic contained on the card.

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VITE:K 2 Gram Positive Ertapenem demonstrated substantially equivalent performance when VITER 2 Gram Positive Enapenen Gomondiation method, as defined in the FDA Class II
compared with the NCCLS reference agar dilution method, as defined in ETDA Class II Compared with the NOOLO releirence agar unaron railaron rail Susceptibility Test (AST) Systems; Guidance for Industry and FDA. Issued Feb. 5, 2003.

The Premarket Notification (510[k]) presents data in support of VTEK 2 Gram Positive The Premiation (QTo[N]) prosents used with fresh and stock clinical isock clinical isocates and stock challenge strains. The external evaluations were designed to confirm the acceptability Stock Challenge Straine: "The Skener by comparing its performance with the NCCLS again of VTEK 2 Gram Positive Extapenen by och positive Ertapenem demonstrated acceptable ulludion relerence mothou. "In Category Agreement when compared to the agar dilution penormance of 30.0% Overall Gategory Agrical demonstrated acceptable results.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol. The logo is black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB 1 8 2005

Ms. Jolyn Tenllado Regulatory Affairs Specialist BioMérieux, Inc. 595 Anglum Road Hazelwood, MO 63042-2320

Re: K050076

R050070
Trade/Device Name: VITEK® Gram Positive Ertapenem (≤0.5 ->8 µg/ml) Regulation Number: 21 CFR 866.1645 Regulation Name: Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility Devices Regulatory Class: Class II Product Code: LON Dated: January 11, 2005 Received: January 12, 2005

Dear Ms. Tenllado:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt have reviewed your becamed the device is substantially equivalent (for the indications forchenout above and harsure) to legally marketed predicate devices marketed in interstate for use stated in the encround) to the enactment date of the Medical Device Amendments, or to conninered pror to they 2011 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 r va may, mererere, mains of the Act include requirements for annual registration, listing of general controll provider ing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device it may be subject to Saten additions (CFR), Parts 800 to 895. In addition, FDA can ou lound further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be actived that i British that your device complies with other requirements of the Act that I 197 has Interes and regulations administered by other Federal agencies. You must of any I catales and registments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice e FR Part 807), tabelies in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 -

This letter will allow you to begin marketing your device as described in your Section 5 10(k)
1978 to the more of the success of the same of your device to a legal I his letter will anow you to ocgin maketing your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivales and thus, p premarket notification. "The PDF Intamg er oussions for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, of Jr If you desire specific information actually of your device, please contact the Office of In
or questions on the promotion and advertising of your and any and any and any and of questions on the promotion and Safety at (240)276-0484. Also, please note the V IITO Diagnostic Device Devilation and reach and the motification" (21CFR Part 807.97). regulation entitled, "Misolanding of Torento on your responsibilities under the Act from the You may other other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Sales, a For

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):_K 0500 74

Device Name: VITEK® 2 Gram Positive Ertapenem (≤0.5 - >8 µg/ml)

Indications For Use:

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

prited on and Positive Ertapenem is designed for antimicrobial susceptibility testing of Staphylococcus aureus (methicillin susceptible strains only), and Streptococcus Staphylococcas auread (motholiin CErtapenem is a qualitative test. It is intended for use with the VITEK 2 System as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents.

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 Diagnostic Devices (OIVD)

Division Sign-Off

Car of In Vitro Diagnostic De t in manon and Safety

Page 1 of 1

KOSODTL 510(k)_

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.”