← Product Code [LON](/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LON) · K041982

# VITEK 2 GRAM NEGATIVE ERTAPENEM (K041982)

_bioMerieux, Inc. · LON · Sep 14, 2004 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LON/K041982

## Device Facts

- **Applicant:** bioMerieux, Inc.
- **Product Code:** [LON](/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LON.md)
- **Decision Date:** Sep 14, 2004
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.1645
- **Device Class:** Class 2
- **Review Panel:** Microbiology

## Intended Use

The VITEK® 2 Antimicrobiat 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, Staphylococus sp., Enterococus sp., Streptococus agalactiae, and S. pneumoniae. VITEK® 2 Gram Negative Ertapenem 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 dilution technique for determining the minimum inhibitory concentration (MIC) microdilution methodology.

## Device Story

VITEK® 2 system performs automated antimicrobial susceptibility testing (AST) on isolated bacterial colonies. Organism suspension is prepared in saline, standardized to McFarland 0.5, and loaded into a 64-microwell test card. Instrument automatically dilutes, fills, and seals cards; incubates at 35.5°C; and performs optical scanning every 15 minutes. Optics measure light transmittance to track bacterial growth. Discriminate analysis algorithm processes growth parameters to calculate Minimal Inhibitory Concentration (MIC) and provide categorical interpretation (S/I/R). Used in clinical laboratories by technicians. Results assist clinicians in selecting appropriate antimicrobial therapy for patients with gram-negative infections.

## Clinical Evidence

Bench testing only. Performance evaluated using 403 clinical and challenge isolates of Enterobacteriaceae. Comparison to NCCLS M7 agar dilution reference method showed 98.8% Category Agreement (CA). Reproducibility (inter- and intra-assay) exceeded 95%. No clinical data provided; resistance detection capability for ertapenem remains unknown due to lack of resistant strains in the study set.

## Technological Characteristics

Microdilution-based AST card with 64 microwells containing premeasured antibiotic and culture medium. Sensing principle: transmittance optics measuring light blockage by bacterial growth. Instrument: VITEK® 2 automated system. Connectivity: integrated system. Software: algorithm-based MIC calculation using discriminate analysis. Sterilization: not specified.

## Regulatory 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.

## Special Controls

*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.”

## Predicate Devices

- VITEK® 2 Gram Negative AST Panel for gatifloxacin ([K032788](/device/K032788.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).

{0}------------------------------------------------

K041982

SEP 1 4 2004

Image /page/0/Picture/2 description: The image shows the logo for bioMérieux. The logo consists of the word "BIOMÉRIEUX" in a stylized font, with a vertical line running through the center of the text. At the center of the vertical line is a black circle with a textured pattern.

### 510(k) SUMMARY

### VITEK® 2 Gram Negative Ertapenem

#### 510(k) Submission Information:

| Submitter's Name:    | bioMérieux, Inc.                                                                                       |
|----------------------|--------------------------------------------------------------------------------------------------------|
| Address:             | 595 Anglum Road<br>Hazelwood, MO 63042                                                                 |
| Contact Person:      | Nancy Weaver<br>Staff Regulatory Affairs Specialist                                                    |
| Phone Number:        | 314-731-8695                                                                                           |
| Fax Number:          | 314-731-8689                                                                                           |
| Date of Preparation: | July 22, 2004                                                                                          |
| B. Device Name:      |                                                                                                        |
| Formal/Trade Name:   | VITEK® 2 Gram Negative Ertapenem                                                                       |
| Classification Name: | Fully Automated Short-Term Incubation Cycle<br>Antimicrobial Susceptibility Device,<br>21 CFR 866.1645 |
| Common Name:         | VITEK 2 AST-GN Ertapenem                                                                               |
| C. Predicate Device: | VITEK 2 Gram Negative Susceptibility Test for<br>Gatifloxacin (K032788)                                |

#### D. 510(k) Summary:

VITEK® 2 Gram Negative Ertapenem is designed for antimicrobial susceptibility testing of Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii, Citrobacter koseri, Enterobacter aerogenes, Enterobacter cloacae, Klebsiella oxytoca (excluding ESBL producing strains), Morganella morganii, Proteus mirabilis, Proteus vulgaris, and Serratia marcescens. 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 dilution 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

#### bioMérieux, Inc.

595 Anglum Road, Hazelwood, Missouri 63042-2320, USA Phone: 314/731-8500 800/638-4835 Fax: 314/731-8700

{1}------------------------------------------------

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.

VITEK 2 Gram Negative Ertapenem demonstrated substantially equivalent performance when compared with the NCCLS reference agar dilution method, as defined in the FDA When compared Mill Introls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA. Issued Feb. 5, 2003.

The Premarket Notification (510[k]) presents data in support of VITEK 2 Gram Negative The Tremants. An external evaluation was conducted with fresh and stock clinical isolates and stock challenge strains. The external evaluations were designed to confirm the and otochility of VITEK 2 Gram Negative Ertapenem by comparing its performance with the NCCLS agar dilution reference method. VITEK 2 Gram Negative Ertapenem dernonstrated acceptable performance of 98.8% overall Category Agreement when compared to the agar dilution reference method. Reproducibility and Quality Control demonstrated acceptable results.

{2}------------------------------------------------

Public Health Service

Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (USA). The seal features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

# SEP 1 4 2004

Ms. Nancy Weaver Staff Regulatory Affairs Specialist BioMérieux, Inc. 595 Anglum Road Hazelwood, MO 63042-2320

k041982 Re:

Trade/Device Name: VITEK® 2 Gram Negative 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: July 22, 2004 Received: July 23, 2004

Dear Ms. Weaver:

We have reviewed your Section 510(k) premarket notification of intent to market the device wo nave roviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use suated in the exerce , 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, de neces that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, incress, mains of the Act include requirements for annual registration, listing of general controls provisions of wactice, 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 your do room additional controls. Existing major regulations affecting your device it may be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r least of advised that i Dr is issualled on our device complies with other requirements of the Act that I DA has made a acterinalations administered by other Federal agencies. You must or any I carated and the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

{3}------------------------------------------------

#### Page 2

This letter will allow you to begin marketing your device as described in your Section 510(k) I his icted with anow you to organizatial equivalence of your device of your device to a legally prematice notification " results in a classification 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, or questions on the promotion and advertising of your device, please contact the Office of of questions on the promotion and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Tod may of Small Manufacturers, International 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/dsma/dsmamain.html.

Sincerely yours,

Saartys

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

{4}------------------------------------------------

# Indications for Use

510(k) Number (if known):_K041982

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

Indications For Use:

The VITEK® 2 Antimicrobiat Susceptibility Test (AST) is intended to be used with the The VITEN 2 Antimorobial Oacoopinalitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococus sp., Enterococus sp., Streptococus agalactiae, and S.
Staphylococus sp., Enterococus sp., Streptococus agalactiae, and S.
pneumoniae. VITEK® 2 Gram Negative Er susceptibility testing of Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii, Susceptiblity tooking of Enterobacter aerogenes, Enterobacter cloacae, Klebsiella oxytoca Citrobacter Roson, EnteroBactor Col. Morganella morganii, Proteus mirabilis, Proteus (axcluding EODE producing carens) It is intended for use with the VITEK 2 System as a valgaris, and Gorratia merosestion of in vitro susceptibility to antimicrobial agents.

Prescription Use ਮ (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)

Lucille A. Poole

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

Page 1 of 1

510(k)_KO4 1992

p. 10

---

**Source:** [https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LON/K041982](https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LON/K041982)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com