DRIED GRAM NEGATIVE MIC/COMBO PANELS

K020037 · Dade Microscan, Inc. · JWY · Mar 22, 2002 · Microbiology

Device Facts

• Record ID: K020037
• Device Name: DRIED GRAM NEGATIVE MIC/COMBO PANELS
• Applicant: Dade Microscan, Inc.
• Product Code: JWY · Microbiology
• Decision Date: Mar 22, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1640
• Device Class: Class 2

Intended Use

The MicroScan® ESBL plus ESBL Confurmation Panel is designed for use in the determination of antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing gram negative bacilli and for the detection of ESBL production in Escherichia coli, Klebsiella oxytoca and Klebsiella pneumoniae. After inoculation, panels are incubated for a minimum of 16 hours at 35°C in a non-CO2 incubator, and read visually, according to the Package Insert. This particular submission is for the addition of the antimicrobials Ceftazidime (0.5-128 ug/ml), Cefotaxime (0.5-128 ug/ml), Ceftazidime/Clavulanic Acid (0.12/4-32/4 ug/ml) and Cefotaxime/Clavulanic Acid (0.12/4-32/4 µg/ml) to the test panel.

Device Story

MicroScan® Dried Gram-Negative MIC/Combo Panels are miniaturized broth dilution susceptibility tests. Panels contain dehydrated antimicrobial agents; rehydrated with water after inoculation with standardized organism suspension. Incubated at 35°C for minimum 16 hours in non-CO2 incubator. Minimum Inhibitory Concentration (MIC) determined by visual observation of lowest concentration showing growth inhibition. Used in clinical laboratories to identify antimicrobial susceptibility and confirm ESBL production in specific gram-negative bacilli. Results assist clinicians in selecting appropriate antibiotic therapy for patients with bacterial infections.

Clinical Evidence

Efficacy and challenge testing performed using ESBL-producing and non-ESBL-producing strains, including AmpC and HiK-1 types. Results compared against molecular characterization data. Overall agreement >90%. Inoculum reproducibility testing (Turbidity and Prompt methods) and Quality Control testing demonstrated acceptable performance.

Technological Characteristics

Miniaturized broth dilution panels; dehydrated antimicrobial agents; rehydrated with water. Incubation: 35°C, minimum 16 hours, non-CO2. Visual reading method. Antimicrobials: Ceftazidime, Cefotaxime, Ceftazidime/Clavulanic Acid, Cefotaxime/Clavulanic Acid.

Indications for Use

Indicated for determination of antimicrobial susceptibility and detection of ESBL production in rapidly growing gram-negative bacilli, specifically Escherichia coli, Klebsiella oxytoca, and Klebsiella pneumoniae, isolated from solid media.

Regulatory Classification

Identification

An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.

Predicate Devices

• MicroScan Dried Gram-Negative MIC/Combo Panels

Submission Summary (Full Text)

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## MAR 2 2 2002

K 020037

#### 510(k) Submission Information:

| Device Manufacturer: | Dade MicroScan Inc. |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact name: | Cynthia Van Duker, Regulatory Affairs Manager |
| Fax: | 916-374-3144 |
| Date prepared: | January 2, 2002 |
| Product Name: | Microdilution Minimum Inhibitory Concentration (MIC) Panels |
| Trade Name: | MicroScan® Dried Gram Negative MIC/Combo Panels with<br>Ceftazidime, Cefotaxime, Ceftazidime/Clavulanic Acid and<br>Cefotaxime/Clavulanic Acid |
| 510(k) Notification: | New antimicrobials - Ceftazidime/Clavulanic Acid and Ceftriaxone/Clavulanic Acic<br>New Intended Use – Ceftazidime and Ceftriaxone |
| Predicate device: | MicroScan Dried Gram-Negative MIC/Combo Panels |

#### 510(k) Summary:

The MicroScan® ESBL plus ESBL Confirmation Panel is designed for use in the determination of antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing gram negative bacilli and for the detection of ESBL production in Escherichia coli, Klebsiella oxytoca and Klebsiella pneumoniae.

The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test that have been diluted in broth and dehydrated. Various antimicrobials agents are diluted in broth to concentrations bridging the range of clinical interest. Panels are rehydrated with water, after inoculation with a standardized suspension of the organism. After incubation in a non-CO2 incubator at 35 °C for a minimum of 16 hours, the minimum inhibitory concentration (MIC) for the test organism is determined by observing the lowest antimicrobial concentration showing inhibition of growth.

Ceftazidime and Ceftriaxone have been cleared for susceptibility testing via Premarket Notification Submissions . This Premarket Notification (510[k]) presents data in support of a request for a new intended use (confirmation of suspected E. coli, K. oxytoca, and K. pneumoniae extended spectrum beta-lactamases) similar to that described in the NCCLS document M100-S9 for Ceftazidime, and Ceftriaxone alone and in combination with Clavulanic Acid.

Efficacy and Challenge testing with MicroScan® Dried Gram Negative panel with Ceftazidime, Ceftazidime/Clavulanic Acid, Ceftriaxone and Ceftriaxone/Clavulanic Acid was conducted with both ESBL Collainens Claraducing strains including AmpC and HiK 1 type strains. The Efficacy and Challenge studies were designed to confirm the acceptability of these antimicrobial agents for confirmation of ESBLs (E. coli, K. oveoca, and K. pneumoniae) by comparing the panel susceptibility results against previously generated molecular characterization data. The Dried panel antimicrobial agents demonstrated an overall Agreement of > 90% with the ESBL and non-ESBL producing strains.

Inoculum reproducibility testing with the MicroScan® Dried Gram Negative panel with Ceftazidime, mobilime/Clavulanic Acid, Ceftriaxone and Ceftriaxone/Clavulanic Acid demonstrated acceptable reproducibility regardless of which inoculum method (i.e., Turbidity and Prompt) was used.

The MicroScan® Dried Gram Negative panel with Ceftazidime/Clavulanic Acid, Ceftriaxone I ho Mitroovar "Directorial cid antimicrobial agents demonstrated acceptable Quality Control throughout each phase of the ESBL evaluation.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## MAR 2 2 2002

Ms. Cynthia Van Duker Regulatory Affairs Manager Dade Behring Inc. 1584 Enterprise Boulevard West Sacramento, CA 95691

k020037 Re:

Trade/Device Name: MicroScan® Dried Gram-Negative MIC/Combo Panels with Ceftazidime, (0.5-128 µg/ml), Cefotaxime (0.5-128 µg/ml), Ceftazidime/Clavulanic Acid (0.12/4-32/4 µg/ml), and Cefotaxime/Clavulanic Acid (0.12/4-32/4 µg/ml)

Regulation Number: 21 CFR 866.1640

Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: Class II Product Code: JWY Dated: January 2, 2002 Received: January 4, 2002

Dear Ms. Van Duker:

We have reviewed your Section 510(k) premarket notification of intent to market the device w o no re ro review a your worked the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce arior 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 either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be fray of 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 Part 801); 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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This letter will allow you to begin marketing your device as described in your 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 ' additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### INDICATIONS FOR USE STATEMENT

Page 1 of 1 .

# 510(k) Number (if known): K ク2 ಲಂ 37

#### MicroScan® Dried Gram-Negative MIC/Combo Panels with Ceftazidime (0.5-128 Device Name: ug/ml), Cefotaxime (0.5-128 µg/ml), Ceftazidime/Clavulanic Acid (0.12/4-32/4 ug/ml) and Cefotaxime/Clavulanic Acid (0.12/4-32/4 ug/ml)

### Indications For Use:

The MicroScan® ESBL plus ESBL Confurmation Panel is designed for use in the determination of antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing gram negative bacilli and for the detection of ESBL production in Escherichia coli, Klebsiella oxytoca and Klebsiella pneumoniae. After inoculation, panels are incubated for a minimum of 16 hours at 35°C in a non-CO2 incubator, and read visually, according to the Package Insert.

This particular submission is for the addition of the antimicrobials Ceftazidime (0.5-128 ug/ml), Cefotaxime (0.5-128 ug/ml), Ceftazidime/Clavulanic Acid (0.12/4-32/4 ug/ml) and Cefotaxime/Clavulanic Acid (0.12/4-32/4 µg/ml) to the test panel.

The Gram-Negative organisms which may be used for detection of ESBL production in this panel are:

> Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Fredde M. Poole

(Division Sign-Off) (Division of Clinical Laboratory Devices

510(k) Number K020037

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use - - - -

(Optional Format 1-2-96)

OR