MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS , ESBL SCREEN

K981199 · Dade Microscan, Inc. · LRG · Nov 18, 1998 · Microbiology

Device Facts

• Record ID: K981199
• Device Name: MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS , ESBL SCREEN
• Applicant: Dade Microscan, Inc.
• Product Code: LRG · Microbiology
• Decision Date: Nov 18, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1640
• Device Class: Class 2

Intended Use

For use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli.

Device Story

MicroScan® Dried Gram Negative MIC/Combo Panels are in vitro diagnostic devices used in clinical laboratories to determine antimicrobial susceptibility and species identification of aerobic/facultatively anaerobic gram-negative bacilli. This submission adds an indication for detecting suspected ESBL-producing E. coli, K. oxytoca, and K. pneumoniae. The device utilizes antimicrobial agents (Cefpodoxime, Ceftazidime, Aztreonam, Cefotaxime, Ceftriaxone) in dried panel format. Laboratory technicians inoculate panels using Turbidity, Log, or Prompt methods; panels are processed via autoScan®-4 or WalkAway® systems. The system measures bacterial growth inhibition to determine MIC values. Results are interpreted by clinicians to guide antibiotic therapy for patients with suspected gram-negative infections. The device provides rapid susceptibility data, aiding in the identification of potential ESBL-producing organisms, though confirmation via alternate methods is required.

Clinical Evidence

Bench testing only. Efficacy study compared MicroScan® panel susceptibility results against molecular characterization data for ESBL and non-ESBL producing strains, including AmpC-type strains. Reproducibility testing across three inoculum methods (Turbidity, Log, Prompt) and two instrument platforms (autoScan®-4, WalkAway®) showed >95% agreement with the comparative system. Quality control was maintained throughout the evaluation.

Technological Characteristics

Dried microdilution panels containing specific antimicrobial agents (Cefpodoxime, Ceftazidime, Aztreonam, Cefotaxime, Ceftriaxone). Sensing principle based on bacterial growth inhibition in the presence of antibiotics. Compatible with automated systems (autoScan®-4, WalkAway®).

Indications for Use

Indicated for screening Escherichia coli, Klebsiella oxytoca, or K. pneumoniae strains suspected of producing extended-spectrum beta-lactamases (ESBLs) using panels containing Cefpodoxime, Ceftazidime, Aztreonam, Cefotaxime, or Ceftriaxone at 1 ug/ml. Performance characteristics with isolates other than E. coli and Klebsiella spp. have not been established. An alternate method is required for confirmation testing.

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.

Submission Summary (Full Text)

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Attachment C

#### DADE MICROSCAN INC. 1584 Enterprise Boulevard West Sacramento, CA 95691 Tel: [phone]

# DADE BEHRING K981199

### 510(k) Submission Information:

| Device Manufacturer: | Dade MicroScan Inc. |
|----------------------|---------------------------------------------------------------|
| Contact name: | Sharolyn Lentsch, Regulatory Affairs Manager |
| Fax: | 916-374-3144 |
| Date prepared: | October 7, 1998 |
| Product Name: | Microdilution Minimum Inhibitory Concentration (MIC) Panels |
| Trade Name: | MicroScan® Dried Gram Negative MIC/Combo Panels with |
| | Cefpodoxime, Ceftazidime, Aztreonam, Cefotaxime, Ceftriaxone- |
| 510(k) Notification: | New Indication for Use |
| Reference method: | Molecular Characterization Tests |

### 510(k) Summary:

MicroScan® Dried Gram Negative MIC/Combo Panels with Cefpodoxime, Ceftazidime, Aztreonam, Cefotaxime, Ceftriaxone were cleared for susceptibility testing via Premarket Notification submissions. This Premarket Notification (510/kl) presents data in support of a request for a new indication for use (detection of suspected Escherichia coli, Klebsiella oxytoca, and K. pneumoniae extended spectrum beta-lactamases), similar to that described in the NCCLS documents M7-A4 and M100-S9.

Efficacy testing with MicroScan® Dried Gram Negative Ceftazidime, Aztreonam, Cefotaxime, Ceftriaxone antimicrobial agents was conducted with ESBL and non-ESBL producing strains and AmpC-type strains. The Efficacy study was designed to confirm the acceptability of the MicroScan® Dried Gram Negative Cefpodoxime, Ceftazidime, Aztreonam, Cefotaxime, Ceftriaxone antimicrobial agents for detection of suspected ESBLs (E. coli, K. oxytoca, and K. pneumoniae) by comparing the panel susceptibility results against previously generated molecular characterization data.

Inoculum and instrument reproducibility testing with the MicroScan® Dried Gram Negative Cefpodoxime, Ceftazidime, Aztreonam, Cefotaxime, Ceftriaxone antimicrobial agents demonstrated acceptable reproducibility with >95% of the results in agreement with the comparative system, regardless of which inoculum method (i.e., Turbidity, Log, and Prompt), or instrument (autoScan®-4 and WalkAway® System) was used.

The MicroScan® Dried Gram Negative Cefpodoxime, Ceftazidime, Aztreonam, Cefotaxime, Ceftriaxone antimicrobial agents demonstrated acceptable Quality Control throughout each phase of the ESBL evaluation.

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Public Health Service

Image /page/1/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human figures. The figures are connected at the shoulders and appear to be reaching upwards.

## NOV 1 8 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Sharolyn J. Lentsch Regulatory Affairs Manager Dade Microscan, Inc./Dade Behring 1584 Enterprise Boulevard West Sacramento, California 95691

Re: K981199/S1 Trade Name: MicroScan® Dried Gram Negative MIC/Combo Panels Product Code: LRG Regulatory Class: II JWY II Dated: October 7, 1998 October 8, 1998 Received:

Dear Ms.Lentsch:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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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Attachment E

## Indications for Use Statement

| 510(k) No.: | To be assigned by FDA |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | MicroScan® Dried Gram Negative MIC/Combo Panels<br>Cefpodoxime (0.015-64 ug/ml)<br>Ceftazidime (0.5-64 ug/ml)<br>Aztreonam (0.5-64 ug/ml)<br>Cefotaxime (1*-64 ug/ml)<br>Ceftriaxone (1-128 ug/ml) |
| | * 1 ug/ml will be for ESBL screening only. Performance<br>characteristics with isolates other than E. coli and Klebsiella<br>spp., have not been established. |
| Intended Use: | For use in determining antimicrobial agent susceptibility<br>and/or identification to the species level of aerobic and<br>facultatively anaerobic gram-negative bacilli. |
| Indications for Use: | This submission requests clearance of the following new<br>Indication for Use: |
| | Panels containing Cefpodoxime, Ceftazidime, Aztreonam<br>Cefotaxime, or Ceftriaxone at 1 ug/ml can be used to<br>screen for Escherichia coli, Klebsiella oxytoca, or<br>K. pneumoniae strains suspected of producing extended-<br>spectrum beta-lactamases (ESBLs). |

An alternate method is required for confirmation testing.

Woody Dubois

h-Off) ision of Clinical Laboratory Devices 510(k) Number

PRESCRIPTION USE X