DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS

K983711 · Dade Microscan, Inc. · JWY · Apr 27, 1999 · Microbiology

Device Facts

• Record ID: K983711
• Device Name: DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS
• Applicant: Dade Microscan, Inc.
• Product Code: JWY · Microbiology
• Decision Date: Apr 27, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1640
• Device Class: Class 2

Indications for Use

To determine gram-negative and gram-positive bacterial susceptibility against the antimicrobial agent Grepafloxacin. There are no organisms for which MicroScan® panels are intended for testing, that are included in the 'Indications and Usage' as stated in the FDA approval of Grepafloxacin. The following secondary organisms included for the testing of MicroScan® panels have in vitro data but the safety and effectiveness in treating clinical infections have not been established: Citrobacter freundii, Citrobacter (diversus) koseri, Enterobacter aerogenes, Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Staphylococcus aureus (methicillin-susceptible), Staphylococcus epidermidis (methicillin-susceptible), Streptococcus agalactiae, Streptococcus pyogenes. The MicroScan® Dried Gram-Positive MIC/Combo Panels with Grepafloxacin are not intended for use with Streptococcus pneumoniae and viridans streptococci.

Device Story

MicroScan® Dried MIC/Combo Panels are in vitro diagnostic devices used to determine bacterial susceptibility to the antimicrobial agent Grepafloxacin. Panels contain dried antimicrobial agents; clinical laboratory personnel inoculate panels with bacterial isolates using Turbidity or Prompt methods. Panels are processed using automated instruments (autoScan-4 or WalkAway®). Instruments measure bacterial growth inhibition to determine Minimum Inhibitory Concentration (MIC). Results assist clinicians in selecting appropriate antibiotic therapy. Device provides standardized, reproducible susceptibility testing compared to reference methods.

Clinical Evidence

Bench testing only. External evaluations compared dried panels to NCCLS frozen reference panels using fresh/stock clinical isolates and challenge strains. Gram-negative panel demonstrated 98.8% Essential Agreement; Gram-positive panel demonstrated 97.5% Essential Agreement. Reproducibility and precision confirmed across multiple inoculum methods (Turbidity, Prompt) and instruments (autoScan-4, WalkAway®). Quality control performance was acceptable.

Technological Characteristics

Dried microdilution panels containing Grepafloxacin (0.002 - 8 mcg/ml). Utilizes automated optical density/growth measurement via autoScan-4 or WalkAway® instruments. Compatible with Turbidity and Prompt inoculum preparation methods. In vitro diagnostic use.

Indications for Use

Indicated for determining in vitro susceptibility of specific gram-negative and gram-positive bacteria to Grepafloxacin. Includes various Enterobacteriaceae, S. aureus, S. epidermidis, S. agalactiae, and S. pyogenes. Contraindicated for Streptococcus pneumoniae and viridans streptococci.

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

• NCCLS Frozen Grepafloxacin Reference Panels

Submission Summary (Full Text)

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4/2/99

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

# DADE BEHRING

# 510(k) Summary

### 510(k) Submission Information:

| Device Manufacturer: | Dade MicroScan Inc. |
|----------------------|-------------------------------------------------------------------|
| Contact name: | Cynthia Van Duker, Sr. Regulatory Affairs Specialist |
| Fax: | 916-374-3144 |
| Date prepared: | October 16, 1998 |
| Product Name: | Microdilution Minimum Inhibitory Concentration (MIC) Panels |
| Trade Name: | MicroScan® Dried Gram-Negative and Gram-Positive MIC/Combo Panels |
| Intended Use: | To determine antimicrobial agent susceptibility |
| 510(k) Notification: | New antimicrobial - Grepafloxacin |
| Predicate device: | NCCLS Frozen Grepafloxacin Reference Panels |

### 510(k) Summary:

The proposed MicroScan® Dried Gram-Negative and Gram-Positive MIC/Combo Panel with Grepationalin demonstrated substantially equivalent performance with an NCCLS frozen Grepafloxacin Reference Panel, as defined in the FDA DRAFT document "Review Criteria for Assessment of Antimicrobial Susceptibility Devices" (dated May 31, 1991).

The Premarket Notification (510[k]) presents data in support of the new antimicrobial, Grepafloxacin, for the MicroScan® Dried Gram Negative and Gram Positive MIC/Combo Panels.

Both the gram-negative and gram-positive external evaluations were conducted with fresh and stock Efficacy isolates and stock Challenge strains. The external evaluations were designed to confirm the acceptability of the proposed Dried Grepafloxacin panels by comparing their performance with an NCCLS frozen Grepafloxacin Reference panel.

The Dried gram-negative Grepafloxacin panel demonstrated acceptable performance with an overall Essential Agreement of 98.8% when compared with the frozen Grepafloxacin Reference panel. The Dried gram-positive Grepafloxacin panel demonstrated acceptable performance with an overall Essential Agreement of 97.5% when compared with the frozen Grepafloxacin Reference panel.

Inoculum and instrument reproducibility testing was conducted; both the gram-negative and the grampositive Dried Grepafloxacin panels demonstrated acceptable reproducibility and precision, regardless of which inoculum method (i.e., Turbidity and Prompt), or instrument (autoScan-4 and WalkAway") was used.

Quality Control performance was acceptable for both the gram-negative and the gram-positive Dried Grepafloxacin panels.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 7 1999

Cynthia Van Duker Senior Associate, Regulatory Affairs Dade Microscan, Inc. 1584 Enterprise Boulevard West Sacramento, CA 95691

Re: K983711

> Trade Name: MicroScan® Dried Gram-Negative and Gram-Positive MIC/Combo Panels with Grepafloxacin Product Code: JWY Dated: March 25, 1999 Received: March 26, 1999

Dear Ms. Van Duker:

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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory 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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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

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 at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Sutman

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 B

# Indications for Use Statement

| 510(k) No.: | K983711 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | MicroScan® Dried Gram-Negative and Gram-Positive<br>MIC/Combo Panels with Grepafloxacin (0.002 - 8 mcg/ml<br>on the gram-negative and gram-positive panels) |
| Indications for Use: | To determine gram-negative and gram-positive bacterial<br>susceptibility against the antimicrobial agent Grepafloxacin. |
| | There are no organisms for which MicroScan® panels are<br>intended for testing, that are included in the 'Indications and<br>Usage' as stated in the FDA approval of Grepafloxacin.<br>The following secondary organisms included for the testing<br>of MicroScan® panels have in vitro data but the safety and<br>effectiveness in treating clinical infections have not been<br>established: Citrobacter freundii, Citrobacter (diversus)<br>koseri, Enterobacter aerogenes, Enterobacter cloacae,<br>Escherichia coli, Klebsiella oxytoca, Klebsiella<br>pneumoniae, Morganella morganii, Proteus mirabilis,<br>Proteus vulgaris, Staphylococcus aureus (methicillin-<br>susceptible), Staphylococcus epidermidis (methicillin-<br>susceptible), Streptococcus agalactiae, Streptococcus<br>pyogenes.<br>The MicroScan® Dried Gram-Positive MIC/Combo Panels |

with Grepafloxacin are not intended for use with Streptococcus pneumoniae and viridans streptococci.

Woody Dubois

(Division Sign-Off) Division of Clinical Laboratory Devices K9837 510(k) Number

PRESCRIPTION USE X