DRIED GRAM-NEGATIVE MIC/COMBO PANELS

K971376 · Dade Microscan, Inc. · JWY · May 30, 1997 · Microbiology

Device Facts

• Record ID: K971376
• Device Name: DRIED GRAM-NEGATIVE MIC/COMBO PANELS
• Applicant: Dade Microscan, Inc.
• Product Code: JWY · Microbiology
• Decision Date: May 30, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1640
• Device Class: Class 2

Indications for Use

To determine gram-negative bacterial susceptibility against the antimicrobial agent Meropenem.

Device Story

MicroScan Dried Gram-Negative MIC/Combo Panels are in vitro diagnostic devices used to determine the minimum inhibitory concentration (MIC) of the antimicrobial agent Meropenem against specific Gram-negative bacteria. The panels contain dried antimicrobial agents; clinical laboratory personnel inoculate the panels with bacterial isolates using either Turbidity or Prompt methods. The panels are processed and read using automated instruments (autoScan-4 or WalkAway). The system measures bacterial growth inhibition to determine the MIC. Results are provided to clinicians to guide antimicrobial therapy selection for patients with Gram-negative bacterial infections. The device supports clinical decision-making by identifying effective antibiotic concentrations, potentially improving patient outcomes through targeted treatment.

Clinical Evidence

Performance evaluated using fresh and stock clinical efficacy isolates and stock challenge strains. Compared against NCCLS frozen Meropenem reference panels. Demonstrated 99.1% overall Essential Agreement. Reproducibility and precision testing performed across multiple inoculum methods (Turbidity, Prompt) and instrument platforms (autoScan-4, WalkAway). Quality control performance was acceptable.

Technological Characteristics

Dried microdilution MIC/Combo panels containing Meropenem (0.004 - 32 mcg/ml). Compatible with automated reading systems (autoScan-4 and WalkAway). Supports Turbidity and Prompt inoculum methods.

Indications for Use

Indicated for determining susceptibility of Gram-Negative Bacteria (Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa) to the antimicrobial agent Meropenem.

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 Meropenem Reference Panels

Submission Summary (Full Text)

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

K971376

Dade MicroScan Inc. MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem Premarket Notification April 11, 1997

MAY 3.0 1997

### DADE INTERNATION/

MicroScan Inc 1584 Enterprise Boulevard West Sacramento, CA 95691 916.372.1900

#### 510(k) Submission Information:

| Device Manufacturer: | Dade MicroScan Inc. |
|----------------------|------------------------------------------------------------|
| Contact name: | Sharolyn Lentsch, Sr. Regulatory Affairs Administrator |
| Fax: | 916-374-3144 |
| Date prepared: | April 11, 1997 |
| Product Name: | Microdilution Minimum Inhibitory Concentration (MIC) Panel |
| Trade Name: | MicroScan® Dried Gram-Negative MIC/Combo Panels |
| Intended Use: | To determine antimicrobial agent susceptibility |
| 510(k) Notification: | New antimicrobial - Meropenem |
| Predicate device: | NCCLS Frozen Meropenem Reference Panels |

#### 510(k) Summary:

The proposed MicroScan® Dried Gram-Negative MIC/Combo Panel with Meropenem demonstrated substantially equivalent performance when compared with an NCCLS frozen Meropenem 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, Meropenen, for the MicroScan® Dried Gram-Negative MIC/Combo Panels.

The gram-negative 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 Meropenem panels by comparing their performance with an NCCLS frozen Meropenem Reference panel.

The Dried gram-negative Meropenem panel demonstrated acceptable performance with an overall Essential Agreement of 99.1% when compared with the frozen Meropenem Reference panel.

Inoculum and instrument reproducibility testing was conducted; the gram-negative Dried Meropenem 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 the gram-negative Dried Meropenem panels.

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

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle symbol.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Sharolyn J. Lentsch Sr. Regulatory Affairs Administrator Dade International MicroScan Inc. 1584 Enterprise Boulevard West Sacramento, CA 95691

MAY 30 1997

Re: K971376

Trade Name: MicroScan® Dried Gram-Negative MIC/Combo Panels/Meropenem Regulatory Class: II Product Code: JWY Dated: April 11, 1997 Received: April 14, 1997

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 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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.

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

## Page 2

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 vour 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 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

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

Dade MicroScan Inc. MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenern Premarket Notification April 11, 1997

# Intended Use Statement

To be assigned by FDA 510(k) No .: - -------------Device Name: MicroScan® Dried Gram-Negative MIC/Combo Panels with Meropenem (0.004 - 32 mcg/ml) To determine gram-negative bacterial susceptibility against the Indications for Use: antimicrobial agent Meropenem. Organisms with indications for testing* include: Gram-Negative Bacteria Escherichia coli Klebsiella pneumoniae Pseudomonas aeruginosa

> * As taken from the Indications and Usage section of the manufacturer's package insert (as provided by the Meropenem manufacturer, Zeneca Pharmaceuticals).

Okaim Hansen

510fk) Number