DRIED GRAM-POSITIVE MIC/COMBO PANELS

K972799 · Dade Microscan, Inc. · LTT · Oct 10, 1997 · Microbiology

Device Facts

• Record ID: K972799
• Device Name: DRIED GRAM-POSITIVE MIC/COMBO PANELS
• Applicant: Dade Microscan, Inc.
• Product Code: LTT · Microbiology
• Decision Date: Oct 10, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1640
• Device Class: Class 2

Indications for Use

To determine antimicrobial agent susceptibility

Device Story

MicroScan Dried Gram-Positive MIC/Combo Panels are in vitro diagnostic devices used to determine the minimum inhibitory concentration (MIC) of the antimicrobial agent Meropenem against gram-positive bacteria. The panels are used in clinical laboratory settings. The device utilizes microdilution technology to assess bacterial susceptibility. Results are interpreted by healthcare professionals to guide antibiotic treatment decisions. The system supports various inoculation methods (Turbidity and Prompt) and is compatible with automated instruments like the autoScan-4 and WalkAway Systems for reading and analysis. The device provides quantitative susceptibility data, assisting clinicians in selecting appropriate antimicrobial therapy for patients with bacterial infections.

Clinical Evidence

Performance evaluated using fresh and stock Efficacy isolates and stock Challenge strains. Compared against NCCLS frozen Meropenem Reference panels. Overall Essential Agreement reported at 97.2%. Reproducibility and precision testing conducted for inoculum methods (Turbidity and Prompt) and instruments (autoScan-4 and WalkAway Systems). Quality Control performance was acceptable.

Technological Characteristics

Microdilution MIC panels containing dried antimicrobial agent (Meropenem). Concentration range: 0.06-32 µg/ml. Compatible with automated reading systems (autoScan-4, WalkAway).

Indications for Use

Indicated for determining gram-positive bacterial susceptibility against the antimicrobial agent Meropenem. Includes Viridans group streptococci, though these are contraindicated for use with Meropenem on these specific panels.

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)

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11412199

Dade MicroScan Inc. MicroScan Dried Gram Positive MIC/Combo Panels with Meropenem Premarket Notification July 25, 1997

OCT 10 1997

# IA DR

510(k) Summary

### DADE INTERNATIONAL

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: | July 25, 1997 |
| Product Name: | Microdilution Minimum Inhibitory Concentration (MIC) Panels |
| Trade Name: | MicroScan® Dried Gram-Positive 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-Positive 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 a new antimicrobial, Meropenen, for the MicroScan® Dried Gram-Positive MIC/Combo Panels.

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

The Dried Gram-Positive Meropenem panel demonstrated acceptable performance with an overall Essential Agreement of 97.2% when compared with the frozen Meropenem Reference panel.

Inoculum and instrument reproducibility testing was conducted; both the Gram-Positive Dried Meropenem panels demonstrated acceptable reproducibility and precision, regardless of which inoculum and WalkAway Systems) was used. method (i.e., Turbidity and Prompt), or instrument (autoScan-4

Quality Control performance was acceptable for the Gram-Positive Dried Meropenem panels.

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol. The text is in all caps and is evenly spaced around the circle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT 10 1997

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

Re: K972799

> Trade Name: Dried Gram-Positive MIC/Combo Panels Regulatory Class: II Product Code: LTT Dated: July 25, 1997 Received: July 28, 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 current Good Manufacturing Practice requirement, 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 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 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 Autman

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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Dade MicroScan Inc. MicroScan Dried Gram Positive MIC/Combo Pancls with Meropenem Premarket Notification K972799 - Amendment 1 Ocuber 3, 1997

## Indications for Use Statement

510(k) No.:

K972799

Device Name:

MicroScan® Dried Gram-Positive MIC/Combo Panels with Meropenem (0.06-32 µg/ml)

Indications for Use: To determine gram-positive bacterial susceptibility against the antimicrobial agent Meropenem. Organisms with indications for testing* include:

> Gram-Positive Bacteria Viridans group streptococci

Although viridans streptococci are indicated for testing* with the antimicrobial agent Meropenem, they are contraindicated for use with Meropenem on MicroScun Dried Gram-Positive MIC/Combo Panels.

* As taken from the Indications and Usage section of each manufacturers' package insert (Zeneca).

Jean Cooper

(Division Sign-Off) Division of Clinical Laboratory Devices K972799 510(k) Number_

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The Counter Use

(Optional Format 1-2-96)

9710031_DOC

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