DRIED GRAM-POSITIVE MIC/COMBO PANELS

K972524 · Dade Intl., Inc. · JWY · Sep 8, 1997 · Microbiology

Device Facts

• Record ID: K972524
• Device Name: DRIED GRAM-POSITIVE MIC/COMBO PANELS
• Applicant: Dade Intl., Inc.
• Product Code: JWY · Microbiology
• Decision Date: Sep 8, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1640
• Device Class: Class 2

Indications for Use

To determine gram-positive bacterial susceptibility against the antimicrobial agent Sparfloxacin. Organisms with indications for testing* include: Sparfloxacin Gram-Positive Bacteria Staphylococcus aureus

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 Sparfloxacin against gram-positive bacteria (Staphylococcus aureus). The panels are used in clinical laboratories by trained personnel. The device utilizes dried antimicrobial agents on panels; samples are inoculated using Turbidity or Prompt methods. The panels are processed and read using automated systems (autoScan-4 and WalkAway Systems). The output provides MIC values, which assist clinicians in selecting appropriate antibiotic therapy for patients with bacterial infections. The device benefits patients by providing standardized susceptibility testing to guide effective treatment.

Clinical Evidence

Bench testing only. Performance evaluated by comparing the dried Sparfloxacin panel against the NCCLS frozen Sparfloxacin reference panel using fresh and stock efficacy isolates and challenge strains. Overall Essential Agreement was 98.4%. Reproducibility and precision testing conducted across multiple inoculum methods (Turbidity and Prompt) and instrument platforms (autoScan-4 and WalkAway Systems) showed acceptable performance. Quality control performance was acceptable.

Technological Characteristics

Dried microdilution MIC/Combo panels containing Sparfloxacin (0.015-32 µg/ml). Designed for use with automated reading systems (autoScan-4 and WalkAway). Supports Turbidity and Prompt inoculum methods. In vitro diagnostic device.

Indications for Use

Indicated for determining susceptibility of gram-positive bacteria, specifically Staphylococcus aureus, to the antimicrobial agent Sparfloxacin.

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 Sparfloxacin Reference Panels

Submission Summary (Full Text)

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K972524

Dade MicroScan Inc. MicroScan Dried Gram Positive MIC/Combo Panels with Sparfloxacin Premarket Notification K972524 - Amendment 1 August 29, 1997

SEP - 8 1997

510(k) Summary

### DADE INTERNATIONA

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 3, 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 - Sparfloxacin |
| Predicate device: | NCCLS Frozen Sparfloxacin Reference Panels |

### 510(k) Summary:

The proposed MicroScan® Dried Gram-Positive MIC/Combo Panel with Sparfloxacin demonstrated substantially equivalent performance when compared with an NCCLS frozen Sparfloxacin 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, Sparfloxacin, 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 Sparfloxacin panel by comparing its performance with an NCCLS frozen Sparfloxacin Reference panel.

The Dried Gram-Positive Sparfloxacin panel demonstrated acceptable performance with an overall Essential Agreement of 98.4% when compared with the frozen Sparfloxacin Reference panel.

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

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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

DEPARTMENT OF HEALTH & HUMAN SERVICES - USA

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Sharolyn Lentsch Senior Regulatory Affairs Administrator Dade International MicroScan, Inc. 1584 Enterprise Boulevard West Sacramento, California 95691

SEP - 8 1997

K972524 Re: Trade Name: MicroScan® Dried Gram Positive MIC/Combo Panels New Antimicrobial - Sparfloxacin II Product Code: JWY Regulatory Class: LRG II Dated: July 3, 1997 Received: July 7, 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 A substantially equivalent determination assumes compliance to 895. 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 requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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 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 Panels with Sparfloxacin Premarket Notification K972524 - Amendment 1 August 29, 1997

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# Intended Use Statement

| 510(k) No.: | K972524 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | MicroScan® Dried Gram-Positive MIC/Combo Panels with<br>Sparfloxacin (0.015-32 µg/ml) |
| Indications for Use: | To determine gram-positive bacterial susceptibility against the<br>antimicrobial agent Sparfloxacin. Organisms with indications for<br>testing* include: |
| | Sparfloxacin<br>Gram-Positive Bacteria<br>Staphylococcus aureus |

* As taken from the Indications and Usage section of the manufacturers' package insert (Rhone Poulenc Rorer Pharmaceuticals for Sparfloxacin).

Rea Pal

(Division Sign-Off) Division of Clinical 510(k) Number

_ For Prescription Use