DRIED GRAM-POSITIVE MIC/COMBO PANELS

K051202 · Dade Behring, Inc. · JWY · Jun 23, 2005 · Microbiology

Device Facts

• Record ID: K051202
• Device Name: DRIED GRAM-POSITIVE MIC/COMBO PANELS
• Applicant: Dade Behring, Inc.
• Product Code: JWY · Microbiology
• Decision Date: Jun 23, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1640
• Device Class: Class 2

Intended Use

To determine antimicrobial agent susceptibility.

Device Story

MicroScan® Dried Gram-Positive MIC/Combo Panels consist of dehydrated Mueller Hinton Broth and nutrients in microdilution wells. Device rehydrated and inoculated with bacterial suspension (turbidity or Prompt® method); incubated 16-24 hours at 35°C. Growth detection performed via visual observation or automated optics systems (autoSCAN® 4 or WalkAway®). System identifies minimum inhibitory concentration (MIC) and categorical interpretation (SIR). Used in clinical microbiology laboratories to determine susceptibility of gram-positive cocci to vancomycin. Output informs antibiotic selection and resistance monitoring, specifically aiding detection of vancomycin-resistant S. aureus (VRSA).

Clinical Evidence

Bench testing only. Performance evaluated using fresh/stock clinical isolates and challenge strains compared to CLSI frozen reference panels. Essential Agreement for vancomycin was >99%. Reproducibility and precision confirmed across multiple inoculum methods (Turbidity, Prompt) and instruments (autoSCAN-4, WalkAway). Quality control testing met acceptance criteria.

Technological Characteristics

Dried microdilution panels containing Mueller Hinton Broth and nutrients. Growth-based detection via optical systems. Inoculation via turbidity or Prompt® methods. Incubation 16-24 hours at 35°C. Compatible with autoSCAN® 4 and WalkAway® automated readers. Software utilizes growth algorithms for MIC determination.

Indications for Use

Indicated for determining quantitative/qualitative antimicrobial susceptibility of rapidly growing aerobic and facultative anaerobic gram-positive cocci, including Enterococcus spp., Staphylococcus spp. (including S. aureus and S. epidermidis), Streptococcus agalactiae, and Streptococcus bovis. For prescription use.

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

• MicroScan® Dried Gram-Positive and Gram-Negative MIC/Combo Panels (k862140)

Submission Summary (Full Text)

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Kos/202

## JUN 2 3 2005

## 510(k) Summary

#### 510(k) Submission Information:

| Device Manufacturer: | Dade Behring, Inc. |
|----------------------|------------------------------------------------------------------|
| Contact name: | Cynthia Van Duker, Regulatory Affairs Manager |
| Fax: | 916-374-3144 |
| Date prepared: | May 10, 2005 |
| 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 - Vancomycin |
| Predicate device: | MicroScan Dried Gram-Positive and Gram-Negative MIC/Combo Panels |

#### 510(k) Summarv:

MicroScan® Dried Gram-Positive MIC/Combo Panels are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-positive cocci.

The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test that have been diluted in broth and dehydrated. Various antimicrobial agents are diluted in broth to concentrations bridging the range of clinical interest. Panels are rehydrated with water after inoculation with a standardized suspension of the organism. After incubation in a non-CO2 incubator for 16-24 hours, the minimum inhibitory concentration (MIC) for the test organism is read by determining the lowest antimicrobial concentration showing inhibition of growth.

The proposed MicroScan® Dried Gram-Positive MIC/Combo Panel demonstrated substantially equivalent performance when compared with a CLSI (formerly NCCLS) frozen Reference Panel, as defined in the FDA document "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA", dated February 5, 2003. The Premarket Notification (510/k]) presents data in support of the MicroScan® Dried Gram-Positive MIC/Combo Panel with vancomycin.

The external evaluation was conducted with fresh and stock Efficacy isolates and stock Challenge strains. The external evaluations were designed to confirm the acceptability of the proposed Dried Gram-Positive Panel by comparing its performance with a CLSI frozen Reference panel. Challenge strains were compared to Expected Results determined prior to the evaluation. The Dried Gram-Positive Panel demonstrated acceptable performance with an overall Essential Agreement of >99% for vancomycin when compared with the frozen Reference panel.

Inoculum and instrument reproducibility testing demonstrated acceptable reproducibility and precision with vancomycin, regardless of which inoculum method (i.e., Turbidity and Prompt), or instrument (autoSCAN-46 and WalkAway®) was used.

Quality Control testing demonstrated acceptable results for vancomycin.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the symbol.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 2 3 2005

Ms. Cynthia Van Duker Regulatory Affairs Manager Dade Behring Inc. 1584 Enterprise Boulevard West Sacramento, CA 95691-9972

k051202 Re: -

K051202
Trade/Device Name: MicroScan® Dried Gram-Positive MIC/Combo Panels with Vancomycin (0.25 -- 128 mcg/ml) Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: Class II Product Code: JWY, LRG, LTW, LTY Dated: May 10, 2005 Received: May 18, 2005

Dear Ms. Van Duker:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have teviewed your becamed the device is substantially equivalent (for the indications felerenced above and nave acterimes ally marketed predicate devices marketed in interstate for use stated in the encreate) to regars and the Medical Device Amendments, or to conniteres pror to May 20, 2017, 12:17 accordance with the provisions of the Federal Food, Drug, devices that have been rechasined in asse approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The 1 ou may, therefore, market the act include requirements for annual registration, listing of general controls provisions practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (600 a00 ro) als. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations a may be subject to subject to such additions (CFR), Parts 800 to 895. In addition, FDA be found in Trite letter announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r least of advised that I Drisonation that your device complies with other requirements of the Act that I DA has made a associations administered by other Federal agencies. You must or any rederal statutes and regations and with the limited to: registration and listing (21 Comply with and the Hos (21 CFR Parts 801 and 809); and good manufacturing practice CI K Fart 807), laboring (QS) regulation (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 5 10(k) I his letter will anow you to obgin marketing your marketing your device to a legally premarket notification: "The PDF Intentig sification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, of by If you desire specific information acourtising of your device, please contact the Office of In
or questions on the promotion and advertising of your device, the colors and th of questions on the promotion and Safety at [phone]. Also, please note the Vill Diagnosite Device Device in and the market notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the You may of and Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address (000)/www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Sales, a Hoy

Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known):_KOS (202

Device Name: MicroScan® Dried Gram-Positive MIC/Combo Panels with Vancomycin (0.25 = 128 mcg/ml)

Indications For Use:

The MicroScan® Dried Gram-Positive MIC/Combo Panel is used to determine The MiteroBour - 2 Walitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-positive on sond moculation, panels are incubated for 16 - 24 hours at 35℃ +/- 1℃ in a coool. I treer moreansed partier visually or with MicroScan instrumentation, according to the Package Insert.

This particular submission is for the addition of the antimicrobial vancomycin at concentrations of 0.25 to 128 mcg/ml to the test panel.

The gram-positive organisms which may be used for vancomycin susceptibility testing in this panel are:

> Enterococcus spp. (e.g., Enterococcus faecalis) Staphylococcus spp. (including Staphylococcus aureus) Staphylococcus epidermidis (including methicillin-resistant strains) Streptococcus agalactiae Streptococcus bovis

Prescription Use _ _ Sc (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Ludolui he. Paole

ivision Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

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510(k) K051202

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