MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH ERYTHROMYCIN

K050043 · Dade Behring, Inc. · LRG · Mar 29, 2005 · Microbiology

Device Facts

• Record ID: K050043
• Device Name: MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH ERYTHROMYCIN
• Applicant: Dade Behring, Inc.
• Product Code: LRG · Microbiology
• Decision Date: Mar 29, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1640
• Device Class: Class 2

Intended Use

The MicroScan® Dried Gram-Positive MIC/Combo Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-positive cocci. The panels are incubated for 16 – 20 hours at 35℃ +/- 1℃ in a non-CO2 incubator, and read either visually or with MicroScan instrumentation, according to the Package Insert. This particular submission is for the addition of the antimicrobial Erythromycin at concentrations of 0.25 to 16 mcg/ml to the test panel. The gram-positive organisms which may be used for Erythromycin susceptibility testing in this panel are: Staphylococcus aureus.

Device Story

MicroScan® Dried Gram-Positive MIC/Combo Panels consist of dehydrated Mueller Hinton Broth and nutrients in microdilution wells. Device determines antimicrobial susceptibility of gram-positive cocci. Inoculum prepared via turbidity method or Prompt® system; panels rehydrated and inoculated with 0.1 ml suspension. Incubation at 35°C for 16-20 hours in non-CO2 incubator. Growth measured via visual observation or automated instruments (autoScan® 4 or WalkAway®). Instruments use optics and growth algorithms to detect inhibition. Output includes minimum inhibitory concentration (MIC) and categorical interpretation (SIR). Used in clinical microbiology laboratories to guide antibiotic therapy decisions.

Clinical Evidence

Bench testing only. Performance evaluated using fresh and stock Efficacy isolates and stock Challenge strains. Compared against NCCLS frozen Reference Panel. Overall Essential Agreement for Erythromycin was >96%. Reproducibility and precision confirmed across different inoculum methods (Turbidity and Prompt) and instruments (autoSCAN-4® and WalkAway®). Quality Control testing met acceptance criteria.

Technological Characteristics

Dried microdilution panels containing Mueller Hinton Broth and nutrients. Growth-based detection principle. Dimensions/form factor: multi-well panel. Connectivity: standalone or networked via autoScan® 4 or WalkAway® instruments. Software: growth algorithms for automated reading. Sterilization: not specified.

Indications for Use

Indicated for determining quantitative and/or qualitative antimicrobial susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-positive cocci. Includes addition of erythromycin (0.25-16 ug/mL). Contraindicated for Listeria monocytogenes.

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

Submission Summary (Full Text)

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MAR 2 9 2005

K050043

### 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: | January 5, 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 - Erythromycin |
| Predicate device: | MicroScan Dried Gram-Positive and Gram-Negative MIC/Combo Panels |

#### 510(k) Summary:

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 16-20 hours, the minimum inhibitory concentration (MC) 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 an 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 Erythromycin.

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 an NCCLS 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 >96% for Erythromycin when compared with the frozen Reference panel.

Inoculum and instrument reproducibility testing demonstrated acceptable reproducibility and precision with Erythromycin, regardless of which inoculum method (i.e., Turbidity and Prompt), or instrument (autoSCAN-4® and WalkAway®) was used.

Quality Control testing demonstrated acceptable results for Erythromycin.

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

## MAR 2 9 2005

Food and Druq Administration 2098 Gaither Road Rockville MD 20850

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

k050043 Re:

Trade/Device Name: MicroScan® Dried Gram-Positive MIC/Combo Panels with Erythromycin (0.25 - 16 mcg/ml) Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: Class II Product Code: LRG Dated: March 22, 2005 Received: March 24, 2005

Dear Ms. Van Duker:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mcan that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (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 510(k) I mis lotter with anon. The FDA finding of substantial equivalence of your device to a legally premated newice results in a classification 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, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Sales a Story

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): Ko ≤ 0043/S /

Device Name: MicroScan® Dried Gram-Positive MIC/Combo Panels with Erythromycin (0.25_ 16 mcg/ml)

Indications For Use:

The MicroScan® Dried Gram-Positive MIC/Combo Panel is used to determine r no fiferooval - E revelitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-positive on sond media of rapies goods are incubated for 16 – 20 hours at 35℃ +/- 1℃ in a non-CO2 incubator, and read either visually or with MicroScan instrumentation, according to the Package Insert.

This particular submission is for the addition of the antimicrobial Erythromycin at concentrations of 0.25 to 16 mcg/ml to the test panel.

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

Staphylococcus aureus

____ لا__ Prescription Use __________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

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

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Ko 50043 /SI 510(k) -