MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS, MODEL B1017

K091264 · Siemens Healthcare Diagnostics · LTT · Jul 22, 2009 · Microbiology

Device Facts

• Record ID: K091264
• Device Name: MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS, MODEL B1017
• Applicant: Siemens Healthcare Diagnostics
• Product Code: LTT · Microbiology
• Decision Date: Jul 22, 2009
• 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 suscept of colonies grown on solid media of rapidly growing arcoire and the stores of the stores of the stores of the stores of the stores of the lock of the lock for t on anous at 3 visually or with MicroScan instrumentation, according to the Package Insert. This particular submission is for the evaluation of antimicrobi vancomycin on the MicroScan Dried Gram-Positive MIC/Combo Panels utilizing the updated Staphylococcus aureus interpretative criteria (S ≤ 2, I = 4 -8, R ≥ 16). 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

Device Story

MicroScan® Dried Gram-Positive MIC/Combo Panels contain dehydrated microdilutions of antimicrobial agents in Mueller Hinton Broth. Panels are rehydrated and inoculated with bacterial suspensions (turbidity or Prompt™ method) at 3-7x10^5 CFU/ml. Incubation occurs at 35°C for 16-24 hours. Growth is assessed via visual observation or automated optics systems (autoSCAN® 4 or WalkAway®). The device determines the Minimum Inhibitory Concentration (MIC) and categorical interpretation (SIR) for Vancomycin. Results assist clinicians in identifying antimicrobial susceptibility for gram-positive cocci, including S. aureus. The system provides quantitative/qualitative data to guide antibiotic therapy decisions.

Clinical Evidence

Bench testing only. Re-evaluation of 51 clinical and 43 challenge S. aureus isolates from original K051202 submission using updated breakpoints. Combined performance across all inoculation/reading methods showed >95% Essential Agreement (EA). Category Agreement (CA) for challenge isolates was >90% when minor discrepancies within EA were excluded. No new clinical studies were conducted.

Technological Characteristics

Miniaturized broth dilution susceptibility test; dehydrated antimicrobial agents in panel wells. Rehydrated with water. Incubation 16-20 hours at non-CO2 conditions. Compatible with visual or automated MicroScan instrumentation reading. Complies with Class II Special Controls Guidance for AST systems.

Indications for Use

Indicated for determining quantitative/qualitative antimicrobial susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-positive cocci, including Enterococcus spp., Staphylococcus spp. (including S. aureus and MRSA), Streptococcus agalactiae, and Streptococcus bovis.

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 MIC/Combo Panels – Vancomycin (K051202)

Submission Summary (Full Text)

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1091264

# JUL 2 2 2009

## Page 1 of 1

### 510(k) Summary

#### 510(k) Submission Information:

| Device Manufacturer: | Siemens Healthcare Diagnostics |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact name: | Shannon Popson, Regulatory Affairs Senior Technical Specialist |
| Fax: | 916-374-3330 |
| Date prepared: | April 21, 2009 |
| 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: | Device Modification - Evaluation of reformulated Vancomycin (K051202)<br>versus S. aureus interpretive criteria ( $S ≤ 2$ , $I = 4 -8$ , $R ≥ 16$ ). |
| | |
| Predicate device: | MicroScan Dried Gram-Positive 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 (MIC) for the test organism is read by determining the lowest antimicrobial concentration showing inhibition of growth.

The proposed MicroScan Dricd Gram-Positive MIC/Combo Panel demonstrated substantially equivalent performance when compared with an CLSI 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 March 5, 2007.

This Special Premarket Notification [510(k)] presents support of a request for a device modification and the updating of the product labeling with S. aureus interpretive criteria of (S < 2, I = 4 -8, R ≥ 16).

Data collected from the external validation of vancomycin (K051202) was processed using the modified S. aureus interpretive criteria (S ≤ 2, I = 4 -8, R ≥ 16). The Dried panel performance was compared with frozen Reference panels using stock and fresh isolates (Efficacy phase), and challenge strains (Challenge phase). 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 99.3% for vancomycin when compared with the frozen Reference panel.

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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993

## JUL 2 2 2009

Ms. Shannon Popson Regulatory Affairs Senior Technical Specialist Siemens Healthcare Diagnostics 2040 Enterprise Blvd West Sacramento, CA 95691

Re: k091264

> 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: LTT, LRG,JWY,LTW Dated: July 14, 2009 Received: July 15, 2009

Dear Ms Popson:

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 mean that FDA has made a determination that your device complies with other requirements of the Act

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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). This letter will allow you to begin marketing your device as described in your Section 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 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). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely yours,

Luella ter Poole, MS

Sue A. Huse, M.S., Ph.D. Acting for

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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## Indication for Use

### 510(k) Number (if known):

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

Indication For Use:

The MicroScan® Dried Gram-Positive MIC/Combo Panel is used to
determine quantitative and/or qualitative antimicrobial agent suscept of colonies grown on solid media of rapidly growing arcoire and the stores of the stores of the stores of the stores of the stores of the lock of the lock for
t on anous at 3 visually or with MicroScan instrumentation, according to the Package Insert.

This particular submission is for the evaluation of antimicrobi vancomycin on the MicroScan Dried Gram-Positive MIC/Combo Panels utilizing the updated Staphylococcus aureus interpretative criteria (S ≤ 2, I = 4 -8, R ≥ 16).

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 _ (21 CFR Part 801 Subpart D) Over the Counter Use (21 CFR Part 801 Subpart C)

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

And/Or

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)

Ludie Poole

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K091267

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