MICROSCAN MICROSTREP PLUS PANEL CEFOTAXIME (0.015 - 8 MCG/ML

K063101 · Dade Behring, Inc. · LRG · Nov 1, 2006 · Microbiology

Device Facts

• Record ID: K063101
• Device Name: MICROSCAN MICROSTREP PLUS PANEL CEFOTAXIME (0.015 - 8 MCG/ML
• Applicant: Dade Behring, Inc.
• Product Code: LRG · Microbiology
• Decision Date: Nov 1, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1640
• Device Class: Class 2

Intended Use

The MicroScan MICroSTREP plus® Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae. After inoculation, panels are incubated for 20 - 24 hours at 35°C +/- 1°C in a non-CO2 incubator, and read visually according to the Package Insert. Additionally, the panels may be incubated in and read by a MicroScan® WalkAway instrument.

Device Story

MicroScan® MICroSTREP plus® Panel is a 96-well plastic dish containing dehydrated microdilutions of Cefotaxime (0.015–8 µg/mL). Panels are rehydrated with Mueller-Hinton broth supplemented with 2–5% lysed horse blood and inoculated with standardized bacterial suspensions (approx. 5 × 10⁵ CFU/mL). After 20–24 hours incubation at 35°C, growth is assessed to determine the Minimum Inhibitory Concentration (MIC). The device supports both manual visual reading and automated reading via the MicroScan® WalkAway System, which utilizes optics light detection to measure growth. The automated system provides quantitative and qualitative susceptibility results, assisting clinicians in identifying appropriate antimicrobial therapy for streptococcal infections. The system is intended for use in clinical laboratory settings.

Clinical Evidence

Bench testing only. Reproducibility was assessed using 10 isolates across 4 sites (360 results), demonstrating >95% reproducibility for both manual and automated methods. Performance was validated using 70 streptococcal challenge isolates (including 53 S. pneumoniae) compared to reference broth dilution. Essential Agreement (EA) was 92.9% for manual and 92.5% for automated reading. One very major discrepancy (vmj) was noted in the automated method (1/22, 4.5%) for meningitis breakpoints. No clinical efficacy studies were required as the manual method was previously established.

Technological Characteristics

Miniaturized broth dilution susceptibility test system. Panels contain antimicrobial agents in concentrations bridging clinical interest. Rehydrated with Mueller-Hinton broth, 2-5% lysed horse blood, and 50 mM HEPES. Incubation at 35°C +/- 1°C. Automated reading via MicroScan WalkAway instrument. Regulatory class II, product codes LRG and LTT.

Indications for Use

Indicated for testing Streptococcus pneumoniae, Streptococcus pyogenes, and Streptococcus species using MICroSTREP plus® Panels on the MicroScan® WalkAway System. Prescription use only. Turbidity method of inoculum preparation required.

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 MICroSTREP plus® Panel (K021111)

Submission Summary (Full Text)

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KO63101

NOV - 1 2006

## 510(k) Summary Information:

| Device Manufacturer: | Dade Behring Inc. |
|----------------------|-------------------------------------------------------------------------------------------------------------|
| Contact name: | Maureen Mende, Regulatory Affairs, Group Manager |
| Phone/Fax: | 916-374-3174/916-374-3144 |
| Date prepared: | October 3, 2006 |
| Product Name: | Microdilution Minimum Inhibitory Concentration (MIC) Panels |
| Trade Name: | MicroScan MICroSTREP plus® Panel |
| Intended Use: | To determine bacterial susceptibility to Cefotaxime |
| Indication for Use: | For determining antimicrobic susceptibility with aerobic streptococci<br>including Streptococcus pneumoniae |
| Predicate device: | MicroScan MICroSTREP plus® Panel (K021111) |

## 510(k) Summary:

The MicroScan MICroSTREP plus® Panel is used to determine quantitative and/or qualitative r no microbial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae. After inoculation, panels are incubated for 20 - 24 hours at 35°C +/-1 ℃ in a non-CO2 incubator, and read according to the Package Insert.

The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test. Various antimicrobial agents are diluted in water, buffer or minute concentrations of broth to concentrations bridging the range of clinical interest. Panels are rehydrated with 115 ul Muellerecontractle supplemented with 2-5% lysed horse blood (LHB) and buffered with 50 mM HEPES, after inoculation of the broth with a standardized suspension of the organism in saline. After incubation in a non-CO2 incubator for 20-24 hours, the minimum inhibitory concentration (MIC) for the test organism is manually read by observing the lowest antimicrobial concentration showing inhibition of growth. Additionally, the panels may be incubated in and read by a MicroScan WalkAway instrument.

The proposed instrument read method for the MicroScan MICroSTREP plus® Panel demonstrated substantially equivalent performance with streptococcal isolates when compared with an expected result generated on a 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 February 5, 2003.

This Premarket Notification (510[k]) presents data in support of reading the MICroSTREP plus Panel with Cefotaxime on the MicroScan® WalkAway instrument.

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The evaluation was conducted with stock and CDC Challenge strains. The evaluations were designed to confirm the acceptability of the proposed instrument read method for the MICroSTREP plus® Panel by comparing its performance with Expected Results determined before the evaluation. The MICroSTREP plus® Panel demonstrated acceptable performance with an overall Essential Agreement of 93% for Cefotaxime instrument read results compared with the Expected Result.

Instrument reproducibility testing demonstrated acceptable reproducibility and precision with Cefotaxime and the WalkAway® instrument.

Quality Control testing demonstrated acceptable results for Cefotaxime.

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Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Maureen Mende Regulatory Affairs Group Manager Dade Behring Inc. 2040 Enterprise Boulevard West Sacramento, CA 95691

NOV - 1 2006

Re: k063101

Trade/Device Name: MicroScan MICroSTREP plus® Panel Cefotaxime (0.015 - 8 mcg/ml) Regulation Number: 21 CFR § 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: II Product Code: LRG, LTT Dated: October 3, 2006 Received: October 10, 2006

Dear Ms. Mende:

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, brug, 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, isting 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 not mean 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) 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 frem mober [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Sally, artur

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 Statement

510(k) No.:

K063101 (To be assigned by FDA)

Device Name:

MicroScan MICroSTREP plus® Panel Cefotaxime (0.015 - 8 mcg/ml)

Intended Use

The MicroScan MICroSTREP plus® Panel is used to determine Indications for Use: quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae. After inoculation, panels are incubated for 20 - 24 hours at 35°C +/- 1°C in a non-CO2 incubator, and read visually according to the Package Insert. Additionally, the panels may be incubated in and read by a MicroScan® WalkAway instrument.

To determine bacterial antimicrobial agent susceptibility

This particular submission is for the addition of instrument read capability of the antimicrobial Cefotaxime, at concentrations of 0.015 -8 mcg/ml on the MicroScan MICroSTREP plus® Panel.

The organisms which may be used for Cefotaxime susceptibility testing in this panel are:

Streptococcus pneumoniae Streptococcus pyogenes (Group A beta-hemolytic streptococci) Streptococcus spp.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ AND/OR (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)

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K06 3101