MICROSCAN MICROSTREP PLUS PANEL TETRACYCLINE (0.006 TO 16 MCG/ML)

K062923 · Dade Behring, Inc. · LRG · Oct 13, 2006 · Microbiology

Device Facts

• Record ID: K062923
• Device Name: MICROSCAN MICROSTREP PLUS PANEL TETRACYCLINE (0.006 TO 16 MCG/ML)
• Applicant: Dade Behring, Inc.
• Product Code: LRG · Microbiology
• Decision Date: Oct 13, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1640
• Device Class: Class 2

Intended Use

To determine bacterial antimicrobial agent susceptibility

Device Story

MicroScan MICroSTREP plus Panel is a miniaturized broth dilution susceptibility test system. It uses panels rehydrated with Mueller-Hinton broth, 2-5% lysed horse blood, and 50 mM HEPES buffer. After inoculation with standardized organism suspensions, panels are incubated for 20-24 hours at 35°C in a non-CO2 incubator. Results are determined by visual inspection or by using the MicroScan WalkAway instrument. The instrument reads the lowest antimicrobial concentration (MIC) that inhibits bacterial growth. This submission specifically adds instrument-read capability for Tetracycline (0.06 to 16 mcg/ml). Healthcare providers use these MIC results to guide antimicrobial therapy decisions for patients with streptococcal infections. The device is intended for professional use in clinical laboratory settings.

Clinical Evidence

Bench testing only. Reproducibility study (10 isolates, 3 sites, 3 days) showed >95% reproducibility for both manual and automated methods. Comparison study of 70 streptococcal challenge isolates (including 53 S. pneumoniae) demonstrated 97.1% Essential Agreement (EA) for automated reading vs. reference broth dilution. No significant trending or performance differences observed between manual and automated reading methods.

Technological Characteristics

Miniaturized broth dilution susceptibility test. Components: panels rehydrated with Mueller-Hinton broth, 2-5% lysed horse blood (LHB), and 50 mM HEPES buffer. Incubation: 20-24 hours at 35°C +/- 1°C in non-CO2 incubator. Readout: visual or automated via MicroScan WalkAway instrument. Connectivity: integrated with WalkAway instrument system.

Indications for Use

Indicated for determining quantitative and/or qualitative antimicrobial susceptibility of aerobic streptococci, including Streptococcus pneumoniae, grown on solid media. Tetracycline testing is indicated for Streptococcus spp. and Streptococcus pneumoniae.

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 (K062923)

Submission Summary (Full Text)

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# 510(k) Summary Information:

OC1 1 3 2006

| Device Manufacturer: | Dade Behring Inc. |
|----------------------|----------------------------------------------------------------------------------------------------------|
| Contact name: | Libby Warriner, Regulatory Affairs |
| Phone/Fax: | 916-374-3244/916-374-3144 |
| Date prepared: | September 20, 2006 |
| Product Name: | Microdilution Minimum Inhibitory Concentration (MIC) Panels |
| Trade Name: | MicroScan MICroSTREP plus® Panel |
| Intended Use: | To determine bacterial susceptibility to Tetracycline |
| Indication for Use: | For determining antimicrobic susceptibility with aerobic streptococci including Streptococcus pneumoniae |
| Predicate device: | MicroScan® MICroSTREP plus® Panel |

### 510(k) Summary:

The MicroScan MICroSTREP plus® Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococi, allumicrolial agent subscopiesmer of occulation, panels are incubated for 20 – 24 hours at merading by option on on-CO2 incubator, and read according to the Package Insert.

The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test. I he allimicrobial susceptions) collect in water, buffer or minute concentrations of broth to v anous animilieroom ugans are and interest. Panels are rehydrated with 115 ul Mueller-Concentrations origing are railly 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. ITES Los, atter inceculation of also erom were 20-24 hours, the minimum inhibitory concentration Alter inculture in a non CO2 mousaly read by observing the lowest antimicrobial concentration (INIC) for the test of gamels may be incubated in and be incubated in and read by a MicroScan® WalkAway instrument.

The proposed instrument read method for the MicroScan MICroSTREP plus® Panel demonstrated I he proposed instrantent read measure with streptococcal isolates when compared with an expected Substantally cqurrated on a CLSI frozen Reference Panel, as defined in the FDA document "Class II Special 16301 generated on a CEDERNEDA 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 Tetracycline on the MicroScan® WalkAway instrument.

The external evaluation was conducted with stock and CDC Challenge strains. The external I he catelliar were designed to confirm the acceptability of the proposed instrument read method for evaluations were designed to commission its performance with Expected Results determined the MICroof REP plus - Pailer of STREP plus Panel demonstrated acceptable performance with

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an overall Essential Agreement of 97.1% for Tetracycline instrument read results compared with the Expected Result.

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

Quality Control testing demonstrated acceptable results for Tetracycline.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Libby Warriner Regulatory Affairs/Quality Systems Compliance Senior Specialist Dade Behring, Inc. 1584 Enterprise Boulevard West Sacramento, CA 95691-9972

OCT 1 3 2006

Re: k062923

Trade/Device Name: MicroScan MICroSTREP plus® Panel Tetracycline (0.06 to 16 mcg/ml) Regulation Number: 21 CFR § 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: II Product Code: LRG, LTT Dated: September 20, 2006 Received: September 28, 2006

Dear Ms. Warriner:

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 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 10(k) I his letter will anow you to begin marketing your as revivalence of your device to a legally premarked notification: "The PDTV mailing of bossification 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, II you desire specific information acour and advertising of your device, please contact the Office of In
or questions on the promotion and advertising of your and advanced th of questions on the promotion and Safety at [phone]. Also, please note the Viro Diagnostic Device Evaluation and Sales to (21) = (21) = (21CFF Part 807.97).
regulation entitled, "Misbranding by reference to premarket notification" (21CF). Alfremtha fegulation entitled, "Misoranding by folcrence to proder the Act may be obtained from the Other general information on your responsional 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,

Sally artman

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.: | K062923<br>(To be assigned by FDA) |
|-------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | MicroScan MICroSTREP plus ^® Panel<br>Tetracycline (0.06 to 16 mcg/ml) |
| Intended Use | To determine bacterial antimicrobial agent susceptibility |
| Indications for Use: | The MicroScan MICroSTREP plus ^® Panel is used to determine<br>quantitative and/or qualitative antimicrobial agent susceptibility of<br>colonies grown on solid media of aerobic streptococci, including<br><i>Streptococcus pneumoniae</i> . After inoculation, panels are incubated<br>for 20 - 24 hours at 35°C +/- 1°C in a non-CO2 incubator, and read<br>visually according to the Package Insert. Additionally, the panels<br>may be incubated in and read by a MicroScan ^® WalkAway<br>instrument. |
| | This particular submission is for the addition of instrument read<br>capability of the antimicrobial Tetracycline, at concentrations of<br>0.06 to 16 mcg/ml on the MicroScan MICroSTREP plus ^® Panel. |
| | The organisms which may be used for Tetracycline susceptibility<br>testing on this panel are: |
| <i>Streptococcus</i> spp.<br><i>Streptococcus pneumoniae</i> | |
| Prescription Use<br>X<br>(Part 21 CFR 801 Subpart D) | AND/OR<br>Over-The-Counter Use<br>(21 CFR 807 Subpart C) |
| (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF<br>NEEDED) | |
| | Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) |
| | <div> <img alt="Signature" src="signature.png"/> </div> Division Sign-Off |

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Office of In Vitro Diagnostic Device Onnee tion and Safety

510(k) | KD62923