DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH AMPICILLIN

K020160 · Dade Behring, Inc. · LTT · Mar 14, 2002 · Microbiology

Device Facts

• Record ID: K020160
• Device Name: DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH AMPICILLIN
• Applicant: Dade Behring, Inc.
• Product Code: LTT · Microbiology
• Decision Date: Mar 14, 2002
• 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 Gram-Positive cocci. After inoculation, panels are incubated for 16 - 20 hours at 35°C +/- 1°C in a non-CO2 incubator, and read either visually or with MicroScan instrumentation, according to the Package Insert. This particular submission is for a revised QC range of ≥ 0.5 mcg/ml for S. aureus ATCC #29213 with Ampicillin. The Gram-Positive organisms which may be used for Ampicillin susceptibility testing in this panel are: Staphylococcus aureus (beta-lactamase and non-beta-lactamase producing) Staphylococcus epidermidis (beta-lactamase and non-beta-lactamase producing) Staphyloccus saprophyticus (beta-lactamase and non-beta-lactamase producing) Streptococcus faecalis (Enterococcus) Streptococcus pyogenes The MicroScan® Dried Gram-Positive MIC/Combo Panels with Ampicillin are not intended for use with Streptococcus pneumoniae and viridans streptococci.

Device Story

MicroScan® Dried Gram-Positive MIC/Combo Panels are miniaturized broth dilution susceptibility tests. Panels contain dehydrated antimicrobial agents. Clinical laboratory personnel inoculate panels with standardized organism suspensions from solid media; rehydrate; incubate 16-20 hours at 35°C in non-CO2 incubator. Device determines Minimum Inhibitory Concentration (MIC) by identifying lowest antimicrobial concentration inhibiting growth. Results read visually or via MicroScan instrumentation. Output informs clinicians of antimicrobial susceptibility to guide antibiotic therapy selection for patients with Gram-positive cocci infections.

Clinical Evidence

Bench testing only. Performance compared to NCCLS frozen Reference Panel to validate revised Quality Control range for Ampicillin with S. aureus ATCC 29213.

Technological Characteristics

Dehydrated broth microdilution panels containing antimicrobial agents. Manual or automated (MicroScan instrumentation) reading. Incubation at 35°C +/- 1°C for 16-20 hours in non-CO2 environment.

Indications for Use

Indicated for determining antimicrobial susceptibility of rapidly growing aerobic and facultative Gram-Positive cocci (S. aureus, S. epidermidis, S. saprophyticus, S. faecalis, S. pyogenes). Not for use with S. pneumoniae or viridans streptococci.

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

Submission Summary (Full Text)

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MAR 1 4 2002

K020140

# 510(k) Summary

#### 510(k) Submission Information:

| Device Manufacturer: | Dade MicroScan Inc. |
|----------------------|------------------------------------------------------------|
| Contact name: | Cynthia Van Duker, Regulatory Affairs Manager |
| Fax: | 916-374-3144 |
| Date prepared: | January 16, 2002 |
| Product Name: | Microdilution Minimum Inhibitory Concentration (MIC) Panel |
| Trade Name: | MicroScan® Dried Gram-Positive MIC/Combo Panels |
| Intended Use: | To determine antimicrobial agent susceptibility |
| 510(k) Notification: | New QC range - Ampicillin |
| 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 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-CO, 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® Dried Gram-Positive MIC/Combo Panel demonstrated substantially equivalent performance when compared with an NCCLS frozen Reference Panel, as defined in the FDA DRAFT document "Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices", dated March 8, 2000. The Premarket Notification (510[k]) presents data in support of a revised Quality Control range for Ampicillin with S. aureus ATCC 29213 on the MicroScan® Dried Gram-Positive MIC/Combo Panel.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The text is written in all capital letters.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR 1 4 2002

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

k020160 Re:

Trade/Device Name: MicroScan® Dried Gram-Positive MIC/Combo Panels with Ampicillin (0.008-128 mcg/ml) Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: Class II Product Code: LTT, JWY Dated: January 16, 2002 Received: January 17, 2002

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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## Page 2 -

This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### INDICATIONS FOR USE STATEMENT

Page 1 of 1 .

### 510(k) Number (if known): K O2O l 00

## Device Name: MicroScan® Dried Gram-Positive MIC/Combo Panels with Ampicillin (0.008 - 128 mcg/ml)

#### Indications For 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 Gram-Positive cocci. After inoculation, panels are incubated for 16 - 20 hours at 35°C +/- 1°C in a non-CO2 incubator, and read either visually or with MicroScan instrumentation, according to the Package Insert.

This particular submission is for a revised QC range of ≥ 0.5 mcg/ml for S. aureus ATCC #29213 with Ampicillin.

The Gram-Positive organisms which may be used for Ampicillin susceptibility testing in this panel are:

> Staphylococcus aureus (beta-lactamase and non-beta-lactamase producing) Staphylococcus epidermidis (beta-lactamase and non-beta-lactamase producing) Staphyloccus saprophyticus (beta-lactamase and non-beta-lactamase producing) Streptococcus faecalis (Enterococcus) Streptococcus pyogenes

The MicroScan® Dried Gram-Positive MIC/Combo Panels with Ampicillin are not intended for use with Streptococcus pneumoniae and viridans streptococci.

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

OR

510(k) Number k02 0160

Prescription Use J (Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)