DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH PENICILLIN

{0}------------------------------------------------ # 510(k) Summary 0 20162 ## 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) Panels | | Trade Name: | MicroScan ^® Dried Gram-Positive MIC/Combo Panels | | Intended Use: | To determine antimicrobial agent susceptibility | | 510(k) Notification: | New QC range - Penicillin | | 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 MicroScan® Dried Gram-Positive MIC/Comfoo I and acceptibility 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 usceptibility tost that have The antimicrobial susceptionity tests are immaturizations of agents are diluted in broth to concentrations been diluted in broth and deliyated. Vanous anninorotat agents and more the minimum bridging the range of chilical interest: Tancis are rears are 16-20 hours, the minimum suspension of the organism. After incubation in a non-CO2 incubation the lowest antimi suspension of the organism. After incuration in a non- Organism is read by determining the lowest antimicrobial concentration showing inhibition of growth. The proposed MicroScan® Dried Gram-Positive MIC/Combo Panel demonstratially equivalent The proposed MicroScan "Dried Crain-I Ositive NTC/Ochiro Panel as defined in the FDA DRAFT performance when compared with an NCCLS frozen Reference in Caraceribility Devices" performance when compared with an NCCLS from the research of Antimicrobial Susceptibility Devices ", dated document "Ouldance on Review Chicha for Assessments data in support of a revised Quality Control March 8, 2000. The Premarker (VolthCaton (Srophy) prosens Can and Supply of Gram-Positive MIC/Combo Panel. {1}------------------------------------------------ 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 eagle with three lines representing its body and wings. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle. 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 Re: k020162 Trade/Device Name: MicroScan® Dried Gram-Positive MIC/Combo Panels with Penicillin (0.03-32, 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. {2}------------------------------------------------ ## 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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrb/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 {3}------------------------------------------------ #### INDICATIONS FOR USE STATEMENT Page_1 of_1_. ## 510(k) Number (if known): K ہود ہے۔ ہے کہ کے کہ # Device Name: MicroScan® Dried Gram-Positive MIC/Combo Panels with Penicillin (0.03 -32, 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 ≥ 0.25 mcg/ml for S. aureus ATCC 29213 with Penicillin. The Gram-Positive organisms which may be used for Penicillin susceptibility testing in this panel are: > Staphylococci (except penicillinase-producing strains) Streptococci (group A) The MicroScan® Dried Gram-Positive MIC/Combo Panels with Penicillin are not intended for use with Streptococcus pneumoniae and viridans streptococci. # (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) | | <div align="center">Freddie L. Poole</div> | |---------------|--------------------------------------------| | | (Division Sign-Off) | | | Division of Clinical Laboratory Devices | | 510(k) Number | K020162 | | Prescription Use | Over-The-Counter Use | |------------------|----------------------| |------------------|----------------------| OR Prescriptic (Per 21 CFR 801.109) Over The Counter Use: **__**. (Optional Format 1-2-96)