RPMI 1640 AGAR W/MOPS AND 2% GLUCOSE

K072827 · Remel, Inc. · MJE · Nov 26, 2007 · Microbiology

Device Facts

• Record ID: K072827
• Device Name: RPMI 1640 AGAR W/MOPS AND 2% GLUCOSE
• Applicant: Remel, Inc.
• Product Code: MJE · Microbiology
• Decision Date: Nov 26, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1700
• Device Class: Class 2

Intended Use

Remel RPMI 1640 Agar w/ MOPS and 2% Glucose is a solid medium recommended for use with antibiotic gradient-based systems for quantitative determination of susceptibility to antifungal agents when testing Candida spp. directly from colonies grown on nonselective media.

Device Story

RPMI 1640 Agar w/ MOPS and 2% Glucose is a solid culture medium used in clinical microbiology laboratories. It serves as a growth substrate for Candida spp. when performing antifungal susceptibility testing via gradient-based systems (e.g., antibiotic gradient strips). The medium is inoculated with Candida colonies; an antibiotic gradient strip is applied to the surface. During incubation, the antibiotic diffuses into the agar, creating a concentration gradient. After incubation, a symmetrical inhibition ellipse forms around the strip. The intersection of the inhibition zone with the strip indicates the Minimum Inhibitory Concentration (MIC). Healthcare providers interpret these MIC values to guide antifungal therapy decisions. The medium supports accurate susceptibility testing by providing a standardized environment for fungal growth and drug diffusion, facilitating the determination of appropriate antifungal treatment for patients with Candida infections.

Clinical Evidence

No clinical data provided. The device relies on bench testing demonstrating performance comparable to the CLSI reference method for antifungal broth microdilution.

Technological Characteristics

Solid culture medium containing RPMI-1640, MOPS buffer, 2% glucose, and agar. Designed for use with preformed antibiotic gradient strips. Operates via diffusion-based antibiotic release into the agar matrix. Non-automated, manual interpretation of inhibition ellipses.

Indications for Use

Indicated for quantitative determination of antifungal susceptibility of Candida spp. using antibiotic gradient-based systems. For use with colonies grown on nonselective media.

Regulatory Classification

Identification

A culture medium for antimicrobial susceptibility tests is a device intended for medical purposes that consists of any medium capable of supporting the growth of many of the bacterial pathogens that are subject to antimicrobial susceptibility tests. The medium should be free of components known to be antagonistic to the common agents for which susceptibility tests are performed in the treatment of disease.

Predicate Devices

• Mueller Hinton Agar w/ 2% NaCl

Submission Summary (Full Text)

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K072827

## 510(k) SUMMARY

| Contact Information: | Andre Hsiung<br>Technical Projects Manager<br>Remel Inc.<br>Thermo Fisher Scientific<br>12076 Santa Fe Drive<br>Lenexa, KS 66215<br>Phone: [phone]<br>Fax: [phone]<br>email: [e-mail] | |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | July 14, 2007 | NOV 2 6 2007 |
| Device Trade Name: | RPMI 1640 Agar w/ MOPS and 2% Glucose | |
| Predicate Device: | Mueller Hinton Agar w/ 2% NaCl | |
| Device Classification: | 21 CFR 866.1700; Culture medium for antimicrobial<br>susceptibility tests | |
| Intended Use: | Remel RPMI 1640 Agar w/ MOPS and 2% Glucose is a solid<br>medium recommended for use with antibiotic gradient-based<br>systems for quantitative determination of susceptibility to<br>antifungal agents when testing Candida spp. directly from<br>colonies grown on nonselective media. | |
| Device Description: | RPMI-1640 was developed by Moore et al. at Roswell Park<br>Memorial Institute. The formulation is based on the RPMI-<br>1630 series of media utilizing a bicarbonate buffering system<br>and alterations in the amounts of amino acids and vitamins.<br>RPMI-1640 medium has demonstrated wide applicability in<br>cell culture and also as the reference method for antifungal<br>broth microdilution recommended by Clinical Laboratory<br>Standards Institute (CLSI). When properly supplemented<br>with MOPS, glucose, and agar RPMI-1640 has<br>demonstrated accuracy for use with gradient-based systems<br>with results comparable to that obtained with the CLSI<br>reference method for testing Candida spp. against antifungal<br>agents.<br>The gradient method is based on a combination of the<br>concepts of both dilution and diffusion tests, but differs from<br>conventional disk methods by the use of a preformed, stable<br>antibiotic gradient strip. When the strip is applied to the<br>inoculated agar plate, there is an immediate release of the | |
| Characteristic | Device | Predicate |
| Intended Use | Remel's RPMI 1640 Agar w/ MOPS and 2%<br>Glucose is a solid medium recommended for use<br>with antibiotic gradient-based systems for<br>quantitative determination of susceptibility to<br>antifungal agents when testing Candida spp.<br>directly from colonies grown on nonselective<br>media. | Remel's Mueller Hinton Agar w/ 2% NaCl is<br>a solid medium recommended for use with<br>antibiotic gradient-based systems for<br>quantitative<br>determination of susceptibility to methicillin<br>and oxacillin when testing staphylococci<br>directly from colonies grown on nonselective<br>media. |
| Incubation | 35° C | 35° C |
| Inoculation | Candida spp. | Staphylococcus spp. |
| Technology | To be used with predefined and preformed<br>antifungal gradient on a plastic strip. Single<br>antifungal agent per strip. | To be used with predefined and preformed<br>oxacillin gradient on a plastic strip |
| Interpretation | MICs should be read at approximately 90%<br>inhibition of growth ignoring faint hazes and<br>minute colonies for Flucytosine and 80% inhibition<br>for Fluconazole and Itraconazole. | MIC is read at the end point where there is<br>complete inhibition |

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antibiotic into the agar matrix. A continuous and exponential gradient of antibiotic concentration is created beneath the carrier. After incubation a symmetrical inhibition ellipse centered along the carrier is seen. The zone edge intersects the strip at the minimum inhibitory concentration (MIC) value given in ug/ml. For antifungal testing, due to trailing effect, MICs should be read at approximately 90% inhibition of growth, ignoring faint hazes and minute colonies for flucytosine and 80% inhibition for fluconazole and itraconazole.

## Device Comparison:

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Public Health Service

Food and Drug Administratio 2098 Gaither Road Rockville MD 20850

NOV 2 6 2007

Mr. Andre Hsiung Technical Project Manager Remel Inc. Thermo Fisher Scientific 12076 Santa Fe Drive Lenexa, KS 66215

Re: k072827

> Trade/Device Name: RPMI 1640Agar w/ MOPS and 2% Glucose Regulation Number: 21 CFR 866.1700 Regulation Name: Culture medium for antimicrobial susceptibility test Regulatory Class: Class II Product Code: MJE Dated: October 1, 2007 Received: October 3, 2007

Dear Mr. Hsiung:

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 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), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at 240-276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely yours,

Sally attaym

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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## Indications for Use

510(k) Number (if known): k072827

Device Name: RPMI 1640 Agar w/ MOPS and 2% Glucose

Indications For Use: Remel RPMI 1640 Agar w/ MOPS and 2% Glucose is a plated medium recommended for use with antibiotic gradient-based systems for quantitative determination of susceptibility to antifungal agents when testing Candida spp. directly from colonies grown on nonselective media.

× Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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)

Eudette Poole
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Office of In Vitro Diagnostic Device Evaluation and Safety

07282 510(k).