(54 days)
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No
The device description focuses on a culture medium and a gradient diffusion method for determining antifungal susceptibility, with no mention of AI or ML technologies.
No
This device is a solid medium used for the quantitative determination of susceptibility to antifungal agents, specifically for testing Candida species. It is a diagnostic tool, not a therapeutic one.
No
The device is a medium used for quantitative determination of susceptibility to antifungal agents, which is a test for diagnostic purposes, but the device itself is a medium, not a diagnostic device.
No
The device description clearly describes a physical growth medium (agar) used for laboratory testing, not a software application.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the medium is "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." This describes a test performed in vitro (outside the body) on a biological sample (Candida spp. colonies) to provide information about a patient's condition (susceptibility to antifungal agents).
- Device Description: The description details the composition and function of the medium in the context of a diagnostic test (antifungal susceptibility testing). It explains how the medium is used with gradient strips to determine the minimum inhibitory concentration (MIC), which is a key diagnostic parameter.
- Predicate Device: The mention of a "Predicate Device(s)" like "Mueller Hinton Agar w/ 2% NaCl" further supports its classification as an IVD. Predicate devices are typically other legally marketed IVDs that a new device is compared to for regulatory purposes.
In summary, the device is a reagent used in a laboratory setting to perform a test on a biological sample to aid in the diagnosis and treatment of a patient's condition (specifically, determining the effectiveness of antifungal medications). This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Remel's 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
MJE
Device Description
RPMI-1640 was developed by Moore et al. at Roswell Park Memorial Institute. The formulation is based on the RPMI-1630 series of media utilizing a bicarbonate buffering system and alterations in the amounts of amino acids and vitamins. RPMI-1640 medium has demonstrated wide applicability in cell culture and also as the reference method for antifungal broth microdilution recommended by Clinical Laboratory Standards Institute (CLSI). When properly supplemented with MOPS, glucose, and agar RPMI-1640 has demonstrated accuracy for use with gradient-based systems with results comparable to that obtained with the CLSI reference method for testing Candida spp. against antifungal agents. The gradient method is based on a combination of the concepts of both dilution and diffusion tests, but differs from conventional disk methods by the use of a preformed, stable antibiotic gradient strip. When the strip is applied to the inoculated agar plate, there is an immediate release of the 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Mueller Hinton Agar w/ 2% NaCl
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 866.1700 Culture medium for antimicrobial susceptibility tests.
(a)
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.(b)
Classification. Class II (performance standards).
0
510(k) SUMMARY
| Contact Information: | Andre Hsiung
Technical Projects Manager
Remel Inc.
Thermo Fisher Scientific
12076 Santa Fe Drive
Lenexa, KS 66215
Phone: (913) 895-4264
Fax: (913) 895-4264
email: andre.hsiung@thermofisher.com | |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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
susceptibility tests | |
| 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 Description: | RPMI-1640 was developed by Moore et al. at Roswell Park
Memorial Institute. The formulation is based on the RPMI-
1630 series of media utilizing a bicarbonate buffering system
and alterations in the amounts of amino acids and vitamins.
RPMI-1640 medium has demonstrated wide applicability in
cell culture and also as the reference method for antifungal
broth microdilution recommended by Clinical Laboratory
Standards Institute (CLSI). When properly supplemented
with MOPS, glucose, and agar RPMI-1640 has
demonstrated accuracy for use with gradient-based systems
with results comparable to that obtained with the CLSI
reference method for testing Candida spp. against antifungal
agents.
The gradient method is based on a combination of the
concepts of both dilution and diffusion tests, but differs from
conventional disk methods by the use of a preformed, stable
antibiotic gradient strip. When the strip is applied to the
inoculated agar plate, there is an immediate release of the | |
| Characteristic | Device | Predicate |
| Intended Use | Remel's 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. | Remel's Mueller Hinton Agar w/ 2% NaCl is
a solid medium recommended for use with
antibiotic gradient-based systems for
quantitative
determination of susceptibility to methicillin
and oxacillin when testing staphylococci
directly from colonies grown on nonselective
media. |
| Incubation | 35° C | 35° C |
| Inoculation | Candida spp. | Staphylococcus spp. |
| Technology | To be used with predefined and preformed
antifungal gradient on a plastic strip. Single
antifungal agent per strip. | To be used with predefined and preformed
oxacillin gradient on a plastic strip |
| Interpretation | 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. | MIC is read at the end point where there is
complete inhibition |
, ,
1
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:
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.
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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Page 2 -
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 (800) 638-2041 or (240) 276-3150 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
4
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
Division Sign-Off
Division Sign-Off
Page 1 of
Office of In Vitro Diagnostic Device Evaluation and Safety
07282 510(k).