(46 days)
Not Found
No
The device description and performance studies focus on traditional broth dilution susceptibility testing and visual interpretation, with no mention of AI or ML.
No.
The device is used to determine antimicrobial susceptibilities and detect ESBL production, which supports diagnosis and treatment selection, but it is not directly applied to treat a disease or condition.
Yes
The "Intended Use / Indications for Use" section states that the device is designed for "determination of antimicrobial susceptibilities" and "detection of ESBL production," which are diagnostic purposes for identifying the characteristics of microorganisms.
No
The device description explicitly states that the panels are "miniaturizations of the broth dilution susceptibility test that have been diluted in broth and dehydrated" and are "rehydrated with water, after inoculation with a standardized suspension of the organism." This indicates a physical, hardware-based component (the dried panels) is central to the device's function, not just software.
Based on the provided text, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is designed to determine antimicrobial susceptibilities and screen/confirm ESBL production in bacterial colonies grown on solid media. This involves testing biological samples (bacterial cultures) in vitro (outside the body).
- Device Description: It describes a miniaturized broth dilution susceptibility test where antimicrobial agents are diluted and dehydrated in panels. These panels are rehydrated with a suspension of the organism and incubated. The results (MIC) are determined by observing growth inhibition. This is a classic description of an in vitro diagnostic test.
- Performance Studies: The text describes "Efficacy and Challenge studies" comparing the panel results against a "CLSI frozen Reference result or the molecular characterization result." This type of validation is typical for IVD devices to demonstrate their performance against a recognized standard.
- Predicate Devices: The mention of predicate devices with K numbers (K013423, K020037) which are also described as "ESBL Screen" and "ESBL Confirmation" panels further supports that this device falls under the category of IVDs, specifically those used for microbial identification and susceptibility testing.
Therefore, the device clearly fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
To be used in the screening of Escherichia coli, Klebsiella spp. and Proteus mirabilis suspected of producing Extended-Spectrum Beta-Lactamases.
To be used in the confirmation of Extended-Spectrum Beta-Lactamase production in Escherichia coli, Klebsiella spp. and Proteus mirabilis.
The MicroScan® Dried Gram Negative Panel is designed for use in the determination of antimicrobial susceptibilities of colonies grown on solid media of rapidly growing gram negative bacilli and screening for suspected ESBL production in E. coli, Klebsiella spp and P. mirabilis.
The MicroScan® ESBL plus Dried ESBL Confirmation Panel is designed for use in the determination of antimicrobial susceptibilities of colonies grown on solid media of rapidly growing gram negative bacilli and for the detection of ESBL production in E. coli, Klebsiella spp and P. mirabilis.
This particular submission is for the addition of P. mirabilis to the intended use of the antimicrobics: cefpodoxime (0.015-64 µgml), ceftazidime (0.5-128 µg/ml) and cefotaxime (0.5-128 ug/ml) for ESBL screening, and for the antimicrobics ceftazidime (0.5-128 µg/ml), ceftazidime/clavulanic acid (0.12/4-32/4 µg/ml), cefotaxime (0.5-128 ug/ml) and cefotaxime/clavulanic acid (0.12/4-32/4 µg/ml) for ESBL confirmation.
The Gram Negative organisms which may be used for screening of suspected of ESBL production in this panel are:
Escherichia coli
Klebsiella oxytoca
Klebsiella pneumoniae
Proteus mirabilis
The Gram Negative organisms which may be used for confirmation of ESBL production in this panel are:
Escherichia coli
Klebsiella oxvioca
Klebsiella pneumoniae
Proteus mirabilis
Product codes
JWY, LRG, LTT
Device Description
MicroScan® Dried Gram Negative MIC/Combo Panels are designed for use in determining quanfitative and/or qualitative antimicrobial agent susceptibility for Gram Negative organisms and screening for suspected ESBL production in E. coli, Klebsiella spp., and P. mirabilis.
MicroScan® ESBL plus ESBL Confirmation Panel is designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility for Gram Negative organisms and confirmation of ESBL production in E. coli, Klebsiella spp., and P. mirabilis.
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-CO2 incubator at 35 °C for a minimum of 16 hours. the minimum inhibitory concentration (MIC) for the test organism is determined by observing the lowest antimicrobial concentration showing inhibition of growth.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Efficacy and Challenge studies with MicroScan® Dried Gram Negative panel with cefpodoxime, ceflazidime, ceftazidime/clavulanic acid, cefotaxime/clavulanic acid were conducted on both fresh and stock isolates and stock challenge strains. The Design Validation studies were designed to confirm the acceptability of these antimicrobial agents for screening (Cpd, Caz, Cft) and confirmation (Caz, Caz /CA, Cft/CA) of suspected ESBL production with P. mirabilis by comparing the panel susceptibility results against the CLSI frozen Reference result or the molecular characterization result (Challenge). The dried Test panel antimicrobial agents demonstrated an overall Agreement of > 90% for both screen and confirmation with the ESBL and non-ESBL-producing strains,
Inoculation method reproducibility testing with the MicroScan® Dried Gram Negative panel with cefpodoxime, ceftazidime, ceftazidime/clavulanic acid, cefotaxime/clavulanic acid demonstrated acceptable reproducibility regardless of which inoculation method (i.e., Turbidity and Prompt) was used.
The MicroScan® Dried Gram Negative panel with cefpodoxime, ceftazidime/clavulanic acid, cefotaxime and cefotaxime/clavulanic acid antimicrobial agents demonstrated acceptable Quality Control throughout each phase of the ESBL evaluation.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
overall Agreement of > 90%
Predicate Device(s)
MicroScan® Dried Gram Negative Panels
Reference Device(s)
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).
Not Found
§ 866.1640 Antimicrobial susceptibility test powder.
(a)
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.(b)
Classification. Class II (performance standards).
0
K061536
JUL 18 2006
510(k) Summary
510(k) Submission Information:
| Device Manufacturer: | Dade Behring Inc. |
|---|---|
| Contact name: | Maureen Mende, Regulatory Affairs Group Manager |
| Fax: | 916-374-3144 |
| Date prepared: | May 30, 2006 |
| Product Name: | Microdilution Minimum Inhibitory Concentration (MIC) Panels |
| Trade Name: | MicroScan® Dried Gram Negative MIC/Combo Panels |
| Intended Use: | To be used in the screening of Escherichia coli, Klebsiella spp. and |
| Proteus mirabilis suspected of producing Extended-Spectrum Beta-Lactamases. | |
| To be used in the confirmation of Extended-Spectrum Beta-Lactamase production in | |
| Escherichia coli, Klebsiella spp. and Proteus mirabilis . | |
| 510(k) Notification: | Modification to K013423- ESBL Screen |
| Modification to K020037- ESBL Confirmation | |
| Predicate device: | MicroScan® Dried Gram Negative Panels |
510(k) Summary:
MicroScan® Dried Gram Negative MIC/Combo Panels are designed for use in determining quanfitative and/or qualitative antimicrobial agent susceptibility for Gram Negative organisms and screening for suspected ESBL production in E. coli, Klebsiella spp., and P. mirabilis.
MicroScan® ESBL plus ESBL Confirmation Panel is designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility for Gram Negative organisms and confirmation of ESBL production in E. coli, Klebsiella spp., and P. mirabilis.
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-CO2 incubator at 35 °C for a minimum of 16 hours. the minimum inhibitory concentration (MIC) for the test organism is determined by observing the lowest antimicrobial concentration showing inhibition of growth.
The antimicrobics: cefpodoxime, ceftazidime, aztreonam, cefotaxime and ceftriaxone were cleared by FDA in September, 2001 (K013423) for use as a screen for suspected ESBL-producing E. coli, K. oxytoca and K. pneumoniae on MicroScan® Dried Gram Negative Panels. This Premarket Notification 510(k) presents data in support of a request for a new intended use (screening of suspected P. mirabilis extended-spectrum beta-lactamases) similar to that described in the CLSI document M100-S16 for the following applicable antimicrobial agents: cefpodoxime, ceftazidime, and cefotaxime.
The antimicrobics: ceftazidime/clavulanic acid, cefotaxime and cefotaxime/clayulanic acid have been cleared for confirmation of suspected extended-spectrum beta-lactamases with E. coli, K. oxytoca and K. pneumoniae via Premarket Notification (K020037). This Premarket Notification 510(k) presents data in support of a request for a new intended use (confirmation of suspected P. mirabilis extended-spectrum betalactamases) similar to that described in the CLSI document M100-S16 for ceftaxime alone and in combination with clavulanic acid.
Efficacy and Challenge studies with MicroScan® Dried Gram Negative panel with cefpodoxime, ceflazidime, ceftazidime/clavulanic acid, cefotaxime/clavulanic acid were conducted on both fresh and stock isolates and stock challenge strains. The Design Validation studies were designed to confirm the acceptability of these antimicrobial agents for screening (Cpd, Caz, Cft) and confirmation (Caz, Caz /CA, Cft/CA) of suspected ESBL production with P. mirabilis by comparing the panel susceptibility results against the CLSI frozen Reference result or the molecular characterization result (Challenge). The dried Test panel antimicrobial agents demonstrated an overall Agreement of > 90% for both screen and confirmation with the ESBL and non-ESBL-producing strains,
1
Inoculation method reproducibility testing with the MicroScan® Dried Gram Negative panel with cefpodoxime, ceftazidime, ceftazidime/clavulanic acid, cefotaxime/clavulanic acid demonstrated acceptable reproducibility regardless of which inoculation method (i.e., Turbidity and Prompt) was used.
The MicroScan® Dried Gram Negative panel with cefpodoxime, ceftazidime/clavulanic acid, cefotaxime and cefotaxime/clavulanic acid antimicrobial agents demonstrated acceptable Quality Control throughout each phase of the ESBL evaluation.
510(k) p.mirabilis 06202006.doc
2
Image /page/2/Picture/1 description: The image shows a logo for the Department of Health and Human Services. The logo features a stylized eagle with three stripes across its body. The words "Department of Health and Human Services" are arranged in a circular pattern around the eagle.
Re:
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Maureen Mende Regulatory Affairs Group Manager Dade Behring Inc. 2040 Enterprise Blvd. West Sacramento, CA 95691
JUL 18 2006
K061536 Trade/Device Name: MicroScan® Dried Gram Negative MIC/Combo Panels with Cefpodoxime (0.015-64 ug/ml), Ceftazidime (0.5-128 ug/ml), Ceftazidime/Clavulanic acid (0.12/4-32/4 ug/ml), Cefotaxime (0.5-128 µg/ml) and Cefotaxime/Clavulanic acid (0.12/4-32/4 ug/ml) Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Regulatory Class: Class II Product Code: JWY, LRG, LTT Dated: May 30, 2006 Received: June 2, 2006
Dear Ms. Mende:
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).
3
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 information about the application of labeling requirements to your device. or questions on the promotion and advertising of your device, 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). 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/cdrh/dsma/dsmamain.html.
Sincerely yours,
Sally anton
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):
Device Name: MicroScan® Dried Gram Negative MIC/Combo Panels with cefpodoxime (0.015-64µg/ml), ceftazidime (0.5-128 µg/ml), ceftazidime/clavulanic_acid (0.12/4-32/4 ug/ml), cefotaxime (0.5-128 ug/ml) and cefotaxime/clavulanic acid (0.12/4-32/4 ug/ml)
Indications For Use:
The MicroScan® Dried Gram Negative Panel is designed for use in the determination of antimicrobial susceptibilities of colonies grown on solid media of rapidly growing gram negative bacilli and screening for suspected ESBL production in E. coli, Klebsiella spp and P. mirabilis.
The MicroScan® ESBL plus Dried ESBL Confirmation Panel is designed for use in the determination of antimicrobial susceptibilities of colonies grown on solid media of rapidly growing gram negative bacilli and for the detection of ESBL production in E. coli, Klebsiella spp and P. mirabilis.
After inoculation, panels are incubated for a minimum of 16 hours at 35℃ in a non-CO2 incubator, and read visually, according to the Package Insert.
This particular submission is for the addition of P. mirabilis to the intended use of the antimicrobics: cefpodoxime (0.015-64 µgml), ceftazidime (0.5-128 µg/ml) and cefotaxime (0.5-128 ug/ml) for ESBL screening, and for the antimicrobics ceftazidime (0.5-128 µg/ml), ceftazidime/clavulanic acid (0.12/4-32/4 µg/ml), cefotaxime (0.5-128 ug/ml) and cefotaxime/clavulanic acid (0.12/4-32/4 µg/ml) for ESBL confirmation.
The Gram Negative organisms which may be used for screening of suspected of ESBL production in this panel are:
Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae Proteus mirabilis
The Gram Negative organisms which may be used for confirmation of ESBL production in this panel are:
Escherichia coli Klebsiella oxvioca Klebsiella pneumoniae Proteus mirabilis
Page 1 of
Ludlui he. Cooly
Office of In Vitro Diagnostic Γ.
Evaluation and Safety be ix
510(k) p.mirabilis 06202006.doc
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Prescription Use ਮ (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)
Page 2 of _2
Fueddila Paolo
Division Sign-Off
Office of in Vitro Diagnostic Device Evaluati 110 Salery
510(k) K061536
pg. 2 of 2
510(k) p.mirabilis 06202006.doc
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