(152 days)
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No
The summary describes a traditional broth dilution susceptibility test and its performance metrics, with no mention of AI or ML technologies.
No
This device is an in vitro diagnostic tool used for determining antimicrobial susceptibility, not for treating any condition.
Yes
The device is used to determine antimicrobial agent susceptibility, specifically for staphylococci to penicillinase stable beta-lactams, which directly informs treatment decisions and is a key function of a diagnostic device.
No
The device is a physical panel containing dried antimicrobial agents used for susceptibility testing, which is a hardware component. While it can be read visually or with instrumentation, the core device itself is not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The primary intended use is to "determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-positive cocci." This is a classic definition of an in vitro diagnostic test, as it is performed on a sample (bacterial colonies) taken from a patient (or potentially a sample related to a patient's infection) to provide information about their condition (susceptibility to antibiotics).
- Device Description: The description further clarifies that the tests are "miniaturizations of the broth dilution susceptibility test," which is a standard laboratory method for determining antibiotic susceptibility. The process involves rehydrating the panel with a standardized suspension of the organism and incubating it to observe growth inhibition, all of which are in vitro procedures.
- Cefoxitin Screen: The addition of the Cefoxitin Screen is specifically intended to "determine the susceptibility of staphylococci to the penicillinase stable beta-lactams." This is a diagnostic test to identify resistance mechanisms in bacteria, which is crucial for guiding antibiotic treatment.
- Performance Studies: The performance studies compare the device's results to established diagnostic methods like the CLSI cefoxitin disk diffusion test and mecA PCR, further confirming its role as a diagnostic tool.
The device is used to analyze a biological sample (bacterial colonies) outside of the body to provide information relevant to a patient's health and treatment. This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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 anaerobic gram-positive cocci. After inoculation, panels are incubated for 16 - 24 hours at 35℃ +/- 1℃ in a non-CO2 incubator, and read either visually or with MicroScan instrumentation, according to the Package Insert.
The MicroScan Cefoxitin Screen is intended to determine the susceptibility of staphylococci to the penicillinase stable beta-lactams.
This particular submission is for the addition of the antimicrobial test the Cefoxitin Screen, at a concentration of 4 mcg/ml, to the test panel.
The gram-positive organisms which may be used for Cefoxitin Screen susceptibility testing in this panel are:
Staphylococcus aureus Staphylococcus lugdunensis
Product codes (comma separated list FDA assigned to the subject device)
LRG
Device Description
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 anaerobic 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 rchydrated with water after inoculation with a standardized suspension of the organism. After incubation in a non-CO2 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.
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
The external design validation (Clinical Trial) was conducted with fresh and stock Efficacv isolates and stock Challenge strains. The external evaluations were designed to confirm the acceptability of the proposed Dried Gram-Positive Pancl by comparing its performance with results of the CLSI cefoxitin disk diffusion test and mecA PCR. Challenge strains were compared to Expected Results determined prior to the evaluation.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Cefoxitin Screen dcmonstrated acceptable performance with an overall Categorical Agrecment of 97.8% when compared with the CLSI cefoxitin disk diffusion test, and 98.7% when compared to mecA PCR. Overall sensitivity was 98.6% and specificity was 96.9% compared to cefoxitin disk diffusion results. Overall sensitivity was 99.7% and specificity was 97.7% compared to mecA PCR results.
Inoculum and instrument reproducibility testing demonstrated acceptable reproducibility and precision with the Cefoxitin Screen, regardless of which inoculum method (i.e., Turbidity and Prompt™), or instrument (autoSCAN-4® and WalkAway®) was used.
Quality Control testing demonstrated acceptable results for the Cefoxitin Screen Well (CfxS), cefoxitin at a concentration of 4 mcg/ml.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
overall Categorical Agrecment of 97.8% when compared with the CLSI cefoxitin disk diffusion test, and 98.7% when compared to mecA PCR. Overall sensitivity was 98.6% and specificity was 96.9% compared to cefoxitin disk diffusion results. Overall sensitivity was 99.7% and specificity was 97.7% compared to mecA PCR results.
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.
MicroScan Dried Gram-Positive MIC/Combo Panels
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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§ 866.1640 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).
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510(k) Summary
Image /page/0/Picture/2 description: The image contains a handwritten sequence of characters. The sequence starts with the letter 'K', followed by the number '081013'. The numbers are written in a cursive style, and the overall image has a simple, unadorned appearance.
510(k) Submission Information:
| Device Manufacturer: | Siemens Healthcare Diagnostics |
|---|---|
| Contact name: | Libby Warriner, Regulatory Affairs Senior Compliance Specialist |
| Fax: | 916-374-3144 |
| Date prepared: | April 7, 2008 |
| Product Name: | Microdilution Minimum Inhibitory Concentration (MIC) Panels |
| Trade Name: | MicroScan® Dried Gram-Positive MIC/Combo Panels |
| Intended Use: | To determine the susceptibility of staphylococci to penicillinase- |
| stable beta-lactams | |
| 510(k) Notification: | New antimicrobial test - Cefoxitin Screen |
| 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 anaerobic 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 rchydrated with water after inoculation with a standardized suspension of the organism. After incubation in a non-CO2 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 with the Cefoxitin Screen demonstrated substantially equivalent performance when compared with the CLSI cefoxitin disk diffusion test and mecA PCR, as defined in the FDA document "Class II Special Controls Guidance Document: Antimicrobial Susccptibility Test (AST) Systems: Guidance for Industry and FDA", dated March 5, 2007, and "Guidance for Industry and FDA Staff-Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests", dated March 13, 2007. The Premarket Notification (510[k]) presents data in support of the MicroScan Dricd Gram-Positive MIC/Combo Pancl with the Cefoxitin Screen.
The external design validation (Clinical Trial) was conducted with fresh and stock Efficacv isolates and stock Challenge strains. The external evaluations were designed to confirm the acceptability of the proposed Dried Gram-Positive Pancl by comparing its performance with results of the CLSI cefoxitin disk diffusion test and mecA PCR. Challenge strains were compared to Expected Results determined prior to the evaluation.
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The Cefoxitin Screen dcmonstrated acceptable performance with an overall Categorical Agrecment of 97.8% when compared with the CLSI cefoxitin disk diffusion test, and 98.7% when compared to mecA PCR. Overall sensitivity was 98.6% and specificity was 96.9% compared to cefoxitin disk diffusion results. Overall sensitivity was 99.7% and specificity was 97.7% compared to mecA PCR results.
Inoculum and instrument reproducibility testing demonstrated acceptable reproducibility and precision with the Cefoxitin Screen, regardless of which inoculum method (i.e., Turbidity and Prompt™), or instrument (autoSCAN-4® and WalkAway®) was used.
Quality Control testing demonstrated acceptable results for the Cefoxitin Screen Well (CfxS), cefoxitin at a concentration of 4 mcg/ml.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle. The logo is black and white.
SEP - 8 2008
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Libby Warriner Regulatory Affairs Compliance Specialist Siemens Healthcare Diagnostics 2040 Enterprise Blyd West Sacramento, CA 95691
Re: K081013
Trade/Device Name: MicroScan® Dried Gram -- Positive MIC/Combo Panels with Cefoxitin Screen (4 mcg/ml) Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Regulatory Class: Class II Product Code: LRG Dated: August 25, 2008 Received: August 28, 2008
Dear Ms Warriner:
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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Sally attayna
Sally A. Hoivat. 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): KO8 |0 |3
Dovice Name: MicroScan® Dried Gram-Positive MIC/Combo Panels with the Cefoxitin Screen (4 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 anaerobic gram-positive cocci. After inoculation, panels are incubated for 16 - 24 hours at 35℃ +/- 1℃ in a non-CO2 incubator, and read either visually or with MicroScan instrumentation, according to the Package Insert.
The MicroScan Cefoxitin Screen is intended to determine the susceptibility of staphylococci to the penicillinase stable beta-lactams.
This particular submission is for the addition of the antimicrobial test the Cefoxitin Screen, at a concentration of 4 mcg/ml, to the test panel.
The gram-positive organisms which may be used for Cefoxitin Screen susceptibility testing in this panel are:
Staphylococcus aureus Staphylococcus lugdunensis
Prescription Use V (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)
Freddie Poole
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
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510(k) K081013