(105 days)
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No
The document describes a traditional broth microdilution susceptibility test read visually or with MicroScan instrumentation, with no mention of AI or ML.
No
This device is used for in vitro diagnostic testing to determine antimicrobial susceptibility, not to treat or diagnose a disease or condition in a patient.
Yes
The device determines quantitative and/or qualitative antimicrobial agent susceptibility, which provides information about the state of a disease or medical condition by indicating whether a specific organism is resistant or susceptible to certain antimicrobial agents. This information is crucial for guiding treatment decisions, thus serving a diagnostic purpose.
No
The device description clearly states it is a physical panel containing dehydrated antimicrobial agents that are rehydrated and incubated. It is a hardware-based diagnostic test.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is used to determine the susceptibility of microorganisms to antimicrobial agents. This is a classic function of an IVD, as it provides information about a patient's condition (in this case, the susceptibility of an infection to treatment) by testing a sample taken from the patient (the bacterial colonies).
- Device Description: The description details a miniaturized broth dilution susceptibility test, which is a common method used in clinical laboratories to perform in vitro diagnostic testing.
- Performance Studies: The performance studies describe a clinical trial comparing the device's performance to a recognized standard (CLSI D-zone disk diffusion test) using clinical isolates. This type of validation is typical for IVDs to demonstrate their accuracy and reliability for clinical use.
- Key Metrics: The reporting of metrics like Categorical Agreement, Sensitivity, and Specificity are standard performance indicators for IVDs used in diagnostic testing.
The device is designed to be used in vitro (outside the body) to analyze a biological sample (bacterial colonies) to provide diagnostic information relevant to patient care (antimicrobial susceptibility).
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°C +/- 1°C in a non-CO2 incubator, and read either visually or with MicroScan instrumentation, according to the Package Insert.
The MicroScan Inducible Clindamycin test is intended to detect inducible clindamycin resistance in staphylococci in a broth microdilution system. The ICd test applies to isolates that are erythromycin resistant or intermediate and clindamycin susceptible or intermediate.
This particular submission is for the addition of the Inducible Clindamycin test, consisting of 4 mcg/ml of erythromycin and 0.5 mcg/ml of clindamycin, to the test panel.
The gram-positive organisms which may be used for the Inducible Clindamycin test in this panel are:
Staphylococcus spp
Product codes
JWY, LRG, LTT, LTW
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 rehydrated 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 antiry icrobial 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
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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 Efficacy isolates and stock Challenge strains. The external evaluations were designed to confirm the acceptability of the proposed Dried Gram-Positive Panel by comparing its parts romance with results of the CLSI D-zone disk diffusion test. Challenge strains were compared to Expected Results determined prior to the evaluation.
Summary of Performance Studies
The proposed MicroScan Dried Gram-Positive MIC/Combo Panel with the Inducible Clindamycin test demonstrated substantially equivalent performance when compared with the CLSI D-zone disk diffusion test, as defined in the FDA document "Class InSucci a Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Pouidance 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 Dried Gram-Positive MIC/Combo Panel with the Inducible Clindamycin test.
The MicroScan Inducible Clindamycin test demonstrated acceptable performance with an overall Categorical Agreement of 98.7% when compared with the CLSI D-zone disk diffusion test.
Inoculum and instrument reproducibility testing demonstrated acceptable reproducibility and precision with Inducible Clindamycin, 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 MicroScan Inducible Clindamycin test.
Key Metrics
Overall sensitivity was 98.1% and specificity was 100.0%.
Predicate Device(s)
MicroScan Dried Gram-Positive MIC/Combo Panels
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) Summary
AUG - 8 2008
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 23, 2008 |
| Product Name: | Microdilution Minimum Inhibitory Concentration (MIC) Panels |
| Trade Name: | MicroScan Dried Gram-Positive MIC/Combo Panels |
| Intended Use: | Detection of inducible clindamycin resistance in staphylococci |
| 510(k) Notification: | New antimicrobial test – Inducible Clindamycin |
| 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 rehydrated 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 antiry icrobial concentration showing inhibition of growth.
The proposed MicroScan Dried Gram-Positive MIC/Combo Panel with the Inducible Clindamycin test demonstrated substantially equivalent performance when compared with the CLSI D-zone disk diffusion test, as defined in the FDA document "Class InSucci a Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Pouidance 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 Dried Gram-Positive MIC/Combo Panel with the Inducible Clindamycin test.
The external design validation (Clinical Trial) was conducted with fresh and stock Efficacy isolates and stock Challenge strains. The external evaluations were designed to confirm the acceptability of the proposed Dried Gram-Positive Panel by comparing its parts romance with results of the CLSI D-zone disk diffusion test. Challenge strains were compared to Expected Results determined prior to the evaluation.
1
The MicroScan Inducible Clindamycin test demonstrated acceptable performance with an overall Categorical Agreement of 98.7% when compared with the CLSI D-zone disk diffusion test. Overall sensitivity was 98.1% and specificity was 100.0%.
Inoculum and instrument reproducibility testing demonstrated acceptable reproducibility and precision with Inducible Clindamycin, 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 MicroScan Inducible Clindamycin test.
2
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 three lines representing its wings and body. The eagle is positioned inside a circle, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" encircling it.
Food and Druq Administration 2098 Gaither Road Rockville MD 20850
Ms. Libby Warriner Regulatory Affairs Compliance Specialist Siemens Healthcare Diagnostics 1584 Enterprise Blvd West Sacramento, CA 95691
AUG - 8 2008
Re: K081182
Trade/Device Name: MicroScan® Dried Gram Positive MIC/Combo Panels with the Inducible Clindamycin test
Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: Class II Product Code: JWY, LRG, LTT, LTW Dated: July 23, 2008 Received: July 25, 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 predicated devices 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 vours.
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): K081187
Device Name: MicroScan Dried Gram-Positive MIC/Combo Panels with the Inducible Clindamycin Test
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°C +/- 1°C in a non-CO2 incubator, and read either visually or with MicroScan instrumentation, according to the Package Insert.
The MicroScan Inducible Clindamycin test is intended to detect inducible clindamycin resistance in staphylococci in a broth microdilution system. The ICd test applies to isolates that are erythromycin resistant or intermediate and clindamycin susceptible or intermediate.
This particular submission is for the addition of the Inducible Clindamycin test, consisting of 4 mcg/ml of erythromycin and 0.5 mcg/ml of clindamycin, to the test panel.
The gram-positive organisms which may be used for the Inducible Clindamycin test in this panel are:
Staphylococcus spp
Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
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Office of In Vitro Diagnostic Deviceage 1 of 1_
Evaluation and Safety
510(k) K081182