(189 days)
Not Found
No
The document describes a traditional broth dilution susceptibility test and its comparison to a reference method, with no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is used to determine the antimicrobial susceptibility of bacteria, which aids in diagnosis and treatment selection, but it does not directly treat or prevent a disease.
Yes
The device determines antimicrobial susceptibility of colonies, which is a diagnostic test to identify which antibiotics will be effective against a bacterial infection.
No
The device is a physical panel used for antimicrobial susceptibility testing, which is a hardware component. While it can be read with MicroScan instrumentation (which likely involves software), the core device being submitted is the dried panel itself.
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 quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-positive bacteria." This is a diagnostic test performed in vitro (outside of the body) on biological samples (bacterial colonies).
- Device Description: The description details how the test works, involving the rehydration of dehydrated antimicrobial agents with a standardized suspension of the organism and incubation to determine the minimum inhibitory concentration (MIC). This process is characteristic of an in vitro diagnostic test.
- Performance Studies: The performance studies compare the device's performance to a "CLSI frozen Reference panel," which is a standard method for evaluating the accuracy of in vitro diagnostic tests for antimicrobial susceptibility. The metrics reported (Categorical Agreement) are also standard for evaluating the performance of such devices.
- Predicate Device: The predicate device listed (K003619; MicroScan Dried Gram-Positive MIC/Combo Panels - Linezolid) is also an IVD, indicating that this type of device falls under the category of in vitro diagnostics.
The device is designed to provide information about the susceptibility of bacteria to antimicrobial agents, which is crucial for guiding treatment decisions for infections. This is a classic example of an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
To determine antimicrobial agent susceptibility
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 bacteria. After inoculation, panels are incubated for 16 - 20 hours at 35°C +/- 1°C in a non-CO2 incubator, and read either visually or with MicroScan instrumentation, according to the Package Insert.
This particular submission is for the addition of the antimicrobial Tigecycline at concentrations of 0.12 - 8 mcg/ml to the test panel. MicroScan® Dried Gram-Positive Tigecycline is a qualitative test.
Tigecycline has been shown to be active against the organisms listed below according to the FDA label for the antimicrobial.
Active in vitro and in clinical infections:
Enterococcus faecalis (vancomycin-susceptible isolates) Staphylococcus aureus (methicillin-susceptible and -resistant isolates)
Active in vitro but clinical significance unknown: Staphylococcus epidermidis (methicillin-susceptible and -resistant isolates)
Product codes
LTT, JWY, LRG, 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 bacteria.
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 antimicrobial concentration showing inhibition of growth.
Mentions image processing
Not Found
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 evaluation 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 performance with a CLSI frozen Reference panel. 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 Tigecvcline demonstrated substantially equivalent performance when compared with an CLSI frozen Reference Panel, as defined in the FDA document "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA", dated August 28, 2009. The Premarket Notification (510|k|) presents data in support of the MicroScan Dried Gram-Positive MIC/Combo Panel with Tigecycline. MicroScan Dried Gram-Positive Tigecycline is a qualitative test.
Inoculum and instrument reproducibility testing demonstrated acceptable reproducibility and precision with Tigecycline, 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 Tigecycline.
Key Metrics
Categorical Agreement of 99.4% for Tigecycline
Predicate Device(s)
MicroScan Dried Gram-Positive MIC/Combo Panels - Linezolid (K003619)
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
K/3/275
510(k) Summary
NOV 08 2013
510(k) Submission Information:
| Device Manufacturer: | Siemens Healthcare Diagnostics |
|---|---|
| Contact name: | Elisabeth Warriner, Regulatory Technical Specialist |
| Phone: | 916-374-3244 |
| Fax: | 916-372-6418 |
| Date prepared: | August 27, 2013 |
| Product Name: | Microdilution Minimum Inhibitory Concentration (MIC) Panels |
| Trade Name: | MicroScan® Dried Gram-Positive MIC/Combo Panels with Tigecycline (0.12-8 |
| mcg/ml) | |
| Intended Use: | To determine antimicrobial agent susceptibility |
| Classification: | Class II |
| Product Code: | LTT |
| 510(k) Notification: | New antimicrobial - Tigecycline |
| Predicate device: | MicroScan Dried Gram-Positive MIC/Combo Panels - Linezolid (K003619) |
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 bacteria.
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 antimicrobial concentration showing inhibition of growth.
The proposed MicroScan Dried Gram-Positive MIC/Combo Panel with Tigecvcline demonstrated substantially equivalent performance when compared with an CLSI frozen Reference Panel, as defined in the FDA document "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA", dated August 28, 2009. The Premarket Notification (510|k|) presents data in support of the MicroScan Dried Gram-Positive MIC/Combo Panel with Tigecycline. MicroScan Dried Gram-Positive Tigecycline is a qualitative test.
The external evaluation 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 performance with a CLSI frozen Reference panel. Challenge strains were compared to Expected Results determined prior to the evaluation. The Dried Gram-Positive Panel demonstrated acceptable performance with an overall Categorical Agreement of 99.4% for Tigecycline when compared with the frozen Reference panel.
Inoculum and instrument reproducibility testing demonstrated acceptable reproducibility and precision with Tigecycline, 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 Tigecycline.
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Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services (DHHS). The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Homoshim Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
SIEMENS HEALTHCARE DIAGNOSTICS, INC. ELISABETH WARRINER REGULATORY TECHNICAL SPECIALIST 1584 ENTERPRISE BLVD. WEST SACRAMENTO CA 95691
November 8. 2013
Re: K131275
Trade/Device Name: MicroScan Dried Gram-Positive MIC/Combo Panels with Tigecycline (0.12 - 8mcg/ml) Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: II Product Code: LTT, JWY, LRG, LTW Dated: September 27, 2013 Received: September 30, 2013
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2-Ms. Warriner
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometries/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Uwe Scherf -Sior
Sally Hojvat, M.Sc., PhD. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known):__K131275
Device Name: _ MicroScan® Dried Gram-Positive MIC/Combo Panels with Tigecycline (0.12 - 8 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 bacteria. After inoculation, panels are incubated for 16 - 20 hours at 35°C +/- 1°C in a non-CO2 incubator, and read either visually or with MicroScan instrumentation, according to the Package Insert.
This particular submission is for the addition of the antimicrobial Tigecycline at concentrations of 0.12 - 8 mcg/ml to the test panel. MicroScan® Dried Gram-Positive Tigecycline is a qualitative test.
Tigecycline has been shown to be active against the organisms listed below according to the FDA label for the antimicrobial.
Active in vitro and in clinical infections:
Enterococcus faecalis (vancomycin-susceptible isolates) Staphylococcus aureus (methicillin-susceptible and -resistant isolates)
Active in vitro but clinical significance unknown: Staphylococcus epidermidis (methicillin-susceptible and -resistant isolates)
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 Diagnostics and Radiological Health (OIR)
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