(102 days)
Not Found
No
The summary describes a traditional broth dilution susceptibility test system and does not mention any AI or ML components. The performance evaluation focuses on agreement with a reference panel, not on the performance of an AI/ML algorithm.
No.
This device is designed for in vitro diagnostic testing to determine antimicrobial susceptibility, not for direct therapeutic intervention or treatment of disease.
Yes
The device determines quantitative and/or qualitative antimicrobial agent susceptibility of bacterial colonies, which is a diagnostic function to determine the effectiveness of antimicrobials against specific pathogens.
No
The device is a physical panel containing dehydrated antimicrobial agents used for susceptibility testing, which is then incubated and read by instrumentation. While software may be involved in reading or interpreting results, the core device is a hardware component (the panel).
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly 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 enterococci and staphylococci." This is a diagnostic test performed in vitro (outside the body) on biological samples (bacterial colonies).
- Device Description: The description details how the device works by performing miniaturized broth dilution susceptibility tests on bacterial suspensions. This is a standard method for in vitro diagnostic testing in microbiology.
- Performance Studies: The performance studies describe the evaluation of the device's accuracy in determining antimicrobial susceptibility, which is a key aspect of validating an IVD.
- Predicate Device(s): The predicate devices listed are also IVDs (Antimicrobial Susceptibility Test (AST) Systems), indicating that this device falls within the same regulatory category.
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 device.
N/A
Intended Use / Indications for Use
The MicroScan® Synergies plus™ 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 enterococci and staphylococci. After inoculation, panels are incubated for 4.5 - 18 hours at 35°C +/- 1°C, in a WalkAway® SI, or equivalent, and read by the MicroScan® Instrumentation. Additionally, the panels may be incubated in a non-CO2 incubator and the Antimicrobial Susceptibility Testing (AST) portions can be read visually, according to the Package Insert.
This particular submission is for the addition of the antimicrobial Gentamicin Synergy Screen, at a concentration of 500 µg/ml, for enterococci, to the test panel.
The gram-positive organisms which may be used for Gentamicin Synergy Screen susceptibility testing in this panel are:
Enterococcus species
Product codes
LON, LRG, JWY, LLT
Device Description
MicroScan® Synergies plus''' Gram-Positive MIC/Combo Panels, utilizing both the MicroScan® Rapid Fluorogenic Identification and Dried Overnight Antimicrobial Susceptibility Tcsting (AST) technologies, 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 enterococci and staphylococci.
The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test that have been diluted in water and dehydrated. Various antimicrobial agents are diluted in water, buffer, or minute concentrations of broth, to concentrations bridging the range of clinical interest. Panels are rehydrated with Synergies plus" Pos Broth, after inoculation with a standardized suspension of the organism. After incubation in the WalkAway® SI, or equivalent, System, for 4.5 -18 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
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
The external validation was conducted with fresh and stock Efficacy isolates and stock Challenge strains. The external validations were designed to confirm the acceptability of the proposed Synergies plus™ Gram-Positive Panel by comparing its performance with a frozen Reference panel. Challenge strains were compared to Expected Results determined prior to the evaluation.
Summary of Performance Studies
The proposed MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panel demonstrated substantially equivalent performance when compared with a frozen Reference Pancl, as defined in the FDA document "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA", dated February 5, 2003. The Premarket Notification (510[k]) presents data in support of the MicroScan" Synergies plus™ Gram-Positive MIC/Combo Panel with Gentamicin Synergy Screen.
The external validation was conducted with fresh and stock Efficacy isolates and stock Challenge strains. The external validations were designed to confirm the acceptability of the proposed Synergies plus™ Gram-Positive Panel by comparing its performance with a frozen Reference panel. Challenge strains were compared to Expected Results determined prior to the evaluation. The Synergies plus" Gram-Positive Panel demonstrated acceptable performance with an overall Categorical Agreement of 97.0% for Gentamicin Synergy Screen when compared with the frozen Reference panel.
Instrument reproducibility testing demonstrated acceptable reproducibility and precision for Gentamicin Synergy Screen with Turbidity inoculum preparation method and the WalkAway® SI System or equivalent.
Quality Control testing demonstrated acceptable results for Gentamicin Synergy Screen.
Key Metrics
Categorical Agreement of 97.0%
Predicate Device(s)
MicroScan® Synergies plus™ Gram-Negative MIC/Combo Panels and MicroScan® Dried Gram-Positive Panels
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.1645 Fully automated short-term incubation cycle antimicrobial susceptibility system.
(a)
Identification. A fully automated short-term incubation cycle antimicrobial susceptibility system is a device that incorporates concentrations of antimicrobial agents into a system for the purpose of determining in vitro susceptibility of bacterial pathogens isolated from clinical specimens. Test results obtained from short-term (less than 16 hours) incubation are used to determine the antimicrobial agent of choice to treat bacterial diseases.(b)
Classification. Class II (special controls). The special control for this device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA.”
0
K071317 AUG 2 V 2007
510(k) Submission Information:
Device Manufacturer: Dade Behring Inc. Contact name: Robert Eusebio, Regulatory Affairs Manager 916-374-3144 Fax: Date prepared: May3, 2007 Product Name: Microdilution Minimum Inhibitory Concentration (MiC) Panels MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panels Trade Name: To determine antimicrobial agent susceptibility Intended Use: New antimicrobial - Gentamicin Synergy Screen 510(k) Notification: MicroScan® Synergies plus™ Gram-Negative MIC/Combo Predicate device: Panels and MicroScan® Dried Gram-Positive Panels
510(k) Summary:
MicroScan® Synergies plus''' Gram-Positive MIC/Combo Panels, utilizing both the MicroScan® Rapid Fluorogenic Identification and Dried Overnight Antimicrobial Susceptibility Tcsting (AST) technologies, 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 enterococci and staphylococci.
The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test that have been diluted in water and dehydrated. Various antimicrobial agents are diluted in water, buffer, or minute concentrations of broth, to concentrations bridging the range of clinical interest. Panels are rehydrated with Synergies plus" Pos Broth, after inoculation with a standardized suspension of the organism. After incubation in the WalkAway® SI, or equivalent, System, for 4.5 -18 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® Synergies plus™ Gram-Positive MIC/Combo Panel demonstrated substantially equivalent performance when compared with a frozen Reference Pancl, as defined in the FDA document "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA", dated February 5, 2003. The Premarket Notification (510[k]) presents data in support of the MicroScan" Synergies plus™ Gram-Positive MIC/Combo Panel with Gentamicin Synergy Screen.
The external validation was conducted with fresh and stock Efficacy isolates and stock Challenge strains. The external validations were designed to confirm the acceptability of the proposed Synergies plus™ Gram-Positive Panel by comparing its performance with a frozen Reference panel. Challenge strains were compared to Expected Results determined prior to the evaluation. The Synergies plus" Gram-Positive Panel demonstrated acceptable performance with an overall Categorical
1
Agreement of 97.0% for Gentamicin Synergy Screen when compared with the frozen Reference panel.
Instrument reproducibility testing demonstrated acceptable reproducibility and precision for Gentamicin Synergy Screen with Turbidity inoculum preparation method and the WalkAway® SI System or equivalent.
Quality Control testing demonstrated acceptable results for Gentamicin Synergy Screen.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (USA). The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or other bird in flight. The symbol is composed of three curved lines that form the body and wings of the bird, and two wavy lines that represent the tail feathers.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Robert Eusebio Regulatory Affairs Specialist Dade Behring, Inc. 2040 Enterprise Blvd West Sacramento. CA 95691
AUG 2 0 2007
Re: K071317
Trade/Device Name: MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panels with Gentamicin Synergy Screen (500ug/ml) Regulation Number: 21 CFR 866.1645 Regulation Name: Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility Devices Regulatory Class: Class II Product Code: LON, LRG, JWY, LLT Dated: May 9, 2007 Received: August 7, 2007
Dear Mr. Eusebio:
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). This letter
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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,
Saqaisk
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
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Indications for Use
510(k) Number (if known): K07 | 3)7
Device Name: MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panels with Gentamicin Synergy Screen (500 ug/ml)
Indications For Use:
The MicroScan® Synergies plus™ 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 enterococci and staphylococci. After inoculation, panels are incubated for 4.5 - 18 hours at 35°C +/- 1°C, in a WalkAway® SI, or equivalent, and read by the MicroScan® Instrumentation. Additionally, the panels may be incubated in a non-CO2 incubator and the Antimicrobial Susceptibility Testing (AST) portions can be read visually, according to the Package Insert.
This particular submission is for the addition of the antimicrobial Gentamicin Synergy Screen, at a concentration of 500 µg/ml, for enterococci, to the test panel.
The gram-positive organisms which may be used for Gentamicin Synergy Screen susceptibility testing in this panel are:
Enterococcus species
Prescription Use X (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 W. Lade
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K071317
Page 1 of 1
510(k) Summary
GmS 510k with limitation.doc 7/31/2007