(39 days)
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No
The document describes a traditional antimicrobial susceptibility testing panel and instrumentation, with no mention of AI or ML in the device description, intended use, or performance studies.
No.
This device is an in vitro diagnostic (IVD) tool used for antimicrobial susceptibility testing, which provides information for diagnosis and treatment decisions but does not directly deliver therapy.
Yes
This device is used to determine the antimicrobial susceptibility of bacterial colonies, which provides information to aid in the diagnosis and treatment of infections.
No
The device description clearly states it is a physical panel ("MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panels") that utilizes both identification and AST technologies. It is rehydrated, inoculated, incubated, and read by instrumentation or visually. This involves physical components and processes, not just software.
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 enterococci and staphylococci." This is a classic example of an in vitro diagnostic test, as it analyzes biological samples (bacterial colonies) outside of the body to provide information about a patient's condition (susceptibility to antibiotics).
- Device Description: The description details how the device works by performing "miniaturizations of the broth dilution susceptibility test" and rehydrating dehydrated antimicrobial agents with a broth inoculated with the organism. This process is performed in vitro (in a lab setting) to determine the minimum inhibitory concentration (MIC), which is a key diagnostic parameter for guiding antibiotic treatment.
- Performance Studies: The performance studies describe comparing the device's performance to a "frozen Reference panel" and evaluating "Efficacy isolates and stock Challenge strains." These are all standard practices for validating the performance of an IVD device.
- Predicate Device(s): The listed predicate devices are also IVD panels used for antimicrobial susceptibility testing.
The entire context of the document describes a device designed to perform a diagnostic test on biological samples in a laboratory setting, which aligns perfectly with the definition 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℃ +/- 1℃, 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 linezolid, at concentrations of 0.5 to 16 ug/ml Long Dilution Sequence and 0.5 - 4 ug/ml 4-Dilution Breakpoint Sequence, for enterococci and staphylococci, to the test panel.
The Gram-positive organisms which may be used for linezolid susceptibility testing in this panel are:
Enterococcus faecium (vancomycin-resistant) Staphylococcus aureus (methicillin-susceptible and methicillin-resistant)
Product codes
LON, LRG, JWY, LTT
Device Description
MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panels, utilizing both the MicroScan® Rapid Fluorogenic Identification and Dried Overnight Antimicrobial Susceptibility Testing (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, or equivalent, 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
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Mentions AI, DNN, or ML
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Input Imaging Modality
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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 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The proposed MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panel demonstrated substantially equivalent performance when compared with a 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 February 5, 2003. The Premarket Notification (510/k]) presents data in support of the MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panel with linezolid.
The Synergies plus" Gram-Expected Results determined proprable performance with an overall Essential I ostire I and demonstrator association Sequence and 4-Dilution Agteencer of 76.070, 10, 10, 10, 10, 10, 10, 2019 - 10:15 Breakpoint Sequence, for Linezolid when compared with the frozen Reference panel.
Instrument reproducibility testing demonstrated acceptable reproducibility and mstrainent reproductive with Turbidity inoculum preparation method and the WalkAway® SI System or equivalent.
Quality Control testing demonstrated acceptable results for linezolid.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Overall Essential I ostire I and demonstrator association Sequence and 4-Dilution Agteencer of 76.070, 10, 10, 10, 10, 10, 10, 2019 - 10:15 Breakpoint Sequence, for Linezolid when compared with the frozen Reference panel.
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.
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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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§ 866.1645 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.”
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OCT 20 2006
510(k) Summary
510(k) Submission Information: Device Manufacturer: D Dade Behring Inc. Contact name: Robert Eusebio, Regulatory Affairs Manager 916-374-3144 Fax: Date prepared: August 21, 2006 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 - linezolid 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 Testing (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, or equivalent, 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 Panel, 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 linezolid.
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
1
Expected Results determined prior to the evaluation. The Synergies plus" Gram-Expected Results determined proprable performance with an overall Essential I ostire I and demonstrator association Sequence and 4-Dilution Agteencer of 76.070, 10, 10, 10, 10, 10, 10, 2019 - 10:15
Breakpoint Sequence, for Linezolid when compared with the frozen Reference panel.
Instrument reproducibility testing demonstrated acceptable reproducibility and mstrainent reproductive with Turbidity inoculum preparation method and the WalkAway® SI System or equivalent.
Quality Control testing demonstrated acceptable results for linezolid.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged around the eagle in a circular pattern.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Robert Eusebio Regulatory Affairs Manager Dade Behring, Inc. 1584 Enterprise Boulevard West Sacramento, CA 95691-9972
OCT 2 0 2006
Re: K062705 Trade/Device Name: MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panels Linezolid (0.5-16 µg/ml Long Dilution Sequence and 0.5 – 4 µg/ml 4 - Dilution Breakpoint Sequence) Regulation Number: 21 CFR 866.1645 Regulation Name: Fully automated short-term incubation cycle antimicrobial susceptibility system. Regulatory Class: Class II Product Code: LON, LRG, JWY, LTT Dated: September 7, 2006 Received: September 20, 2006
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 indicons for use stated in the enclosure) to legally marketed predicated devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical In microa in microsities 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, intiling 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 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 O intor gonetar in the 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 artom
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):
Device Name: MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panels with Linezolid (0.5 - 16 ug/ml Long Dilution Sequence and 0.5 - 4 ug/ml 4-Dilution Breakpoint Sequence)
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℃ +/- 1℃, 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 linezolid, at concentrations of 0.5 to 16 ug/ml Long Dilution Sequence and 0.5 - 4 ug/ml 4-Dilution Breakpoint Sequence, for enterococci and staphylococci, to the test panel.
The Gram-positive organisms which may be used for linezolid susceptibility testing in this panel are:
Enterococcus faecium (vancomycin-resistant) Staphylococcus aureus (methicillin-susceptible and methicillin-resistant)
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)
Luddi W. Poole
Division Sign-Off
sion Sign-C
Lzd 510k.doc 10/11/2006
Office of In Vitro Diagnostic Device Evaluation and Safety
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