(54 days)
MicroScan® Synergies plus™ Gram-Negative MIC/Combo Panels, MicroScan® Dried Gram-Positive Panels
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No
The summary describes a traditional broth dilution susceptibility test system and its performance characteristics, with no mention of AI or ML technologies.
No.
This device is designed to determine the susceptibility of bacteria to antimicrobial agents, which is a diagnostic function, not a therapeutic one. It helps in selecting the appropriate treatment but does not directly treat a condition or provide therapy.
Yes
This device determines the susceptibility of microorganisms to antimicrobial agents, which is a diagnostic function to guide treatment decisions.
No
The device description explicitly mentions "MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panels" which are physical panels containing dehydrated antimicrobial agents. It also mentions incubation in a "WalkAway® SI, or equivalent" system, which is a piece of hardware. While software is likely involved in reading and interpreting the results from the panels and the instrument, the core of the device involves physical components (panels) and hardware (incubator/reader).
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "determine antimicrobial agent susceptibility" of specific microorganisms (staphylococci and enterococci). This is a diagnostic test performed in vitro (outside the body) on a biological sample (colonies grown on solid media).
- Device Description: The device description explicitly states that the antimicrobial susceptibility tests are "miniaturizations of the broth dilution susceptibility test." Broth dilution susceptibility testing is a standard in vitro method used in clinical microbiology laboratories to determine the minimum inhibitory concentration (MIC) of an antimicrobial agent against a microorganism.
- Process: The process involves inoculating the panel with a standardized suspension of the organism, incubating it, and then reading the results to determine the MIC. This entire process is performed in vitro.
- Regulatory Context: The document mentions comparison to a "frozen Reference panel" and adherence to FDA guidance for "Antimicrobial Susceptibility Test (AST) Systems." AST systems are a well-established category of IVD devices.
Therefore, based on the intended use, the device description, and the context of its use in determining antimicrobial susceptibility of microorganisms, this device clearly falls under the definition of an In Vitro Diagnostic.
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 staphylococci and enterococci. 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 Rifampin, at concentrations of 0.25 to 8 ug/ml, to the test panel.
The gram-positive organisms which may be used for Rifampin susceptibility testing in this panel are:
Staphylococcus aureus (including methicillin-resistant strains/MRSA) Staphylococcus epidermidis
Product codes (comma separated list FDA assigned to the subject device)
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 staphylococci and enterococci.
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™ Post Broth, after inoculation with a standardized suspension of the organism. After incubation in the WalkAway® SZ 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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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 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 Rifampin. The Synergies plus™ Gram-Positive Panel demonstrated acceptable performance with an overall Essential Agreement of >98% for Rifampin when compared with the frozen Reference panel.
Instrument reproducibility testing demonstrated acceptable reproducibility and precision filled and reproduction inoculum preparation method and the WalkAway® SI System or equivalent.
Quality Control testing demonstrated acceptable results for Rifampin.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Essential Agreement of >98% for Rifampin
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® Synergies plus™ Gram-Negative MIC/Combo Panels, MicroScan® Dried Gram-Positive 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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§ 866.1645 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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510(k) Summary
510(k) Submission Information:
| Device Manufacturer: | Dade Behring Inc. |
|---|---|
| Contact name: | Robert Eusebio, Regulatory Affairs Manager |
| Fax: | 916-374-3144 |
| Date prepared: | April 25, 2005 |
| Product Name: | Microdilution Minimum Inhibitory Concentration (MIC) Panels |
| Trade Name: | MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panels |
| Intended Use: | To determine antimicrobial agent susceptibility |
| 510(k) Notification: | New antimicrobial - Rifampin |
| Predicate device: | MicroScan® Synergies plus™ Gram-Negative MIC/Combo 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 staphylococci and enterococci.
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™ Post Broth, after inoculation with a standardized suspension of the organism. After incubation in the WalkAway® SZ 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 Rifampin.
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 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
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demonstrated acceptable performance with an overall Essential Agreement of >98% for Rifampin when compared with the frozen Reference panel.
Instrument reproducibility testing demonstrated acceptable reproducibility and precision filled and reproduction inoculum preparation method and the WalkAway® SI System or equivalent.
Quality Control testing demonstrated acceptable results for Rifampin.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized representation of a human figure, with three abstract shapes forming the body and head.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL 27 2005
Mr. Robert Eusebio Regulatory Affairs Manager Dade Behring, Inc. 1584 Enterprise Boulevard West Sacramento, CA 95691-9972
K051478 Re: Trade/Device Name: MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panels Rifampin (0.25-8 µg/ml) 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: June 1, 2005 Received: June 29, 2005
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 for use stated in the encreated of the enactment date of the Medical Device Amendments, or to conniner or prior to 1125 20, 2017 11:11 accordance with the provisions of the Federal Food, Drug, de nees mat have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, mercere, mains of the Act include requirements for annual registration, listing of general controls pro risevring 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 it may of cacions 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 I loase oc advised that I DT brosantes over device complies with other requirements of the Act that I Dri has made a astad regulations administered by other Federal agencies. You must or any I cacal statutes and regaraments, 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) I mis leter will anon you wo ought finding of substantial equivalence of your device to a legally premaired notification: ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' 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)276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the I va may overnit ones generational 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/industry/support/index.html
Sincerely yours,
Sales, a Form
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): 4051478
Device Name: MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panels with Rifampin (0.25 - 8 µg/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 staphylococci and enterococci. 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 Rifampin, at concentrations of 0.25 to 8 ug/ml, to the test panel.
The gram-positive organisms which may be used for Rifampin susceptibility testing in this panel are:
Staphylococcus aureus (including methicillin-resistant strains/MRSA) Staphylococcus epidermidis
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)
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KO 51478
510(k)