(54 days)
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® SZ, 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 Levofloxacin, at concentrations of 0.03 to 16 ug/ml, to the test panel.
The gram-positive organisms which may be used for Levofloxacin susceptibility testing in this panel are:
Enterococcus faecalis Staphylococcus aureus (methicillin-susceptible strains) Staphylococcus epidermidis (methicillin-susceptible strains) Staphylococcus saprophyticus Staphylococcus haemolyticus
MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panels, utilizing both the MicroScan® Rapid MIC and Synergies plus™ Gram-Positive Antimicrobial Susceptibility Testing (AST) technologies, are for use in determining quantitative 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 dried in water and dehydrated. Various antimicrobial agents are diluted in water, buffer, or minute amounts of clinical interest. Panels are rehydrated with Synergies plus™ Pos Broth, after inoculation with a standardized suspension of the organism. After incubation, for 4.5 - 18 hours, the minimum inhibitory concentration in the wells is determined by determining the lowest antimicrobial concentration showing inhibition of growth.
Here's a summary of the acceptance criteria and the study details for the MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panels with Levofloxacin, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Metric | Acceptance Criteria | Reported Device Performance (Levofloxacin) |
|---|---|---|
| Essential Agreement | >95% (FDA Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Class II Special Controls Guidance Document, Jan 5, 2003) | >98% |
| Reproducibility | Acceptable (Specific quantitative criteria not provided in summary, but assumed to meet standard for "acceptable reproducibility and precision") | Acceptable |
| Quality Control | Acceptable | Acceptable |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Description: The external evaluation was conducted with fresh and stock Efficacy isolates and stock Challenge strains.
- Sample Size: The exact number of isolates/strains used for the test set is not explicitly stated in the provided summary. However, it's mentioned that the study was designed to confirm performance by comparing it with a frozen Reference panel.
- Data Provenance: The document does not specify the country of origin of the data. It is a prospective evaluation, as new antimicrobial (Levofloxacin) data was generated for the panel.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number or qualifications of experts used to establish the ground truth. The comparison was made against a "frozen Reference panel," which implies a standardized method of determining ground truth.
4. Adjudication Method for the Test Set
The document does not explicitly state an adjudication method. The comparison was against a "frozen Reference panel," indicating a direct comparison rather than a human consensus-based adjudication process for each individual test result.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No MRMC comparative effectiveness study is mentioned. This device is an automated antimicrobial susceptibility testing panel, and the study focuses on its standalone analytical performance against a reference method, not on human reader performance or improvement with AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance study was done. The entire evaluation described in the summary is focused on the performance of the MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panel with Levofloxacin, comparing its results to a standardized reference method. The device automates the determination of MICs.
7. The Type of Ground Truth Used
The ground truth used was established by a "frozen Reference panel." This implies a reference standard or method for determining antimicrobial susceptibility, likely involving a recognized laborious and precise method that serves as the gold standard for comparison (e.g., agar dilution or broth microdilution performed under highly controlled conditions by a reputable laboratory).
8. The Sample Size for the Training Set
The document does not specify a training set sample size. This type of device relies on established principles of broth microdilution and the "new antimicrobial" (Levofloxacin) is being added to an existing, validated panel. Therefore, a separate "training set" in the context of machine learning might not be directly applicable, or if internal development involved a training set, it is not detailed in this 510(k) summary.
9. How the Ground Truth for the Training Set Was Established
Since a training set is not explicitly mentioned or detailed, the method for establishing its ground truth is not provided.
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K0513//
JUL 1 2 2005
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 - Levofloxacin |
| Predicate device: | MicroScan® Synergies plus™ Gram-Negative MIC/Combo Panels andMicroScan® Dried Gram-Positive Panels |
510(k) Summary:
) Sunlimal y .
MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panels, utilizing both the MicroScan® Rapid MICrossen Sylerges pras Grain Fosteright Antimicrobial Susceptibility Testing (AST) technologies, r labogethe for use in determining quantitative 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 I he antinued in water and dehydrated. Various antimicrobial agents are diluted in water, buffer, or minute been untiled in watch and delythated. Various untilisers of clinical interest. Panels are rehydrated with Synergies plus" Pos Broth, after inoculation with a standardized suspension of the organism. After Syllergics pus - 1 03 Droum, and movement, for 4.5 - 18 hours, the minimum inhibitory meddation in the wants thays of by determining the lowest antimicrobial concentration showing inhibition of growth.
The proposed MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panel demonstrated substantially TIE proposed Microbean "Official Prace Reference Panel, as defined in the FDA document equivalent performance Midance Document: Antimicrobial Susceptibility Test (AST) Systems; Class II Special Controls Guidiner Document y 5, 2003. The Premarket Notification (510[k]) presents Outdates for madely and I Dr. , as were gies plus" Gram-Positive MIC/Combo Panel with Levofloxacin.
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-The external evaluations were performance with a frozen Reference panel. Challenge strains were Fositive Faller by companing is performation. The Synergies plus " Gram-Positive Panel demonstrated acceptable performance with an overall Essential Agreement of >98% for Levofloxacin when compared with the frozen Reference panel.
Instrument reproducibility testing demonstrated acceptable reproducibility and precision for Levofloxacin, with Turbidity inoculum preparation method and the WalkAway® SJ System or equivalent.
Quality Control testing demonstrated acceptable results for Levofloxacin.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three curved lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the eagle. The eagle is positioned in the center of the logo, and the text is placed around the perimeter.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL 1 2 2005
Mr. Robert Eusebio Regulatory Affairs Manager Dade Behring Inc. 1584 Enterprise Boulevard West Sacramento, CA 95691-9972
Re: K051311 Trade/Device Name: MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panels with Levofloxacin (0.03 - 16 ug/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, JWY, LRG, LTT, LTW Dated: May 13, 2005 Received: May 24, 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 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 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 Division of Small 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/industry/support/index.html
Sincerely yours,
Sales, a For
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 Levofloxacin (0.03-16 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 staphylococci and enterococci. After inoculation, panels are incubated for 4.5 - 18 hours at 35℃ +/- 1℃, in a WalkAway® SZ, 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 Levofloxacin, at concentrations of 0.03 to 16 ug/ml, to the test panel.
The gram-positive organisms which may be used for Levofloxacin susceptibility testing in this panel are:
Enterococcus faecalis Staphylococcus aureus (methicillin-susceptible strains) Staphylococcus epidermidis (methicillin-susceptible strains) Staphylococcus saprophyticus Staphylococcus haemolyticus
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)
Division Sign-Off
Division Sign-Off
Page 1 of 1
Lvf510k.doc
Office of In Vitro Diagnostic Device Evaluation and Safety K05131
§ 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.”