(53 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 enterococci and staphylococci. After inoculation, panels are incubated for 4.5 - 18 hours at 35°C +/- 1°C, in a WalkAway® SZ, or equivalent, and read by the MicroScan® Instrumentation. Additionally, the panels may be incubated in a non-CO2incubator 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 nitrofurantoin, at concentrations of 2 to 256 ug/ml, for enterococci and staphylococci, to the test panel.
The gram-positive organisms which may be used for nitrofurantoin susceptibility testing in this panel are:
Enterococcus species Staphylococcus aureus
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, 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.
1. Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (from "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA", dated February 5, 2003) | Reported Device Performance (MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panels with nitrofurantoin) |
|---|---|---|
| Overall Essential Agreement | Not explicitly stated in the provided text, but implied as a benchmark for "acceptable performance" compared to a reference method. | 98.8% |
| Reproducibility and Precision | Acceptable reproducibility and precision | Demonstrated acceptable reproducibility and precision |
| Quality Control Testing | Acceptable results | Demonstrated acceptable results |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not explicitly state the exact sample size used for the test set. It mentions "external validation was conducted with fresh and stock Efficacy isolates and stock Challenge strains." However, the specific number of isolates is not quantifiable from the given information.
The data provenance is from an external validation study. The location of this study (e.g., country of origin) is not specified. The study appears to be retrospective in that it uses "stock Efficacy isolates and stock Challenge strains," suggesting they were collected prior to the study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of experts to establish ground truth for the test set. Instead, the performance of the device was compared against a "frozen Reference Panel" and "Expected Results determined prior to the evaluation" for challenge strains. This suggests an objective, standardized reference method was used rather than expert consensus.
4. Adjudication Method for the Test Set
Not applicable. The ground truth was established by comparison to a "frozen Reference Panel" and "Expected Results," not through human adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The provided text describes a study evaluating the performance of an automated antimicrobial susceptibility testing system against a reference method. It does not involve human readers evaluating cases or comparing human performance with and without AI assistance.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Performance
Yes, this was a standalone performance study. The MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panels system is an automated device designed to determine antimicrobial susceptibility. The study evaluated the performance of this automated system directly (algorithm only) against a reference method.
7. Type of Ground Truth Used
The ground truth was established by comparison to a "frozen Reference Panel" and "Expected Results" for challenge strains. This implies a standardized, objective, and predefined reference for antimicrobial susceptibility.
8. Sample Size for the Training Set
The document does not provide any information regarding a training set or its sample size. The focus is on the validation of the device's performance against a reference.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set information is provided.
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510(k) Summary
510(k) Submission Information:
NOV 2 0 2006
Device Manufacturer: Dade Behring Inc. Contact name: Robert Eusebio, Regulatory Affairs Manager Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: 916-374-3144 Date prepared: September 22, 2006 Product Name: Microdilution Minimum Inhibitory Concentration (MIC) Panels Trade Name: MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panels To determine antimicrobial agent susceptibility Intended Use: 510(k) Notification: New antimicrobial - nitrofurantoin 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 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 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 nitrofurantoin.
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
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Expected Results determined prior to the evaluation. The Synergies plus™ Gram-Positive Panel demonstrated acceptable performance with an overall Essential Agreement of 98.8% for nitrofurantoin when compared with the frozen Reference panel.
Instrument reproducibility testing demonstrated acceptable reproducibility and precision for Nitrofurantoin with Turbidity inoculum preparation method and the WalkAway® SI System or equivalent.
Quality Control testing demonstrated acceptable results for nitrofurantoin.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The eagle is depicted in black, and the text is also in black. The logo is simple and recognizable, representing the department's mission to protect the health of all Americans.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 2 0 2006
Mr. Robert Eusebio Regulatory Affairs Manager Dade Behring, Inc. 1584 Enterprise Boulevard West Sacramento, CA 95691-9972
Re: K062938 Trade/Device Name: MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panels Nitrofurantion (2 - 256 ug/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: September 25, 2006 Received: October 19, 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 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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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 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/dsma/dsmamain.html.
Sincerely vours,
Sally, axtropm
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): K06 2938
Device Name: MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panels with Nitrofurantoin (2 - 256 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® SZ, or equivalent, and read by the MicroScan® Instrumentation. Additionally, the panels may be incubated in a non-CO2incubator 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 nitrofurantoin, at concentrations of 2 to 256 ug/ml, for enterococci and staphylococci, to the test panel.
The gram-positive organisms which may be used for nitrofurantoin susceptibility testing in this panel are:
Enterococcus species Staphylococcus aureus
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, Qffice of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Fd 510k.doc 9/25/2006
Office of In Vitro Diagnostic Device Evaluation and starty
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510(k) K062938
§ 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.”