(19 days)
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No
The summary describes a standard broth dilution susceptibility test read by an automated system. There is no mention of AI or ML in the device description, intended use, or performance studies. The evaluation compares the device to a reference panel, which is a standard regulatory practice and does not imply AI/ML use.
No.
This device is designed to determine antimicrobial susceptibility, which is a diagnostic function, not a therapeutic intervention.
Yes
The device determines quantitative and/or qualitative antimicrobial agent susceptibility, which provides information on how effective an antimicrobial agent will be against a specific microorganism, aiding in the diagnosis and treatment of infections. This falls under the definition of a diagnostic device as it provides information for diagnosis and guiding treatment.
No
The device is a physical panel containing dried antimicrobial agents, which is inoculated and incubated. While it is read by an instrument (WalkAway® System), the core device being submitted is a physical consumable panel, not 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-Negative bacilli". This is a classic description of an in vitro diagnostic test, as it involves analyzing a biological sample (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 using miniaturized broth dilution susceptibility tests in micro-titer wells. This process involves testing the interaction of the organism with antimicrobial agents in a laboratory setting, which is the core of in vitro diagnostics.
- Performance Studies: The performance studies describe comparing the device's performance to a "frozen Reference panel" and evaluating "Efficacy isolates" and "Challenge strains". These are all standard practices for validating the performance of an in vitro diagnostic device.
- Predicate Device: The mention of a "Predicate Device(s)" which is "MicroScan Dried Gram Negative MIC/Combo Panels" further confirms that this device falls within the category of IVDs, as predicate devices are used in the regulatory process for new IVDs.
The device is designed to be used in a laboratory setting to test samples (bacterial colonies) taken from a patient, and the results are used to inform clinical decisions about antibiotic treatment. This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
MicroScan® Synergies plus™ Gram-Negative 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-Negative bacilli (Enterobacteriaceae, glucose non-fermenters, and non-Enterobacteriaceae glucose fermenters. After inoculation, panels are read on the WalkAway® SI System or equivalent (upgraded WalkAway® 40 or WalkAway® 96) according to the Package Insert.
This particular submission is for the antimicrobial Cefuroxime on the Synergies plus™ Gram-Negative MIC/Combo Panels.
The Gram-Negative organisms which may be used for Cefuroxime susceptibility testing in this panel are:
Citrobacter spp Escherichia coli Klebsiella oxytoca Morganella morganii Proteus mirabilis Providencia rettgeri Shigella spp Salmonella spp
The MicroScan® Synergies plus" Gram-Negative with Cefuroxime is not intended for use with:
Enterobacter sop Klebsiella pneumoniae
Product codes
LON
Device Description
MicroScan® rapID/S plus™ Gram-Negative MIC/Combo Panels 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-negative bacilli. The MicroScan® rapID/S plus™ Gram-Negative MIC/Combo Panels are read on the WalkAway® System or equivalent (upgraded WalkAway® 40 or WalkAway® 96 instruments).
The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test that have been diluted in Mueller-Hinton Broth to concentrations bridging the range of clinical interest and are presented in micro-titer wells in dried form. rapID/S plus™ panels are inoculated and rehydrated with a standardized suspension of the organism and incubated at 35°C in the WalkAway® SY System or equivalent for 4.5 - 18 hours. The minimum inhibitory concentration (MIC) for the test organism is determined by 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 rapID/S p/us™ Gram-Negative Panel by comparing its performance with an NCCLS 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® rapID/S plus™ Gram-Negative MIC/Combo Panel demonstrated substantially equivalent performance when compared with an NCCLS frozen Reference Panel, as defined in the FDA DRAFT document "Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices", dated March 8, 2000.
The rapID/S plus™ Gram-Negative Panel demonstrated acceptable performance with an overall Essential Agreement of 97% for Cefuroxime, with parenteral and oral breakpoints, when compared with the frozen Reference panel.
Instrument reproducibility testing demonstrated acceptable reproducibility and precision with Cefuroxime with Turbidity inoculum preparation method and the WalkAway® SI System or equivalent (upgraded WalkAway® 40 or WalkAway® 96 instruments).
Quality Control testing demonstrated acceptable results for Cefuroxime.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Essential Agreement of 97%
Predicate Device(s)
MicroScan Dried Gram Negative MIC/Combo Panels
Reference Device(s)
Not Found
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).
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.”
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a bird or eagle in flight, composed of three curved lines that suggest the wings and body. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the emblem.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 3 0 2004
Mr. Robert Eusebio Manager Regulatory Affairs Dade MicroScan, Inc. 1584 Enterprise Boulevard West Sacramento, CA 95691
K020328 Re: Trade/Device Name: MicroScan® Synergies plus™ Gram-Negative MIC/Combo Panels with Cefuroxime (1-64 µg/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 Dated: July 30, 2004 Received: August 3, 2004
Dear Mr. Eusebio:
This letter corrects our substantially equivalent letter of February 19, 2004, regarding the trade name which was changed to MicroScan® Synergies Plus to better reflect the intended use of the device.
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 ecommerce prave 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 (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 additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to continue 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 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-3084. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Freddie L. Pade for
Sally A. Hojvat, M.Sc., Ph. 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 Statement
510(k) Number (if known): K020328
MicroScan® Synergies plus" Gram-Negative MIC/Combo Panels with Cefuroxime Device Name: (1 - 64 µg/ml)
Indications For Use:
MicroScan® Synergies plus™ Gram-Negative 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-Negative bacilli (Enterobacteriaceae, glucose non-fermenters, and non-Enterobacteriaceae glucose fermenters. After inoculation, panels are read on the WalkAway® SI System or equivalent (upgraded WalkAway® 40 or WalkAway® 96) according to the Package Insert.
This particular submission is for the antimicrobial Cefuroxime on the Synergies plus™ Gram-Negative MIC/Combo Panels.
The Gram-Negative organisms which may be used for Cefuroxime susceptibility testing in this panel are:
Citrobacter spp Escherichia coli Klebsiella oxytoca Morganella morganii Proteus mirabilis Providencia rettgeri Shigella spp Salmonella spp
The MicroScan® Synergies plus" Gram-Negative with Cefuroxime is not intended for use with:
Enterobacter sop Klebsiella pneumoniae
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)
Fredahtu Paul
Division Sign-Off
Page 1 of __ l
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) 020328
3
FEB 1 9 2002
510(k) Summary
510(k) Submission Information:
| Device Manufacturer: | Dade Behring Inc. |
|---|---|
| Contact name: | Maureen Mende, Group Manager Regulatory Affairs |
| Fax: | 916-374-3144 |
| Date prepared: | January 29, 2002 |
| Product Name: | Microdilution Minimum Inhibitory Concentration (MIC) Panels |
| Trade Name: | MicroScan® rapID/S plus™ Gram-Negative MIC/Combo panels |
| Intended Use: | To determine antimicrobial agent susceptibility |
| 510(k) Notification: | Antimicrobials: Cefuroxime |
| Predicate device: | MicroScan Dried Gram Negative MIC/Combo Panels |
510(k) Summary:
MicroScan® rapID/S plus™ Gram-Negative MIC/Combo Panels 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-negative bacilli. The MicroScan® rapID/S plus™ Gram-Negative MIC/Combo Panels are read on the WalkAway® System or equivalent (upgraded WalkAway® 40 or WalkAway® 96 instruments).
The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test that have been diluted in Mueller-Hinton Broth to concentrations bridging the range of clinical interest and are presented in micro-titer wells in dried form. rapID/S plus™ panels are inoculated and rehydrated with a standardized suspension of the organism and incubated at 35°C in the WalkAway® SY System or equivalent for 4.5 - 18 hours. The minimum inhibitory concentration (MIC) for the test organism is determined by the lowest antimicrobial concentration showing inhibition of growth.
The proposed MicroScan® rapID/S plus™ Gram-Negative MIC/Combo Panel demonstrated substantially equivalent performance when compared with an NCCLS frozen Reference Panel, as defined in the FDA DRAFT document "Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices", dated March 8, 2000. The Premarket Notification (510[k]) presents data in support of the MicroScan® rapID/S plus™ Gram-Negative MIC/Combo Panel with Cefuroxime.
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 rapID/S p/us™ Gram-Negative Panel by comparing its performance with an NCCLS frozen Reference panel. Challenge strains were compared to Expected Results determined prior to the evaluation. The rapID/S plus™ Gram-Negative Panel demonstrated acceptable performance with an overall Essential Agreement of 97% for Cefuroxime, with parenteral and oral breakpoints, when compared with the frozen Reference panel.
Instrument reproducibility testing demonstrated acceptable reproducibility and precision with Cefuroxime with Turbidity inoculum preparation method and the WalkAway® SI System or equivalent (upgraded WalkAway® 40 or WalkAway® 96 instruments).
Quality Control testing demonstrated acceptable results for Cefuroxime.