(13 days)
WalkAway® S/ System, WalkAway® 96
No
The summary describes a traditional broth dilution susceptibility test read by an automated system, with no mention of AI or ML in the device description, intended use, or performance studies.
No.
This device is designed to determine antimicrobial susceptibility, which is a diagnostic function, not a therapeutic intervention.
Yes
The device determines the quantitative and/or qualitative antimicrobial agent susceptibility of bacterial colonies, which is a diagnostic function as it identifies the effectiveness of antibiotics against specific microorganisms.
No
The device description clearly states it is a physical panel with dried antimicrobial agents in micro-titer wells, which is inoculated and incubated. It is read on a hardware system (WalkAway® SY System or equivalent). This is a hardware-based device with associated software for reading and interpretation, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section 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 definition of an in vitro diagnostic test, as it involves testing a sample (bacterial colonies) outside of the body to provide information about a patient's condition (susceptibility to antibiotics).
- Device Description: The description further clarifies that the device is a "miniaturization of the broth dilution susceptibility test" and involves incubating the organism with antimicrobial agents to determine the minimum inhibitory concentration (MIC). This process is performed in a laboratory setting using a sample derived from a patient.
- Performance Studies: The performance studies compare the device's performance to a "NCCLS frozen Reference panel," which is a standard reference method for in vitro susceptibility testing. This further confirms its role as an IVD.
The device is designed to be used in a laboratory setting to analyze a biological sample (bacterial colonies) to provide information relevant to patient care (which antibiotics will be effective). 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® S/ System or equivalent Ichnemore: "This "how and WalkAway" 96) according to the Package Insert.
This particular submission is for the antimicrobial Meropenem on the rapID/S plus " Gram-Negative MIC/Combo Panels.
The Gram-Negative organisms which may be used for Meropenem susceptibility testing in this panel are:
Acinetobacter spp Aeromonas hydrophila Citrobacter koseri (diversus) Citrobacter freundii Escherichia coli Enterobacter cloacae Hafnia alvei Klebsiella oxytoca Klebsiella pneumoniae Morganella morganii Pasteurella multocida Proteus mirabilis Proteus vulgaris Serratia marcescens Shigella spp Salmonella spp Yersinia enterolitica
The MicroScan® rapID/S plus "Gram-Negative with Meropenem is not intended for use with:
Pseudomonas aeruginosa
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® SY 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℃ in the WalkAway® SV 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
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
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 plus ™ 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 greater than 97.3% for Meropenem when compared with the frozen Reference panel.
Instrument reproducibility testing demonstrated acceptable reproducibility and precision with Meropenem 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 Meropenem.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Essential Agreement of greater than 97.3% for Meropenem.
Predicate Device(s)
MicroScan Dried Gram Negative MIC/Combo Panels
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with medicine and healthcare.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 3 0 200
Mr. Robert Eusebio Manager Regulatory Affairs Dade MicroScan, Inc. 1584 Enterprise Boulevard West Sacramento, CA 95691
K020249 Re: Trade/Device Name: MicroScan® plus™ Gram-Negative MIC/Combo Panels with Meropenem (0.12-32 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 6, 2002, regarding the trade I his letter corrects our subominatify oque 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 we nave roviewed your becamed in in it is substantially equivalent [(for the indications for use stated in the enclosure)] to legally marketed predicate devices marketed in interstate for ass based in the enactment date of the enactment date of the Medical Device Amendments or to commerce print to May 20, 1978, are exactions of the Federal Food. Drug, Drug, do floos that have over 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 therefore, markeville as a reactivements 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 11 your de roo to additional controls. Existing major regulations affecting your device can be may be subject to additions, 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 I lease of actives and I Drivination that your device complies with other requirements of the Act that I Dri has intact a wond regulations administered by other Federal agencies. You must of any I coclar statutes and regulations annuding, but not limited to: registration and listing (21 Comply with an the Fee orequirements)01); good manufacturing practice requirements as set OF K Fart 607); adoling (21 CFR Part 820); and if applicable, the electronic form in the quality by evense (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) This letter will anow you to commission of substantial equivalence of your device to a legally premailed notification. The Pro Massification 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 11 Jud as a sport 809.10 for in vitro diagnostic devices), please contact the Office of Compliance additionally Part 00710 For questions on the promotion and advertising of your device, at ( 3 ) 2 t t 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. Rood for
Salty 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
2
Indications for Use Statement
510(k) Number (if known): K020249
MicroScan® Synergies plus™ Gram-Negative MIC/Combo Panels with Meropenem Device Name: (0.12 - 32 ug/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® S/ System or equivalent Ichnemore: "This "how and WalkAway" 96) according to the Package Insert.
This particular submission is for the antimicrobial Meropenem on the rapID/S plus " Gram-Negative MIC/Combo Panels.
The Gram-Negative organisms which may be used for Meropenem susceptibility testing in this panel are:
Acinetobacter spp Aeromonas hydrophila Citrobacter koseri (diversus) Citrobacter freundii Escherichia coli Enterobacter cloacae Hafnia alvei Klebsiella oxytoca Klebsiella pneumoniae Morganella morganii Pasteurella multocida Proteus mirabilis Proteus vulgaris Serratia marcescens Shigella spp Salmonella spp Yersinia enterolitica
The MicroScan® rapID/S plus "Gram-Negative with Meropenem is not intended for use with:
Pseudomonas aeruginosa
X Prescription Use (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)
ncurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Luddi Pool
Division Sign-Off
Division Sign 511
Office of In Vitro Diagnostic Device Evaluation and Safety
Page 1 of __ 1
510(k) 020249
3
FEB 0 6 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 22, 2002 |
| Product Name: | Microdilution Minimum Inhibitory Concentration (MIC) Panel |
| Trade Name: | MicroScan® rapID/S plus ™ Gram-Negative MIC/Combo panel |
| Intended Use: | To determine antimicrobial agent susceptibility |
| 510(k) Notification: | Antimicrobials: Meropenem |
| 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® SY 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℃ in the WalkAway® SV 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 Meropenem.
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 plus ™ 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 greater than 97.3% for Meropenem when compared with the frozen Reference panel.
Instrument reproducibility testing demonstrated acceptable reproducibility and precision with Meropenem 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 Meropenem.