(19 days)
MicroScan Dried Gram Negative MIC/Combo Panels
WalkAway® S/, WalkAway® 40, WalkAway® 96
No
The document describes a traditional antimicrobial susceptibility testing panel and automated reading system. There is no mention of AI or ML in the intended use, device description, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No.
The device is used to determine the susceptibility of bacteria to antimicrobial agents, which aids in diagnosis and treatment selection, but it does not directly treat or restore bodily functions.
Yes
The device determines quantitative and/or qualitative antimicrobial susceptibility of bacterial colonies, which is a diagnostic function used to guide treatment decisions.
No
The device description explicitly mentions "panels" which are physical components containing dried antimicrobial agents, and the use of "WalkAway® S/ System or equivalent" instruments for reading the panels. This indicates a hardware component is integral to the device's function.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly 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 diagnostic test performed in vitro (outside the body) on a biological sample (bacterial colonies).
- Device Description: The description further clarifies that the device contains antimicrobial susceptibility tests in micro-titer wells, which are used to determine the susceptibility of organisms. This is a standard format for in vitro diagnostic tests.
- Performance Studies: The document describes performance studies comparing the device to a "frozen Reference panel" and demonstrating "Essential Agreement". This type of testing is typical for validating the performance of an IVD.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (MicroScan Dried Gram Negative MIC/Combo Panels) strongly indicates that this device is being submitted for regulatory clearance as an IVD. K numbers are associated with 510(k) submissions to the FDA for medical devices, including IVDs.
Therefore, based on the provided information, the MicroScan® Synergies plus™ Gram-Negative MIC/Combo Panel is 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 (upgraded WalkAway® 40 or WalkAway® 96) according to the Package Insert.
This particular submission is for the antimicrobial Piperacillin/Tazobactam on the Synergies plus" Gram-Negative MIC/Combo Panels.
The Gram-Negative organisms which may be used for Piperacillin/Tazobactam susceptibility testing in this panel are:
Escherichia coli (Piperacillin-resistant, ß-lactamase producing) Klebsiella oxytoca Klebsiella pneumoniae Morganella morganii Proteus mirabilis Proteus vulgaris Pseudomonas aeruginosa Serratia spp.
The MicroScan® Synergies plus™ Gram-Negative with Piperacillin/Tazobactam is not intended for use with:
Acinetobacter spp. Citrobacter spp. Enterobacter spp
Product codes
LON
Device Description
The antimicrobial susceptibility tests are miniaturizations susceptibility tost that have The antimicrobial susceptibility tests are inninatinations bridging in clinical interest and are been diluted in Mueller-Himon Broun to concentuations of the coulded and rehydrated with a presented in micro-titer wells in arred form. Tapines at 350 in the Walks ways System or equivalent standardized suspension of the organism and included at 35 ° In the was any was and one of 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
Not Found
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 demonstratled substantially The proposed MicroScan® Tapp273 plus - Gran-Negarro Parel, as defined in the FDA
equivalent performance when compared with an Assessment of Animisrobial Susceptibility Devices", DRAFT document Culture on Review Citieria 10 110[k]) presents data in support of the MicroScan® dated March '6, 2000. - The Premient with Piperacillin/Tazobactam.
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 rapIDS plis" Grain The external evaluations were designed to commit the acceptabling on area. Challenge stains Negative Panel by companies with an to evelopment. The rapIDS plus™ CrapIDS plus™ Cram-Negative were compared to Frozel Results determined prof to the overall Essential Agreement of greater than 94 % for I and demonstrator associated with the frozen Reference panel.
testing demonstrated acceptable reproducibility and precision with Instrument reproducibility Instrument reproductioning testing includio preparation method and the WalkAway® SI System or r perachin ruzobucture walkAway® 40 or WalkAway® 96 instruments).
Quality Control testing demonstrated acceptable results for Piperacillin/Tazobactam.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Essential Agreement of greater than 94 %
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.”
0
510(k) Summary
K 020511
| 510(k) Submission Information: | |
|---|---|
| Device Manufacturer: | Dade Behring Inc. |
| Contact name: | Maureen Mende, Group Manager Regulatory Affairs |
| Fax: | 916-374-3144 |
| Date prepared: | February 13, 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: Piperacillin/Tazobactam |
| 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 determing MicroScan® rapLDS plus™ Gram-Negative This. Contines grown on solid media of rapidly of rapidly quantiative and facultative anaerobic gram-sacive bacilli. The MicroScan® rapIDS plas™ rapIDS plas™ Gramgrowing aerobic and facultative anaerobic graili-ligative basin. The University of System or equivalent (upgraded WalkAway® 40 or WalkAway® 96 instruments).
The antimicrobial susceptibility tests are miniaturizations susceptibility tost that have The antimicrobial susceptibility tests are inninatinations bridging in clinical interest and are been diluted in Mueller-Himon Broun to concentuations of the coulded and rehydrated with a presented in micro-titer wells in arred form. Tapines at 350 in the Walks ways System or equivalent standardized suspension of the organism and included at 35 ° In the was any was and one of the lowest antimicrobial concentration showing inhibition of growth.
The proposed MicroScan® rapID/S plus™ Gram-Negative MIC/Combo Panel demonstratled substantially The proposed MicroScan® Tapp273 plus - Gran-Negarro Parel, as defined in the FDA
equivalent performance with an NCCLS frozen Referice ration Successibility Davices" equivalent performance when compared with an Assessment of Animisrobial Susceptibility Devices", DRAFT document Culture on Review Citieria 10 110[k]) presents data in support of the MicroScan® dated March '6, 2000. - The Premient with Piperacillin/Tazobactam.
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 rapIDS plis" Grain The external evaluations were designed to commit the acceptabling on area. Challenge stains Negative Panel by companies with an to evelopment. The rapIDS plus™ CrapIDS plus™ Cram-Negative were compared to Frozel Results determined prof to the overall Essential Agreement of greater than 94 % for I and demonstrator associated with the frozen Reference panel.
testing demonstrated acceptable reproducibility and precision with Instrument reproducibility Instrument reproductioning testing includio preparation method and the WalkAway® SI System or r perachin ruzobucture walkAway® 40 or WalkAway® 96 instruments).
Quality Control testing demonstrated acceptable results for Piperacillin/Tazobactam.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. 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 human figure with outstretched arms. The figure is made up of three curved lines that resemble a bird in flight.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP 1 4 2004
Mr. Robert Eusebio Manager Regulatory Affairs Dade MicroScan, Inc. 1584 Enterprise Boulevard West Sacramento, CA 95691
Re: K020511
Trade/Device Name: MicroScan® Synergies Plus Gram Negative MIC/Combo Panels with Piperacillin/Tazobactam (1/4, 4/4 - 256/4 ug/ml) -Regulation Number: 21 CFR 866.1645 Regulation Name: Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility System Regulatory Class: II Product Code: LON Dated: February 13, 2002 Received: February 15, 2002
Dear Mr. Eusebio:
This letter corrects our substantially equivalent letter of March 6, 2002, 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 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 (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.
2
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 Poole
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
3
Indications for Use Statement
510(k) Number (if known): K020511
Device Name: MicroScan® Synergies plus™ Gram-Negative MIC/Combo Panels with Piperacillin/Tazobactam (1/4, 4/4 - 256/4 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 (upgraded WalkAway® 40 or WalkAway® 96) according to the Package Insert.
This particular submission is for the antimicrobial Piperacillin/Tazobactam on the Synergies plus" Gram-Negative MIC/Combo Panels.
The Gram-Negative organisms which may be used for Piperacillin/Tazobactam susceptibility testing in this panel are:
Escherichia coli (Piperacillin-resistant, ß-lactamase producing) Klebsiella oxytoca Klebsiella pneumoniae Morganella morganii Proteus mirabilis Proteus vulgaris Pseudomonas aeruginosa Serratia spp.
The MicroScan® Synergies plus™ Gram-Negative with Piperacillin/Tazobactam is not intended for use with:
Acinetobacter spp. Citrobacter spp. Enterobacter spp
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)
freddin M. Poole
Sision Sign-Off
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
Office of In Vitro Diagnostic Device Evaluation and Safely
510(k) K020511