(20 days)
Not Found
No
The summary describes a traditional broth dilution susceptibility test read by an automated instrument, with no mention of AI or ML in the device description, performance studies, or key metrics.
No.
This device is used to determine antimicrobial agent susceptibility, not to treat a condition or disease.
Yes
The device is used to determine the antimicrobial susceptibility of Gram-Negative bacilli, which aids in diagnosing the effectiveness of antibiotics against specific bacterial infections, thus providing diagnostic information for treatment decisions.
No
The device description explicitly states that the panels are read on the WalkAway® SI System or equivalent instruments, which are hardware components. The submission is for a specific antimicrobial agent used with these panels and instruments, not for a standalone software application.
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 the antimicrobial agent susceptibility of bacterial colonies grown on solid media. 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 is a miniaturization of the broth dilution susceptibility test, which is a standard in vitro method for determining antimicrobial susceptibility.
- Performance Studies: The performance studies describe evaluating the device's performance against a reference panel, which is typical for validating an IVD.
- Predicate Device: The mention of a predicate device (MicroScan Dried Gram Negative MIC/Combo Panels) which is also an IVD, further supports the classification of this device as an IVD.
The device is used to analyze a biological sample (bacterial colonies) in vitro to provide information about the susceptibility of those bacteria to antimicrobial agents, which is a key characteristic 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 Tetracycline on the Synergies plus** Gram-Negative MIC/Combo Panels.
The Gram-Negative organisms which may be used for Tetracycline susceptibility testing in this panel are:
Acinetobacter calcoaceticus
Acinetobacter spp
Escherichia coli
Enterobacter aerogenes
Klebsiella oxytoca
Klebsiella ozaenae
Klebsiella pneumoniae
Klebsiella rhinoscleromatis
Klebsiella spp
Shigella flexneri
Shigella sonnei
Shigella spp
Product codes
LON
Device Description
MicroScan® rapID/S plus™ Gram-Negative MIC/Combo Panels are designed for use in eteterming quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing and facultative anaerobic gram-negative bacilli. The MicroScan® rapID/S play® 40 growing aeroon: and faculiative androone grain negative occessed or equivalent (upgraded WalkAway® 40 or WalkAway® 96 instruments).
The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test that have The antimicrobial susceptionity tests are inimations bridging the range of clinical interest and are been unders in micro-titer wells in dried form. rapID/S plus™ panels are inoculated with a standardized suspension of the organism and incubated at 35°C in the WalkAway® SI System or equivalent standardized suspension of the organism and measuration (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-The extential evaluations were tessgired to commit an NCCLS frozen Reference panel. CCCallenge strains Negative Pater by Companie to performation with the evaluation.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The rapID/S plus™ of the September Were compared to Expected Nesults dolernment prior of any essential Agreement of 92.7% for Tetracycline when compared with the frozen Reference panel.
Instrument reproducibility testing demonstrated acceptable reproducibility and precision with Tetracycline 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 Tetracycline.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Essential Agreement of 92.7% for Tetracycline
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
Image /page/0/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is a stylized caduceus, which is a symbol of medicine. The caduceus is made up of three intertwined snakes and a staff.
AUG 3 0 2004
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Robert Eusebio Manager Regulatory Affairs Dade MicroScan, Inc. 1584 Enterprise Boulevard West Sacramento, CA 95691
Re: K020173 Trade/Device Name: MicroScan® Synergies plus™ Gram-Negative MIC/Combo Panels with Tetracycline (0.12-128 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 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.
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,
Leedsville Road
Astin 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
2
Indications for Use Statement
510(k) Number (if known): K020173
MicroScan® Synergies plus™ Gram-Negative MIC/Combo Panels with Tetracycline Device Name: (0.12-128 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® SI System or equivalent (upgraded WalkAway® 40 or WalkAway® 96) according to the Package Insert.
This particular submission is for the antimicrobial Tetracycline on the Synergies plus** Gram-Negative MIC/Combo Panels.
The Gram-Negative organisms which may be used for Tetracycline susceptibility testing in this panel are:
Acinetobacter calcoaceticus Acinetobacter spp Escherichia coli Enterobacter aerogenes Klebsiella oxytoca Klebsiella ozaenae Klebsiella pneumoniae Klebsiella rhinoscleromatis Klebsiella spp Shigella flexneri Shigella sonnei Shigella 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)
Freddie L. Pooly
vision Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
Page 1 of _ 1
510(k) 020 173
3
K020173
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 15, 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: Tetracycline |
| 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 eteterming quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing and facultative anaerobic gram-negative bacilli. The MicroScan® rapID/S play® 40 growing aeroon: and faculiative androone grain negative occessed or equivalent (upgraded WalkAway® 40 or WalkAway® 96 instruments).
The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test that have The antimicrobial susceptionity tests are inimations bridging the range of clinical interest and are been unders in micro-titer wells in dried form. rapID/S plus™ panels are inoculated with a standardized suspension of the organism and incubated at 35°C in the WalkAway® SI System or equivalent standardized suspension of the organism and measuration (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 The proposed MRTOSCall TaptDib Pras - One Negal Reference Panel, as defined in the FDA DRAFT document "Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices", DRAPT Uccument Ourlance on Reviow Criceation (510[k]) presents data in support of the MicroScan® rapID/S plus™ Gram-Negative MIC/Combo Panel Tetracycline.
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-The extential evaluations were tessgired to commit an NCCLS frozen Reference panel. CCCallenge strains Negative Pater by Companie to performation with the evaluation. The rapID/S plus™ of the September Were compared to Expected Nesults dolernment prior of any essential Agreement of 92.7% for Tetracycline when compared with the frozen Reference panel.
Instrument reproducibility testing demonstrated acceptable reproducibility and precision with Tetracycline 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 Tetracycline.