(49 days)
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No
The summary describes a standard antimicrobial susceptibility testing panel and automated reading system based on broth dilution and growth inhibition, with no mention of AI or ML.
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 cure a disease itself.
Yes
The device is used to determine antimicrobial agent susceptibility, specifically the minimum inhibitory concentration (MIC) of various Gram-Negative bacilli to Trimethoprim/Sulfamethoxazole. This information is crucial for guiding treatment decisions, which is a diagnostic purpose.
No
The device description clearly states that the device is a physical panel containing dried antimicrobial agents in micro-titer wells, which is inoculated with a suspension and incubated. This is a hardware component.
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 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 on a biological sample (bacterial colonies) to provide information about a patient's potential response to antimicrobial treatment.
- Device Description: The description details a "miniaturization of the broth dilution susceptibility test" which is a standard laboratory method for determining the minimum inhibitory concentration (MIC) of an antimicrobial agent against a microorganism. This process is performed in vitro (outside the body).
- Performance Studies: The performance studies compare the device's performance to a "NCCLS frozen Reference panel," which is a common practice for validating the accuracy and reliability of IVD devices used in clinical microbiology.
The device is designed to be used in a laboratory setting to analyze a biological sample (bacterial culture) and provide diagnostic information relevant to patient care (antimicrobial susceptibility). 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 Microboun - Bynergios prac - etimicrobial 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 (Enerobution, 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 Trimethoprim/Sulfamethoxazole on the Synergies plus™ Gram-Negative MIC/Combo Panels.
The Gram-Negative organisms which may be used for Trimethoprim/Sulfamethoxazole susceptibility testing in this panel are:
Escherichia coli
Enterobacter spp
Klebsiella spp
Proteus spo
Shigella flexneri
Shigella sonnei
The MicroScan® Synergies plus™ Gram-Negative with Trimethoprim/Sulfamethoxazole is not intended for use with:
P. 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 ™ Cram-Negative MIC/Combo Panels are read on the WalkAway 57 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 with a standardized suspension of the organism and incubated at 35℃ in the WalkAway® SI 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 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
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 97.5% for Trimethoprim/Sulfamethoxazole when compared with the frozen Reference panel.
Instrument reproducibility testing demonstrated acceptable reproducibility and precision with Trimethoprim/Sulfamethoxazole with Turbidity inoculum preparation method and the WalkAway® System or equivalent (upgraded WalkAway® 40 or WalkAway® 96 instruments). Quality Control testing demonstrated acceptable results for Trimethoprim/Sulfamethoxazole.
Key Metrics
Essential Agreement of 97.5%
Predicate Device(s)
MicroScan Dried Gram Negative MIC/Combo Panels
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus-like symbol with three curved lines representing the department's mission of promoting health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the symbol.
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
K020248 Re: Trade/Device Name: MicroScan® Synergies plus™ Gram-Negative MIC/Combo Panels with Trimethoprim/ Sulfamethoxazole (0.25/4.75- 64/1216 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 March 14, 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, al (301) of 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/dsmadsmamain.html.
Sincerely yours,
Luddiu. Roofe for
ly A. Hojvat, M.Sc., 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): K020248
Device Name: MicroScan® Synergies plus™ Gram-Negative MIC/Combo Panels with Trimethoprim/Sulfamethoxazole (0.25/4.75 - 64/1216 ug/ml)
Indications For Use:
MicroScan® Synergies plus™ Gram-Negative MIC/Combo Panel is used to determine Microboun - Bynergios prac - etimicrobial 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 (Enerobution, 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 Trimethoprim/Sulfamethoxazole on the Synergies plus™ Gram-Negative MIC/Combo Panels.
The Gram-Negative organisms which may be used for Trimethoprim/Sulfamethoxazole susceptibility testing in this panel are:
Escherichia coli Enterobacter spp Klebsiella spp Proteus spo Shigella flexneri Shigella sonnei
The MicroScan® Synergies plus™ Gram-Negative with Trimethoprim/Sulfamethoxazole is not intended for use with:
P. aeruginosa
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)
Division Sign-Off
Page 1 of _ 1
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) 020248
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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) Panels |
| Trade Name: | MicroScan® rapID/S plus™ Gram-Negative MIC/Combo panels |
| Intended Use: | To determine antimicrobial agent susceptibility |
| 510(k) Notification: | Antimicrobials: Trimethoprim/Sulfamethoxazole |
| 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 ™ Cram-Negative MIC/Combo Panels are read on the WalkAway 57 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 with a standardized suspension of the organism and incubated at 35℃ in the WalkAway® SI 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 Trimethoprim/Sulfamethoxazole.
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 97.5% for Trimethoprim/Sulfamethoxazole when compared with the frozen Reference panel.
Instrument reproducibility testing demonstrated acceptable reproducibility and precision with Trimethoprim/Sulfamethoxazole with Turbidity inoculum preparation method and the WalkAway® System or equivalent (upgraded WalkAway® 40 or WalkAway® 96 instruments).
Quality Control testing demonstrated acceptable results for Trimethoprim/Sulfamethoxazole.