(99 days)
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NCCLS frozen Reference panel
No
The document describes a traditional broth dilution susceptibility test read by an automated instrument. There is no mention of AI or ML in the device description, intended use, or performance studies. The performance evaluation compares the device to a reference panel, which is a standard method for validating traditional susceptibility testing devices.
No
This device is an in-vitro diagnostic (IVD) device used to determine antimicrobial susceptibility, which informs treatment decisions but does not directly treat a patient.
Yes
Explanation: The device, the MicroScan® Synergies plus™ Gram-Negative MIC/Combo Panel, is explicitly stated to be used to "determine quantitative and/or qualitative antimicrobial agent susceptibility" of bacterial colonies. This process of identifying the susceptibility of an organism to an antimicrobial agent is a diagnostic test, as it provides information crucial for guiding treatment decisions.
No
The device description explicitly mentions physical components like "micro-titer wells in dried form" and the need for incubation and reading on the "WalkAway® SI System or equivalent," indicating it is a hardware-based system with associated software, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is used to determine the antimicrobial susceptibility of bacterial colonies grown on solid media. This is a test performed in vitro (outside the body) on a biological sample (bacterial colonies).
- Device Description: It describes a miniaturized broth dilution susceptibility test presented in micro-titer wells. This is a common format for in vitro diagnostic tests.
- Performance Studies: The performance studies compare the device's results to a reference panel, which is typical for validating an in vitro diagnostic device.
- Predicate Device: The predicate device is also described as "MicroScan Dried Gram Negative MIC/Combo Panels," which are clearly IVD devices used for susceptibility testing.
The core function of the device is to analyze a biological sample (bacterial growth) in vitro to provide information about its characteristics (susceptibility to antimicrobial agents), which is 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 Ampicillin on the Synergies plus" Gram-Negative MIC/Combo Panels.
The Gram-Negative organisms which may be used for Ampicillin susceptibility testing in this panel are:
Escherichia coli Salmonella spp.
The MicroScan® Synergies plus™ Gram-Negative with Ampicillin is not intended for use with:
Citrobacter spp. Enterobacter spp. Klebsiella spp. Providencia spp. Proteus mirabilis Proteus vulgaris Shigella spp.
Product codes (comma separated list FDA assigned to the subject device)
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 SI 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® 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
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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™ Cram-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 Premarket Notification (510[k]) presents data in support of the MicroScan® rapID/S plus™ Gram-Negative MIC/Combo Panel with Ampicillin.
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™ Cram-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 97.6% for Ampicillin when compared with the frozen Reference panel.
Instrument reproducibility testing demonstrated acceptable reproducibility and precision with Turbidity inoculum preparation method and the WalkAway S7 System or equivalent (upgraded WalkAway 40 or WalkAway® 96 instruments).
Quality Control testing demonstrated acceptable results for Ampicillin.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Essential Agreement of 97.6% for Ampicillin
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
MicroScan Dried Gram Negative MIC/Combo Panels
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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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).
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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.”
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with its head turned to the left. The eagle is composed of three curved lines that form its head, body, and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Public Health Service
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
K020398 Re: Trade/Device Name: MicroScan® Synergies plus™ Gram-Negative MIC/Combo Panels with Ampicillin (0.25- 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 May 16, 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/dsmadsmamain.html.
Sincerely yours,
Freddi tu. Pode
for
Sally 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): K020398
Device Name: MicroScan® Synergies plus" Gram-Negative MIC/Combo Panels with Ampicillin (0.25 - 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 Ampicillin on the Synergies plus" Gram-Negative MIC/Combo Panels.
The Gram-Negative organisms which may be used for Ampicillin susceptibility testing in this panel are:
Escherichia coli Salmonella spp.
The MicroScan® Synergies plus™ Gram-Negative with Ampicillin is not intended for use with:
Citrobacter spp. Enterobacter spp. Klebsiella spp. Providencia spp. Proteus mirabilis Proteus vulgaris 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)
Ludwita. Pool
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
Page 1 of _ 1
510(k) 020398
3
MAY 1 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: | May 14, 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: Ampicillin |
| 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 SI 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® 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 with Ampicillin.
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™ Cram-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 97.6% for Ampicillin when compared with the frozen Reference panel.
Instrument reproducibility testing demonstrated acceptable reproducibility and precision with Turbidity inoculum preparation method and the WalkAway S7 System or equivalent (upgraded WalkAway 40 or WalkAway® 96 instruments).
Quality Control testing demonstrated acceptable results for Ampicillin.