(160 days)
Not Found (no K/DEN number is provided for the predicate device)
Not Found
No
The description focuses on a traditional broth dilution susceptibility test read by an automated system, with no mention of AI/ML for interpretation or analysis.
No.
This device is an in vitro diagnostic (IVD) test that determines the susceptibility of bacteria to antimicrobial agents, providing information for treatment but not directly performing therapy.
Yes
This device is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of bacterial colonies, which directly aids in diagnosing the appropriate treatment for infections.
No
The device is a physical panel containing dried antimicrobial agents used for in vitro diagnostic testing. While it is read by an instrument (WalkAway® SI System), the core device being submitted is the physical panel itself, not software.
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 the antimicrobial agent susceptibility of bacterial colonies grown on solid media. This is a classic definition of an in vitro diagnostic test, as it involves testing biological samples (bacterial colonies) outside of the body to provide information about a patient's condition (in this case, how susceptible the bacteria causing an infection are to certain antibiotics).
- Device Description: The description further clarifies that the device is a miniaturization of the broth dilution susceptibility test, which is a standard laboratory method for determining antimicrobial susceptibility. This reinforces its role as a diagnostic tool used in a laboratory setting.
- Testing of Biological Samples: The device is designed to be inoculated with a suspension of the organism (bacteria), which is a biological sample.
- Providing Diagnostic Information: The output of the device is the minimum inhibitory concentration (MIC) or qualitative susceptibility results, which are used by healthcare professionals to guide treatment decisions for patients with bacterial infections. This information is directly relevant to diagnosing and managing a patient's condition.
Therefore, based on the provided information, the MicroScan® Synergies plus™ Gram-Negative MIC/Combo Panel, including the Ceftazidime component, clearly fits 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 Ceftazidime on the Synergies plus™ Gram-Negative MIC/Combo Panels.
The Gram-Negative organisms which may be used for Ceftazidime susceptibility testing in this panel are:
Citrobacter spp Escherichia coli Enterobacter spp (excluding Enterobacter cloacae) Klebsiella spp Proteus spo Pseudomonas spp Serratia spp
The MicroScan® Synergies plus™ Gram-Negative Ceftazidime is not intended for use with:
Enterobacter cloacae
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® S7 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 Premarket Notification (510[k]) presents data in support of the MicroScan® rapID/S plus™ Gram-Negative MIC/Combo Panel Ceftazidime.
The rapID/S plus™ Gram-Negative Panel demonstrated acceptable performance with an overall Essential Agreement of greater than 96% for Ceftazidime when compared with the frozen Reference panel.
Instrument reproducibility testing demonstrated acceptable reproducibility and precision with Ceftazidime with Turbidity inoculum preparation method and the WalkAway® S! System or equivalent (upgraded WalkAway® 40 or WalkAway® 96 instruments).
Quality Control testing demonstrated acceptable results for Ceftazidime.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Essential Agreement of greater than 96% for Ceftazidime
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.
Not Found
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).
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing protection and care.
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
Re: K020413 Trade/Device Name: MicroScan® Synergies plus™ Dried Gram-Negative MIC/Combo Panels with Ceftazidime (1-16 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 July 17, 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,
Luddiitu. 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): K020413
MicroScan® Synergies plus™ Gram-Negative MIC/Combo Panels with Ceftazidime Device Name: (1 - 16 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 Ceftazidime on the Synergies plus™ Gram-Negative MIC/Combo Panels.
The Gram-Negative organisms which may be used for Ceftazidime susceptibility testing in this panel are:
Citrobacter spp Escherichia coli Enterobacter spp (excluding Enterobacter cloacae) Klebsiella spp Proteus spo Pseudomonas spp Serratia spp
The MicroScan® Synergies plus™ Gram-Negative Ceftazidime is not intended for use with:
Enterobacter cloacae
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)
Luella Poole
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
Page 1 of __ 1
510(k) 020413
3
K0204/13
JUL 1 7 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: | February 6, 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: Ceftazidime |
| 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® S7 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 Ceftazidime.
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 96% for Ceftazidime when compared with the frozen Reference panel.
Instrument reproducibility testing demonstrated acceptable reproducibility and precision with Ceftazidime with Turbidity inoculum preparation method and the WalkAway® S! System or equivalent (upgraded WalkAway® 40 or WalkAway® 96 instruments).
Quality Control testing demonstrated acceptable results for Ceftazidime.