(56 days)
LRG, JWY, LTT, LTW
Not Found
No
The description focuses on traditional broth dilution susceptibility testing and visual or instrument-assisted reading of growth inhibition, with no mention of AI or ML algorithms for interpretation or analysis.
No.
This device is designed to determine antimicrobial susceptibility of microorganisms, which is a diagnostic function, not a therapeutic one. It provides information about which antibiotics might be effective, but it does not directly treat or alleviate a disease.
Yes
The device determines antimicrobial agent susceptibility, which is a diagnostic function used to guide treatment decisions for bacterial infections.
No
The device is a physical panel containing dried antimicrobial agents used for susceptibility testing, which is a hardware component. While it can be read with MicroScan instrumentation (which likely involves software), the core device itself is not software-only.
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 bacterial colonies. This is a diagnostic test performed in vitro (outside the body) on a biological sample (bacterial colonies).
- Device Description: The description further elaborates on the process, which involves rehydrating dehydrated antimicrobial susceptibility tests with a standardized suspension of the organism and then reading the minimum inhibitory concentration (MIC). This is a standard method for in vitro diagnostic testing in microbiology.
- Performance Studies: The performance studies compare the device's performance to a reference panel, which is typical for validating an IVD device.
- Predicate Device: The predicate device listed is also described as "MIC/Combo Panels," which are commonly used for in vitro diagnostic susceptibility testing.
The entire context of the document describes a device used to perform a diagnostic test on a biological sample in a laboratory setting, which aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The MicroScan® Dried Gram-Positive 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-positive cocci. After inoculation, panels are incubated for 16 - 20 hours at 35°C +/- 1°C in a non-CO2 incubator, and read either visually or with MicroScan instrumentation, according to the Package Insert.
This particular submission is for the addition of the antimicrobial Daptomycin at concentrations of 0.03 to 16 mcg/ml to the test panel.
The gram-positive organisms which may be used for Daptomycin susceptibility testing in this panel are:
- Enterococcus faecalis (vancomycin-susceptible and resistant strains)
- Enterococcus faecium (including vancomycin-resistant strains)
- Staphylococcus aureus (including methicillin-resistant strains)
- Staphylococcus epidermidis (including methicillin-resistant strains)
- Staphylococus haemolyticus
- Streptococcus agalactiae
Product codes
LRG, JWY, LTT, LTW
Device Description
MicroScan® Dried Gram-Positive 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-positive cocci.
The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test that have been diluted in broth and dehydrated. Various antimicrobial agents are diluted in broth to concentrations bridging the range of clinical interest. Panels are rehydrated with water after inoculation with a standardized suspension of the organism. After incubation in a non-CO2 incubator for 16-20 hours, the minimum inhibitory concentration (MIC) for the test organism is read by determining 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 Dried Gram-Positive 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® Dried Gram-Positive MIC/Combo Panel demonstrated substantially equivalent performance when compared with an NCCLS frozen Reference Panel, as defined in the FDA document "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA'', dated February 5, 2003. The Premarket Notification (510[k]) presents data in support of the MicroScan® Dried Gram-Positive MIC/Combo Panel with Daptomycin.
The Dried Gram-Positive Panel demonstrated acceptable performance with an overall Essential Agreement of >97% for Daptomycin when compared with the frozen Reference panel.
Inoculum and instrument reproducibility testing demonstrated acceptable reproducibility and precision with Daptomycin, regardless of which inoculum method (i.e., Turbidity and Prompt), or instrument (autoSCAN-48 and WalkAway®) was used.
Quality Control testing demonstrated acceptable results for Daptomycin.
Key Metrics
Essential Agreement of >97% for Daptomycin
Predicate Device(s)
MicroScan Dried Gram-Positive and Gram-Negative MIC/Combo Panels
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.1640 Antimicrobial susceptibility test powder.
(a)
Identification. An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.(b)
Classification. Class II (performance standards).
0
1043545
FEB 17 2005
510(k) Summary
510(k) Submission Information:
| Device Manufacturer: | Dade Behring, Inc. |
|---|---|
| Contact name: | Cynthia Van Duker, Regulatory Affairs Manager |
| Fax: | 916-374-3144 |
| Date prepared: | December 17, 2004 |
| Product Name: | Microdilution Minimum Inhibitory Concentration (MIC) Panels |
| Trade Name: | MicroScan® Dried Gram-Positive MIC/Combo Panels |
| Intended Use: | To determine antimicrobial agent susceptibility |
| 510(k) Notification: | New antimicrobial - Daptomycin |
| Predicate device: | MicroScan Dried Gram-Positive and Gram-Negative MIC/Combo Panels |
510(k) Summary:
MicroScan® Dried Gram-Positive 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-positive cocci.
The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test that have been diluted in broth and dehydrated. Various antimicrobial agents are diluted in broth to concentrations bridging the range of clinical interest. Panels are rehydrated with water after inoculation with a standardized suspension of the organism. After incubation in a non-CO2 incubator for 16-20 hours, the minimum inhibitory concentration (MIC) for the test organism is read by determining the lowest antimicrobial concentration showing inhibition of growth.
The proposed MicroScan® Dried Gram-Positive MIC/Combo Panel demonstrated substantially equivalent performance when compared with an NCCLS frozen Reference Panel, as defined in the FDA document "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA'', dated February 5, 2003. The Premarket Notification (510[k]) presents data in support of the MicroScan® Dried Gram-Positive MIC/Combo Panel with Daptomycin.
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 Dried Gram-Positive Panel by comparing its performance with an NCCLS frozen Reference panel. Challenge strains were compared to Expected Results determined prior to the evaluation. The Dried Gram-Positive Panel demonstrated acceptable performance with an overall Essential Agreement of >97% for Daptomycin when compared with the frozen Reference panel.
Inoculum and instrument reproducibility testing demonstrated acceptable reproducibility and precision with Daptomycin, regardless of which inoculum method (i.e., Turbidity and Prompt), or instrument (autoSCAN-48 and WalkAway®) was used.
Quality Control testing demonstrated acceptable results for Daptomycin.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three arms, representing the department's mission to protect the health of all Americans and provide essential human services. The figure is positioned to the right of the department's name, which is arranged in a circular pattern around the figure. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB 1 7 2005
Ms. Cynthia Van Duker Regulatory Affairs Manager Dade Behring, Inc. 1584 Enterprise Blvd. West Sacramento, CA 95691
K043545 Re:
Trade/Device Name: MicroScan® Dried Gram-Positive MIC/Combo Panels with Daptomycin (0.03 - 16 mcg/ml) Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: Class II Product Code: LRG, JWY, LTT, LTW Dated: December 17, 2004 Received: January 4, 2005
Dear Ms. Van Duker:
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 application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, aterest 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 such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r reaso or as 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Salazar
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
3
Indications for Use
510(k) Number (if known): K 043543 ك
Device Name: MicroScan® Dried Gram-Positive MIC/Combo Panels with Daptomycin (0.03 - 16 mcg/ml)
Indications For Use:
The MicroScan® Dried Gram-Positive 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-positive cocci. After inoculation, panels are incubated for 16 - 20 hours at 35°C +/- 1°C in a non-CO2 incubator, and read either visually or with MicroScan instrumentation, according to the Package Insert.
This particular submission is for the addition of the antimicrobial Daptomycin at concentrations of 0.03 to 16 mcg/ml to the test panel.
The gram-positive organisms which may be used for Daptomycin susceptibility testing in this panel are:
Enterococcus faecalis (vancomycin-susceptible and resistant strains) Enterococcus faecium (including vancomycin-resistant strains) Staphylococcus aureus (including methicillin-resistant strains) Staphylococcus epidermidis (including methicillin-resistant strains) Staphylococus haemolyticus Streptococcus agalactiae
Prescription Use J (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)
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510(k) K043545