(43 days)
MicroScan Dried Gram-Positive and Gram-Negative MIC/Combo Panels
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No
The summary describes a traditional broth dilution susceptibility test panel and its performance compared to a reference method. There is no mention of AI or ML in the device description, intended use, or performance studies. The "MicroScan instrumentation" mentioned is likely an automated reader for the panel, not an AI/ML-driven system.
No.
The device determines antimicrobial susceptibility of microorganisms, which aids in diagnostic decisions, but it does not directly treat or prevent a disease or condition in a patient.
Yes
The device 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," which directly supports and informs clinical diagnosis and treatment decisions by identifying effective antibiotics.
No
The device description clearly indicates it is a physical panel with dehydrated antimicrobial agents used in a laboratory setting, requiring incubation and either visual or instrument-based reading. This is a hardware-based device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is explicitly stated to be 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." This is a classic definition of an in vitro diagnostic test, as it is performed on a sample (bacterial colonies) taken from the body (or grown from a sample taken from the body) to provide information about a medical condition (susceptibility to antibiotics).
- Device Description: The description further clarifies that the tests are "miniaturizations of the broth dilution susceptibility test," which is a standard laboratory method for determining antibiotic susceptibility. This reinforces its use in a laboratory setting for diagnostic purposes.
- Performance Studies: The performance studies compare the device's performance to a "CLSI frozen Reference panel," which is a standard reference method used in clinical microbiology laboratories for AST. This comparison is typical for validating an IVD device.
- Predicate Device: The mention of "MicroScan Dried Gram-Positive and Gram-Negative MIC/Combo Panels" as predicate devices further indicates that this device falls within the category of AST systems, which are regulated as IVDs.
Therefore, based on the provided information, the MicroScan® Dried Gram-Positive MIC/Combo Panel is clearly 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 - 24 hours at 35℃ +/- 1℃ in a non-CO2 incubator. Results are read either visually or with MicroScan instrumentation, according to the Package Insert.
This particular submission is for the addition of the antimicrobial vancomycin at concentrations of 0.25 to 128 mcg/ml to the test panel.
The gram-positive organisms which may be used for vancomycin susceptibility testing in this panel are:
Enterococcus spp. (e.g., Enterococcus faecalis) Staphylococcus spp. (including Staphylococcus aureus) Staphylococcus epidermidis (including methicillin-resistant strains) Streptococcus agalactiae Streptococcus bovis
Product codes (comma separated list FDA assigned to the subject device)
JWY, LRG, LTW, LTY
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 16-24 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
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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 Dried Gram-Positive Panel by comparing its performance with a CLSI 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® Dried Gram-Positive MIC/Combo Panel demonstrated substantially equivalent performance when compared with a CLSI (formerly 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 vancomycin.
The external evaluation demonstrated acceptable performance with an overall Essential Agreement of >99% for vancomycin when compared with the frozen Reference panel.
Inoculum and instrument reproducibility testing demonstrated acceptable reproducibility and precision with vancomycin, regardless of which inoculum method (i.e., Turbidity and Prompt), or instrument (autoSCAN-46 and WalkAway®) was used.
Quality Control testing demonstrated acceptable results for vancomycin.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Essential Agreement of >99% for vancomycin.
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-Positive and 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
§ 866.1640 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
Kos/202
JUN 2 3 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: | May 10, 2005 |
| 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 - Vancomycin |
| Predicate device: | MicroScan Dried Gram-Positive and Gram-Negative MIC/Combo Panels |
510(k) Summarv:
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 16-24 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 a CLSI (formerly 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 vancomycin.
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 a CLSI 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 >99% for vancomycin when compared with the frozen Reference panel.
Inoculum and instrument reproducibility testing demonstrated acceptable reproducibility and precision with vancomycin, regardless of which inoculum method (i.e., Turbidity and Prompt), or instrument (autoSCAN-46 and WalkAway®) was used.
Quality Control testing demonstrated acceptable results for vancomycin.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the symbol.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 2 3 2005
Ms. Cynthia Van Duker Regulatory Affairs Manager Dade Behring Inc. 1584 Enterprise Boulevard West Sacramento, CA 95691-9972
K051202 Re: -
K051202
Trade/Device Name: MicroScan® Dried Gram-Positive MIC/Combo Panels with Vancomycin (0.25 -- 128 mcg/ml) Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: Class II Product Code: JWY, LRG, LTW, LTY Dated: May 10, 2005 Received: May 18, 2005
Dear Ms. Van Duker:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have teviewed your becamed the device is substantially equivalent (for the indications felerenced above and nave acterimes ally marketed predicate devices marketed in interstate for use stated in the encreate) to regars and the Medical Device Amendments, or to conniteres pror to May 20, 2017, 12:17 accordance with the provisions of the Federal Food, Drug, devices that have been rechasined in asse approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The 1 ou may, therefore, market the act include requirements for annual registration, listing of general controls provisions 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 If your device is classified (600 a00 ro) als. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations a may be subject to subject to such additions (CFR), Parts 800 to 895. In addition, FDA be found in Trite letter announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r least of advised that I Drisonation that your device complies with other requirements of the Act that I DA has made a associations administered by other Federal agencies. You must or any rederal statutes and regations and with the limited to: registration and listing (21 Comply with and the Hos (21 CFR Parts 801 and 809); and good manufacturing practice CI K Fart 807), laboring (QS) regulation (QS) regulation (21 CFR Part 820).
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Page 2 -
This letter will allow you to begin marketing your device as described in your Section 5 10(k) I his letter will anow you to obgin marketing your marketing your device to a legally premarket notification: "The PDF Intentig sification 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, of by If you desire specific information acourtising of your device, please contact the Office of In
or questions on the promotion and advertising of your device, the colors and th of questions on the promotion and Safety at (240)276-0484. Also, please note the Vill Diagnosite Device Device in and the market notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the You may of and Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address (000)/www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Sales, a Hoy
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
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Indications for Use
510(k) Number (if known):_KOS (202
Device Name: MicroScan® Dried Gram-Positive MIC/Combo Panels with Vancomycin (0.25 = 128 mcg/ml)
Indications For Use:
The MicroScan® Dried Gram-Positive MIC/Combo Panel is used to determine The MiteroBour - 2 Walitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-positive on sond moculation, panels are incubated for 16 - 24 hours at 35℃ +/- 1℃ in a coool. I treer moreansed partier visually or with MicroScan instrumentation, according to the Package Insert.
This particular submission is for the addition of the antimicrobial vancomycin at concentrations of 0.25 to 128 mcg/ml to the test panel.
The gram-positive organisms which may be used for vancomycin susceptibility testing in this panel are:
Enterococcus spp. (e.g., Enterococcus faecalis) Staphylococcus spp. (including Staphylococcus aureus) Staphylococcus epidermidis (including methicillin-resistant strains) Streptococcus agalactiae Streptococcus bovis
Prescription Use _ _ Sc (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)
Ludolui he. Paole
ivision Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
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510(k) K051202
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