(56 days)
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
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.
Here's a summary of the acceptance criteria and study details for the MicroScan® Dried Gram-Positive MIC/Combo Panels with Daptomycin, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Overall Essential Agreement with NCCLS frozen Reference Panel | >97% for Daptomycin |
| Reproducibility for Daptomycin (all inoculum methods and instruments) | Acceptable |
| Quality Control testing for Daptomycin | Acceptable |
Study Details
-
Sample Sizes and Data Provenance:
- Test Set:
- Clinical Isolates: "fresh and stock Efficacy isolates"
- Challenge Strains: "stock Challenge strains"
- The specific number of isolates/strains is not provided, only the categories.
- Data Provenance: Not explicitly stated, but clinical isolates often come from various clinical sites (implicitly retrospective as 'stock' or 'fresh' isolates) for such studies. Challenge strains are typically laboratory-derived.
- Test Set:
-
Number of Experts and Qualifications for Ground Truth (Test Set):
- External Evaluation: The study was an "external evaluation," implying independent assessment.
- Ground Truth Determination: Comparison was made against an "NCCLS frozen Reference panel" and "Expected Results determined prior to the evaluation" for challenge strains. No specific number or qualifications of experts involved in establishing the NCCLS reference or "expected results" are detailed in this summary, but these are standard reference methods in microbiology.
-
Adjudication Method (Test Set):
- Not explicitly stated. The comparison was primarily against a reference panel and predetermined expected results.
-
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No MRMC comparative effectiveness study involving human readers and AI assistance was mentioned. This device is an automated antimicrobial susceptibility testing system, not an image-based diagnostic intended for human interpretation with or without AI augmentation.
-
Standalone Performance (Algorithm Only):
- Yes, this was a standalone performance study. The "MicroScan® Dried Gram-Positive MIC/Combo Panel" itself is the device being evaluated for its ability to determine MICs compared to a reference standard. The results are read either "visually or with MicroScan instrumentation." The reported performance of ">97% essential agreement" refers to the device's accuracy in producing results.
-
Type of Ground Truth Used:
- Reference Standard: NCCLS frozen Reference Panel. NCCLS (now CLSI) reference panels are accepted gold standards for antimicrobial susceptibility testing, representing expert consensus on methodology and expected results for known strains.
- Predetermined Expected Results: For Challenge strains, results were compared to "Expected Results determined prior to the evaluation," which would have been established using a defined reference method.
-
Sample Size for Training Set:
- Not applicable as this is not a machine learning model requiring a training set in the typical sense. The device's performance is based on its inherent biochemical and mechanical design, not on a learned algorithm from a dataset in the way AI/ML products are.
-
How Ground Truth for Training Set was Established:
- Not applicable for the reason stated above. The system's "training" would be its initial chemical and biological design and manufacturing processes, validated through studies like this.
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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.
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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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Page 2
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
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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)
| Division Sign-Off |
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ffice of In Vitro Diagnostic Device Evaluation and Satety
510(k) K043545
§ 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).