(68 days)
The MicroScan® Dried 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. 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 amoxicillin/ K. clavulanate at concentrations of 0.25/0.12 to 128/64 mcg/ml to the test panel.
The gram-negative organisms which may be used for amoxicillin/K. clavulanate susceptibility testing in this panel are:
Enterobacter species
Escherichia coli
Klebsiella species
Proteus mirabilis
MicroScan® Dried Gram-Negative MIC/Combo Panels are designed for use in determining quantitative MICIOSCalle Direct Stan-Negative MICH of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic Gram-Negative bacilli.
The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test that have The allumic louial stiscopulary tosts are minicationic agents are diluted in broth to concentrations bridging the range of clinical interest. Parlous are relydrated with water after inoculation with a standardized suspension of the organism. After incubation in a non-CO- incubator for 16-20 hours, the minimum inizitory suspension of the organism. There measurement is read by determining the lowest antimicrobial concentration showing inhibition of growth.
Here's a breakdown of the acceptance criteria and the study details for the MicroScan® Dried Gram-Negative MIC/Combo Panels with Amoxicillin/K. Clavulanate, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria (Predicate Equivalent) | Reported Device Performance |
|---|---|
| Substantially equivalent performance 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" (specific metric not explicitly stated, but implies high agreement). | The Dried Gram-Negative Panel achieved an overall Essential Agreement of >99% for amoxicillin/K. clavulanate when compared with the frozen Reference panel. |
| Acceptable reproducibility and precision for amoxicillin/K. clavulanate, regardless of inoculum method (Turbidity and Prompt) or instrument (autoSCAN-4 and WalkAway®). | Inoculum and instrument reproducibility testing demonstrated acceptable reproducibility and precision with amoxicillin/K. clavulanate, regardless of which inoculum method (i.e., Turbidity and Prompt), or instrument (autoSCAN-4 and WalkAway®) was used. (Specific metrics for "acceptable" are not provided in the summary but were evidently met). |
| Acceptable Quality Control (QC) results for amoxicillin/K. clavulanate. | Quality Control testing demonstrated acceptable results for amoxicillin/K. clavulanate. (Specific metrics for "acceptable" are not provided). |
Study Details
This submission describes a comparative study to demonstrate substantial equivalence to a predicate device (NCCLS frozen Reference Panel) for the addition of a new antimicrobial, amoxicillin/K. clavulanate, to an existing panel.
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Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated as a numerical value (i.e., number of isolates or tests). The study used "fresh and stock Efficacy isolates and stock Challenge strains."
- Data Provenance: Not explicitly stated (e.g., country of origin). The data is described as from "external evaluation," implying it was conducted outside of Dade MicroScan Inc.'s immediate environment, likely at clinical or reference laboratories. The study is retrospective, as it uses "stock Efficacy isolates and stock Challenge strains" in addition to fresh isolates.
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Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. However, the ground truth is established by the NCCLS frozen Reference panel, which inherently suggests expert consensus in its development and validation, as NCCLS (now CLSI) is a recognized standard-setting body in clinical laboratory testing.
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Adjudication Method for the Test Set:
- Adjudication Method: Not explicitly described in terms like "2+1" or "3+1." The evaluation compares the device's performance directly against the "NCCLS frozen Reference panel." This implies the reference panel is the ground truth against which the device results are compared, rather than a separate adjudication process among experts for each test case.
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If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. This study focuses on the performance of a device for antimicrobial susceptibility testing, not on human reader performance or AI assistance in reading, and thus, an effect size of human improvement with AI is not applicable here. The device is read either visually or with MicroScan instrumentation.
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If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone performance evaluation was implicitly done, and is the primary focus. The device (MicroScan® Dried Gram-Negative MIC/Combo Panel) itself is being evaluated for its ability to determine MIC values compared to a reference method. While human readers can interpret the results visually, the "device performance" itself refers to the panel's accuracy in producing the MIC, independent of the human interpretation stage for the Essential Agreement metric. The mention of "MicroScan instrumentation" also points to automated reading capabilities, which would be standalone.
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The Type of Ground Truth Used:
- The ground truth used is the NCCLS frozen Reference Panel. This represents a highly standardized and validated method that serves as a gold standard (or a very strong reference standard) for antimicrobial susceptibility testing, implicitly based on established microbiological principles and expert consensus within the NCCLS (now CLSI) framework.
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The Sample Size for the Training Set:
- Not applicable / Not provided. The document describes a performance evaluation (validation/test set) against a reference standard. It does not describe a machine learning algorithm that would require a distinct "training set" in the conventional sense. The "fresh and stock Efficacy isolates and stock Challenge strains" constitute the test set for performance comparison.
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How the Ground Truth for the Training Set was Established:
- Not applicable. As no distinct training set for an AI/ML model is described, there's no ground truth establishment for such a set. The performance is assessed against the NCCLS frozen Reference Panel as the ground truth.
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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 16, 2003 |
| Product Name: | Microdilution Minimum Inhibitory Concentration (MIC) Panels |
| Trade Name: | MicroScan® Dried Gram-Negative MIC/Combo Panels |
| Intended Use: | To determine antimicrobial agent susceptibility |
| 510(k) Notification: | New Antimicrobic - amoxicillin/K. clavulanate |
| Predicate device: | MicroScan Dried Gram-Negative and Gram-Positive MIC/Combo Panels |
510(k) Summary:
MicroScan® Dried Gram-Negative MIC/Combo Panels are designed for use in determining quantitative MICIOSCalle Direct Stan-Negative MICH of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic Gram-Negative bacilli.
The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test that have The allumic louial stiscopulary tosts are minicationic agents are diluted in broth to concentrations bridging the range of clinical interest. Parlous are relydrated with water after inoculation with a standardized suspension of the organism. After incubation in a non-CO- incubator for 16-20 hours, the minimum inizitory suspension of the organism. There measurement is read by determining the lowest antimicrobial concentration showing inhibition of growth.
The proposed MicroScan® Dried Gram-Negative MIC/Combo Panel demonstrated substantially equivalent I he proposed when compared with an NCCLS frozen Reference Panel, as defined in the FDA document "Class performatics with compared with Antimicrobial Susceptibility Test (AST) Systems; Guidance for II Special Coulrois Oulunce Documban. ThinHereranet Rotification (510[k]) presents data in support of the MicroScan® Dried Gram-Negative MIC/Combo Panel with amoxicillin/K. clavulanate.
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-Negative The external evaluations were assisted by the in NCCLS frozen Reference panel. Challenge strains were Fanel by comparing its performation while in the evaluation. The Dried Gram-Negative Panel compared to Expected Rosats assimment if pan overall Essential Agreement of >99% for amoxicillin/K. clavulanate when compared with the frozen Reference panel.
Inoculum and instrument reproducibility testing demonstrated acceptable reproducibility and precision with amoxicillin/K. clavulanate, regardless of which inoculum method (i.e., Turbidity and Prompt), or instrument (autoSCAN-4 and WalkAway®) was used.
Quality Control testing demonstrated acceptable results for amoxicillin/K. clavulanate.
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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 consists of a stylized human figure with three arms or lines extending upwards, representing growth and development. The figure is positioned to the right of the department's name, which is arranged in a circular fashion around the logo. The text reads 'Department of Health & Human Services USA'.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB 2 5 2004
Ms. Cynthia Van Duker Regulatory Affairs Manager Dade MicroScan Inc. 1584 Enterprise Boulevard West Sacramento, CA 95691
K033940 Re:
Trade/Device Name: MicroScan® Dried Gram-Negative MIC/Combo Panels with Amoxicillin/K. Clavulanate (0.25/0.12-128/64 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 16, 2003 Received: December 29, 2003
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 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 such 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.
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.
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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.
Saartys
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
K033940 510(k) Number (if known):
MicroScan® Dried Gram-Negative MIC/Combo Panels with Amoxicillin/K. Device Name: Clavulanate (0.25/0.12 - 128/64 mcg/ml)
Indications For Use:
The MicroScan® Dried 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. 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 amoxicillin/ K. clavulanate at concentrations of 0.25/0.12 to 128/64 mcg/ml to the test panel.
The gram-negative organisms which may be used for amoxicillin/K. clavulanate susceptibility testing in this panel are:
Enterobacter species Escherichia coli Klebsiella species Proteus mirabilis
Prescription Use V (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)
vision Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
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510(k) KD33946
§ 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).