(43 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 - 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
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.
This solicitation is for the addition of the antimicrobial vancomycin at concentrations of 0.25 to 128 mcg/ml to MicroScan® Dried Gram-Positive MIC/Combo Panels.
1. Table of Acceptance Criteria & Reported Device Performance:
| Performance Metric | Acceptance Criteria (from FDA's "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems") | Reported Device Performance (Vancomycin) |
|---|---|---|
| Overall Essential Agreement | >90% for vancomycin | >99% |
| Inoculum Reproducibility | Acceptable reproducibility | Acceptable |
| Instrument Reproducibility | Acceptable reproducibility | Acceptable |
| Quality Control | Acceptable results | Acceptable |
2. Sample Size & Data Provenance:
- Test Set Sample Size: The document does not specify the exact number of isolates used for the external evaluation. It mentions "fresh and stock Efficacy isolates and stock Challenge strains."
- Data Provenance: Not explicitly stated, but "external evaluation" suggests different sites. The document implies a multicenter evaluation, as it refers to "external evaluation" in plural sense, and thus suggests multicenter data.
- Retrospective/Prospective: Not explicitly stated. The use of "fresh and stock Efficacy isolates" suggests a mix, where "fresh" could imply prospective collection for the study, while "stock" would be retrospective.
3. Number of Experts & Qualifications for Ground Truth (Test Set):
- The document does not specify the number or qualifications of experts used to establish the ground truth for the test set. Instead, it refers to a "CLSI (formerly NCCLS) frozen Reference Panel" as the gold standard.
4. Adjudication Method for the Test Set:
- Not applicable as the ground truth was established by comparison to a reference standard (CLSI frozen Reference Panel), not through expert adjudication of images/data from the device. "Challenge strains were compared to Expected Results determined prior to the evaluation".
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done. The study focuses on the standalone performance of the device against a reference method.
6. Standalone Performance Study:
- Yes, a standalone (algorithm only) performance study was conducted. The MicroScan® Dried Gram-Positive MIC/Combo Panel's performance was compared directly to a CLSI frozen Reference Panel.
7. Type of Ground Truth Used:
- Reference Standard: CLSI (Clinical and Laboratory Standards Institute, formerly NCCLS) frozen Reference Panel. This is considered a gold standard for antimicrobial susceptibility testing. For challenge strains, "Expected Results" determined prior to the evaluation were used.
8. Sample Size for the Training Set:
- Not applicable for this type of device and study. Antimicrobial susceptibility test (AST) systems are typically validated against established reference methods (like CLSI) rather than being "trained" in the machine learning sense. The device's underlying principles are based on broth dilution, not a trainable algorithm.
9. How Ground Truth for the Training Set was Established:
- Not applicable (see point 8). The "ground truth" for the development of the AST system itself would be the established scientific principles of antimicrobial activity and bacterial growth inhibition, as defined and standardized by organizations like CLSI.
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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.
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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 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
Page 1 of 1
510(k) K051202
8
§ 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).