(51 days)
To determine bacterial antimicrobial agent susceptibility
The MicroScan MICroSTREP plus ® Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae . After inoculation, panels are incubated for 20 - 24 hours at 35°C +/- 1°C in a non-CO2 incubator, and read visually according to the Package Insert. Additionally, the panels may be incubated in and read by a MicroScan ® WalkAway instrument.
This particular submission is for the addition of instrument read capability of the antimicrobial Trimethoprim/Sulfamethoxazole, at concentrations of 0.06/1.15 to 8/152 mcg/ml on the MicroScan MICroSTREP plus® Panel.
The organisms which may be used for Trimethoprim/Sulfamethoxazole susceptibility testing on this panel are:
Streptococcus pneumoniae
The MicroScan MICroSTREP plus® Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae. After inoculation, panels are incubated for 20 - 24 hours at 35°C +/- 1°C in a non-CO2 incubator, and read according to the Package Insert.
The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test. Various antimicrobial agents are diluted in water, buffer or minute concentrations of broth to concentrations bridging the range of clinical interest. Panels are rehydrated with 115 µl Mueller-Hinton broth supplemented with 2-5% lysed horse blood (LHB) and buffered with 50 mM HEPES, after inoculation of the broth with a standardized suspension of the organism in saline. After incubation in a non-CO2 incubator for 20-24 hours, the minimum inhibitory concentration (MIC) for the test organism is manually read by observing the lowest antimicrobial concentration showing inhibition of growth. Additionally, the panels may be incubated in and read by a MicroScan® WalkAway instrument.
Here's an analysis of the provided text, outlining the acceptance criteria and study details for the MicroScan MICroSTREP plus® Panel with Trimethoprim/Sulfamethoxazole instrument read capability:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Overall Essential Agreement with Expected Result | 100% for Trimethoprim/Sulfamethoxazole instrument read results |
| Instrument reproducibility | Demonstrated acceptable reproducibility and precision |
| Quality Control testing | Demonstrated acceptable results |
2. Sample size used for the test set and the data provenance:
- Sample size: Not explicitly stated. The document mentions "stock and CDC Challenge strains" were used for external evaluation.
- Data Provenance: The strains were "stock and CDC Challenge strains," suggesting they are well-characterized, potentially from reference collections. The country of origin is not specified, but CDC generally refers to the U.S. Centers for Disease Control and Prevention. The study appears to be a prospective evaluation based on its design to "confirm the acceptability of the proposed instrument read method" by comparing its performance with "Expected Results determined before the evaluation."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of experts: Not explicitly stated.
- Qualifications of experts: Not explicitly stated. The ground truth ("Expected Results") was based on a "CLSI frozen Reference Panel," implying that the standard for establishing these results would follow CLSI (Clinical and Laboratory Standards Institute) guidelines, which are established by expert consensus in microbiology.
4. Adjudication method for the test set:
- The document implies a direct comparison of the instrument read results to the "Expected Results" from the CLSI frozen Reference Panel. There is no mention of a traditional expert adjudication process (e.g., 2+1, 3+1) as one might find in image-based diagnostic studies. The "Expected Results" themselves serve as the adjudicated ground truth.
5. 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 explicitly done. This study focuses on validating the performance of an instrument read method compared to a reference standard, not on comparing human readers with and without AI assistance. The previous method was a "manual read" by observing the lowest antimicrobial concentration showing inhibition of growth. The new method is an "instrument read." The study aims to show the instrument read method is substantially equivalent to the expected results, not necessarily that it improves human reader performance or replaces human readers directly.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone study was done. The "instrument read method" assesses the performance of the MicroScan WalkAway instrument in interpreting the susceptibility panels. This is an algorithm-only evaluation where the instrument provides the result without direct human intervention in the interpretation phase for the test strains. The output is directly compared to the "Expected Result."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth used was based on expert consensus embodied in a standardized reference method. Specifically, the "Expected Results" were generated on a CLSI frozen Reference Panel, which represents the gold standard for antimicrobial susceptibility testing, established and validated through extensive expert consensus within the CLSI framework.
8. The sample size for the training set:
- Not explicitly stated in the provided text. The document describes the external evaluation with "stock and CDC Challenge strains," which corresponds to the test set. Information on a separate training set for algorithm development is not included.
9. How the ground truth for the training set was established:
- Not applicable, as a separate training set and its ground truth establishment are not discussed in the provided text. The document focuses on the external validation of the instrument read method using a test set with pre-established "Expected Results" from a CLSI reference panel.
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AUG 2 3 2005
510(k) Summary Information:
| Device Manufacturer: | Dade Behring Inc. |
|---|---|
| Contact name: | Maureen Mende, Regulatory Affairs Group Manager |
| Phone/Fax: | 916-374-3174/916-374-3144 |
| Date prepared: | June 26, 2006 |
| Product Name: | Microdilution Minimum Inhibitory Concentration (MIC) Panel |
| Trade Name: | MicroScan MICroSTREP plus® Panel |
| Intended Use: | To determine bacterial susceptibility toTrimethoprim/Sulfamethoxazole |
| Indication for Use: | For determining antimicrobic susceptibility withStreptococcus pneumoniae |
| Predicate device: | MicroScan® MICroSTREP plus® Panel |
510(k) Summary:
The MicroScan MICroSTREP plus® Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae. After inoculation, panels are incubated for 20 - 24 hours at 35°C +/- 1°C in a non-CO2 incubator, and read according to the Package Insert.
The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test. Various antimicrobial agents are diluted in water, buffer or minute concentrations of broth to concentrations bridging the range of clinical interest. Panels are rehydrated with 115 µl Mueller-Hinton broth supplemented with 2-5% lysed horse blood (LHB) and buffered with 50 mM HEPES, after inoculation of the broth with a standardized suspension of the organism in saline. After incubation in a non-CO2 incubator for 20-24 hours, the minimum inhibitory concentration (MIC) for the test organism is manually read by observing the lowest antimicrobial concentration showing inhibition of growth. Additionally, the panels may be incubated in and read by a MicroScan® WalkAway instrument.
The proposed instrument read method for the MicroScan MICroSTREP plus® Panel demonstrated substantially equivalent performance with streptococcal isolates when compared with an expected result generated on a CLSI 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.
This Premarket Notification (510[k]) presents data in support of reading the MICroSTREP plus Panel with Trimethoprim/Sulfamethoxazole on the MicroScan® WalkAway instrument.
The external evaluation was conducted with stock and CDC Challenge strains. The external evaluations were designed to confirm the acceptability of the proposed instrument read method
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for the MICroSTREP plus® Panel by comparing its performance with Expected Results determined before the evaluation. The MICroSTREP plus® Panel demonstrated acceptable performance with an overall Essential Agreement of 100% for Trimethoprim/Sulfamethoxazole instrument read results compared with the Expected Result.
Instrument reproducibility testing demonstrated acceptable reproducibility and precision with Trimethoprim/ Sulfamethoxazole and the WalkAway® instrument.
Quality Control testing demonstrated acceptable results for Trimethoprim/Sulfamethoxazole.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wing-like shapes, symbolizing service to the nation. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 2 3 2006
Ms. Maureen Mende Regulatory Affairs Group Manager Dade Behring, Inc. 2040 Enterprise Boulevard West Scaramento, California 95691
Re: K061872
Trade/Device Name: MicroScan MICroSTREP plus® Panel Trimethoprim/Sulfamethoxazole (0.06/1.15 - 8/152 mcg/ml) Regulation Number: 21 CFR & 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: II Product Code: LRG, LTT Dated: June 28, 2006 Received: July 19, 2006
Dear Ms. Mende:
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 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 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 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 (240)276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97), Other general information on your responsibilities under the Act may be obtained 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,
Sally, artton
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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Indication for Use Statement
| 510(k) No.: | K061872(To be assigned by FDA) |
|---|---|
| Device Name: | MicroScan MICroSTREP plus ® PanelTrimethoprim/Sulfamethoxazole (0.06/1.15 - 8/152 mcg/ml) |
| Intended Use | To determine bacterial antimicrobial agent susceptibility |
| Indications for Use: | The MicroScan MICroSTREP plus ® Panel is used to determinequantitative and/or qualitative antimicrobial agent susceptibility ofcolonies grown on solid media of aerobic streptococci, includingStreptococcus pneumoniae . After inoculation, panels are incubatedfor 20 - 24 hours at 35°C +/- 1°C in a non-CO2 incubator, andread visually according to the Package Insert. Additionally, thepanels may be incubated in and read by a MicroScan ® WalkAwayinstrument. |
This particular submission is for the addition of instrument read capability of the antimicrobial Trimethoprim/Sulfamethoxazole, at concentrations of 0.06/1.15 to 8/152 mcg/ml on the MicroScan MICroSTREP plus® Panel.
The organisms which may be used for Trimethoprim/Sulfamethoxazole susceptibility testing on this panel are:
Streptococcus pneumoniae
| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use ________ |
|---|---|---|
| ------------------------------------------------------------------------ | ---- | ------------------------------- |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Sall
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) $\frac{K_{0}6(87)}{}$
viii
§ 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).