(17 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 Chloramphenicol, at concentrations of 1 to 32 mcg/ml on the MicroScan MICroSTREP plus ® Panel.
The organisms which may be used for Chloramphenicol susceptibility testing on this panel are: Susceptible streptococci, including 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 ul 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 provided text describes the 510(k) summary for the MicroScan MICroSTREP plus® Panel for determining bacterial susceptibility to Chloramphenicol using the MicroScan® WalkAway instrument.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Set by FDA Guidance) | Reported Device Performance (Chloramphenicol) | Metric |
|---|---|---|
| "acceptable performance" (as defined in FDA guidance "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA", dated February 5, 2003) | 100% | Overall Essential Agreement |
| Acceptable reproducibility and precision | Acceptable | Instrument reproducibility |
| Acceptable results for Quality Control | Acceptable | Quality Control testing |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated as a single number. The study used "stock and CDC Challenge strains." The FDA guidance cited for AST systems would typically define the minimum number of isolates required for evaluation, but this specific number is not provided in the summary.
- Data Provenance: The study was an "external evaluation" conducted with "stock and CDC Challenge strains." This suggests a combination of curated and potentially geographically diverse strains, but specific countries of origin are not mentioned. The study appears to be prospective in the sense that the device was evaluated on these strains to confirm its performance against pre-established expected results.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Number of Experts: Not explicitly stated.
- Qualifications of Experts: Not explicitly stated. However, the ground truth was established by a "CLSI frozen Reference Panel," which implies that the "Expected Results" were determined by established, standardized methods and likely confirmed by expert microbiologists or reference laboratories adhering to Clinical and Laboratory Standards Institute (CLSI) guidelines.
4. Adjudication Method for the Test Set:
- The text describes comparing the instrument-read results "with an expected result generated on a CLSI frozen Reference Panel." This indicates a direct comparison to a pre-defined reference standard rather than an adjudication process between multiple human readers for the specific device test itself.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The study focuses on evaluating the instrument's performance against a reference standard, not on comparing human reader performance with and without AI assistance.
6. Standalone (Algorithm Only) Performance:
- Yes, a standalone performance study was done. The entire premise of the submission is to demonstrate the performance of the MicroScan® WalkAway instrument (which automates the reading process) when determining susceptibility to Chloramphenicol on the MICroSTREP plus® Panel. The "Essential Agreement of 100% for Chloramphenicol instrument read results compared with the Expected Result" directly reflects the standalone performance of the instrument/algorithm.
7. Type of Ground Truth Used:
- Expert Consensus / Reference Standard: The ground truth was established as "Expected Results determined before the evaluation" using a "CLSI frozen Reference Panel." This implies that the expected MIC values were determined through recognized, standardized laboratory methods, likely involving expert consensus on the interpretation of those reference methods (e.g., broth microdilution or agar dilution as per CLSI guidelines).
8. Sample Size for the Training Set:
- The document does not specify a separate training set. This is a 510(k) submission for a device that uses an instrument to read pre-determined assays. The "instrument read method" performance is being evaluated, implying the instrument's reading capabilities were developed and validated prior to this submission. The text focuses on the test set performance to show equivalence. In older submissions for IVD devices, explicit training/validation splits with detailed sample sizes were not always outlined as they might be for modern AI/ML systems.
9. How the Ground Truth for the Training Set Was Established:
- As no separate training set is explicitly mentioned, the method for establishing ground truth for a training set is not provided. The development of the WalkAway instrument's reading algorithm would have involved its own internal validation and calibration processes, but these details are not part of this 510(k) summary. The "Expected Results" for the test set were based on the CLSI frozen Reference Panel.
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AUG 2 4 2006
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: | July 25, 2006 |
| Product Name: | Microdilution Minimum Inhibitory Concentration (MIC) Panels |
| Trade Name: | MicroScan MICroSTREP plus® Panel |
| Intended Use: | To determine bacterial susceptibility to Chloramphenicol |
| Indication for Use: | For determining antimicrobic susceptibility with aerobicstreptococci including Streptococcus 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 ul 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 Chloramphenicol 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 for the MICroSTREP plus® Panel by comparing its performance with Expected Results determined before the evaluation. The MICroSTREP plus® Panel demonstrated acceptable
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performance with an overall Essential Agreement of 100% for Chloramphenicol instrument read results compared with the Expected Result.
Instrument reproducibility testing demonstrated acceptable reproducibility and precision with Chloramphenicol and the WalkAway® instrument.
Quality Control testing demonstrated acceptable results for Chloramphenicol.
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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 tail feathers. 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
Ms. Maureen Mende Regulatory Affairs Group Manager Dade Behring, Inc. 2040 Enterprise Boulevard West Sacramento, CA 95691-9972
AUG 2 4 2006
Re: K062293
Trade/Device Name: MicroScan MICroSTREP plus® Panel Chloramphenicol (1 to 32 mcg/ml) Regulation Number: 21 CFR § 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: II Product Code: LRG, LTT Dated: July 25, 2006 Received: August 7, 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 vours,
Sally attorn
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.: | K062293(To be assigned by FDA) |
|---|---|
| Device Name: | MicroScan MICroSTREP plus ® PanelChloramphenicol (1 to 32 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 readcapability of the antimicrobial Chloramphenicol, at concentrationsof 1 to 32 mcg/ml on the MicroScan MICroSTREP plus ® Panel. | |
| The organisms which may be used for Chloramphenicolsusceptibility testing on this panel are: | |
| Susceptible streptococci, including Streptococcus pneumoniae |
Prescription Use ___ X (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)
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SINIKI KO6 2
§ 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).