(16 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 Levofloxacin, at concentrations of 0.12 to 16 mcg/ml on the MicroScan MICroSTREP plus® Panel.
The organisms which may be used for Levofloxacin susceptibility testing on this panel are:
Streptococcus pneumoniae (including penicillin-resistant strains) Streptococcus pyogenes Streptococcus (Group C/F) Streptococcus (Group G) Streptococcus agalactiae Viridans group streptococci
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.
Acceptance Criteria and Study Details for MicroScan MICroSTREP plus® Panel (K062276)
Here's a breakdown of the acceptance criteria and study details for the MicroScan MICroSTREP plus® Panel as presented in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Success Metric) | Reported Device Performance (Levofloxacin Instrument Read) |
|---|---|
| Overall Essential Agreement | 100% Essential Agreement |
| Instrument reproducibility | Acceptable reproducibility and precision |
| Quality Control testing | Acceptable results |
Note: The specific numerical targets for "acceptable" essential agreement, reproducibility, and precision are not explicitly defined in the provided text beyond the statement that the essential agreement should meet the "FDA document 'Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA', dated February 5, 2003."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The text mentions "stock and CDC Challenge strains" were used for external evaluations. However, the exact number of strains or individual tests performed is not specified.
- Data Provenance: The data provenance is described as using "stock and CDC Challenge strains." This implies a retrospective data set, likely sourced from culture collections. The country of origin is not explicitly stated, but "CDC Challenge strains" suggests a U.S. origin.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The study refers to "Expected Results determined before the evaluation" which were based on a "CLSI frozen Reference Panel." This suggests that the ground truth was established by recognized reference methods and interpreted by experts. However, the number of experts and their specific qualifications are not explicitly stated in the provided text.
4. Adjudication Method for the Test Set
The text indicates that the device's instrument read results were compared with "Expected Results." This implies a comparison against a pre-established ground truth, rather than an adjudication method involving multiple readers for the test set itself. There is no mention of a 2+1, 3+1, or similar adjudication process for the new device's readings.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being performed. The study focuses on comparing the instrument's performance against expected results, not on quantifying the improvement of human readers with AI assistance.
6. Standalone Performance Study
Yes, a standalone performance study was performed (algorithm only without human-in-the-loop performance). The study evaluated the "proposed instrument read method" (MicroScan® WalkAway instrument) for its ability to determine MIC, comparing its results directly with "Expected Results" from a CLSI frozen Reference Panel. This assesses the algorithm's performance independent of human interpretation of the instrument's output.
7. Type of Ground Truth Used
The type of ground truth used was expert consensus / reference method. The "Expected Results" were determined before the evaluation using a "CLSI frozen Reference Panel." The CLSI (Clinical and Laboratory Standards Institute) sets standards for laboratory testing, and their reference panels would be considered a reliable ground truth established through standardized methods and expert consensus.
8. Sample Size for the Training Set
The provided text does not explicitly state the sample size for the training set. The study description focuses on the evaluation of the instrument, not on the development or training of its underlying algorithm.
9. How the Ground Truth for the Training Set Was Established
As the text does not mention a training set or the development process for the algorithm, it does not provide information on how the ground truth for a training set was established.
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510(k) Summary Information:
AUG 2 3 2006
| 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 Levofloxacin |
| Indication for Use: | For determining antimicrobic susceptibility with aerobic streptococci including Streptococcus pneumoniae |
| Predicate device: | MicroScan® MICroSTREP plus® Panel (K020556) |
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 Levofloxacin on the MicroScan® WalkAway instrument.
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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 performance with an overall Essential Agreement of 100% for Levofloxacin instrument read results compared with the Expected Result.
Instrument reproducibility testing demonstrated acceptable reproducibility and precision with Levofloxacin and the WalkAway® instrument.
Quality Control testing demonstrated acceptable results for Levofloxacin.
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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 and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three overlapping shapes that resemble ribbons or stylized human figures.
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 Scaramento, California 95691
AUG 2 3 2006
Re: K062276 Trade/Device Name: MicroScan MICroSTREP plus® Panel Levofloxacin (0.12 - 16 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 yours,
Sally anton
Sally A. Hoivat, 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 .:
4062276 (To be assigned by FDA)
Device Name:
MicroScan MICroSTREP plus® Panel Levofloxacin (0.12 to 16 mcg/ml)
Intended Use
To determine bacterial antimicrobial agent susceptibility
Indications for Use:
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 Levofloxacin, at concentrations of 0.12 to 16 mcg/ml on the MicroScan MICroSTREP plus® Panel.
The organisms which may be used for Levofloxacin susceptibility testing on this panel are:
Streptococcus pneumoniae (including penicillin-resistant strains) Streptococcus pyogenes Streptococcus (Group C/F) Streptococcus (Group G) Streptococcus agalactiae Viridans group streptococci
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 Histoph Statestic Devices (OIVD)
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k)________________________________________________________________________________________________________________________________________________________________________
§ 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).