(21 days)
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 Meropenem, at concentrations of 0.03 to 4 mcg/ml on the MicroScan MICroSTREP plus® Panel.
The organisms which may be used for Meropenem susceptibility testing in this panel are:
Streptoccus pneumoniae (excluding penicillin-resistant strains) 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℃ +/-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 Device Performance Study for MicroScan MICroSTREP plus® Panel (Meropenem)
This document describes the acceptance criteria and the study conducted to demonstrate the substantial equivalence of the MicroScan MICroSTREP plus® Panel with Meropenem, specifically for instrument-read results using the MicroScan® WalkAway instrument.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Essential Agreement | ≥ 90% | 98% |
| Reproducibility | Acceptable | Demonstrated acceptable reproducibility and precision |
| Quality Control | Acceptable | Demonstrated acceptable results |
Note: The acceptance criteria for Essential Agreement (≥ 90%) is derived from the FDA Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA (February 5, 2003), which is referenced in the 510(k) summary.
2. Sample Size and Data Provenance for the Test Set
- Sample Size: The document does not explicitly state the exact number of isolates or tests performed in the evaluation for Essential Agreement. However, it mentions the evaluation was conducted with "stock and CDC Challenge strains."
- Data Provenance: The data provenance is not explicitly stated in terms of country of origin but is implied to be from Dade Behring Inc. (USA) as the manufacturer. The study is prospective as it involves evaluations designed to confirm acceptability against pre-determined Expected Results.
3. Number and Qualifications of Experts for Ground Truth
The document does not mention the use of human experts to establish ground truth for the test set.
4. Adjudication Method for the Test Set
No adjudication method is described, as the ground truth was established by a reference method rather than expert consensus.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was conducted. This study focused on the performance of the instrument-read method compared to a reference standard, not on human reader performance with or without AI assistance.
6. Standalone Performance Study
Yes, a standalone performance study was done. The study evaluated the performance of the algorithm only (MicroScan® WalkAway instrument read method) without human intervention or human-in-the-loop performance, by comparing its results to an established reference method.
7. Type of Ground Truth Used for the Test Set
The ground truth used was an expected result generated on a CLSI frozen Reference Panel. This represents a recognized standard for determining antimicrobial susceptibility, aligning with established laboratory methods.
8. Sample Size for the Training Set
The document does not explicitly mention a separate "training set" or its sample size. The evaluation was framed as a comparison against an "Expected Result" from a reference panel, which suggests a validation study rather than a machine learning training process with a distinct training set. If the MicroScan WalkAway instrument uses an algorithm that was previously developed and trained, the details of that training are not provided in this submission.
9. How Ground Truth for the Training Set Was Established
As noted in section 8, a separate training set is not explicitly discussed. For the purpose of the evaluation, the "Expected Results" for comparison were determined before the evaluation, using a CLSI frozen Reference Panel. This implies that the reference panel served as the gold standard for defining correct susceptibility results against which the instrument's performance was measured.
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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: | October 3, 2006 |
| Product Name: | Microdilution Minimum Inhibitory Concentration (MIC) Panels |
| Trade Name: | MicroScan MICroSTREP plus® Panel |
| Intended Use: | To determine bacterial susceptibility to Meropenem |
| Indication for Use: | For determining antimicrobic susceptibility with aerobic streptococci, including Streptococcus pneumoniae |
| Predicate device: | MicroScan MICroSTREP plus® Panel (K020938) |
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℃ +/-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 Meropenem on the MicroScan® WalkAway instrument.
The evaluation was conducted with stock and CDC Challenge strains. The evaluations were designed to confirm the acceptability of the proposed instrument read method for the MICroSTREP
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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 98% for Meropenem instrument read results compared with the Expected Result.
Instrument reproducibility testing demonstrated acceptable reproducibility and precision with Meropenem and the WalkAway® instrument.
Quality Control testing demonstrated acceptable results for Meropenem.
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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 consists of a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA", which is arranged in a circular fashion around the left side of the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Maureen Mende Regulatory Affairs, Group Manager Dade Behring, Inc. 1584 Enterprise Boulevard West Sacramento, CA 95691-9972
OCT 2 7 2006
Re: K063065
Trade/Device Name: MicroScan MICroSTREP plus® Panel Meropenem (0.03 - 4 mcg/ml) Regulation Number: 21 CFR § 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: II Product Code: LRG, LTT Dated: October 3, 2006 Received: October 6, 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. 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.:
063065 (To be assigned by FDA)
Meropenem (0.03 - 4 mcg/ml)
MicroScan MICroSTREP plus® Panel
Intended Use
Indications for Use:
Device Name:
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.
To determine bacterial antimicrobial agent susceptibility
This particular submission is for the addition of instrument read capability of the antimicrobial Meropenem, at concentrations of 0.03 to 4 mcg/ml on the MicroScan MICroSTREP plus® Panel.
The organisms which may be used for Meropenem susceptibility testing in this panel are:
Streptoccus pneumoniae (excluding penicillin-resistant strains) 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 In Vitro Diagnostic Devices
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Office of In Vitro Diagnostic Device Page 1 of Evaluation and Safery
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§ 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).