(45 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℃ +/- 1℃ in a non-CO2 incubator, and read visually according to the Package Insert.
This particular submission is for the addition of the antimicrobial Amoxicillin/Clavulanic Acid at concentrations of 0.015/0.008 to 16/8 mcg/ml to the test panel
The organisms which may be used for Amoxicillin/ Clavulanic Acid susceptibility testing in 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 inculation, 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.
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 (MC) for the test organism is manually read by observing the lowest antimicrobial concentration showing inhibition of growth.
The MicroScan® MICroSTREP plus™ Panel is intended to determine bacterial susceptibility to Amoxicillin/Clavulanic Acid, specifically for Streptococcus pneumoniae. The device is a microdilution minimum inhibitory concentration (MIC) panel that provides quantitative and/or qualitative antimicrobial agent susceptibility readings.
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from FDA DRAFT document "Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices", dated March 8, 2000) | Reported Device Performance (MicroScan® MICroSTREP plus™ Panel with Amoxicillin/Clavulanic Acid) |
|---|---|
| Essential Agreement (≥ 90%) | 99% Essential Agreement |
| Reproducibility (Acceptable) | Acceptable Reproducibility |
| Quality Control (Acceptable) | Acceptable Quality Control |
Essential Agreement is defined as the agreement between the MIC obtained by the test device and the MIC obtained by the reference method (NCCLS frozen Reference Panel) within ±1 doubling dilution.
2. Sample Size and Data Provenance
The study used "fresh and stock Efficacy isolates and stock Challenge strains" for the external evaluation. No specific numerical sample size is provided for the test set.
The provenance of data is not explicitly stated in terms of country of origin. The study was a retrospective evaluation comparing the device's performance to an established reference method.
3. Number and Qualifications of Experts for Ground Truth
The document does not explicitly state the number or qualifications of experts used to establish the ground truth for the test set. The ground truth was established by an "NCCLS frozen Reference Panel," which implicitly suggests standardized and expert-derived values based on established guidelines.
4. Adjudication Method
The adjudication method is not explicitly mentioned. However, the comparison was made against a "NCCLS frozen Reference Panel," implying a predefined and standardized ground truth rather than a real-time adjudication process by experts on a case-by-case basis.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no indication that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was conducted. The evaluation focuses on the device's performance against a reference panel, not on the improvement of human readers with AI assistance. The reading of the panels is described as "manually read by observing the lowest antimicrobial concentration showing inhibition of growth," implying a human-in-the-loop, but without comparison to AI assistance.
6. Standalone Performance Study
A standalone performance study was conducted. The "external evaluation was conducted with fresh and stock Efficacy isolates and stock Challenge strains" to confirm the acceptability of the proposed MICroSTREP plus™ Panel by comparing its performance with an NCCLS frozen Reference panel. This directly measures the algorithm's performance (the MicroScan panel's ability to produce accurate MICs) in isolation.
7. Type of Ground Truth Used
The ground truth used was based on an NCCLS frozen Reference Panel. This represents a standardized, expert-developed reference method for antimicrobial susceptibility testing, which serves as the gold standard for comparison in such studies.
8. Sample Size for the Training Set
The document does not provide information about a separate training set or its sample size. The focus is on the performance of the device against the reference standard. Given the nature of a microdilution panel (a physical product with pre-determined reagent concentrations), it's unlikely to have a "training set" in the context of machine learning algorithms. The development of such panels relies on extensive microbiological research and standardization.
9. How Ground Truth for the Training Set was Established
As there is no explicit mention of a training set in the context of the device's development as an AI/ML product, this information is not applicable. The device relies on a chemical and biological methodology for determining susceptibility, not a machine learning model that requires a training phase with labeled data. The "ground truth" for the overall methodology would stem from established microbiological principles and NCCLS (now CLSI) guidelines.
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MAY 0 6 2002
510(k) Summary Information:
| Device Manufacturer: | Dade MicroScan Inc. |
|---|---|
| Contact name: | Cynthia Van Duker, Regulatory Affairs Manager |
| Fax: | 916-374-3144 |
| Date prepared: | March 21, 2002 |
| Product Name: | Microdilution Minimum Inhibitory Concentration (MIC) Panels |
| Trade Name: | MicroScan® MICroSTREP plus™ Panel |
| Intended Use: | To determine bacterial susceptibility to Amoxicillin/Clavulanic Acid |
| Indication for Use | For determining antimicrobic susceptibility with Streptococcus pneumoniae |
| Predicate device: | MicroScan® Streptococcus MIC Panel (K963641). |
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 inculation, 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.
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 (MC) for the test organism is manually read by observing the lowest antimicrobial concentration showing inhibition of growth.
The proposed MicroScan® MICroSTREP plus™ Panel demonstrated substantially equivalent performance with streptococcal isolates when compared with an NCCLS frozen Reference Panel, as defined in the FDA DRAFT document "Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices", dated March 8, 2000.
The Premarket Notification (510[k]) presents data in support of the new MCroSTREP plus™ Panel with Amoxicillin/Clavulanic Acid.
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 MICroSTREP plus™ Panel by comparing its performance with an NCCLS frozen Reference panel. The MCroSTREP plus™ Panel demonstrated acceptable performance with an overall Essential Agreement of 99% for Amoxicillin/Clavulanic Acid when compared with the frozen Reference panel.
Reproducibility testing demonstrated acceptable reproducibility and precision with Amoxicillin/ Clavulanic Acid.
Quality Control testing demonstrated acceptable results for Amoxicillin/Clavulanic Acid.
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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 consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Cynthia Van Duker Regulatory Affairs Manager Dade Behring Inc. 1584 Enterprise Boulevard West Sacramento, CA 95691
K020937 Re:
K020937
Trade/Device Name: MicroScan® MICroSTREP plus™ Panels with Amoxicillin/Clavulanic acid at 0.015/0.008-16/8 µg/ml Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Regulatory Class: Class II Product Code: JWY Dated: March 21, 2002 Received: March 22, 2002
Dear Ms. Van Duker:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications felerenced above and nave determined by marketed predicate devices marketed in interstate for use stated in the encreative) it it's enactment date of the Medical Device Amendments, or to conimeres prior to May 20, 1976, the excordance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). and Cosmetic Treef the device, subject to the general controls provisions of the Act. The Tourmay, therefore, market the act include requirements for annual registration, listing of general controls provisions of ractice, 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 classined (600 a00 ro) als. Existing major regulations affecting your device can inay be subject to such additions, Title 21, Parts 800 to 898. 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 I lease be advisou that I Dr over device complies with other requirements of the Act that I Dri has made a acterimations administered by other Federal agencies. You must of any I cacal statuted and reguirements, including, but not limited to: registration and listing (21 Comply with an the 11et 31equirements, we see and manufacturing practice requirements as set CI IC rate 077, laoemig (21 OS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality by sections (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 -
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indication for Use Statement
510(k) No .:
Device Name:
Intended Use
Indications for Use:
(To be assigned by FDA)
MicroScan® MICroSTREP plus™ Panel
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℃ +/- 1℃ in a non-CO2 incubator, and read visually according to the Package Insert.
This particular submission is for the addition of the antimicrobial Amoxicillin/Clavulanic Acid at concentrations of 0.015/0.008 to 16/8 mcg/ml to the test panel
The organisms which may be used for Amoxicillin/ Clavulanic Acid susceptibility testing in this panel are:
Streptococcus pneumoniae
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Clinical Laboratory Devices
| 510(k) Number | K020937 |
|---|---|
| --------------- | --------- |
| Prescription Use | ✓ |
|---|---|
| (Per 21 CFR 801.109) |
OR
| Over-The-Counter Use | |
|---|---|
| ---------------------- | -- |
(Optional Format 1-2-96)
§ 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).