(65 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. This particular submission is for the addition of the antimicrobial Levofloxacin at concentrations of 0.12 to 16 mcg/ml to the test panel. The organisms which may be used for Levofloxacin susceptibility testing in 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 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 (MIC) for the test organism is manually read by observing the lowest antimicrobial concentration showing inhibition of growth.
The provided document describes the acceptance criteria and the study that proves the MicroScan® MICroSTREP plus™ Panel with Levofloxacin meets those criteria.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (for Levofloxacin) | Reported Device Performance (Levofloxacin) |
|---|---|
| Overall Essential Agreement with NCCLS frozen Reference Panel | >99% Essential Agreement |
| Acceptable Reproducibility and Precision | Demonstrated acceptable reproducibility and precision |
| Acceptable Quality Control results | Demonstrated acceptable results |
2. Sample Size Used for the Test Set and Data Provenance:
The document states that the external evaluation was conducted with:
- "fresh and stock Efficacy isolates"
- "stock Challenge strains"
The exact sample size (number of isolates/strains) is not explicitly stated in the provided text.
The data provenance is described as "external evaluation," but the country of origin is not specified. It is a prospective study as it involves testing the new device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not specify the number of experts used or their qualifications for establishing the ground truth. It refers to comparing the device's performance with an "NCCLS frozen Reference Panel" and "manual reading" by observing the lowest antimicrobial concentration.
4. Adjudication Method for the Test Set:
The document does not explicitly describe an adjudication method. The comparison is made against an "NCCLS frozen Reference Panel," which implicitly suggests the reference panel values serve as the ground truth. The process is described as "manual reading by observing the lowest antimicrobial concentration showing inhibition of growth" for the test organism in both the reference and the new device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study assesses the performance of a diagnostic device in comparison to a reference standard, not the improvement of human readers with AI assistance. The study focuses on the "MicroScan® MICroSTREP plus™ Panel," which is a laboratory test device, not an AI-assisted diagnostic tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
The device described, the MicroScan® MICroSTREP plus™ Panel, is a laboratory test panel for antimicrobial susceptibility testing. Its performance is evaluated directly. The reading process is described as "manually read by observing the lowest antimicrobial concentration showing inhibition of growth." Therefore, the study presented here is the standalone performance of the test panel as interpreted manually, without any AI or algorithm that would operate independently.
7. The Type of Ground Truth Used:
The ground truth used for comparison was an NCCLS frozen Reference Panel. This serves as a standardized and accepted reference method for antimicrobial susceptibility testing.
8. The Sample Size for the Training Set:
The document does not describe a training set as this is a traditional laboratory diagnostic device, not an AI/machine learning model that requires explicit training data. The study focuses on the performance of the developed panel.
9. How the Ground Truth for the Training Set Was Established:
As there is no described training set for an AI/machine learning model, this question is not applicable.
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APR 2 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: | February 19, 2002 |
| 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, includingStreptococcus 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 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.
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.
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 MICroSTREP plus™ Panel with Levofloxacin.
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 MICroSTREP plus™ Panel demonstrated acceptable performance with an overall Essential Agreement of >99% for Levofloxacin when compared with the frozen Reference panel.
Reproducibility testing demonstrated acceptable reproducibility and precision with Levofloxacin.
Quality Control testing demonstrated acceptable results for Levofloxacin.
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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with three stylized figures underneath it.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR 2 6 2002
Ms. Cynthia Van Duker Regulatory Affairs Manager Dade Behring Inc. 1584 Enterprise Boulevard West Sacramento, CA 95691
K020556 Re:
K02050
Trade/Device Name: MicroScan® MICroSTREP plus™ Panels with Levofloxacin 0.12-16μg/ml
Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: Class II Product Code: JWY Dated: February 19, 2002 Received: February 20, 2002
Dear Ms. Van Duker:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass surfal the encreases of 76, 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, de riod that have been 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 r ou may) ateres, and secting 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 the Code of Federal Regulations, 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 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (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 Sutman
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:
020556 (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°C +/- 1°C in a non-CO2 incubator, and read visually according to the Package Insert.
This particular submission is for the addition of the antimicrobial Levofloxacin at concentrations of 0.12 to 16 mcg/ml to the test panel
The organisms which may be used for Levofloxacin susceptibility testing in this panel are;
Streptococcus pneumoniae (including penicillin-resistant strains) Streptococcus pyogenes Streptococcus (Group C/F) Streptococcus (Group G) Streptococcus agalactiae Viridans group streptococci
Fiedler Pool.
(Division Sign-Off) Division of Člinical Laboratory Devices
510(k) Number K02 0537
*For Prescription Use Only
§ 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).