(73 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 Meropenem at concentrations of 0.03 to 4 mcg/ml to the test panel
The organisms which may be used for Meropenem susceptibility testing in this panel are:
Streptococcus 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°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-CO 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.
Here's an analysis of the acceptance criteria and study detailed in the provided 510(k) summary:
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance (Meropenem) |
|---|---|
| Overall Essential Agreement with NCCLS frozen Reference Panel | 99.1% |
| Reproducibility | Acceptable |
| Quality Control Testing | Acceptable |
Note: The specific numerical threshold for "acceptable" reproducibility and quality control is not explicitly stated in the summary, only that the results were deemed acceptable.
2. Sample Size Used for the Test Set and Data Provenance
The summary does not explicitly state the exact sample size for the test set. It mentions "fresh and stock Efficacy isolates and stock Challenge strains" were used for the external evaluation. The provenance of the data (country of origin, retrospective/prospective) is not specified.
3. Number of Experts and Qualifications for Ground Truth Establishment
The summary does not provide information on 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," implying a standardized, presumably expert-validated, method.
4. Adjudication Method for the Test Set
The summary does not describe an adjudication method for the test set. The external evaluation compared the MicroScan® MICroSTREP plus™ Panel directly against an NCCLS frozen Reference panel.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an in vitro diagnostic (IVD) for antimicrobial susceptibility testing, not a medical imaging or diagnostic device that would typically involve human readers interpreting results in a comparative study.
6. Standalone (Algorithm Only) Performance Study
Yes, a standalone study was conducted. The MicroScan® MICroSTREP plus™ Panel's performance was evaluated by comparing its results directly with an NCCLS frozen Reference Panel. There isn't a "human-in-the-loop" component described for interpreting the panel's results in this evaluation, as the panels are read visually according to the package insert. The comparison is between two automated/semi-automated methods of determining MIC.
7. Type of Ground Truth Used
The ground truth used was an NCCLS frozen Reference Panel. This is a standardized, recognized reference method for antimicrobial susceptibility testing, providing a benchmark for accuracy.
8. Sample Size for the Training Set
The summary does not explicitly mention a "training set" or its sample size. For an IVD device like this, the development process likely involves internal testing and calibration with various strains, but this information is not detailed in the provided 510(k) summary, which focuses on the validation of the final product.
9. How the Ground Truth for the Training Set Was Established
As no specific "training set" is described for this type of device in the summary, information on how its ground truth was established is not provided. The development of such panels would typically involve extensive testing against established reference methods, much like the external evaluation described for the final product.
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JUN 0 3 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 Meropenem |
| 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-CO 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 Meropenem.
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 99.1% for Meropenem when compared with the frozen Reference panel.
Reproducibility testing demonstrated acceptable reproducibility and precision with Meropenen.
Quality Control testing demonstrated acceptable results for Meropenem.
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Image /page/1/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration -2098 Gaither Road Rockville MD 20850
JUN 0 3 2002
Ms. Cynthia Van Duker Regulatory Affairs Manager Dade Behring Inc. 1584 Enterprise Boulevard West Sacramento, CA 95691
Re: K020938
Trade/Device Name: MicroScan® MICroSTREP plus™4 Panels with Meropenem 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 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 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 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 .:
K020938 (To be assigned by FDA)
Device Name:
Intended Use
Indications for Use:
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 Meropenem at concentrations of 0.03 to 4 mcg/ml to the test panel
The organisms which may be used for Meropenem susceptibility testing in this panel are:
Streptococcus pneumoniae (excluding penicillin-resistant strains) Viridans group streptococci
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 | _________________________ |
|---|---|
| --------------- | --------------------------- |
OR
| Prescription Use | ✓ |
|---|---|
| (Per 21 CFR 801.109) |
| 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).