(65 days)
Not Found
No
The device description and performance studies indicate a manual, visual reading of results based on broth dilution, with no mention of automated analysis, image processing, or AI/ML terms.
No.
This device is designed to determine the susceptibility of bacteria to antimicrobial agents, aiding in diagnostic rather than direct therapeutic purposes.
Yes
The device determines bacterial antimicrobial agent susceptibility, which is a diagnostic function used to guide treatment decisions.
No
The device description clearly outlines a physical panel that is inoculated with a bacterial suspension, incubated, and then visually read. This involves physical components and processes, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "determine bacterial antimicrobial agent susceptibility." This is a diagnostic test performed in vitro (outside the body) on a sample (bacterial colonies).
- Device Description: The description details a laboratory test method involving rehydrating panels with broth, inoculating with a standardized suspension of the organism, incubating, and reading the minimum inhibitory concentration (MIC). This is a classic description of an in vitro diagnostic test for antimicrobial susceptibility.
- Performance Studies: The performance studies compare the device's performance to a "frozen Reference panel," which is a standard practice for evaluating the accuracy of IVD tests.
- Predicate Device: The mention of a "Predicate Device" (K963641; MicroScan® Streptococcus MIC Panel) is a strong indicator that this device is being submitted for regulatory review as an IVD, as predicate devices are used for demonstrating substantial equivalence in the IVD regulatory pathway.
All these elements point to the device being an in vitro diagnostic product used to provide information about a patient's condition (specifically, the susceptibility of bacteria isolated from a patient to certain antimicrobial agents).
N/A
Intended Use / Indications for Use
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
Product codes (comma separated list FDA assigned to the subject device)
JWY
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Essential Agreement of >99% for Levofloxacin
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
MicroScan® Streptococcus MIC Panel (K963641).
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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, including |
| 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 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.
1
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.
2
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
3
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