(470 days)
Not Found
No
The device description details a manual broth dilution method with visual reading of results after incubation. There is no mention of automated analysis, algorithms, or any technology that would suggest the use of AI or ML.
No.
The device is used to determine bacterial susceptibility to antimicrobial agents, which aids in diagnosis and treatment selection, but it does not directly treat or prevent a disease or condition.
Yes
The device determines bacterial susceptibility to antimicrobials, which is a diagnostic process to identify effective treatments.
No
The device description clearly describes a physical panel with dehydrated antimicrobial agents that are rehydrated and incubated. The MIC is then manually 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 clearly states that the device is used to "determine bacterial susceptibility to Levofloxacin" and "for determining antimicrobic susceptibility of aerobic non-enterococcal streptococci including Streptococcus pneumoniae." This involves testing biological samples (bacterial colonies) in vitro (outside the body) to provide information about a patient's potential response to an antimicrobial agent.
- Device Description: The description details a miniaturized broth dilution susceptibility test where bacterial colonies are grown and then exposed to different concentrations of antimicrobial agents in a panel. This process is performed in vitro to assess the bacteria's susceptibility.
- Performance Studies: The performance studies compare the device's performance to a "frozen Reference panel," which is a standard method for in vitro susceptibility testing. The metrics used (Essential Agreement) are also relevant to the performance of in vitro diagnostic tests.
- Predicate Device: The predicate device listed is the "MicroScan® Streptococcus MIC panel," which is also an IVD used for antimicrobial susceptibility testing.
All of these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
To determine bacterial susceptibility to Levofloxacin
For determining antimicrobic susceptibility of aerobic non-enterococcal streptococci including Streptococcus pneumoniae.
The MicroScan® MICroSTREP plus™ Panel is used to determine quantitative andor qualitative and/or qualitative The MicroScan® MICHS ITCLT plas - 1 ater is asoc to allet media of aerobic non-entercococcal antimicrobial agent susceptibility of colonies grown on solid media organizator f antiniticroolat agent susceptioning of collection, panels are incubation, panels are the siteplococci, including or epice oose proam. Incubator, and read visually according to the Package Insert.
This particular submission is for the addition of the antimicrobial Levofloxacin at concentrations of 0.002 - 16 mcg/ml to the test panel
The organisms which may be used for Levofloxacin susceptibility testing in this panel are; I it organismis without may treptococci including Streptococcus pneumoniae.
Product codes
JWY
Device Description
MicroScan® MICroSTREP plus™ Panels are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic nonenterococcal streptococci, including Streptococcus pneumoniae.
The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test that have been diluted in water and dehydrated. 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), after inoculation of the broth with a standardized suspension of the organism. 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
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 "Review Criteria for Assessment of Antimicrobial Susceptibility Devices" (dated May 31, 1991).
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 with Levofloxacin.
Quality Control testing demonstrated acceptable results for Levofloxacin.
Key Metrics
Essential Agreement of 99%
Predicate Device(s)
MicroScan® Streptococcus MIC panel (K963641)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
FEB 1 8 2000
510(k) Summary
510(k) Submission Information:
| Device Manufacturer: | Dade MicroScan Inc. |
|---|---|
| Contact name: | Cynthia Van Duker, Sr. Associate, Regulatory Affairs |
| Fax: | 916-374-3144 |
| Date prepared: | January 17, 2000 |
| 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 of aerobic non-enterococcal |
| streptococci including Streptococcus pneumoniae. | |
| Predicate device: | MicroScan® Streptococcus MIC panel (K963641) |
510(k) Summary:
MicroScan® MICroSTREP plus™ Panels are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic nonenterococcal streptococci, including Streptococcus pneumoniae.
The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test that have been diluted in water and dehydrated. 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), after inoculation of the broth with a standardized suspension of the organism. 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 "Review Criteria for Assessment of Antimicrobial Susceptibility Devices" (dated May 31, 1991).
The Premarket Notification (510[k]) presents data in support of the new MicroScan® 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 with Levofloxacin.
Quality Control testing demonstrated acceptable results for Levofloxacin.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB 1 8 2000
Ms. Cynthia Van Duker Sr. Associate Regulatory Affairs Dade Microscan, Inc. 1584 Enterprise Boulevard West Sacramento, California 95691
Re: K983943
Trade Name: MicroScan® MICroSTREP plus™ Panel (Levofloxacin) Regulatory Class: II Product Code: JWY Dated: January 17, 2000 Received: January 18, 2000
Dear Ms. Van Duker:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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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 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 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
3
Page _ of _
| 510(k) Number (if known): | K983943 |
|---|---|
| Device Name: | MicroSTREP plus Panel - Levofloxacin |
Indications For Use:
The MicroScan® MICroSTREP plus™ Panel is used to determine quantitative andor qualitative and/or qualitative The MicroScan® MICHS ITCLT plas - 1 ater is asoc to allet media of aerobic non-entercococcal
antimicrobial agent susceptibility of colonies grown on solid media organizator f antiniticroolat agent susceptioning of collection, panels are incubation, panels are the siteplococci, including or epice oose proam. Incubator, and read visually according to the Package Insert.
This particular submission is for the addition of the antimicrobial Levofloxacin at concentrations of 0.002 - 16 mcg/ml to the test panel
The organisms which may be used for Levofloxacin susceptibility testing in this panel are; I it organismis without may treptococci including Streptococcus pneumoniae.
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Woody Dubois
510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)