(435 days)
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No
The document describes a traditional microdilution panel for antimicrobial susceptibility testing, read visually. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
This device is used for testing antimicrobial susceptibility of bacteria (determining MIC values), not for treating patients. It is a diagnostic device, not a therapeutic one.
Yes
The device is used to determine antimicrobial agent susceptibility, which is a diagnostic function to determine the most effective treatment for an infection.
No
The device description explicitly states "Microdilution Minimum Inhibitory Concentration (MIC) Panels," which are physical panels containing wells with different concentrations of antimicrobial agents. The submission is for the addition of a specific antimicrobial to this physical panel.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The description explicitly states the device is used to "determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media." This is a classic example of an in vitro test performed on biological samples (bacterial colonies) to provide information about a patient's condition (susceptibility to antibiotics).
- Device Description: The device is described as "Microdilution Minimum Inhibitory Concentration (MIC) Panels." These panels are designed to be used in a laboratory setting to perform in vitro tests.
- Performance Studies: The performance studies described involve testing the device against bacterial isolates and comparing the results to a "frozen Reference panel." This is typical of the validation process for an IVD.
- Predicate Device: The mention of a "Predicate Device" (K963641; MicroScan® Streptococcus MIC panel) which is also an IVD, further supports that this device falls into the same category.
The core function of the device is to analyze biological samples (bacterial colonies) outside of the body to provide diagnostic information (antimicrobial susceptibility), which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
To determine bacterial susceptibility to Vancomycin
For determining antimicrobic susceptibility of aerobic non-enterococcal streptococci including 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 non-entercoccal 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 Vancomycin at concentrations of 0.03 - 16 mcg/ml to the test panel.
Product codes (comma separated list FDA assigned to the subject device)
JWY
Device Description
Microdilution Minimum Inhibitory Concentration (MIC) Panels
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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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™ The Shellar overline of Cormance 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 with surproooooan 10 and 11 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 Vancomycin when compared with the frozen Reference panel.
Reproducibility testing demonstrated acceptable reproducibility with Vancomycin.
Quality Control testing demonstrated acceptable results for Vancomycin.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Essential Agreement of 99% for Vancomycin.
Acceptable reproducibility with Vancomycin.
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.
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.
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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).
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§ 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).
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JAN 1 4 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: | December 13, 1999 |
| Product Name: | Microdilution Minimum Inhibitory Concentration (MIC) Panels |
| Trade Name: | MicroScan® MICroSTREP plus™ Panel |
| Intended Use: | To determine bacterial susceptibility to Vancomycin |
| 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:
animaly." morobour - mr. 2700 11:27 pm susceptibility of colonies grown on solid media of aerobic nonenterococcal streptococci, including Streptococcus pneumoniae
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 with surproooooan 10 and 11 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 Vancomycin.
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™ The Shellar overline of Cormance with an NCCLS frozen Reference panel. The MICroSTREP plus™ Panel demonstrated acceptable performance with an overall Essential Agreement of 99% for Vancomycin when compared with the frozen Reference panel.
Reproducibility testing demonstrated acceptable reproducibility with Vancomycin.
Quality Control testing demonstrated acceptable results for Vancomycin.
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three wavy lines emanating from its body, representing the department's mission to promote health and well-being.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN 1 4 2000
Ms. Cynthia Van Duker Sr. Associate Regulatory Affairs Dade Microscan, Inc. 1584 Enterprise Boulevard Wcst Sacramento, California 95691
Re: K983953
K765733 Regulatory Class: II Product Code: JWY Dated: December 13, 1999 Received: December 14, 1999
Dear Ms. Van Duker:
We have reviewed your Section 510(k) notification of intent to market the device referenced We have leviewed your becally brothy not(x) not is substantially equivalent (for the indications for above and we have decemined the us as as as a vices marketed in interstate use stated in the encrosure) to regary the enactment date of the Medical Device Amendments, commerce prior to May 20, 1770, the element with the provisions of the Federal or to devices that flave been reciassinou in acay, therefore, market the device, subject to the Food, Drug, alla Cosmette Act. The general controls provisions of the Act include general connous provisions of the Tet. The general 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 If your device is classified (bee aco viect to such additional controls. Existing major (Premations affecting your device can be found in the Code of Federal Regulations, Title 21, regulations anceling your device can ve read determination assumes compliance with the I arts 600 to 675. A substantially of e requirements, as set forth in the Quality System Current Good Manafacturing Pravises: General regulation (21 CFR Part 820) and that, Regulation (QS inspections, the Food and Drug Administration (FDA) will verify such through perfodic Q5 inspections, the F60 Pregulation may result in regulatory action. In assumptions. I andre to comply with the announcements concerning your device in the Federal addition, IDA may publish farmer announcement notification submission does not Register. Ticase note: this response to your sections 531 through 542 of the Act for devices arrect any obligation you hingin liarion Control provisions, or other Federal laws or regulations.
2
Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Discase Control and Prevention (CDC) at (770)488-7655.
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" (21 CFR 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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/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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Page of
510(k) Number (if known): K 98 3 953 Device Name: MICroSTREP plus " PANEC - VANCOMYCIN
Indications For Use:
The Indications for Use for the test panel are provided below and in the attachment which follows the FDA recommended format.
The MicroScan® MICroSTREP plus™ Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic non-entercoccal 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 Vancomycin at concentrations of 0.03 - 16 mcg/ml to the test panel
The organisms which may be used for Vancomycin susceptibility testing in this panel are;
Aerobic non-enterococcal streptococci, 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
(Division Sign Off)
(Division Sigff)
Division of Clinical Laboratory Devices
510(k) Number K983953
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96