(74 days)
Not Found
No
The summary describes a standard microdilution method for determining antimicrobial susceptibility and does not mention any AI or ML components.
No.
The device is used to determine the susceptibility of bacteria to antimicrobial agents, which is a diagnostic function, not a therapeutic one.
Yes
Explanation: The device is intended for determining antimicrobial agent susceptibility of Haemophilus spp., which is a specific test used to guide treatment decisions for infections, thus falling under the definition of a diagnostic device.
No
The device description explicitly states "Microdilution Minimum Inhibitory Concentration (MIC) Panels," which are physical laboratory panels used for antimicrobial susceptibility testing. The summary describes the process of incubating these panels and observing growth inhibition, indicating a hardware component is central to the device's function.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "determining quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of Haemophilus spp." This is a classic example of an in vitro test performed on a biological sample (bacterial colonies) to provide information about a patient's potential response to treatment.
- Device Description: The device is described as "Microdilution Minimum Inhibitory Concentration (MIC) Panels." MIC panels are a standard type of IVD used in microbiology laboratories.
- Performance Studies: The performance studies compare the device's performance to a "NCCLS frozen Reference," which is a common practice for validating IVD devices. The metrics reported (Essential Agreement) are also typical for IVD performance evaluation.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K963641) and name (MicroScan® Streptococcus MIC Panel) strongly indicates that this device is being submitted for regulatory clearance as an IVD, likely through the 510(k) pathway, which requires comparison to a legally marketed predicate device.
The information provided clearly aligns with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of this panel is for determining quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of Haemophilus spp.
Product codes (comma separated list FDA assigned to the subject device)
JWY
Device Description
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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 of Haemophilus spp. The external evaluations were designed to confirm the acceptability of the proposed MICroSTREP plus™ Panel - AMPICILLIN, by comparing its performance with an NCCLS frozen Reference.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The MICroSTREP plus™ Panel - AMPICILLIN demonstrated acceptable performance with an overall Essential Agreement of 91.5% when compared with the frozen Reference Panel.
Reproducibility testing demonstrated acceptable results with AMPICILLIN.
Quality Control testing demonstrated acceptable results with AMPICILLIN.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Essential Agreement of 91.5%
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).
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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).
0
K993679
JAN 1 4 2000
510(k) Summary Information:
| Device Manufacturer: Dade MicroScan Inc. | |
|---|---|
| Contact name: | Trevor Wall, Regulatory Affairs Manager |
| Fax: | 916-374-3144 |
| Phone: | 916-374-3332 |
| Date prepared: | October 20, 1999 |
| Product Name: | Microdilution Minimum Inhibitory Concentration (MIC) Panels |
| Trade Name: | MicroScan® MICroSTREP plus™ Panel - Ampicillin |
| Intended Use: | To determine bacterial susceptibility to AMPICILLIN |
| Indication for Use: | For use with Haemophilus spp. |
| Predicate device: | MicroScan® Streptococcus MIC Panel (K963641). |
510(k) Summary:
The proposed MicroScan® MICroSTREP plus™ : AMPICILLIN, demonstrated substantially equivalent performance with Haemophilus isolates when compared with an NCCLS frozen Reference, 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 MICroSTREP plus™ Panel with AMPICILLIN ( 0.015 to 16 mcg/ml).
The external evaluation was conducted with fresh and stock Efficacy isolates and stock Challenge strains of Haemophilus spp. The external evaluations were designed to confirm the acceptability of the proposed MICroSTREP plus™ Panel - AMPICILLIN, by comparing its performance with an NCCLS frozen Reference. The MICroSTREP plus™ Panel - AMPICILLIN demonstrated acceptable performance with an overall Essential Agreement of 91.5% when compared with the frozen Reference Panel.
Reproducibility testing demonstrated acceptable results with AMPICILLIN.
Quality Control testing demonstrated acceptable results with AMPICILLIN.
1
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 stylized image of an eagle with three lines forming its body and head. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
JAN 1 4 2000
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Trevor Wall Regulatory Affairs Manager Dade MicroScan, Inc. 1584 Enterprise Boulevard West Sacramento, California 95691
Re: K993679
Trade Name: MicroScan® MICroSTREP plus™ Panel (Haemophilus/Ampicillin) Regulatory Class: II Product Code: JWY Dated: October 29, 1999 Received: November 1, 1999
Dear Mr. Wall:
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
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 Disease 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 Autman
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):_K99 3679
Device Name: MicroScau MicroScau Micro STREA plus
Indications For Use:
The intended use of this panel is for determining quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of Haemophilus spp.
After incubation in a non-CO2 incubator for 20 - 24 hours, the minimum inhibitory concentration (MIC) for the test organism is determined by observing the lowest antimicrobial concentration showing inhibition of growth.
The two-fold dilutions of AMPICILLIN in the panel range from 0.015 to 16 mcg/ml for testing Haemophilus spp.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Wooley Dubocs
ion of Clinical Laboratory Devices 4611 510(k) Number
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96