(77 days)
Not Found
No
The summary describes a standard microdilution panel for antimicrobial susceptibility testing and does not mention any AI or ML components.
No
The device is an in vitro diagnostic (IVD) device used to determine bacterial susceptibility to antimicrobial agents, not to treat a disease or condition in a patient.
Yes
The device determines the susceptibility of bacteria to an antimicrobial agent, which is a diagnostic function used to guide treatment decisions.
No
The device description explicitly states "Microdilution Minimum Inhibitory Concentration (MIC) Panel," which is a physical laboratory panel used for testing. The performance studies also refer to "Dried Synercid panels," further indicating a hardware component.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "determine gram-positive bacterial susceptibility to the antimicrobial agent Synercid." This is a diagnostic test performed in vitro (outside the body) on a biological sample (bacterial culture) to provide information about a patient's potential response to a specific treatment.
- Device Description: It is described as a "Microdilution Minimum Inhibitory Concentration (MIC) Panel." MIC panels are standard tools used in clinical microbiology laboratories for determining the susceptibility of bacteria to antibiotics, which is a key aspect of in vitro diagnostics.
- Performance Studies: The document describes performance studies comparing the device to a "NCCLS frozen Synercid Reference panel," which is a common practice for validating the performance of IVD devices. The metrics reported (Essential Agreement) are also typical for evaluating the performance of antimicrobial susceptibility testing devices.
- Predicate Device: A predicate device (K983408; Microscan Dried Panels e.g. Trovafloxacin) is listed, which is another strong indicator that this device is being submitted for regulatory review as an IVD, as predicate devices are used to demonstrate substantial equivalence to previously cleared IVDs.
All of these factors point to this device being an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
To determine gram-positive bacterial susceptibility to the antimicrobial agent Synercid. Organisms with indications for testing include: Methicillin-susceptible Staphylococcus aureus Vancomycin resistant Enterococcus faecium Streptococcus pyogenes (Gp.A) Streptococcus agalactiae (Gp.B) Methicillin-resistant Staphylococcus aureus Staphylococcus epidermidis The MicroScan® Dried Gram-Positive MIC/Combo Panels with Synercid are not intended for use with Streptococcus pneumoniae and viridans streptococci.
Product codes (comma separated list FDA assigned to the subject device)
LTT
Device Description
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The proposed MicroScan® Dried Gram-Positive MIC/Combo Panel with Synercid demonstrated substantially equivalent performance when compared with an NCCLS frozen Synercid Reference Panel, as defined in the FDA DRAFT document "Review Criteria for Assessment of Antimicrobial Susceptibility Devices" (dated May 31, 1991). The gram-positive external evaluations were conducted with fresh and stock Efficacy isolates and stock Challenge strains. The external evaluations were designed to confirm the acceptability of the proposed Dried Synercid panels by comparing their performance with an NCCLS frozen Synercid Reference panel. The Dried gram-positive Synercid panel demonstrated acceptable performance with an overall Essential Agreement of 98.4% when compared with the frozen Synercid Reference panel. Inoculum and instrument reproducibility testing was conducted; the gram-positive Dried Synercid panels demonstrated acceptable reproducibility and precision, regardless of which inoculum method (i.e., Turbidity and Prompt), or instrument (autoScan-4 and WalkAway®) was used. Quality Control performance was acceptable for the gram-positive Dried Synercid panels.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Essential Agreement of 98.4%
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.
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
DEC - 2 1999
510(k) Summary
510(k) Submission Information:
| Device Manufacturer: | Dade MicroScan Inc. |
|---|---|
| Contact name: | Trevor Wall, Regulatory Affairs Manager |
| Fax: | 916-374-3144 |
| Date prepared: | September 10, 1999 |
| Product Name: | Microdilution Minimum Inhibitory Concentration (MIC) Panel |
| Trade Name: | MicroScan® Dried Gram-Positive MIC/Combo Panels |
| Intended Use: | To determine microbial susceptibility to Synercid |
| 510(k) Notification: | New antimicrobial - Synercid |
| Predicate device: | Microscan Dried Panels e.g. Trovafloxacin (K983408) |
510(k) Summary:
The proposed MicroScan® Dried Gram-Positive MIC/Combo Panel with Synercid demonstrated substantially equivalent performance when compared with an NCCLS frozen Synercid 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 antimicrobial, Quinupristin/Dalfopristin (Synercid), for the MicroScan® Dried Gram Positive MIC/Combo Panels.
The gram-positive external evaluations were conducted with fresh and stock Efficacy isolates and stock Challenge strains. The external evaluations were designed to confirm the acceptability of the proposed Dried Synercid panels by comparing their performance with an NCCLS frozen Synercid Reference panel.
The Dried gram-positive Synercid panel demonstrated acceptable performance with an overall Essential Agreement of 98.4% when compared with the frozen Synercid Reference panel.
Inoculum and instrument reproducibility testing was conducted; the gram-positive Dried Synercid panels demonstrated acceptable reproducibility and precision, regardless of which inoculum method (i.e., Turbidity and Prompt), or instrument (autoScan-4 and WalkAway®) was used.
Quality Control performance was acceptable for the gram-positive Dried Synercid panels.
1
Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three lines representing its wings and head.
DEC - 2 1999
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: K993102 Trade Name: MicroScan® Dried Gram-Positive MIC/Combo Panels (Synercid) Regulatory Class: II Product Code: LTT Dated: September 14, 1999 Received: September 16, 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.
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 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
3
Intended Use Statement
510(k) No.:
Device Name:
Indications for Use:
MicroScan® Dried Gram-Positive MIC/Combo Panels with Synercid (0.06 - 4 mcg/ml on the gram-positive panels)
To determine gram-positive bacterial susceptibility to the antimicrobial agent Synercid.
Organisms with indications for testing include:
FROM THE INDICATION FOR USE SECTION OF THE MANUFACTURER'S PACKAGE INSERT (7-14-99)
Methicillin-susceptible Staphylococcus aureus Vancomycin resistant Enterococcus faecium Streptococcus pyogenes (Gp.A)
FROM THE MICROBIOLOGY SECTION OF THE MANUFACTURER'S PACKAGE INSERT (7-14-99).
Streptococcus agalactiae (Gp.B) Methicillin-resistant Staphylococcus aureus Staphylococcus epidermidis
The MicroScan® Dried Gram-Positive MIC/Combo Panels with Synercid are not intended for use with Streptococcus pneumoniae and viridans streptococci.
Woody Dubois
PRESCRIPTION USE X
(PER CFR 801.109)
syn510k.doc.DOC