(63 days)
Not Found
No
The summary describes a standard antimicrobial susceptibility testing panel and does not mention any AI or ML components. The performance studies compare the device to a reference panel, which is typical for this type of device.
No
This device is for in-vitro diagnostic use, specifically to determine bacterial susceptibility to an antimicrobial agent, which identifies if the drug will be effective in a patient but does not directly provide therapy.
Yes
The device determines gram-positive bacterial susceptibility against an antimicrobial agent, which is a diagnostic function used to guide treatment decisions.
No
The device description explicitly states "Microdilution Minimum Inhibitory Concentration (MIC) Panels, MicroScan® Dried Gram-Positive MIC/Combo Panels," which are physical laboratory panels used for testing, indicating it is a hardware device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "determine gram-positive bacterial susceptibility against the antimicrobial agent Levofloxacin." 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: The device is described as "Microdilution Minimum Inhibitory Concentration (MIC) Panels." MIC panels are a standard method used in clinical microbiology laboratories to determine the lowest concentration of an antimicrobial agent that inhibits the visible growth of a microorganism. This is a classic example of an in vitro diagnostic test.
- Performance Studies: The performance studies describe comparing the device's performance to a "NCCLS frozen Levofloxacin Reference panel," which is another type of IVD used for the same purpose. The metrics reported (Essential Agreement) are also typical for evaluating the performance of IVD devices.
The information provided clearly indicates that this device is designed to be used in vitro to diagnose or provide information about a medical condition (bacterial infection and its susceptibility to an antibiotic).
N/A
Intended Use / Indications for Use
To determine antimicrobial agent susceptibility.
To determine gram-positive bacterial susceptibility against the antimicrobial agent Levofloxacin. Organisms with indications for testing* include:
Levofloxacin Gram-Positive Bacteria Enterococcus faecalis Staphylococcus aureus Streptococcus pyogenes
- As taken from the Indications and Usage section of the manufacturers' package insert (Ortho-McNeil).
Product codes
JWY, LRG
Device Description
The proposed MicroScan® Dried Gram-Positive MIC/Combo Panel with Levofloxacin demonstrated substantially equivalent performance when compared with an NCCLS frozen Levofloxacin 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 a new antimicrobial Levofloxacin, for the MicroScan® Dried Gram-Positive MIC/Combo Panels.
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
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 Levofloxacin panel by comparing its performance with an NCCLS frozen Levofloxacin Reference panel.
The Dried Gram-Positive Levofloxacin panel demonstrated acceptable performance with an overall Essential Agreement of 99.4% when compared with the frozen Levofloxacin Reference panel.
Inoculum and instrument reproducibility testing was conducted; both the Gram-Positive Dried Levofloxacin panels demonstrated acceptable reproducibility and precision, regardless of which inoculum method (i.e., Turbidity and Prompt), or instrument (autoScan-4 and WalkAway Systems) was used.
Quality Control performance was acceptable for both the Gram-Positive Dried Levofloxacin panels.
Key Metrics
Essential Agreement of 99.4%
Predicate Device(s)
NCCLS Frozen Levofloxacin Reference Panels
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
Dade MicroScan Inc. MicroScan Dried Gram Positive MIC/Combo Panels with Levofloxacin Premarket Notification K972688 - Amendment 1 August 29, 1997
SEP - 8 1997
510(k) Summary
DADE INTERNATIONAL
MicroScan Inc 1584 Enterprise Boulevard West Sacramento. CA 95691 916.372.1900
510(k) Submission Information:
| Device Manufacturer: | Dade MicroScan Inc. |
|---|---|
| Contact name: | Sharolyn Lentsch, Sr. Regulatory Affairs Administrator |
| Fax: | 916-374-3144 |
| Date prepared: | July 3, 1997 |
| Product Name: | Microdilution Minimum Inhibitory Concentration (MIC) Panels |
| Trade Name: | MicroScan® Dried Gram-Positive MIC/Combo Panels |
| Intended Use: | To determine antimicrobial agent susceptibility |
| 510(k) Notification: | New antimicrobial - Levofloxacin |
| Predicate device: | NCCLS Frozen Levofloxacin Reference Panels |
510(k) Summary:
The proposed MicroScan® Dried Gram-Positive MIC/Combo Panel with Levofloxacin demonstrated substantially equivalent performance when compared with an NCCLS frozen Levofloxacin 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 a new antimicrobial Levofloxacin, 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 Levofloxacin panel by comparing its performance with an NCCLS frozen Levofloxacin Reference panel.
The Dried Gram-Positive Levofloxacin panel demonstrated acceptable performance with an overall Essential Agreement of 99.4% when compared with the frozen Levofloxacin Reference panel.
Inoculum and instrument reproducibility testing was conducted; both the Gram-Positive Dried Levofloxacin panels demonstrated acceptable reproducibility and precision, regardless of which inoculum method (i.e., Turbidity and Prompt), or instrument (autoScan-4 and WalkAway Systems) was used.
Quality Control performance was acceptable for both the Gram-Positive Dried Levofloxacin panels.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP - 8 1997
Ms. Sharolyn Lentsch Senior Requlatory Affairs Administrator Dade International MicroScan, Inc. 1584 Enterprise Boulevard West Sacramento, California 95691
Re: K972688 MicroScan® Dried Gram Positive MIC/Combo Panels New Trade Name: Antimicrobial - Levofloxacin Regulatory Class: II Product Code: JWY II LRG Dated: July 3, 1997 Received: July 7, 1997
Dear Ms. Lentsch:
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 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 requirement, 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 Reqister. 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 Requlations.
2
Paqe 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 Putman
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
Dade MicroScan Inc. MicroScan Dried Gram Positive MIC/Combo Panels with Levofloxacin Premarket Notification K972688 - Amendment 1 August 29, 1997
Intended Use Statement
510(k) No .:
Device Name:
MicroScan® Dried Gram-Positive MIC/Combo Panels with Levofloxacin (0.015-32 µg/ml)
Indications for Use:
To determine gram-positive bacterial susceptibility against the antimicrobial agent Levofloxacin. Organisms with indications for testing* include:
Levofloxacin Gram-Positive Bacteria Enterococcus faecalis Staphylococcus aureus Streptococcus pyogenes
- As taken from the Indications and Usage section of the manufacturers' package insert (Ortho-McNeil).
Ae R1
/ for Prescription Use
970829L.DOC