(63 days)
Not Found
NCCLS frozen Sparfloxacin Reference panel
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 using traditional metrics like essential agreement.
No
The device is used to determine bacterial susceptibility to an antimicrobial agent, which is a diagnostic function, not a therapeutic intervention.
Yes
The device determines bacterial susceptibility to an antimicrobial agent, which is a diagnostic function used to guide treatment decisions for infections.
No
The device description explicitly states "Microdilution Minimum Inhibitory Concentration (MIC) Panels," which are physical laboratory panels used for testing. The performance studies also describe comparisons with "frozen Sparfloxacin Reference panel," 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 against the antimicrobial agent Sparfloxacin." This is a diagnostic test performed in vitro (outside the body) on a biological sample (bacteria).
- Device Description: The device is described as "Microdilution Minimum Inhibitory Concentration (MIC) Panels." MIC panels are a standard method used in clinical laboratories to determine the susceptibility of bacteria to antibiotics, which is a key part of the diagnostic process for guiding treatment.
- Performance Studies: The performance studies compare the device to a "NCCLS frozen Sparfloxacin Reference panel," which is a reference standard used in the field of antimicrobial susceptibility testing. This further confirms its role in a diagnostic context.
- Key Metrics: The mention of "Essential Agreement" is a common metric used to evaluate the performance of antimicrobial susceptibility testing devices, indicating how well the device's results agree with a reference method.
All of these elements point to the device being used to perform a diagnostic test on a biological sample outside of the body, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
To determine antimicrobial agent susceptibility
To determine gram-positive bacterial susceptibility against the antimicrobial agent Sparfloxacin. Organisms with indications for testing* include: Sparfloxacin Gram-Positive Bacteria Staphylococcus aureus
Product codes (comma separated list FDA assigned to the subject device)
JWY
Device Description
MicroScan® Dried Gram-Positive MIC/Combo Panels with Sparfloxacin (0.015-32 µg/ml)
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 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 Sparfloxacin panel by comparing its performance with an NCCLS frozen Sparfloxacin Reference panel.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The proposed MicroScan® Dried Gram-Positive MIC/Combo Panel with Sparfloxacin demonstrated substantially equivalent performance when compared with an NCCLS frozen Sparfloxacin Reference Panel, as defined in the FDA DRAFT document "Review Criteria for Assessment of Antimicrobial Susceptibility Devices" (dated May 31, 1991).
The Dried Gram-Positive Sparfloxacin panel demonstrated acceptable performance with an overall Essential Agreement of 98.4% when compared with the frozen Sparfloxacin Reference panel.
Inoculum and instrument reproducibility testing was conducted; the Gram-Positive Dried Sparfloxacin panel 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 the Gram-Positive Dried Sparfloxacin 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.
NCCLS Frozen Sparfloxacin Reference Panels
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).
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Dade MicroScan Inc. MicroScan Dried Gram Positive MIC/Combo Panels with Sparfloxacin Premarket Notification K972524 - Amendment 1 August 29, 1997
SEP - 8 1997
510(k) Summary
DADE INTERNATIONA
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 - Sparfloxacin |
| Predicate device: | NCCLS Frozen Sparfloxacin Reference Panels |
510(k) Summary:
The proposed MicroScan® Dried Gram-Positive MIC/Combo Panel with Sparfloxacin demonstrated substantially equivalent performance when compared with an NCCLS frozen Sparfloxacin 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, Sparfloxacin, 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 Sparfloxacin panel by comparing its performance with an NCCLS frozen Sparfloxacin Reference panel.
The Dried Gram-Positive Sparfloxacin panel demonstrated acceptable performance with an overall Essential Agreement of 98.4% when compared with the frozen Sparfloxacin Reference panel.
Inoculum and instrument reproducibility testing was conducted; the Gram-Positive Dried Sparfloxacin panel 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 the Gram-Positive Dried Sparfloxacin panels.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
DEPARTMENT OF HEALTH & HUMAN SERVICES - USA
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Sharolyn Lentsch Senior Regulatory Affairs Administrator Dade International MicroScan, Inc. 1584 Enterprise Boulevard West Sacramento, California 95691
SEP - 8 1997
K972524 Re: Trade Name: MicroScan® Dried Gram Positive MIC/Combo Panels New Antimicrobial - Sparfloxacin II Product Code: JWY Regulatory Class: LRG II 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 A substantially equivalent determination assumes compliance to 895. 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 requlatory 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 Regulations.
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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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Dade MicroScan Inc. MicroScan Dried Gram Positive MIC/Combo Panels with Sparfloxacin Premarket Notification K972524 - Amendment 1 August 29, 1997
1
Intended Use Statement
| 510(k) No.: | K972524 |
|---|---|
| Device Name: | MicroScan® Dried Gram-Positive MIC/Combo Panels with |
| Sparfloxacin (0.015-32 µg/ml) | |
| Indications for Use: | To determine gram-positive bacterial susceptibility against the |
| antimicrobial agent Sparfloxacin. Organisms with indications for | |
| testing* include: | |
| Sparfloxacin | |
| Gram-Positive Bacteria | |
| Staphylococcus aureus |
- As taken from the Indications and Usage section of the manufacturers' package insert (Rhone Poulenc Rorer Pharmaceuticals for Sparfloxacin).
Rea Pal
(Division Sign-Off) Division of Clinical 510(k) Number
_ For Prescription Use