(52 days)
NCCLS Frozen Sparfloxacin Reference Panels
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No
The summary describes a traditional antimicrobial susceptibility testing panel and its performance compared to a reference method. There is no mention of AI or ML in the device description, intended use, or performance studies.
No.
The device is used to determine bacterial susceptibility to an antimicrobial agent, which is a diagnostic function rather than a therapeutic one.
Yes
The device determines gram-negative bacterial susceptibility against an antimicrobial agent, which is a diagnostic purpose to guide treatment.
No
The device description explicitly states "Microdilution Minimum Inhibitory Concentration (MIC) Panel, MicroScan® Dried Gram-Negative MIC/Combo Panels," which are physical hardware components used for testing. The performance studies also describe testing with instruments like autoScan-4 and WalkAway Systems.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "To determine gram-negative bacterial susceptibility against the antimicrobial agent Sparfloxacin." This is a diagnostic test performed in vitro (outside of the living body) on a biological sample (bacterial culture) to provide information about a patient's potential response to a specific treatment (Sparfloxacin).
- Device Description: The device is a "Microdilution Minimum Inhibitory Concentration (MIC) Panel." MIC panels are standard tools 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 compare the device's performance to a "NCCLS frozen Sparfloxacin Reference panel," which is a reference standard for determining antimicrobial susceptibility. This comparison is typical for validating an IVD device.
- Key Metrics: The key metric reported is "Essential Agreement," which is a common metric used to evaluate the performance of antimicrobial susceptibility testing devices.
All of these factors strongly indicate that this device is intended for use in a laboratory setting to perform a diagnostic test on a biological sample, 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-negative bacterial susceptibility against the antimicrobial agent Sparfloxacin. Organisms with indications for testing* include: Gram-Negative Bacteria Enterobacter cloacae Klebsiella pneumoniae
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 gram-negative 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 panels by comparing their 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-Negative 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/k1) presents data in support of the new antimicrobial, Sparfloxacin, for the MicroScan® Dried Gram-Negative MIC/Combo Panels.
The gram-negative 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 panels by comparing their performance with an NCCLS frozen Sparfloxacin Reference panel.
The Dried Gram-Negative Spartloxacin panel demonstrated acceptable performance with an overall Essential Agreement of 99.1% when compared with the frozen Sparfloxacin Reference panel.
Inoculum and instrument reproducibility testing was conducted; the Gram-Negative Dried Sparfloxacin 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 the Gram-Negative Dried Sparfloxacin panels.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Essential Agreement of 99.1%
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.
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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).
0
Dade MicroScan Inc. MicroScan Dried Gram-Negative MIC/Combo Panels with Sparfloxacin Premarket Notification June 9, 1997
DADE
AUG - I
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: | June 9, 1997 |
| Product Name: | Microdilution Minimum Inhibitory Concentration (MIC) Panel |
| Trade Name: | MicroScan® Dried Gram-Negative 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:
1 ( F I
F
The proposed MicroScan® Dried Gram-Negative 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/k1) presents data in support of the new antimicrobial, Sparfloxacin, for the MicroScan® Dried Gram-Negative MIC/Combo Panels.
The gram-negative 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 panels by comparing their performance with an NCCLS frozen Sparfloxacin Reference panel.
The Dried Gram-Negative Spartloxacin panel demonstrated acceptable performance with an overall Essential Agreement of 99.1% when compared with the frozen Sparfloxacin Reference panel.
Inoculum and instrument reproducibility testing was conducted; the Gram-Negative Dried Sparfloxacin 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 the Gram-Negative Dried Sparfloxacin panels.
1
Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle's head is on the left side of the image. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Sharolyn J. Lentsch Sr. Regulatory Affairs Administrator Dade MicroScan Inc. 1584 Enterprise Boulevard ---West Sacramento, California 95691
AUG - I 1997
Re: K972180
Trade Name: MicroScan® Dried Gram-Negative MIC/Combo Panels/sparfloxacin Regulatory Class: II Product Code: JWY Dated: June 9, 1997 Received: June 10, 1997
Dear Ms. Lentsch:
【出现场的空】【
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 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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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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 vours.
Steven Sutman
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-Negative MIC/Combo Panels with Sparfloxacin Premarket Notification June 9, 1997
Intended Use Statement
| 510(k) No.: | To be assigned by FDA |
|---|---|
| Device Name: | MicroScan® Dried Gram-Negative MIC/Combo Panels with |
| Sparfloxacin (0.015 - 32 mcg/ml) | |
| Indications for Use: | To determine gram-negative bacterial susceptibility against the |
| antimicrobial agent Sparfloxacin. Organisms with indications for | |
| testing* include: |
Gram-Negative Bacteria
Enterobacter cloacae
Klebsiella pneumoniae |
| | * As taken from the Indications and Usage section of the |
Kayonne Muriel, for Adaleen Penka
(Division Sign Off)
manufacturer's package insert (as provided by the Sparfloxacin
manufacturer, Rhone Poulenc Rorer Pharmaceuticals).
(División Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K972180
Prescription Use j (Per 21 CFR 801.109) OR
Over-The Counter Use _
(Optional Format 1-2-96)
SPAR510K.DOC
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