(230 days)
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No
The summary describes a traditional microdilution panel for antimicrobial susceptibility testing and does not mention any AI/ML components or methodologies.
No
The device is used for in vitro diagnostic purposes to determine antimicrobial susceptibility and identify bacteria, not to treat a condition.
Yes
The device is used to determine antimicrobial agent susceptibility and/or identification to the species level of gram-negative bacilli, and to screen for suspected extended-spectrum beta-lactamases (ESBLs), which are all diagnostic activities.
No
The device description explicitly states "Microdilution Minimum Inhibitory Concentration (MIC) Panels. MicroScan® Dried Gram Negative MIC/Combo Panels...". This indicates a physical panel with dried antimicrobial agents, which is a hardware component.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's "For use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli." This involves testing biological samples (bacteria) in vitro (outside the body) to provide information for diagnosis and treatment decisions. The new indication for use also focuses on screening for ESBLs in bacterial strains, which is a diagnostic application.
- Device Description: The device is described as "Microdilution Minimum Inhibitory Concentration (MIC) Panels." These panels are used to perform tests on biological samples in a laboratory setting.
- Performance Studies: The performance studies describe testing with bacterial strains and comparing results to "molecular characterization data," which are laboratory-based tests. This further confirms its use in an in vitro setting.
Therefore, the device fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
For use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli.
This submission requests clearance of the following new Indication for Use:
Panels containing Cefpodoxime, Ceftazidime, Aztreonam, Cefotaxime, or Ceftriaxone at 1 ug/ml can be used to screen for Escherichia coli, Klebsiella oxytoca, or K. pneumoniae strains suspected of producing extended-spectrum beta-lactamases (ESBLs).
An alternate method is required for confirmation testing.
Product codes (comma separated list FDA assigned to the subject device)
LRG
Device Description
MicroScan® Dried Gram Negative MIC/Combo Panels with Cefpodoxime, Ceftazidime, Aztreonam, Cefotaxime, Ceftriaxone were cleared for susceptibility testing via Premarket Notification submissions. This Premarket Notification (510/kl) presents data in support of a request for a new indication for use (detection of suspected Escherichia coli, Klebsiella oxytoca, and K. pneumoniae extended spectrum beta-lactamases), similar to that described in the NCCLS documents M7-A4 and M100-S9.
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Efficacy testing with MicroScan® Dried Gram Negative Ceftazidime, Aztreonam, Cefotaxime, Ceftriaxone antimicrobial agents was conducted with ESBL and non-ESBL producing strains and AmpC-type strains. The Efficacy study was designed to confirm the acceptability of the MicroScan® Dried Gram Negative Cefpodoxime, Ceftazidime, Aztreonam, Cefotaxime, Ceftriaxone antimicrobial agents for detection of suspected ESBLs (E. coli, K. oxytoca, and K. pneumoniae) by comparing the panel susceptibility results against previously generated molecular characterization data.
Inoculum and instrument reproducibility testing with the MicroScan® Dried Gram Negative Cefpodoxime, Ceftazidime, Aztreonam, Cefotaxime, Ceftriaxone antimicrobial agents demonstrated acceptable reproducibility with >95% of the results in agreement with the comparative system, regardless of which inoculum method (i.e., Turbidity, Log, and Prompt), or instrument (autoScan®-4 and WalkAway® System) was used.
The MicroScan® Dried Gram Negative Cefpodoxime, Ceftazidime, Aztreonam, Cefotaxime, Ceftriaxone antimicrobial agents demonstrated acceptable Quality Control throughout each phase of the ESBL evaluation.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
acceptable reproducibility with >95% of the results in agreement with the comparative system
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.
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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
Attachment C
DADE MICROSCAN INC. 1584 Enterprise Boulevard West Sacramento, CA 95691 Tel: +1 (916) 372-1900
DADE BEHRING K981199
510(k) Submission Information:
| Device Manufacturer: | Dade MicroScan Inc. |
|---|---|
| Contact name: | Sharolyn Lentsch, Regulatory Affairs Manager |
| Fax: | 916-374-3144 |
| Date prepared: | October 7, 1998 |
| Product Name: | Microdilution Minimum Inhibitory Concentration (MIC) Panels |
| Trade Name: | MicroScan® Dried Gram Negative MIC/Combo Panels with |
| Cefpodoxime, Ceftazidime, Aztreonam, Cefotaxime, Ceftriaxone- | |
| 510(k) Notification: | New Indication for Use |
| Reference method: | Molecular Characterization Tests |
510(k) Summary:
MicroScan® Dried Gram Negative MIC/Combo Panels with Cefpodoxime, Ceftazidime, Aztreonam, Cefotaxime, Ceftriaxone were cleared for susceptibility testing via Premarket Notification submissions. This Premarket Notification (510/kl) presents data in support of a request for a new indication for use (detection of suspected Escherichia coli, Klebsiella oxytoca, and K. pneumoniae extended spectrum beta-lactamases), similar to that described in the NCCLS documents M7-A4 and M100-S9.
Efficacy testing with MicroScan® Dried Gram Negative Ceftazidime, Aztreonam, Cefotaxime, Ceftriaxone antimicrobial agents was conducted with ESBL and non-ESBL producing strains and AmpC-type strains. The Efficacy study was designed to confirm the acceptability of the MicroScan® Dried Gram Negative Cefpodoxime, Ceftazidime, Aztreonam, Cefotaxime, Ceftriaxone antimicrobial agents for detection of suspected ESBLs (E. coli, K. oxytoca, and K. pneumoniae) by comparing the panel susceptibility results against previously generated molecular characterization data.
Inoculum and instrument reproducibility testing with the MicroScan® Dried Gram Negative Cefpodoxime, Ceftazidime, Aztreonam, Cefotaxime, Ceftriaxone antimicrobial agents demonstrated acceptable reproducibility with >95% of the results in agreement with the comparative system, regardless of which inoculum method (i.e., Turbidity, Log, and Prompt), or instrument (autoScan®-4 and WalkAway® System) was used.
The MicroScan® Dried Gram Negative Cefpodoxime, Ceftazidime, Aztreonam, Cefotaxime, Ceftriaxone antimicrobial agents demonstrated acceptable Quality Control throughout each phase of the ESBL evaluation.
1
Public Health Service
Image /page/1/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human figures. The figures are connected at the shoulders and appear to be reaching upwards.
NOV 1 8 1998
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Sharolyn J. Lentsch Regulatory Affairs Manager Dade Microscan, Inc./Dade Behring 1584 Enterprise Boulevard West Sacramento, California 95691
Re: K981199/S1 Trade Name: MicroScan® Dried Gram Negative MIC/Combo Panels Product Code: LRG Regulatory Class: II JWY II Dated: October 7, 1998 October 8, 1998 Received:
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 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 Requlations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. 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 Failure to comply with the GMP regulation may result in assumptions. requlatory 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
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 (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Butman
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
Attachment E
Indications for Use Statement
| 510(k) No.: | To be assigned by FDA |
|---|---|
| Device Name: | MicroScan® Dried Gram Negative MIC/Combo Panels |
| Cefpodoxime (0.015-64 ug/ml) | |
| Ceftazidime (0.5-64 ug/ml) | |
| Aztreonam (0.5-64 ug/ml) | |
| Cefotaxime (1*-64 ug/ml) | |
| Ceftriaxone (1-128 ug/ml) | |
| * 1 ug/ml will be for ESBL screening only. Performance | |
| characteristics with isolates other than E. coli and Klebsiella | |
| spp., have not been established. | |
| Intended Use: | For use in determining antimicrobial agent susceptibility |
| and/or identification to the species level of aerobic and | |
| facultatively anaerobic gram-negative bacilli. | |
| Indications for Use: | This submission requests clearance of the following new |
| Indication for Use: | |
| Panels containing Cefpodoxime, Ceftazidime, Aztreonam | |
| Cefotaxime, or Ceftriaxone at 1 ug/ml can be used to | |
| screen for Escherichia coli, Klebsiella oxytoca, or | |
| K. pneumoniae strains suspected of producing extended- | |
| spectrum beta-lactamases (ESBLs). |
An alternate method is required for confirmation testing.
Woody Dubois
h-Off) ision of Clinical Laboratory Devices 510(k) Number
PRESCRIPTION USE X