(74 days)
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No
The summary describes a traditional microdilution method for determining antimicrobial susceptibility and compares its performance to a reference panel. There is no mention of AI or ML technologies.
No.
The device is used to determine the susceptibility of bacteria to antimicrobial agents, not to treat a disease or condition in a patient.
Yes
This device, a Microdilution Minimum Inhibitory Concentration (MIC) Panel, determines antimicrobial agent susceptibility and Gram-positive bacterial susceptibility to Meropenem, which is a diagnostic function to guide treatment.
No
The device description explicitly states "Microdilution Minimum Inhibitory Concentration (MIC) Panels" and "MicroScan® Dried Gram-Positive MIC/Combo Panels," which are physical panels containing dried reagents, indicating a hardware component.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "To determine antimicrobial agent susceptibility" and "To determine gram-positive bacterial susceptibility against the antimicrobial agent Meropenem." This clearly indicates the device is used to test samples in vitro (outside the body) to provide information about a patient's condition (specifically, how susceptible their bacteria are to a particular antibiotic).
- Device Description: The device is described as "Microdilution Minimum Inhibitory Concentration (MIC) Panels" and "MicroScan® Dried Gram-Positive MIC/Combo Panels." These are standard types of laboratory tests used for determining bacterial susceptibility.
- Performance Studies: The document describes performance studies comparing the device to a "NCCLS frozen Meropenem Reference panel," which is a common practice for validating IVD devices. The metrics reported (Essential Agreement) are also typical for evaluating the performance of such devices.
- Predicate Device: The mention of "NCCLS Frozen Meropenem Reference Panels" as a predicate device further confirms that this device is being evaluated in the context of existing IVD technology.
All of these factors strongly indicate that this device is an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
To determine antimicrobial agent susceptibility.
To determine gram-positive bacterial susceptibility against the antimicrobial agent Meropenem. Organisms with indications for testing* include: Gram-Positive Bacteria Viridans group streptococci. Although viridans streptococci are indicated for testing* with the antimicrobial agent Meropenem, they are contraindicated for use with Meropenem on MicroScun Dried Gram-Positive MIC/Combo Panels.
- As taken from the Indications and Usage section of each manufacturers' package insert (Zeneca).
Product codes (comma separated list FDA assigned to the subject device)
LTT
Device Description
The proposed MicroScan® Dried Gram-Positive MIC/Combo Panel with Meropenem demonstrated substantially equivalent performance when compared with an NCCLS frozen Meropenem Reference Panel, as defined in the FDA DRAFT document "Review Criteria for Assessment of Antimicrobial Susceptibility Devices" (dated May 31, 1991).
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-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 Meropenem panels by comparing their performance with an NCCLS frozen Meropenem Reference panel.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Dried Gram-Positive Meropenem panel demonstrated acceptable performance with an overall Essential Agreement of 97.2% when compared with the frozen Meropenem Reference panel. Inoculum and instrument reproducibility testing was conducted; both the Gram-Positive Dried Meropenem panels demonstrated acceptable reproducibility and precision, regardless of which inoculum and WalkAway Systems) was used. method (i.e., Turbidity and Prompt), or instrument (autoScan-4. Quality Control performance was acceptable for the Gram-Positive Dried Meropenem panels.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Essential Agreement of 97.2%
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 Meropenem 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
11412199
Dade MicroScan Inc. MicroScan Dried Gram Positive MIC/Combo Panels with Meropenem Premarket Notification July 25, 1997
OCT 10 1997
IA DR
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 25, 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 - Meropenem |
| Predicate device: | NCCLS Frozen Meropenem Reference Panels |
510(k) Summary:
The proposed MicroScan® Dried Gram-Positive MIC/Combo Panel with Meropenem demonstrated substantially equivalent performance when compared with an NCCLS frozen Meropenem 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, Meropenen, 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 Meropenem panels by comparing their performance with an NCCLS frozen Meropenem Reference panel.
The Dried Gram-Positive Meropenem panel demonstrated acceptable performance with an overall Essential Agreement of 97.2% when compared with the frozen Meropenem Reference panel.
Inoculum and instrument reproducibility testing was conducted; both the Gram-Positive Dried Meropenem panels demonstrated acceptable reproducibility and precision, regardless of which inoculum and WalkAway Systems) was used. method (i.e., Turbidity and Prompt), or instrument (autoScan-4
Quality Control performance was acceptable for the Gram-Positive Dried Meropenem panels.
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol. The text is in all caps and is evenly spaced around the circle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 10 1997
· Sharolyn J. Lentsch Sr. Regulatory Affairs Administrator Dade Microscan, Inc. 1584 Enterprise Boulevard West Sacramento, CA 95691
Re: K972799
Trade Name: Dried Gram-Positive MIC/Combo Panels Regulatory Class: II Product Code: LTT Dated: July 25, 1997 Received: July 28, 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 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 vour 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
Dade MicroScan Inc. MicroScan Dried Gram Positive MIC/Combo Pancls with Meropenem Premarket Notification K972799 - Amendment 1 Ocuber 3, 1997
Indications for Use Statement
510(k) No.:
Device Name:
MicroScan® Dried Gram-Positive MIC/Combo Panels with Meropenem (0.06-32 µg/ml)
Indications for Use: To determine gram-positive bacterial susceptibility against the antimicrobial agent Meropenem. Organisms with indications for testing* include:
Gram-Positive Bacteria Viridans group streptococci
Although viridans streptococci are indicated for testing* with the antimicrobial agent Meropenem, they are contraindicated for use with Meropenem on MicroScun Dried Gram-Positive MIC/Combo Panels.
- As taken from the Indications and Usage section of each manufacturers' package insert (Zeneca).
Jean Cooper
(Division Sign-Off) Division of Clinical Laboratory Devices K972799 510(k) Number_
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The Counter Use
(Optional Format 1-2-96)
9710031_DOC
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