(66 days)
No
The device description and performance studies focus on traditional microbiological methods (visual observation of growth and color changes) and do not mention any AI or ML components.
No
This device is for determining the susceptibility of bacteria to antimicrobial agents, which is a diagnostic purpose, not a therapeutic one.
Yes
The device is used for "quantitatively measuring ... the susceptibility of rapidly growing aerobic and facultative anaerobic bacterial pathogens to a battery of antimicrobial agents and determining the biochemical identification of those organisms," which directly relates to diagnosing bacterial infections and guiding treatment.
No
The device description clearly outlines a physical panel with dispensed antimicrobial agents that are frozen, thawed, inoculated, incubated, and then visually observed for growth or color changes. This involves physical components and processes, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the panels are used for "quantitatively measuring... the susceptibility of rapidly growing aerobic and facultative anaerobic bacterial pathogens to a battery of antimicrobial agents and determining the biochemical identification of those organisms." This describes a test performed in vitro (outside the body) on biological samples (bacterial pathogens) to provide information about a patient's condition (susceptibility to antibiotics and identification of the organism).
- Device Description: The description details a laboratory test procedure involving dispensing antimicrobial agents into panels, inoculating with test organisms, incubation, and observation for growth or color changes. This is a typical in vitro diagnostic process.
- Performance Studies: The document describes "Comparative testing" using "CDC challenge strains and clinical isolates," which are standard practices for evaluating the performance of in vitro diagnostic devices. The metrics reported (Essential Agreement, Category Agreement, Reproducibility) are also common performance indicators for IVDs.
Therefore, based on the provided information, the Pasco MIC and MIC/ID panels clearly fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
PASCO MIC AND MIC/ID PANELS are used for quantitatively measuring (with the exception of the Breakpoint/ID panel which provides qualitative measurement or category results) the susceptibility of rapidly growing aerobic and facultative anaerobic bacterial pathogens to a battery of antimicrobial agents and determining the biochemical identification of those organisms.
This 510(k) notification is for the addition of Trovafloxacin to Pasco panels at concentrations of 0.03 to 16 mcg/ml for use in determining the susceptibility of C. freundi, E. aerogenes, E. coli, K. pneumoniae, Morganella morganii, P. mirabilis, P. vulgaris, P. aeruginosa, E. faecalis and methicillin susceptible strains of S. aureus and S. evidermidis. Clinical testing of S. pneumoniae with Trovafloxacin has not been performed with the Pasco system.
Product codes
JTN
Device Description
Varying concentrations of antimicrobial agents (usually in two-fold dilutions) are dispensed into the Pasco panels and the panels are then frozen. Panels are thawed prior to use, inoculated with the test organisms, incubated the traditional 16-24 hours and then observed for visible growth or color changes as described in the package insert.
The lowest concentration of each antimicrobial agent with no apparent visible growth of the test organism is recorded as the minimum inhibitory concentration (MIC). Changes in pH and production of specific metabolites from growth in biochemical substrates are interpreted as described in the package insert for conventional tubed media.
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
Comparative testing of the Pasco test panel to a reference panel was performed at two sites using CDC challenge strains and clinical isolates.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Test results of the gram-negative isolates demonstrated acceptable Essential Agreement (EA) of 99.7%. No Major (M) or Very Major (VM) errors were observed. Category Agreement (CA) was 97% with ten random minor errors noted.
Test results of the gram-positive isolates demonstrated acceptable Essential Agreement (EA) of 99.6% on initial testing and 100% after retesting. One Major error was observed on initial testing of Enterococcus faecalis, however this was resolved upon retest. Category Agreement (CA) was 98% with five random errors noted.
QC endpoints from both the reference and Pasco panels throughout testing were within the recommended acceptable ranges listed in the product information and NCCLS. Reproducibility testing at each site demonstrated 99.5% within the acceptable plus or minus 1 dilution.
The results of the clinical testing, reproducibility testing and QC performance testing supports Substantial Equivalence as outlined in the FDA draft document "Review Criteria For Assessment Of Antimicrobial Susceptibility Devices" (May 1991).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Essential Agreement (EA) of 99.7% for gram-negative isolates.
Category Agreement (CA) was 97% for gram-negative isolates.
Essential Agreement (EA) of 99.6% on initial testing and 100% after retesting for gram-positive isolates.
Category Agreement (CA) was 98% for gram-positive isolates.
Reproducibility testing at each site demonstrated 99.5% within the acceptable plus or minus 1 dilution.
Predicate Device(s)
K974362, K973317, K973695, K972567, K971951, K946126
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.1620 Antimicrobial susceptibility test disc.
(a)
Identification. An antimicrobial susceptibility test disc is a device that consists of antimicrobic-impregnated paper discs used to measure by a disc-agar diffusion technique or a disc-broth elution technique the in vitro susceptibility of most clinically important bacterial pathogens to antimicrobial agents. In the disc-agar diffusion technique, bacterial susceptibility is ascertained by directly measuring the magnitude of a zone of bacterial inhibition around the disc on an agar surface. The disc-broth elution technique is associated with an automated rapid susceptibility test system and employs a fluid medium in which susceptibility is ascertained by photometrically measuring changes in bacterial growth resulting when antimicrobial material is eluted from the disc into the fluid medium. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.(b)
Classification. Class II (performance standards).
0
PASCO LABORATORIES
12750 WEST FORTY-SECOND AVENUE WHEAT RIDGE, COLORADO 80033 (303) 423-9504 0-321-9813 X (303) 467-2313
A Subsidiary of DHF
MAY 1 8 1998
510(k) SUMMARY (page 1 of 2)
DATE:
March 12, 1998
CONTACT PERSON:
Linda K. Dillon Barbara C. Lamoureux
Pasco MIC and MIC/ID Panels
TRADE NAME OF DEVICE:
Antimicrobial Susceptibility Test COMMON NAME:
Class II Antimicrobial Susceptibility CLASSIFICATION NAME: Test Microbiology Panel #83
SUBSTANTIAL EQUIVALENCE:
In review of previous 510(k) notifications for the Pasco MIC and MIC/ID panels (most recently K974362, February 12, 1998 RE: Cefepime; K973317, November 14, 1997 RE: Cefpodoxime; K973695, November 5, 1997 RE: Meropenem; K972567, August 20,1997 RE: Sparfloxacin; K971951, August 15, 1997 RE: Levofloxacin; and K946126, January 17, 1995 RE: Detection of Resistant pneumococci), the FDA has determined the Pasco panels to be substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments.
The term "substantial equivalence" as used in this 510(k) notification is limited to the definition of substantial equivalence as found in the Federal Food, Drug, and Cosmetic Act, as amended and as applied under 21 CFR 807, Subpart E under which a device can be marketed without pre-market approval or reclassification. A determination of substantial equivalency under this notification is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statements related to, or in support of substantial equivalence herein shall be construed as an admission against interest under the US Patent Laws or their application by
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510(k) SUMMARY (page 2 of 2)
(3)
DESCRIPTION OF THE DEVICE:
Varying concentrations of antimicrobial agents (usually in two-fold dilutions) are dispensed into the Pasco panels and the panels are then frozen. Panels are thawed prior to use, inoculated with the test organisms, incubated the traditional 16-24 hours and then observed for visible growth or color changes as described in the package insert.
The lowest concentration of each antimicrobial agent with no apparent visible growth of the test organism is recorded as the minimum inhibitory concentration (MIC). Changes in pH and production of specific metabolites from growth in biochemical substrates are interpreted as described in the package insert for conventional tubed media.
INTENDED USE FOR THE PASCO MIC AND MIC/ID PANELS: PASCO MIC AND MIC/ID PANELS are used for quantitatively measuring (with the exception of the Breakpoint/ID panel which provides qualitative measurement or category results) the susceptibility of rapidly growing aerobic and facultative anaerobic bacterial pathogens to a battery of antimicrobial agents and determining the biochemical identification of those organisms.
SUMMARY/CONCLUSION OF SUBSTANTIAL EQUIVALENCE TESTING: Test panels containing Trovafloxacin at concentrations ranging from 16 to 0.03 mcq/ml were prepared in-house at Pasco using routine manufacturing procedures. Comparative testing of the Pasco test panel to a reference panel was performed at two sites using CDC challenge strains and clinical isolates.
Test results of the gram-negative isolates demonstrated acceptable Essential Agreement (EA) of 99.7%. No Major (M) or Very Major (VM) errors were observed. Category Agreement (CA) was 97% with ten random minor errors noted.
Test results of the gram-positive isolates demonstrated acceptable Essential Agreement (EA) of 99.6% on initial testing and 100% after retesting. One Major error was observed on initial testing of Enterococcusfaecalis, however this was resolved upon retest. Category Agreement (CA) was 98% with five random errors noted.
QC endpoints from both the reference and Pasco panels throughout testing were within the recommended acceptable ranges listed in the product information and NCCLS. Reproducibility testing at each site demonstrated 99.5% within the acceptable plus or minus 1 dilution.
The results of the clinical testing, reproducibility testing and QC performance testing supports Substantial Equivalence as outlined in the FDA draft document "Review Criteria For Assessment Of Antimicrobial Susceptibility Devices" (May 1991).
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an abstract symbol that resembles a stylized human figure.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 1 8 1998
Linda K. Dillon Technical Manager Pasco Laboratories, Inc. 12750 West Forty-Second Avenue Wheat Ridge, Colorado 80033
Re: K980955
Trade Name: Pasco MIC and MIC/ID Panels/Trovafloxacin Regulatory Class: II Product Code: JTN Dated: March 12, 1998 Received: March 13, 1998
Dear Ms. Dillon:
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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (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
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 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
4
Device Name:
PASCO MIC and MIC/ID Panels; Inclusion of Trovafloxacin
Indication For Use:
Pasco MIC and MIC/ID panels are used for quantitatively measuring (with the exception of the Breakpoint/ID panel which provides qualitative measurement of category results) the susceptibility of rapidly growing aerobic and facultative anaerobic bacterial pathogens to a battery of antimicrobial agents and determining the biochemical identification of those organisms.
This 510(k) notification is for the addition of Trovafloxacin to Pasco panels at concentrations of 0.03 to 16 mcg/ml for use in determining the susceptibility of C. freundi, E. aerogenes, E. coli, K. pneumoniae, Morganella morganii, P. mirabilis, P. vulgaris, P. aeruginosa, E. faecalis and methicillin susceptible strains of S. aureus and S. evidermidis. Clinical testing of S. pneumoniae with Trovafloxacin has not been performed with the Pasco system.
Woody Dubois
n of Clinical Laboratory Devices 510(k) Number
801.109 1