(79 days)
Not Found
No
The device description details a traditional, manual method of observing growth and color changes in panels to determine MIC and identification. There is no mention of automated analysis, image processing, or any AI/ML algorithms being used for interpretation. The performance studies focus on agreement with a reference method, not on the performance of an AI/ML model.
No
The device is used to measure the susceptibility of bacteria to antimicrobial agents and determine their biochemical identification, which is for diagnostic purposes, not therapeutic intervention.
Yes
The device's intended use is to measure the susceptibility of bacterial pathogens to antimicrobial agents and determine their biochemical identification, which are diagnostic purposes for guiding treatment decisions.
No
The device description clearly outlines a physical panel containing antimicrobial agents and biochemical substrates, which is inoculated with test organisms and incubated. This involves physical components and processes, not solely 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 is a classic description of an in vitro diagnostic test, performed on biological samples (bacterial pathogens) outside of the body to provide information for diagnosis or treatment.
- Device Description: The description details how the panels are used to test bacterial growth in the presence of antimicrobial agents and observe biochemical changes. This process is performed in a laboratory setting, which is characteristic of IVD testing.
- Performance Studies: The document describes comparative testing using bacterial strains and clinical isolates to evaluate the performance of the device. This type of testing is required for IVD devices to demonstrate their accuracy and reliability.
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 Amoxicillin/ Clavulanic Acid to Pasco panels at concentrations of 0.015/0.0075 to 8/4 mcg/ml for use in determining the susceptibility of S. pneumoniae and non-pneumococcal streptococci.
Product codes
JWY
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 panels are 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
Test results of the 101 S. meumoniae strains demonstrated acceptable Essential Agreement (EA) of 97.4% upon initial testing and 100% upon retesting. Category Agreement (CA) was 100% vith 23 minor errors noted (all of which were within essential agreement). Test results of the 130 non-pneumococcal streptococci strains demonstrated acceptable Essential Agreement (ER) of 99.2% on initial testing. Category Agreement (CA) of the non-pneumococcal strep was 100% with 3 random minor errors noted.
QC endpoints for the QC organism S.pneumoniae ATCC 49619 from both the reference and Pasco panels throughout testing were within the recommended NCCLS acceptable range.
Reproducibility testing of 12 organisms at each site provided 11 organisms with on-scale endpoints. Overall reproducibility data demonstrated 100% within the acceptable plus and 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
Essential Agreement (EA) of 101 S. pneumoniae strains: 97.4% (initial testing) and 100% (retesting)
Category Agreement (CA) of 101 S. pneumoniae strains: 100%
Essential Agreement (ER) of 130 non-pneumococcal streptococci strains: 99.2%
Category Agreement (CA) of non-pneumococcal streptococci strains: 100%
Reproducibility: 100% within plus or minus 1 dilution.
Predicate Device(s)
K982235, K982156, K980955, K974362, K973317, K973695, K972567, K971951, K946126
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
0
@004
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510 (k) Sumary (page : 1 of 2)
DATE:
AUG 26 1990
August 20, 1999
CONTACT PERSON : Linda K. Dillon Chuck Lakel
TRADE NAME OF DEVICE: Pasco MIC and MIC/ID Panels
COMMON NAME: Antimicrobial Susceptibility Test
Class II Antimicrobial Susceptibility Test CLASSIFICATION NAME: Microbiology Panel #83
SUBSTANTIAL EQUIVALENCE:
In review of previous 510(k) notifications for the Pasco MIC and MIC/ID panels (most recently: K982235, July 30, 1998 RE: Minocycline; K982156, July 29, 1998 RE: Cefdinir; K980955 May 18, 1998 RE: Trovafloxacin; 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 premarket 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 the courts.
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 panels are then observed for visible growth or color changes as described in the package insert.
1
510 (k) SUMMARY (page 2 of 2)
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 Amoxicillin/Clavulanic Acid at concentrations ranging from 8/4 to 0.015/0.0075 mcg/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 101 S. meumoniae strains demonstrated acceptable Essential Agreement (EA) of 97.4% upon initial testing and 100% upon retesting. Category Agreement (CA) was 100% vith 23 minor errors noted (all of which were within essential agreement). Test results of the 130 non-pneumococcal streptococci strains demonstrated acceptable Essential Agreement (ER) of 99.2% on initial testing. Category Agreement (CA) of the non-pneumococcal strep was 100% with 3 random minor errors noted.
With amoxicillin/clavulanic acid, antimicrobial activity is due to amoxicillin, so the strains susceptible to amoxicillin are fully susceptible to amoxicillin/clavulanic acid. Amoxicillin/clavulanic acid (Augmentin) is not indicated for treating infections due to S. pneumoniae, S. pyogenes and viridans group streptococci. However, in-vitro susceptibility data are available, BUT THEIR CLINICAL SIGNIFICANCE IS UNKNOWN.
QC endpoints for the QC organism S.pneumoniae ATCC 49619 from both the reference and Pasco panels throughout testing were within the recommended NCCLS acceptable range.
Reproducibility testing of 12 organisms at each site provided 11 organisms with on-scale endpoints. Overall reproducibility data demonstrated 100% 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).
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 26 jago Ms. Linda K. Dillon Technical Manager Pasco Laboratories, Inc. 12750 West Forty-Second Avenue Wheat Ridge, Colorado 80033
Re: K991925
Trade Name: PASCO MIC and MIC/ID Panels Regulatory Class: II Product Code: JWY Dated: June 2, 1999 Received: June 8, 1999
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 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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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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 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
4
Device Nam
PASCO MIC and MIC/ID Panels; Inclusion of Amoxicillin/Clavulanic Acid
ation For Use:
12:41
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 quarted weats and of each of category on and factory of the bacterial
rapidly growing aerobic and facultative and deterning the biochemical identification of those organisms.
This 510(k) notification is for the addition of Amoxicillin/ Clavulanic Acid to Pasco panels at concentrations of 0.015/0.0075 to 8/4 mcg/ml for use in determining the susceptibility of S. pneumoniae and non-pneumococcal streptococci.
With amoxicillin/clavulanic acid, antimicrobial activity is due to
amoxicillin, so the strains susceptible to amoxicillin are fully susceptible to amoxicillin/clavulanic acid. Amoxicillin/clavulanic acid (Augmentin) is not indicated for treating infections due to S. pneumoniae, S. pyogenes and viridans group streptococci. However, in-vitro susceptibility data are available, BUT THEIR CLINICAL SIGNIFICANCE IS UNKNOWN.
Woody Dubose
PRESCRIPTION USE X