(79 days)
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.
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.
This document describes the validation of the Pasco MIC and MIC/ID Panels for antimicrobial susceptibility testing, specifically for the inclusion of Amoxicillin/Clavulanic Acid.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Essential Agreement (EA) | Not explicitly stated but generally high (e.g., >90-95%) | S. pneumoniae: 97.4% (initial), 100% (retesting) |
| Non-pneumococcal streptococci: 99.2% (initial) | ||
| Category Agreement (CA) | Not explicitly stated but generally high (e.g., >90-95%) | S. pneumoniae: 100% (with 23 minor errors) |
| Non-pneumococcal streptococci: 100% (with 3 random minor errors) | ||
| Reproducibility | 100% within acceptable plus or minus 1 dilution | 100% within +/- 1 dilution (11 of 12 organisms with on-scale endpoints) |
| QC Endpoints | Within recommended NCCLS acceptable range | Within recommended NCCLS acceptable range |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size:
- Streptococcus pneumoniae: 101 strains
- Non-pneumococcal streptococci: 130 strains
- Data Provenance: The study was conducted at "two sites" using "CDC challenge strains and clinical isolates." This suggests a combination of laboratory-controlled and potentially real-world (clinical isolates) data. The country of origin is not explicitly stated but implies U.S. context given the FDA submission. The nature of "challenge strains" and "clinical isolates" indicates a prospective or pseudo-prospective approach for the testing phase.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not explicitly state the number or qualifications of experts used to establish the ground truth. However, "reference panel" testing was performed, implying that comparison was made against an established, validated method or panel. This "reference panel" likely represents the 'ground truth' and would have been interpreted by trained laboratory personnel or microbiologists.
4. Adjudication Method for the Test Set
The document does not specify a formal adjudication method (like 2+1 or 3+1). The comparison was made against a "reference panel." Any discrepancies would likely have been resolved by reviewing the results against the reference method's interpretation, possibly with retesting, as indicated by the "retesting" for S. pneumoniae.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or described. This study focuses on the standalone performance of the Pasco panels against a reference method, not on human reader performance with or without AI assistance.
6. Standalone Performance
Yes, a standalone performance study was done. The study directly compared the Pasco MIC and MIC/ID Panels (algorithm/device) to a "reference panel" to assess their accuracy in determining antimicrobial susceptibility.
7. Type of Ground Truth Used
The ground truth used was based on a reference panel. This implies that the results from the Pasco MIC/ID panels were compared to an established, gold-standard method for determining minimum inhibitory concentrations (MICs) and category results for antimicrobial susceptibility. This is a common practice in in-vitro diagnostic device validation.
8. Sample Size for the Training Set
The document does not provide information about a separate "training set" or its sample size. This type of device (antimicrobial susceptibility panel) typically relies on pre-defined chemical reactions and measurements rather than machine learning algorithms that require explicit training sets. The "Pasco MIC and MIC/ID Panels" are described as containing varying concentrations of antimicrobial agents, suggesting a fixed-format assay rather than an adaptive, learnable system.
9. How the Ground Truth for the Training Set Was Established
Since no separate training set is mentioned or implied for an AI/machine learning model, the concept of establishing ground truth for a training set is not applicable here. The device's "training" or development would have involved optimizing the chemical formulations, concentrations, and interpretive rules based on established microbiological principles and validated reference methods.
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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.
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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).
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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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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
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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
§ 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).