(82 days)
PASCO MC 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 Quinupristin to Pasco panels at concentrations of 8-0.03 mcg/ml for use in determining the susseptibility of Staphylococcus aureus (methicillin-susceptible strains only) and Enterococcus faecium (Vancomycin-resistant and multidrug resistant strains only).
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.
Here's a breakdown of the requested information based on the provided text, focusing on the study conducted for Quinupristin in Pasco MIC and MIC/ID Panels:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implicit from "acceptable" and context) | Reported Device Performance (Gram-Positive Strains) | Reported Device Performance (Gram-Negative Strains) |
|---|---|---|---|
| Essential Agreement (EA) | Acceptable agreement (no explicit %) | 100% | 99.7% (initial), 100% (retesting) |
| Major Errors (M) | No major errors | 0 | 0 |
| Very Major Errors (VM) | No very major errors | 0 | 0 |
| Minor Errors (m) | Acceptable minor errors (within EA) | 4 (within EA) | 1 (within EA) |
| Category Agreement (CA) | Acceptable agreement (no explicit %) | 100% | 100% |
| Reproducibility (% within +/- 1 dilution) | Acceptable (no explicit %) | 99.5% (overall) | 99.5% (overall) |
| QC Endpoints | Within recommended acceptable ranges listed in product information and NCCLS | Within acceptable ranges | Within acceptable ranges |
Note: The document states that performance "supports Substantial Equivalence as outlined in the FDA draft document 'Review Criteria For Assessment Of Antimicrobial Susceptibility Devices' (May 1991)." This FDA document would contain the specific numerical acceptance criteria. Without access to that specific document, the exact numerical thresholds for "acceptable" essential agreement, category agreement, and minor error rates are not explicitly stated in the provided text, but the reported performance achieved "acceptable" status.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size:
- Gram-positive strains: 321
- Gram-negative strains: 334
- Reproducibility testing: 12 organisms at each of two sites (total could be inferred as 24, but specific count for the 99.5% calculation of "5 organisms with on-scale endpoints" is not definitively stated).
- Data Provenance:
- Country of Origin: Not explicitly stated, but the submission is to the FDA (United States) and Pasco Laboratories is in Wheat Ridge, Colorado, suggesting US data.
- Retrospective or Prospective: The test panels were "prepared in-house at Pasco using routine manufacturing procedures" and "Comparative testing... was performed at two sites using CDC challenge strains and clinical isolates." This indicates a prospective study where new test panels were created and tested with specific strains.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not explicitly stated.
- Qualifications of Experts: Not explicitly stated.
4. Adjudication Method for the Test Set
- Adjudication Method: Not explicitly described. The comparison was to a "reference panel," implying a comparison to an established method (the "ground truth"). The text doesn't detail how discrepancies between the test panel and reference panel were resolved or adjudicated beyond the listed error types (Major, Very Major, Minor).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
- MRMC Study: No. This document describes the performance of an Antimicrobial Susceptibility Test device (a laboratory test) against a reference method, not an AI-assisted diagnostic imaging or interpretation system involving human readers. Therefore, an MRMC study with AI assistance is not applicable here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Yes, in a sense. The Pasco MIC and MIC/ID Panels are designed to automatically determine the MIC based on visible growth or color changes, and then those results are interpreted. The comparative testing described is essentially a standalone performance evaluation of the device's ability to accurately determine MIC and category results compared to a reference method. It's an algorithm/device-only performance in the context of the assay's output.
7. The Type of Ground Truth Used
- Type of Ground Truth: "Reference panel." This refers to a comparison against an established, validated method for determining antimicrobial susceptibility, implicitly considered the gold standard for this type of testing. "CDC challenge strains" were also used, which are characterized strains with known susceptibilities, further strengthening the ground truth.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not explicitly stated. The document describes the testing of the device for a specific antimicrobial (Quinupristin), not the development or training of the device itself. The Pasco MIC and MIC/ID panels are established devices, and this submission is for the addition of a new antimicrobial. Therefore, it's unlikely a "training set" in the machine learning sense was used for this specific submission. The "routine manufacturing procedures" and "CDC challenge strains" suggest a validation and verification process, not an iterative training process for an algorithm.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as no training set (in the machine learning sense) is described for this specific submission. The established "reference panel" and "CDC challenge strains" would serve as the basis for validating the performance of newly included antimicrobial agents.
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NOV - 3 1999
Image /page/0/Picture/2 description: The image shows the text "510(k) SUMMARY" in bold, followed by the text "(page 1 of 2)" in a smaller font size. The text indicates that the image is a summary document related to a 510(k) submission, and it is the first page of a two-page document. The text is centered and appears to be extracted from a larger document.
| DATE: | August 11, 1999 |
|---|---|
| CONTACT PERSON: | Linda K. DillonChuck Lakel |
| TRADE NAME OF DEVICE: | Pasco MIC and MIC/ID Panels |
| COMMON NAME: | Antimicrobial Susceptibility Test |
| CLASSIFICATION NAME: | Class II Antimicrobial Susceptibility Test 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 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 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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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 MC 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 Quinupristin at concentrations ranging from 8-0.03 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 321 gram-positive strains demonstrated acceptable Essential Agreement (EA) of 100%; No major (M), very major (VM) or minor errors were observed. Category Agreement (CA) was 100% with four random minor errors noted (all of which were within EA).
Test results of the 334 gram-negative strains demonstrated acceptable Essential Agreement (EA) of 99.7% upon initial testing and an EA of 100% on retesting. No major (M), very major (VM) or minor errors were observed. Category agreement (CA) was 100% with one random minor error noted (which was within EA).
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 of 12 organisms at each site provided 5 organisms with on-scale endpoints. Overall reproducibility data 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 a black and white logo for the Department of Health & Human Services - ISSA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - ISSA" arranged around the top half of the circle. Inside the circle is a stylized symbol consisting of three curved lines that resemble a human figure or a bird in flight.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV - 3 1999
Ms. Linda K. Dillon Technical Manager Pasco Laboratories, Inc. 12750 West Forty-Second Avenue Wheat Ridge, Colorado 80033
Re: K992726
Trade Name: PASCO MIC and MIC/ID Panels (Quinupristin/dalfopristin) Regulatory Class: II Product Code: JTN Dated: August 11, 1999 Received: August 13, 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 (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 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
Enclosure
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Device Name:
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.
PASCO MIC and MIC/ID Panels;
Inclusion of Quinupristin/dalfopristin
This 510(k) notification is for the addition of Quinupristin to Pasco panels at concentrations of 8-0.03 mcg/ml for use in determining the susseptibility of Staphylococcus aureus (methicillin-susceptible strains only) and Enterococcus faecium (Vancomycin-resistant and multidrug resistant strains only).
Woody Dubois
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K992726
Prescription Use Y (Per 21 CFR 801.109)
OR
Over-The Counter Use
(Optional Format 1-2-96)
§ 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).