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 Ceftriaxone to Pasco panels at concentrations of 4-0.015 mcg/ml for use in determining the susceptibility of S. pneumoniae and non-pneumococcal streptococci.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Pasco MIC and MIC/ID Panels, specifically for the inclusion of Ceftriaxone:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied from the "Review Criteria For Assessment Of Antimicrobial Susceptibility Devices (May 1991)")	Reported Device Performance (Ceftriaxone in Pasco MIC/ID Panels)
Essential Agreement (EA): Acceptable level (exact percentage not specified, but met)	S. pneumoniae strains (n=101): 99.4% Essential Agreement (EA). No major (M) or very major (VM) errors. No minor errors reported as within EA when describing EA achievement.
Category Agreement (CA): Acceptable level (exact percentage not specified, but met)	N.A.
Major (M) Errors: Zero or an acceptably low number	S. pneumoniae strains (n=101): 0 Major errors.
Very Major (VM) Errors: Zero or an acceptably low number	S. pneumoniae strains (n=101): 0 Very Major errors.
Minor Errors: Acceptable range, often considered within EA for appropriate interpretation	S. pneumoniae strains (n=101): 14 random minor errors were noted; all were within EA.
Essential Agreement (EA): Acceptable level (exact percentage not specified, but met)	Non-pneumococcal strains (n=130): 100% Essential Agreement (EA). No major (M) or very major (VM) errors. No minor errors reported as within EA when describing EA achievement.
Category Agreement (CA): Acceptable level (exact percentage not specified, but met)	N.A.
Major (M) Errors: Zero or an acceptably low number	Non-pneumococcal strains (n=130): 0 Major errors.
Very Major (VM) Errors: Zero or an acceptably low number	Non-pneumococcal strains (n=130): 0 Very Major errors.
Minor Errors: Acceptable range, often considered within EA for appropriate interpretation	Non-pneumococcal strains (n=130): 2 random minor errors were noted; all were within EA.
QC Endpoints (for control organism): Within recommended NCCLS acceptable range	S. pneumoniae ATCC 49619: QC endpoints from both reference and Pasco panels were within the recommended NCCLS acceptable range throughout testing.
Reproducibility: Acceptable agreement (typically +/- 1 dilution)	Reproducibility Testing (12 organisms/site): Overall reproducibility data demonstrated 100% within the acceptable plus or minus 1 dilution.

Note: The document implicitly defines acceptance criteria by stating "acceptable Essential Agreement (EA)" and "acceptable plus or minus 1 dilution" for reproducibility, indicating that these are the targets based on the FDA draft document "Review Criteria For Assessment Of Antimicrobial Susceptibility Devices (May 1991)". Specific percentage thresholds for EA, CA, and error rates are not explicitly stated in this summary.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size:
- S. pneumoniae strains: 101 isolates
- Non-pneumococcal strains: 130 isolates
- Reproducibility testing: 12 organisms at each of two sites (total 24 tests, though results are combined as "100% within acceptable +/- 1 dilution")
- QC organism: S. pneumoniae ATCC 49619
Data Provenance: The study used "CDC challenge strains and clinical isolates." This indicates a mix of well-characterized laboratory strains (CDC challenge strains) and real-world patient samples (clinical isolates). The country of origin is not explicitly stated, but given the submission to the FDA, it's highly likely to be U.S.-based. The study appears to be prospective comparative testing, as it describes "Comparative testing of the Pasco test panel to a reference panel was performed at two sites."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not explicitly state the number of experts used or their qualifications for establishing the ground truth. In antimicrobial susceptibility testing (AST), the "ground truth" is typically established by an independent, validated reference method (e.g., broth microdilution or agar dilution) interpreted by trained laboratory technologists following established guidelines (like NCCLS, now CLSI). The text mentions "a reference panel," which implies such a method was used, but details on who performed or interpreted it are not provided.

4. Adjudication Method for the Test Set

The document does not describe an explicit adjudication method for reconciling discrepancies, such as 2+1 or 3+1. However, the mention of "a reference panel" suggests that the results from the Pasco panel were compared directly to the results from this established reference method, and deviations were categorized as errors (Major, Very Major, Minor). The "ground truth" established by the reference method itself would likely be considered definitive without further adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study is focused on the device's accuracy in determining antimicrobial susceptibility compared to a reference method, not on human reader performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, this study is inherently a standalone performance evaluation of the Pasco MIC and MIC/ID Panels. The device itself performs the susceptibility testing, and the output (MIC values, category results) is then compared to a reference standard. There is no mention of a human-in-the-loop component for the interpretation of the device's primary results in this context; the device provides the MIC, which is then interpreted by a technologist. The comparison is between the device's output and the reference method's output.

7. The Type of Ground Truth Used

The ground truth used was based on a reference panel. This implies a standardized, validated antimicrobial susceptibility testing method (e.g., standard broth microdilution or agar dilution) performed by experts according to established protocols (like those from NCCLS).

8. The Sample Size for the Training Set

The document does not mention a training set or the sample size for a training set. This is not a machine learning or AI-driven device in the contemporary sense. It's a biochemical panel system, and its performance is evaluated against a reference method rather than through a training/validation split. "Test panels containing Ceftriaxone...were prepared in-house at Pasco using routine manufacturing procedures" describes how the test panels themselves were made, not a training process for an algorithm.

9. How the Ground Truth for the Training Set Was Established

As no training set is mentioned for this type of device, the concept of establishing ground truth for a training set is not applicable to this 510(k) summary.

Summary

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K992562

OCT 1 3 1999

510(k) SUMMARY (page 1 of 2)

DATE:	July 30, 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:

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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 Ceftriaxone at concentrations ranging from 4-0.015 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. pneumoniae strains demonstrated acceptable Essential Agreement (EA) of 99.4%. No major (M), very major (VM) or minor errors were observed. Category agreement (CA) was 100% with 14 random minor errors noted (all of which were within EA). Test results of the 130 non-pneumococcal 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 2 random minor errors noted (all of which were within EA).

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 10 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" arranged around the perimeter. Inside the circle is a stylized graphic of three overlapping human profiles, with flowing lines representing hair or movement.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT 1 3 1999

Ms. Linda K. Dillon Technical Manager Pasco Laboratories, Inc. 12750 West Forty-Second Avenue Wheat Ridge, Colorado 80033

Re: · · K992562

Trade Name: Pasco MIC and MIC/ID Panels (Ceftriaxone) Regulatory Class: II Product Code: JTN Dated: July 30, 1999 Received: August 2, 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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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 (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/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:

PASCO MIC and MIC/ID Panels; Inclusion of Ceftriaxone

Indication For Use:

Prescription Use (21 CFR 809.109)

Woody Dubois

Division of Chical Laboratory Devices 510(k) Number _ 19

Regulation Number and Section

§ 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).