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 Chloramphenicol to Pasco panels at concentrations of 16-0.12 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

Based on the provided text, here's an analysis of the acceptance criteria and the study that proves the device meets them:

Device: Pasco MIC and MIC/ID Panels (specifically for Chloramphenicol testing)
Intended Use: Quantitatively measuring the susceptibility of rapidly growing aerobic and facultative anaerobic bacterial pathogens to antimicrobial agents and determining their biochemical identification. This specific 510(k) is for the addition of Chloramphenicol to Pasco panels at concentrations of 16-0.12 mcg/ml for use in determining the susceptibility of S. pneumoniae and non-pneumococcal streptococci.

1. Table of Acceptance Criteria and Reported Device Performance

The study aimed to demonstrate acceptable performance for Essential Agreement (EA) and Category Agreement (CA), and the absence of Major (M), Very Major (VM), or Minor (m) errors. Reproducibility was also assessed.

Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance (S. pneumoniae)	Reported Device Performance (Non-pneumococcal streptococci)
Essential Agreement (EA)	Acceptable (High %)	100%	99.3% (initial), 100% (retesting)
Major Errors (M)	0%	0% (None observed)	0% (None observed)
Very Major Errors (VM)	0%	0% (None observed)	0% (None observed)
Minor Errors (m)	0% (or very low %)	0% (None observed)	0% (None observed)
Category Agreement (CA)	Acceptable (High %)	100%	100%
Random Categorical Errors	Low/Acceptable number	2 (within EA)	3 minor (within EA)
QC Endpoints (S. pneumoniae ATCC 49619)	Within NCCLS acceptable range	Within NCCLS acceptable range	Within NCCLS acceptable range
Reproducibility	100% within +/- 1 dilution	100% within +/- 1 dilution	100% within +/- 1 dilution

Pre-determined Acceptance Criteria (as implied by the "Review Criteria For Assessment Of Antimicrobial Susceptibility Devices (May 1991)"): While specific numerical thresholds for "acceptable" are not explicitly stated in the provided text, the FDA draft document on "Review Criteria For Assessment Of Antimicrobial Susceptibility Devices" (May 1991) would define these, generally expecting high EA and CA (e.g., >90-95%) and very low or zero M/VM errors. The reported performance met these implied criteria.

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

Test Set Sample Sizes:
- S. pneumoniae strains: 101
- Non-pneumococcal streptococci strains: 130
- Reproducibility testing: 12 organisms at each site.
Data Provenance: The comparative testing was performed at "two sites" using "CDC challenge strains and clinical isolates." This indicates a mix of well-characterized reference strains (CDC challenge strains) and real-world specimens (clinical isolates), suggesting a prospective or at least controlled, designed study. The country of origin is not explicitly stated beyond "CDC challenge strains," which implies a US context.

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

The text states that a "reference panel" was used for comparative testing. This "reference panel" would serve as the ground truth.

Number of Experts: Not explicitly stated. The ground truth would typically be established by a reference method, likely performed by trained laboratory personnel following standardized protocols (e.g., broth microdilution or agar dilution as defined by NCCLS/CLSI).
Qualifications of Experts: Not explicitly stated, but assumed to be qualified microbiologists or laboratory technicians proficient in performing and interpreting reference antimicrobial susceptibility testing methods.

4. Adjudication Method for the Test Set

The text does not describe an adjudication method for the test set. Instead, it compares the device's results directly against a "reference panel." This indicates a direct comparison for agreement percentages rather than an independent expert review and adjudication process.

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

No, an MRMC study was not done. This device is an automated antimicrobial susceptibility test system, not an AI-assisted diagnostic imaging tool for human readers. Therefore, the concept of "human readers improve with AI vs. without AI assistance" does not apply here.

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

Yes, a standalone study was performed. The "Pasco test panel" (the device) was directly compared to a "reference panel." The results of the Pasco system, which involves reading of visible growth or color changes as described in the package insert (an automated or semi-automated process for reading results from the panel), were compared to the reference. This is essentially a standalone performance evaluation of the device's ability to determine MICs and categories.

7. The Type of Ground Truth Used

The ground truth was established by results from a reference panel. This reference panel would typically adhere to a recognized standard method for antimicrobial susceptibility testing (e.g., broth microdilution or agar dilution as per NCCLS/CLSI guidelines), which is considered the gold standard for MIC determination.

8. The Sample Size for the Training Set

The text does not mention a training set or a sample size for a training set. This is a traditional IVD device, not a machine learning or AI-based device that typically requires a specific training phase. The device's "training" in a broad sense would be its design, manufacturing, and calibration processes based on established microbiological principles.

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

As no specific training set is mentioned for an AI/ML context, this question is not applicable. The device's functionality is based on established scientific principles of bacterial growth inhibition and biochemical reactions, not on data-driven learning.

Summary

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K992593

OCT 1 4 1999

510(k) SUMMARY (page 1 of 2)

DATE:	August 2, 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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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:

SUMMARY/CONCLUSION OF SUBSTANTIAL EQUIVALENCE TESTING:

Test panels containing Chloramphenicol at concentrations ranging from 16-0.12 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 100%. No major (M), very major (VM) or minor errors were observed. Category agreement (CA) was 100%. Two random categorical errors were noted (both of which were within EA). Test results of the 130 non-pneumococcal streptococci strains demonstrated acceptable Essential Agreement (EA) of 99.3% on initial testing and an EA of 100% on retesting. No major (M), verv major (VM) or minor errors were observed. Category Agreement (CA) was 100% with 3 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 9 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 OC 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 three human profiles facing to the right, with flowing lines beneath them.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT 1 4 1999

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

K992593 Re: Trade Name: PASCO MIC and MIC/ID Panels (Chloramphenicol) Regulatory Class: II Product Code: JTN Dated: August 2, 1999 Received: August 3, 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 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 Chloramphenicol

Woody Dubois

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number: K992593

Prescription Use (Per 21 CFR 801.109) OR

Over-The Counter Use

(Optional Format 1-2-96)

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).