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 Quinupristin/Dalfopristin to Pasco panels at concentrations of 8-0.03 mcg/ml for use in determining the susceptibility of Streptococcus pyogenes and Streptococcus agalactiae.

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 a breakdown of the acceptance criteria and study details based on the provided document:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance (S. pneumoniae, N=101)	Reported Device Performance (Non-pneumococcal, N=130)
Acceptable Essential Agreement (EA)	Initial: 93.6% Retesting: 94.8%	98.5%
Major (M), Very Major (VM) or Minor Errors	No major (M), very major (VM) or minor errors observed	No major (M), very major (VM) or minor errors observed
Category Agreement (CA)	100% (with 1 additional random minor error)	100% (with 16 random minor errors, all within EA)
QC Endpoints for S. pneumoniae ATCC 49619	Within recommended NCCLS acceptable range (with 2 exceptions acceptable in subsequent testing)	N/A (specific to S. pneumoniae)
Reproducibility (within ± 1 dilution)	100% (for 12 organisms with on-scale endpoints)	100% (for 12 organisms with on-scale endpoints at each site)

Note: The document explicitly states that the results "supports Substantial Equivalence as outlined in the FDA draft document 'Review Criteria For Assessment Of Antimicrobial Susceptibility Devices' (May 1991)." This implies the reported device performance met or exceeded the criteria outlined in that FDA document.

Study Details

2. Sample sizes used for the test set and the data provenance:

Test Set (S. pneumoniae strains): 101 strains
Test Set (Non-pneumococcal strains): 130 strains
Data Provenance: The document states "Comparative testing of the Pasco test panel to a reference panel was performed at two sites using CDC challenge strains and clinical isolates." This indicates the data is from multiple sites, includes both CDC challenge strains (likely standardized, external controls) and clinical isolates (real-world patient samples), making it a prospective study in the sense that these specific tests were conducted for this submission. The country of origin is not explicitly stated, but given the FDA submission, it's highly probable to be the United States.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

The document does not specify the number of experts or their qualifications for establishing the ground truth. It mentions "a reference panel" for comparative testing, implying an established method or standard against which the Pasco panel was compared. This "reference panel" itself would have an established ground truth, likely based on standard microbiological techniques and expert interpretation.

4. Adjudication method for the test set:

The document does not explicitly state an adjudication method (e.g., 2+1, 3+1). The "reference panel" comparison suggests that the standard method's results served as the reference for determining essential agreement and errors. This implies a direct comparison rather than a separate expert adjudication process for the test results.

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. This study is for an Antimicrobial Susceptibility Test (AST) panel, not an AI-assisted diagnostic imaging or interpretation device. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable to this device type. The device provides a quantitative or qualitative measurement of susceptibility, not an image or signal for human interpretation.

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

Yes, in essence. The Pasco MIC and MIC/ID Panels are designed to provide direct measurements of antimicrobial susceptibility. While humans observe visible growth or color changes, the interpretation rules for MIC determination and biochemical identification are predefined in the package insert. The "algorithm" here is the established protocol for interpreting the panel results (e.g., "The lowest concentration of each antimicrobial agent with no apparent visible growth of the test organism is recorded as the minimum inhibitory concentration (MIC)"). The performance metrics (EA, CA, error rates, reproducibility) are based on the panel's ability to produce these results accurately, independent of user-to-user variability in interpretation beyond following the stated protocol.

7. The type of ground truth used:

The ground truth was established by a reference panel to which the Pasco panel was compared. This reference panel represents expert consensus on standard microbiological methods for determining minimum inhibitory concentrations and biochemical identification. These reference methods are typically well-validated and widely accepted within microbiology.

8. The sample size for the training set:

The document does not explicitly mention a "training set" in the context of device development. This is typical for AST panels, which are wet laboratory assays rather than machine learning models. The development process involves chemical and biological optimization, not algorithm training on data in the conventional sense. The "training" would be the initial R&D and optimization of the panel's reagents and concentrations.

9. How the ground truth for the training set was established:

As there's no explicitly defined "training set" as understood in machine learning, there's no ground truth established in that manner. The development and optimization of the Pasco panels would have relied on established microbiological principles and validated reference methods to achieve accurate and reproducible results for antimicrobial susceptibility testing.

Summary

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K992717

NOV - 2 1999

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510(k) SUMMARY (page 1 of 2)

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:

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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:

SUMMARY/CONCLUSION OF SUBSTANTIAL EQUIVALENCE TESTING:

Test panels containing Synercid at concentrations ranging from 8-0.03 mcg/ml were prepared inhouse 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 93.6% upon initial testing and an EA of 94.8% on retesting. No major (M), very major (VM) or minor errors were observed. Category agreement (CA) was 100% with 1 additional random minor error noted. Test results of the 130 non-pneumococcal strains demonstrated acceptable Essential Agreement (EA) of 98.5%. No major (M), very major (VM) or minor errors were observed. Category Agreement (CA) was 100% with 16 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 with the exception of 2 endpoints which were acceptable in subsequent testing.

Reproducibility testing of 12 organisms at each site provided 12 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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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV - 2 1999

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

K992717 Re:

Trade Name: PASCO MIC and MIC/ID Panels (Quinupristin/Dalfopristin) Regulatory Class: II Product Code: JTN Dated: August 11, 1999 Received: August 12, 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 Butman

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 Quinupristin/Dalfopristin

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.

Woody Dubois

Division of Cliffical Laboratory Devices 510(k) Number_K9927

Prescription Use ) (Per 21 CFR 801.109) 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).