PASCO MIC AND MIC/ID PANELS by PASCO LABORATORIES, INC.

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 Minocycline to Pasco panels at concentrations of 0.03 to 32 mcg/ml for use in determining the susceptibility of Staphylococcus aureus, Acinetobacter spp., Enterobacter aerogenes, Escherchia coli, Klebsiella spp.and Shigella spp. "Clinical testing of S.pneumoniae with Minocycline has not been performed with the Pasco system".

Device Description

Varying concentrations of antimicrobial agents (usually in twofold 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 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

The provided 510(k) summary describes the acceptance criteria and the study conducted for the Pasco MIC and MIC/ID Panels with the inclusion of Minocycline.

Here's a breakdown of the requested information:

1. Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Target for Substantial Equivalence)	Reported Device Performance (Minocycline on Pasco Panels)
Acceptable Essential Agreement (EA)	Gram-negative strains: 99.8% (initial), 100% (retesting)
No Major (M) errors observed	Gram-negative strains: No Major errors
No Very Major (VM) errors observed	Gram-negative strains: No Very Major errors
Acceptable Category Agreement (CA)	Gram-negative strains: 100% (21 random minor errors noted)
Acceptable Essential Agreement (EA)	Gram-positive strains: 100%
No Major (M) errors observed	Gram-positive strains: No Major errors
No Very Major (VM) errors observed	Gram-positive strains: No Very Major errors
Acceptable Category Agreement (CA)	Gram-positive strains: 100% (6 random minor errors noted)
QC endpoints within recommended ranges (product info & NCCLS)	All QC endpoints within recommended ranges, except 7 within 1 dilution of the mode.
Reproducibility within acceptable +/- 1 dilution	99.5% within acceptable +/- 1 dilution

Note: The document references the "FDA draft document 'Review Criteria For Assessment Of Antimicrobial Susceptibility Devices' (May 1991)" as the basis for these acceptance criteria.

2. Sample Size and Data Provenance

Test Set Sample Size:
- 334 gram-negative strains
- An unspecified number of gram-positive strains (the document states "Test results of the gram-positive Strains demonstrated acceptable Essential Agreement (EA) of 100%," but a specific number is not provided, though it implies a distinct set from the gram-negative strains).
- 12 organisms for reproducibility testing (at each of two sites, totaling 24 independent tests).
Data Provenance: Not explicitly stated in terms of country of origin. The study was performed at "two sites." The data is prospective as it involves comparative testing of newly prepared Minocycline panels against a reference panel. It also used "CDC challenge strains and clinical isolates," indicating a mix of standardized and real-world samples.

3. Number of Experts and Their Qualifications for Ground Truth

This type of study (comparative testing of antimicrobial susceptibility panels) typically does not involve human expert interpretation in the same way as, for example, image analysis. The "ground truth" here is established by the results from a "reference panel."
Therefore, there's no mention of experts establishing ground truth in the traditional sense for the test set. The reference panel itself serves as the gold standard.

4. Adjudication Method for the Test Set

None specified in the context of expert adjudication. The comparison is directly between the Pasco test panel and a "reference panel." Discrepancies (Minor, Major, Very Major errors) are reported based on direct comparison to the reference, not expert reconciliation.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not conducted. This type of study is relevant for evaluating the impact of AI on human reader performance, which is not applicable to the assessment of an antimicrobial susceptibility test panel.

6. Standalone Performance

Yes, a standalone performance evaluation was done. The entire study describes the performance of the Pasco MIC and MIC/ID panel (the device) in determining antimicrobial susceptibility on its own, compared to a reference standard. The reported Essential Agreement, Category Agreement, and error rates are measures of its standalone diagnostic accuracy. There is no human-in-the-loop component described for these performance metrics.

7. Type of Ground Truth Used

The ground truth used was established by a "reference panel." This is a well-accepted methodology in microbiology for validating new antimicrobial susceptibility testing devices, where a validated, often manual or established automated, method serves as the gold standard. The document also mentions "CDC challenge strains," indicating the use of well-characterized reference strains with known susceptibility profiles.

8. Sample Size for the Training Set

The document does not specify a training set sample size. This is because the device described is a physical diagnostic panel that relies on bacterial growth/inhibition and biochemical reactions, not a machine learning algorithm that requires a separate training phase. The manufacturing procedures and panel design are based on established microbiological principles, not data-driven model training.

9. How Ground Truth for the Training Set Was Established

As there is no "training set" in the context of machine learning, this question is not applicable. The underlying principles of antimicrobial susceptibility testing (e.g., minimum inhibitory concentration definitions, biochemical reactions) are well-established "ground facts" in microbiology, upon which the device's design and interpretation rules are built. The manufacturing procedures are "routine," implying they are based on these established principles.

Summary

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K9802235

②

510 (k) SUMMARY (page 1 of 2)

JUL 30 1998

DATE:

JUNE 23, 1998

Linda K. Dillon CONTACT PERSON: Barbara C. Lamoureux

Pasco MIC and MIC/ID Panels TRADE NAME OF DEVICE:

Antimicrobial Susceptibility Test COMMON NAME :

Class II Antimicrobial Susceptibility CLASSIFICATION NAME: Test Microbiology Panel #83

SUBSTANTIAL EQUIVALENCE:

In review of previous 510(k) notifications for the Pasco MIC and MIC/ID panels (most recently 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 Detection of Resistant pneumococci), the FDA has determined RE : 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: 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 Minocycline at concentrations ranging from 32 to 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 334 gram-negative Strains demonstrated acceptable Essential Agreement (EA) of 99.8% upon initial testing and 100% upon retesting. No Major (M) or Very Major (VM) errors were observed. Category Agreement (CA) was 100% with twenty-one random minor errors noted.

Test results of the gram-positive Strains demonstrated acceptable Essential Agreement (EA) of 100%. No Major (M) or Very Major (VM) errors were observed. Category Agreement (CA) was 100% with six random minor errors noted.

QC endpoints from both the reference and Pasco panels throughout testing were within the recommended acceptable ranges listed in the product information and NCCLS with the exception of 7 endpoints which were within 1 dilution of the mode for the strains tested.

Reproducibility testing of 12 organisms at each site provided 7 onscale 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 the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human figures, possibly representing health and well-being. The figures are depicted in a flowing, abstract manner.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL 30 1998

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

K982235 Re:

Trade Name: Pasco MIC and MIC/ID Panels/Minocycline Regulatory Class: II Product Code: JTN Dated: July 23, 1998 Received: July 25, 1998

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 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 requirement, 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 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:

PASCO MIC and MIC/ID Panels; Inclusion of Minocycline

Indication For Use:

Woody Debeau

vision of Clinical Laboratory Devices 510(k) Number_K98 223

PRESCRIPTION USE X

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).