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 Sparfloxacin to Pasco panels at concentrations of 0.03 to 8 mcg/ml for determining the susceptibility of bacterial pathogens with the exception of Haemophilus and S. Pneumoniae.

Device Description

The Pasco MIC panels make use of established technology to guantitatively measure the susceptibility of rapidly growing aerobic and facultative anaerobic bacterial pathogens.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Pasco MIC panels, structured as requested:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Essential Agreement (EA) with reference panels for NCCLS recommended QC strains (S. aureus ATCC 29213, E. faecalis ATCC 29212, P. aeruginosa ATCC 27853, E. coli ATCC 25922). Essential Agreement is defined as Pasco endpoints either agreeing exactly with or being within plus or minus one dilution of the reference panels.	100% Essential Agreement confirmed.
MIC results for both reference and Pasco test panels must fall within the NCCLS recommended QC ranges published for Sparfloxacin.	MIC results from both reference and Pasco test panels were within the NCCLS recommended QC ranges.

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

Sample Size: The study involved "QC performance testing... through 25 consecutive days of testing." For each of the five recommended NCCLS strains, this would mean 25 tests per strain, totaling 125 tests. If multiple tests were performed per day per strain, the total number of individual tests would be higher, but the documentation specifies 25 days of testing.
Data Provenance: Not explicitly stated, but based on the FDA submission addressing a US-based company (Pasco Laboratories, Inc.), it is highly likely the data was generated in the United States. The study was prospective as it was conducted specifically for the purpose of demonstrating device performance and efficacy for regulatory submission.

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

Number of Experts: Not specified.
Qualifications of Experts: Not explicitly stated. The "ground truth" here is the "reference panels" and "published NCCLS recommended QC ranges." These are established standards, likely developed and validated by a consensus of experts in microbiology and clinical laboratory science, rather than by individual experts for this specific study.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable in the traditional sense for human-expert adjudication. The method involved direct comparison of the Pasco panel results to "reference panels" and "published NCCLS recommended QC ranges."

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

This was not a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor did it involve AI. This study evaluated the performance of an in vitro diagnostic (IVD) device (MIC panels) against established reference methods and quality control ranges.

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

This was a standalone study of the device itself (MIC panels). While human technicians perform the assays and read the results, the study evaluated the accuracy of the device in correlation with established methods, without focusing on the human-in-the-loop aspect for improved performance as one might for an AI-assisted diagnostic.

7. The Type of Ground Truth Used

The ground truth was established through:
- Reference Panels: These represent a gold standard for determining antimicrobial susceptibility.
- Published NCCLS (National Committee for Clinical Laboratory Standards) Recommended QC Ranges: These are widely accepted and standardized quality control ranges for antimicrobial susceptibility testing.

8. The Sample Size for the Training Set

The text does not mention a distinct "training set." This type of IVD device (MIC panel) is based on established biochemical and microbiological principles, not a machine learning algorithm requiring a training set in the typical sense. The product's development would involve internal validation and optimization, but these are not referred to as "training" in the context of this regulatory submission summary. The described study is a performance validation test.

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

As no "training set" is described for this device, how its ground truth was established is not applicable. The device's underlying principles are based on well-understood microbiology.

Summary

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SUMMARY OF SAFETY AND EFFECTIVENESS

The Pasco MIC panels make use of established technology to guantitatively measure the susceptibility of rapidly growing aerobic and facultative anaerobic bacterial pathogens. The safety and efficacy of this product was determined by conducting QC performance testing at two laboratories through 25 consecutive days of testing. Endpoint results from the Pasco panels were compared to those from the reference panels and results from both panels were compared to published NCCLS recommended QC ranges.

Test results of the five recommended NCCLS strains (S. aureus ATCC 29213, E. faecalis ATCC 29212, P. aeruginosa ATCC 27853 and
E. coli ATCC 25922) confirmed 100% Essential Agreement in Which the Pasco endpoints either agreed exactly with or were within plus or minus one dilution of the reference panels. Additionally, MIC results from both the reference and the Pasco test panels were within the NCCLS recommended QC ranges published for Sparfloxacin.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

AUG 200 1997 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

K972567 Re: Trade Name: Pasco MIC and MIC/ID Panels Regulatory Class: II Product Code: JWY Dated: June 27, 1997 Received: July 1, 1997

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 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 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 vours.

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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ATTACHMENT 1 Page 1 of 1

Device Name:

PASCO MIC and MIC/ID Panels; Inclusion of SPARFLOXACIN

Indication For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED )

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V (Per 21 CFR 801.109)

Over-The-Counter Use (Optional Format 1-2-96)

Wilhelm, Moritz, des Aichenbuhler

(Division Sign-On)
Division of Clinical Laboratory Devices
510(k) Number K972567

Regulation Number and Section

§ 866.1640 Antimicrobial susceptibility test powder.

(a)
Identification. An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.(b)
Classification. Class II (performance standards).