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 Erythromycin to Pasco panels at concentrations of 2-0.015 mcg/ml for use in determining the susceptibility of 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 (Erythromycin), structured according to your request:

Acceptance Criteria and Device Performance

Acceptance Criteria Category	Specific Metric	Acceptance Limit/Target	Reported Device Performance
Essential Agreement (EA)	Overall EA	~97% (implied by "within the limits specified by the FDA")	97.8% (initial), 98.5% (retesting)
Major (M) Error Rate	Major Errors	3.0% (implied by "within the limits specified by the FDA")	0.9%
Category Agreement (CA)	Overall CA	Not explicitly stated, but generally high for AST devices	99.4%
Random Minor Errors	Random Minor Errors	Not explicitly stated, but target is usually low/zero	0% (none noted)
QC Endpoints	S. pneumoniae ATCC 49619	Within recommended NCCLS acceptable range	Within recommended NCCLS acceptable range
Reproducibility	Within +/- 1 dilution	Not explicitly stated, but generally high for AST devices	98.2%

Study Information

Sample Size Used for the Test Set and Data Provenance:
- Sample Size: 130 non-pneumococcal streptococci strains.
- Data Provenance: The strains included "CDC challenge strains and clinical isolates." The testing was performed at "two sites." The document does not specify the country of origin, but given the FDA submission, it's highly likely to be U.S.-based. The study appears to be prospective comparative testing.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- The document does not specify the number of experts or their qualifications. It mentions "a reference panel" and "reference method results," implying an established and accepted method for determining the true susceptibility.
Adjudication Method for the Test Set:
- The document does not explicitly describe an adjudication method for discrepancies. It notes that "One major (M) error was observed upon initial testing," and for this error, "retest results were acceptable, this error was not considered resolved since the reference method results did not change." This implies that the reference method was considered the definitive truth without further expert review for adjudication.
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
- No, an MRMC comparative effectiveness study was not done. This study assesses the performance of an AST device, which typically involves comparing the device's output to a reference method, rather than comparing human readers' performance with and without AI assistance.
If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done:
- Yes, this was a standalone study. The Pasco MIC and MIC/ID panels are devices that provide automated or semi-automated susceptibility results. The study evaluates the performance of the device itself (the "Pasco test panel") against a "reference panel" or "reference method." While human technicians are involved in the operation of the device and reading results, the performance metrics (EA, M error, CA, reproducibility) directly reflect the device's ability to produce accurate susceptibility measurements, not the performance of human interpretation assisted by the device.
The Type of Ground Truth Used:
- The ground truth was established by a "reference panel" and "reference method results." For Antimicrobial Susceptibility Testing (AST) devices, the reference method is typically a standardized broth microdilution method or an agar dilution method, which is considered the gold standard for determining minimum inhibitory concentrations (MICs).
The Sample Size for the Training Set:
- The document does not provide information regarding a distinct training set. This is common for device studies that focus on analytical performance against a known reference standard, rather than machine learning algorithm development which would typically involve separate training and test sets. The "CDC challenge strains and clinical isolates" used in the comparative testing effectively serve as the evaluation set.
How the Ground Truth for the Training Set Was Established:
- As no distinct training set is mentioned for an algorithm, the method for establishing ground truth for a training set is not applicable in this context. If any internal development/calibration involved data, the ground truth would similarly be established by a reference method.

Summary

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OCT 1 9 1999

K992647

510(k) SUMMARY (page 1 of 2)

DATE:	August 3, 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 Erythromycin at concentrations ranging from 2-0.015 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 130 non-pneumococcal streptococci strains demonstrated acceptable Essential Agreement (EA) of 97.8% on initial testing and 98.5% on retesting. One major (M) error was observed upon initial testing. Although retest results were acceptable, this error was not considered resolved since the reference method results did not change. This represents a 0.9% major (M) error rate, which is within the limits specified by the FDA. Category Agreement (CA) was 99.4% with no random minor errors noted.

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 6 organisms with on-scale endpoints. Overall reproducibility data demonstrated 98.2% 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 features a stylized eagle with three stripes forming its body and wings. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circle's perimeter.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT 1 9 1999

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

K992647 Re: Trade Name: PASCO MIC and MIC/ID Panels (Erythromycin) Regulatory Class: II Product Code: JTN Dated: August 3, 1999 Received: August 6, 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:

PASCO MIC and MIC/ID Panels; Inclusion of Erythromycin

Indication For Use:

This 510(k) notification is for the addition of Erythromycin to Pasco panels at concentrations of 2-0.015 mcg/ml for use in determining the susceptibility of non-pneumococcal streptococci.

Woody Dubois
(Division Sign-Off)

Division of Clini 510(k) Number

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).