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 Spartloxacin to Pasco panels at concentrations of 4-0.03 mcg/ml for use in determining the susceptibility of S. pneumoniae.

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 text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from FDA draft document "Review Criteria For Assessment Of Antimicrobial Susceptibility Devices" (May 1991))	Reported Device Performance (Sparfloxacin on Pasco MIC/ID Panels)
Acceptable Essential Agreement (EA)	S. pneumoniae (101 strains): 99.4% EA
	Non-pneumococcal streptococci (130 strains): Initial testing: 98.5% EA; Retesting: 99.3% EA
No Major (M) Errors	S. pneumoniae: No major errors
	Non-pneumococcal streptococci: No major errors
No Very Major (VM) Errors	S. pneumoniae: No very major errors
	Non-pneumococcal streptococci: No very major errors
Minor Errors (implied low number or resolution upon retest)	S. pneumoniae: No minor errors
	Non-pneumococcal streptococci: One minor error resolved upon retest; 6 random minor errors noted (all within EA)
Acceptable Category Agreement (CA)	S. pneumoniae: 100% CA
	Non-pneumococcal streptococci: 100% CA
QC endpoints for QC organism within recommended NCCLS acceptable range	S. pneumoniae ATCC 49619: Within recommended NCCLS acceptable range for both reference and Pasco panels
Reproducibility (% within +/- 1 dilution)	12 organisms at each site: 100% within acceptable +/- 1 dilution

2. Sample Sizes and Data Provenance

Test Set Sample Size:
- 101 strains of S. pneumoniae
- 130 strains of non-pneumococcal streptococci
- 12 organisms for reproducibility testing (at each of two sites)
Data Provenance: The study was conducted at "two sites" using "CDC challenge strains and clinical isolates." This indicates the data includes both well-characterized laboratory strains and real-world patient samples. The specific country of origin is not explicitly stated, but "CDC" (Centers for Disease Control and Prevention) suggests a US context. The study is prospective in design for the comparative testing of the Pasco panel against a reference method.

3. Number of Experts and Qualifications

The document does not explicitly state the number of experts used to establish the ground truth or their specific qualifications for this particular study. It refers to "reference panel" and "CDC challenge strains," implying established methods for determining susceptibility.

4. Adjudication Method

The document does not describe a specific adjudication method like "2+1" or "3+1." The results are presented as direct comparisons to a "reference panel." For the one minor error in non-pneumococcal streptococci, it states it was "resolved upon retest," which implies a form of re-evaluation, but not necessarily a multi-expert adjudication process.

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

No. This study is an in vitro diagnostic study comparing a device's performance to a reference method, not an MRMC study assessing human reader improvement with or without AI assistance.

6. Standalone Performance

Yes, this study describes the standalone performance of the Pasco MIC and MIC/ID panels (with Sparfloxacin) in determining antimicrobial susceptibility. The performance metrics (Essential Agreement, Category Agreement, error rates) are inherent to the device's ability to produce results.

7. Type of Ground Truth Used

The ground truth was established by a "reference panel" and using "CDC challenge strains." This implies a reference method or gold standard test for antimicrobial susceptibility testing, which provides the true MIC values or category results against which the Pasco panel's performance is measured.

8. Sample Size for the Training Set

The document does not explicitly mention a "training set" or its sample size. This type of antimicrobial susceptibility device typically relies on established manufacturing procedures and analytical validation rather than a separate machine learning training phase. The "routine manufacturing procedures" and quality control (QC) processes ensure the consistency and accuracy of the pre-prepared panels.

9. How Ground Truth for Training Set Was Established

As no specific "training set" or machine learning model is described, the concept of establishing ground truth for a training set is not applicable here. The device's underlying principles are based on microbiological growth inhibition and biochemical reactions, where the "ground truth" for developing and manufacturing the panels themselves likely stems from extensive historical microbiological data, reference methods, and quality control specifications (e.g., NCCLS standards).

Summary

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KGG2420

SEP 27 1999

510(k) SUMMARY (page 1 of 2)

DATE:	July 19, 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: K98235, July 30, 1998 RE: Minocycline; K982156, July 29, 1998 RE: Cefdinir; K980955 May 18, 1998 RE: Trovatloxacin; 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 Sparfloxacin at concentrations ranging from 4-0.03 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 101 S. pneumoniae strains demonstrated acceptable Essential Agreement (EA) of 99.4%. No major (M), very major (VM) or minor errors were observed. Category agreement (CA) was 100% with no additional random minor errors noted. Test results of the 130 nonpneumococcal streptococci strains demonstrated acceptable Essential Agreement (EA) of 98.5% on initial testing and 99.3% on retesting. No major (M) or very major (VM) errors were observed. One minor error was resolved upon retest. Category Agreement (CA) was 100% with 6 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 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 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 seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, arranged in a way that resembles a bird in flight. The image is in black and white.

SEP 2 7 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re: K992420 Trade Name: PASCO MIC and MIC/ID Panels (Sparfloxacin) Regulatory Class: II Product Code: JTN Dated: July 19, 1999 Received: July 21, 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 (OS) 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 Sparfloxacin

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.

This 510(k) notification is for the addition of Spartloxacin to Pasco panels at concentrations of 4-0.03 mcg/ml for use in determining the susceptibility of S. pneumoniae.

Woody Dubois

(Division Sign-Off Division of Clinical Laboratory Devices 510(k) Number _ K99

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).