PASCO MIC AND MIC/ID PANELS

• K Number: K041776
• Device Name: PASCO MIC AND MIC/ID PANELS
• Manufacturer: PASCO LABORATORIES, INC.
• Date Cleared: 2004-08-03 ( 33 days)
• Product Code: JWY
• Regulation Number: 866.1640

Intended Use

Pasco MIC and MIC/ID panels are used for quantitatively measuring 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 the antimicrobial Telithromycin at concentrations of 0.015 - 4 mcg/ml to Pasco Panels for use in testing Streptococcus pneumoniae and Streptococcus spp. other than Streptococcus pneumoniae. Telithromycin has been shown to be active in vitro against most strains of microorganisms listed below, as described in the FDA-approved package insert for this antimicrobic. Active In Vitro and in Clinical Infectious Against: Aerobic gram-positive microorganisms Streptococcus pneumoniae (including multi-drug resistant isolates (MDRSP)) Active In Vitro but their clinical significance is unknown: Aerobic gram-positive microorganisms Streptococcus pyogenes (erythromycin susceptible isolates only) Streptococci (Lancefield groups C and G) Viridans group streptococci

Device Description

Pasco Panels are used for quantitatively measuring 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. Varying concentrations of antimicrobial agents (usually in two-fold dilutions) are dispensed into the Pasco microdilution 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.

Predicate Devices

K041214, K033119, K032518, K032259, K031727, K031205, K031103, K030933, K030620, K011116, K010508, K020331, K001953, K001887, K001721, K001612, K001516, K992853, K992726, K992717, K992646, K992647, K992593, K992562, K992568, K992507, K992546, K992420, K992296, K992297, K992143, K992108, K992076, K992059, K992077, K991925, K946126

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on traditional microbiological methods (visible growth, color changes, MIC determination) and do not mention any computational analysis, algorithms, or learning processes indicative of AI/ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".

Therapeutic

No
This device is an in vitro diagnostic (IVD) tool used to measure the susceptibility of bacteria to antimicrobial agents, which aids in determining the most effective treatment. It is not directly therapeutic but helps guide therapy. Additionally, the device is an antimicrobial susceptibility test (AST) system. Antimicrobial susceptibility systems (ASTs) are not therapeutic devices, since their results are used to assist clinicians in selecting appropriate antimicrobial treatment options, but they do not directly treat a disease.

Diagnostic

Yes

The device quantitatively measures the susceptibility of bacterial pathogens to antimicrobial agents and determines their biochemical identification, which are diagnostic processes used to inform treatment decisions.

SaMD (Software as a Medical Device)

No

The device description clearly describes physical components (microdilution panels with dispensed antimicrobial agents) and a physical process (incubation and visual observation for growth or color changes). This is not a software-only device.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The "Intended Use / Indications for Use" section explicitly states that the Pasco MIC and MIC/ID panels are used for "quantitatively measuring 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 is a classic description of an in vitro diagnostic test used to determine how well bacteria respond to antibiotics.
• Device Description: The description details how the panels are used to determine the "minimum inhibitory concentration (MIC)" of antimicrobial agents for test organisms. This process involves testing the organism outside of the body (in vitro) to diagnose its susceptibility to different treatments.
• Performance Studies: The performance studies involve testing bacterial strains and clinical isolates using the Pasco methodology and comparing the results to a reference methodology. This type of testing is conducted to validate the performance of an IVD device.

The device is designed to be used in a laboratory setting to analyze biological samples (bacterial pathogens) to provide information for the diagnosis and treatment of infections. This aligns directly with the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications 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 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.

Inclusion of Telithromycin

Pasco MIC and MIC/ID panels are used for quantitatively measuring 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 the antimicrobial Telithromycin at concentrations of 0.015 - 4 mcg/ml to Pasco Panels for use in testing Streptococcus pneumoniae and Streptococcus spp. other than Streptococcus pneumoniae. Telithromycin has been shown to be active in vitro against most strains of microorganisms listed below, as described in the FDA-approved package insert for this antimicrobic.

Active In Vitro and in Clinical Infectious Against:

Aerobic gram-positive microorganisms

Streptococcus pneumoniae (including multi-drug resistant isolates (MDRSP))

Active In Vitro but their clinical significance is unknown:

Aerobic gram-positive microorganisms

Streptococcus pyogenes (erythromycin susceptible isolates only) Streptococci (Lancefield groups C and G) Viridans group streptococci

Product codes

JWY

Device Description

Pasco Panels are used for quantitatively measuring 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. Varying concentrations of antimicrobial agents (usually in two-fold dilutions) are dispensed into the Pasco microdilution 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Challenge strains, fresh clinical isolates, stock clinical isolates and QC strains were tested concurrently using both Pasco methodology and reference methodology in panels that contained Telithromycin at concentrations ranging from 0.015 - 4 mcg/ml. Testing was conducted at three test sites.

Test results of 570 challenge and clinical Streptococcus pneumoniae and Streptococcus spp. other than S. pneumoniae demonstrated an Essential Agreement (EA) of 99.00%. No very major (VM), major (M) or minor errors were observed. Category Agreement (CA) was acceptable at 100%.

Summary of Performance Studies

Study type: Not specified beyond "Substantial Equivalence Testing" and "reproducibility testing and QC performance testing".
Sample size: 570 challenge and clinical Streptococcus pneumoniae and Streptococcus spp. other than S. pneumoniae. For reproducibility testing, 12 organisms were tested at each site on three separate days in triplicate.
AUC: Not Found
MRMC: Not Found
Standalone performance: Not Found
Key results: Essential Agreement (EA) of 99.00%. No very major (VM), major (M) or minor errors were observed. Category Agreement (CA) was acceptable at 100%. Inter-site reproducibility of MIC results was 100%. Intra-site reproducibility of MIC results was 100% for all three sites.

Key Metrics

Essential Agreement (EA) of 99.00%.
Category Agreement (CA) of 100%.
Reproducibility: Inter-site and intra-site reproducibility of MIC results was 100%.

Predicate Device(s)

K041214, K033119, K032518, K032259, K031727, K031205, K031103, K030933, K030620, K011116, K010508, K020331, K001953, K001887, K001721, K001612, K001516, K992853, K992726, K992717, K992646, K992647, K992593, K992562, K992568, K992507, K992546, K992420, K992296, K992297, K992143, K992108, K992076, K992059, K992077, K991925, K946126

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

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AUG - 3 2004

K041776

(

510(k) SUMMARY

(page 1 of 3)

DATE:	June 30, 2004
CONTACT PERSON:	Linda K. Dillon
Chuck Lakel
Pasco Laboratories
12750 West 42 nd Avenue
Wheat Ridge, Co 80033
303-423-9504
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 panel: K041214, June 7, 2004 RE: Daptomycin (Streptococcus); K033119, November 18, 2003 RE: Daptomycin (nonfastidious); K032518, September 15, 2003 RE: Gemifloxacin (Streptococcus); K032259, August 19, 2003 RE: Gatifloxacin (Streptococcus); K031727, July 30, 2003 RE Gemifloxacin: K031205, June 13, 2003 RE: Linezolid; K031103, June 12, 2003 RE: Ertapenem; K030933, May 1, 2003 RE: Moxifloxacin; K030620, April 14, 2003 RE: Gatifloxacin; K011116, April 24, 2001 RE: ESBL Confirmatory Test; K010508, April 23, 2001 RE: ESBL Screen Test; K020331, March 20, 2002 RE: Ertapenem; K001953, August 10, 2000 RE: Amoxicillin; K001887, August 9, 2000 RE: Ampicillin; K001721, August 4, 2000 RE: Clarithromycin; K001612, July 18, 2000 RE: Linezolid; K001516, July 12, 2000 RE: Moxifloxacin; K992853, November 4, 1999 RE: Cefdinir; K992726, November 3, 1999 RE: Synercid (non-fastidious); K992717, November 2, 1999 RE: Synercid; K992646, October 19, 1999 RE: Penicillin; K992647, October 19, 1999 RE: Erythromycin; K992593, October 14, 1999 RE: Chloramphenicol; K992562, October 13, 1999 RE: Ceftriaxone; K992568, October 14, 1999 RE: Cefotaxime; K992507, October 18, 1999 RE: Trovafloxacin; K992546, October 12, 1999 RE: Meropenem; K992420, September 27, 1999 RE: Sparfloxacin; K992296, September 21, 1999 RE: Vancomycin; K992297, September 3, 1999 RE: Levofloxacin; K992143, September 16, 1999 RE: Clindamycin; K992108, September 3, 1999 RE: Cefepime; K992076, August 30, 1999 RE: Cefuroxime; K992059, August 30, 1999 RE: Imipenem; K992077, September 3, 1999 RE: Ofloxacin; K991925, August 20, 1999 RE: Amoxicillin/Clavulanic Acid; 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.

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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:

Pasco Panels are used for quantitatively measuring 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. Varying concentrations of antimicrobial agents (usually in two-fold dilutions) are dispensed into the Pasco microdilution 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.

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:

Challenge strains, fresh clinical isolates, stock clinical isolates and QC strains were tested concurrently using both Pasco methodology and reference methodology in panels that contained Telithromycin at concentrations ranging from 0.015 - 4 mcg/ml. Testing was conducted at three test sites.

Test results of 570 challenge and clinical Streptococcus pneumoniae and Streptococcus spp. other than S. pneumoniae demonstrated an Essential Agreement (EA) of 99.00%. No very major (VM), major (M) or minor errors were observed. Category Agreement (CA) was acceptable at 100%.

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510(k) SUMMARY (page 3 of 3)

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QC endpoints for the NCCLS recommended QC organisms (S. pneumoniae ATCC 49619) from panels using both the reference and test methodology were acceptable.

Reproducibility testing of 12 organisms at each site on three separate days in triplicate demonstrated inter-site reproducibility of MIC results of 100%. Intra-site reproducibility of MIC results was 100% for all three sites.

The results of the clinical testing, reproducibility testing and QC performance testing supports Substantial Equivalence as outlined in the FDA document "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

Public Health Service

Food and Drug Administratio 2098 Gaither Road Rockville MD 20850

UG - 3 2004

Ms. Linda K. Dillon R&D Manager BD Diagnostic Systems Pasco Laboratories 12750 W. 42nd Avenue Wheat Ridge, CO 80033-2440

K041776 Re:

Trade/Device Name: PASCO MIC and MIC/ID Panels for Telithromycin at 0.015-4 mcg/ml Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: Class II Product Code: JWY Dated: June 30, 2004 Received: July 1, 2004

Dear Ms. Dillon:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamined the device is substantially equivalent (for the indications ferenced above and nave determined the acresed predicate devices marketed in interstate 101 use stated in the encrosule) to regarry at any and the Medical Device Amendments, or to commerce prior to May 26, 1776, the enaoment with the provisions of the Federal Food, Drug, devices mat nave occh recuire approval of a premarket approval application (PMA). and Cosmetic Act (Act) that do not require appro the general controls provisions of the Act. The 1 ou may, dicierore, market the device, obly of experients for annual registration, listing of general controls provisions of ractice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device it may be subject to such additional controllar Entimages of CFR), Parts 800 to 895. In addition, FDA Can oc louits in This 21, Courseling your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean ITEase be advised that I DA s issuance or a sevice complies with other requirements of the Act that TDA has made a determinations administered by other Federal agencies. You must of ally rederal statutes and regulations annualiters but not limited to: registration and listing (21 Compry with an the 71et 31equirements, models 801 and good manufacturing practice CI K Part 807), laboning (21 CF regulation (QS) regulation (21 CFR Part 820).

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Page 2

This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Saaratzs

Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

K041776 510(k) Number (if known):

Device Name: Pasco MIC and MIC/ID Panels for Telithromycin 0.015 - 4 mcg/ml

Indications For Use: Inclusion of Telithromycin

Pasco MIC and MIC/ID panels are used for quantitatively measuring 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 the antimicrobial Telithromycin at concentrations of 0.015 - 4 mcg/ml to Pasco Panels for use in testing Streptococcus pneumoniae and Streptococcus spp. other than Streptococcus pneumoniae. Telithromycin has been shown to be active in vitro against most strains of microorganisms listed below, as described in the FDAapproved package insert for this antimicrobic.

Active In Vitro and in Clinical Infectious Against:

Aerobic gram-positive microorganisms

Streptococcus pneumoniae (including multi-drug resistant isolates (MDRSP))

Active In Vitro but their clinical significance is unknown:

Aerobic gram-positive microorganisms

Streptococcus pyogenes (erythromycin susceptible isolates only) Streptococci (Lancefield groups C and G) Viridans group streptococci

Prescription Use X (Per 21 CRF 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Piagnostic Devices (OIVD)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k)______