(33 days)
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
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.
The provided 510(k) summary describes the acceptance criteria and study results for the Pasco MIC and MIC/ID Panels for Telithromycin.
1. Table of Acceptance Criteria and Reported Device Performance
| Measure | Acceptance Criteria (Implied by context of Antimicrobial Susceptibility Test (AST) Systems Guidance) | Reported Device Performance (Target organisms: Streptococcus pneumoniae and Streptococcus spp. other than S. pneumoniae) |
|---|---|---|
| Essential Agreement (EA) | Acceptable (typically >90% for AST systems) | 99.00% |
| Category Agreement (CA) | Acceptable (typically >90% for AST systems) | 100% |
| Very Major (VM) Errors | None (critical to prevent under-reporting resistance) | 0 |
| Major (M) Errors | None (critical to prevent over-reporting resistance) | 0 |
| Minor Errors | Acceptable (less critical than VM/M errors, but still tracked) | 0 |
| QC Endpoints | Acceptable for NCCLS recommended QC organisms | Acceptable |
| Inter-site Reproducibility (MIC results) | Acceptable (e.g., within 1 dilution for 95% or more) | 100% |
| Intra-site Reproducibility (MIC results) | Acceptable (e.g., within 1 dilution for 95% or more) | 100% |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 570 challenge and clinical Streptococcus pneumoniae and Streptococcus spp. other than S. pneumoniae strains.
- Data Provenance: The data included "challenge strains, fresh clinical isolates, stock clinical isolates and QC strains." Testing was conducted at "three test sites." The specific country of origin is not explicitly stated, but given the submission to the FDA, it is highly likely to be U.S.-based or follow U.S. regulatory guidelines for data collection. The use of "fresh clinical isolates" suggests a prospective component, alongside "stock clinical isolates" which could be considered retrospective if they were banked prior to the study design.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not specify the number of experts used or their qualifications for establishing the ground truth. For antimicrobial susceptibility testing, the "ground truth" is typically established by a reference methodology performed by trained laboratory personnel, rather than expert clinicians or radiologists.
4. Adjudication Method for the Test Set
The document does not explicitly describe an adjudication method. In AST studies, ground truth is usually determined by established reference methodologies (e.g., broth microdilution according to CLSI/NCCLS guidelines) and confirmed by quality control strains, rather than an expert consensus adjudication process. The comparison is directly between the new device's results and the reference method's results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This type of study is more common for diagnostic imaging devices where human interpretation is a key component. The Pasco MIC and MIC/ID Panels are automated or semi-automated devices for reading antimicrobial susceptibility, and the "readers" are the devices themselves or laboratory technicians following standardized procedures, not typically "human readers" in the sense of a MRMC study.
6. Standalone Performance Study
Yes, a standalone performance study was done. The entire study describes the performance of the Pasco MIC and MIC/ID Panels (the algorithm/device) against a reference methodology without human interpretation influencing the measurement of MICs. The "Essential Agreement" and "Category Agreement" metrics, along with error rates, reproducibility, and QC endpoints, are all measures of the device's standalone performance.
7. Type of Ground Truth Used
The ground truth used was established by reference methodology. The text states: "Challenge strains, fresh clinical isolates, stock clinical isolates and QC strains were tested concurrently using both Pasco methodology and reference methodology...". For AST, reference methodology typically refers to a standardized method like broth microdilution as defined by clinical and laboratory standards organizations (e.g., NCCLS/CLSI).
8. Sample Size for the Training Set
The document does not specify a separate "training set" sample size or discuss how the device was trained. For AST devices like these, particularly older ones, the "training" equivalent often involves calibrating the instrument/methodology to match established reference methods and NCCLS (now CLSI) guidelines, rather than machine learning on a distinct training dataset. The development and validation process would involve internal testing and optimization before the formal pre-market notification study.
9. How the Ground Truth for the Training Set Was Established
As no separate training set is explicitly mentioned or detailed as being used in the context of device "training" (as understood in modern AI/ML terms), the document does not provide information on how ground truth for such a set might have been established. Any internal development and calibration would have also relied on established reference methods and QC strains.
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AUG - 3 2004
(
510(k) SUMMARY
(page 1 of 3)
| DATE: | June 30, 2004 |
|---|---|
| CONTACT PERSON: | Linda K. DillonChuck LakelPasco Laboratories12750 West 42 nd AvenueWheat Ridge, Co 80033303-423-9504 |
| TRADE NAME OF DEVICE: | Pasco MIC and MIC/ID Panels |
| COMMON NAME: | Antimicrobial Susceptibility Test |
| CLASSIFICATION NAME: | Class II Antimicrobial Susceptibility TestMicrobiology 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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3
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)
14
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 (301) 594-3084. 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 (800) 638-2041 or (301) 443-6597 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)______
§ 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).