(38 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. Telithromycin has been shown to be active in vitro against most isolates of the following microorganisms; as described in the FDA-approved package insert for this antimicrobic.
Active In Vitro and in Clinical Infectious Against:
Aerobic Gram-positive microorganisms
Staphylococcus aureus (methicillin and erythromycin susceptible isolates only)
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. 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 inoculation 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 and production of specific metabolites from growth in biochemical substrates are interpreted as described in the package insert for conventional tubed media.
The provided text describes the 510(k) summary for the Pasco MIC and MIC/ID Panels, specifically for the addition of Telithromycin. Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance (Essential Agreement - EA) |
|---|---|
| Not explicitly stated as a numerical threshold in the provided text, but implied to be high enough to support "Substantial Equivalence". | 100% Essential Agreement for Telithromycin based on testing 207 challenge and clinical Staphylococcus aureus isolates. |
Note: While a numerical acceptance criterion for Essential Agreement is not explicitly stated, the FDA typically looks for very high agreement (often >90-95%) for antimicrobial susceptibility tests to be deemed substantially equivalent. The 100% reported performance clearly meets such an implied high standard.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: 207 challenge and clinical Staphylococcus aureus isolates were tested.
- Data Provenance: Not explicitly stated as a country of origin. The data is from a "multi-site" study (three test sites). The methodology involved "challenge strains, fresh clinical isolates, stock clinical isolates and QC strains," indicating a mix of laboratory curated strains and real-world clinical samples. The study is prospective in the sense that these tests were performed specifically for the 510(k) submission using the device and reference methodology concurrently.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- This information is not provided in the given text. The ground truth (reference methodology) is implied to be established by the "reference methodology," but the human expert involvement in reading or interpreting these reference results, or setting up the "challenge strains," is not detailed.
4. Adjudication Method for the Test Set:
- This information is not provided in the given text. It is usual for AST studies to compare the device's results against a well-established reference method, often without explicit expert adjudication of discrepancies, as the reference method itself is considered the gold standard.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
- No, this was not an MRMC comparative effectiveness study. This device is an Antimicrobial Susceptibility Test (AST) panel, which provides quantitative measurements (Minimum Inhibitory Concentration - MIC) of bacterial susceptibility to antibiotics. It is not an AI-assisted diagnostic tool that helps human readers interpret images or complex data in the traditional sense of an MRMC study. Therefore, the concept of "human readers improving with AI vs. without AI assistance" does not apply here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- The Pasco MIC and MIC/ID Panels are standalone devices in that they provide results (MIC values and biochemical identifications) based on the growth patterns and color changes in the microdilution wells. While human observation and interpretation of these changes are required, the "algorithm" that determines susceptibility is inherent in the design and formulation of the wells (e.g., specific concentrations of antimicrobials). The results are directly read from the panel after incubation. The study compares the device's output to a reference methodology, which is a standalone performance comparison.
7. The Type of Ground Truth Used:
- The ground truth was established by "reference methodology." While not explicitly detailed, for AST devices, this typically refers to a standardized laboratory method, such as broth microdilution or agar dilution, performed according to guidelines from organizations like the Clinical and Laboratory Standards Institute (CLSI) or NCCLS (as cited in the text). This is a well-established and accepted laboratory standard for determining MIC values.
8. The Sample Size for the Training Set:
- This information is not applicable/provided in the context of this device. The Pasco MIC and MIC/ID Panels are not machine learning or AI-based devices that require a "training set" in the computational sense. Their performance is based on chemical and biological reactions, and their development would involve iterative design and testing rather than algorithm training.
9. How the Ground Truth for the Training Set Was Established:
- This information is not applicable as there is no "training set" in the context of a machine learning algorithm. The device's underlying principles are based on established microbiology and pharmacology.
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1(09233/
510(k) SUMMARY (page 1 of 3)
| DATE: | September 30, 2004 |
|---|---|
| CONTACT PERSON: | Linda K. DillonChuck LakelPasco Laboratories12750 West 42nd AvenueWheat Ridge, Co 80033303-390-3240 |
| 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 panels: K041776, August 3, 2004 RE: Telithromycin (Streptococcus); K041214, June 7, 2004 RE: Daptomycin (Streptococcus); K032518, September 15, 2003 RE: Gemifloxacin (Strep), K032259, August 19, 2003 RE: Gatifloxacin (Strep); K033119, November 18, 2003 RE: Daptomycin; 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
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510(k) SUMMARY
(page 2 of 3)
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 I he term - substantial equivalence as found in the Federal Food, Drug, and Cosmetic demintion of substantial equilted and a comments of CFR 807, Subpart E under which a device can Act, as amended and as approval or reclassification. A determination of oc marketed without pro mail this notification is not intended to have any bearing substantial equivalency and entre ent infringement suits or any other patent matters. No whatsocver on the rootation of prof, substantial equivalence herein shall be construed statements reluted to, or in beppen cer the US Patent Laws or their application by the courts.
DESCRIPTION OF THE DEVICE:
DESCRIPTION OF Corporatitatively measuring the susceptibility of rapidly growing I aso I and facultative anaerobic bacterial pathogens to a battery of antimicrobial agents and determining the biochemical identification of those organisms. Varying and determining and 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 the Faso International 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 tHand 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 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 207 challenge and clinical Staphylococcus aureus demonstrated an Essential Agreement (EA) of 100%.
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510(k) SUMMARY
(page 3 of 3)
QC endpoints for the NCCLS recommended QC organisms (S. aureus ATCC 29213 and QC enaponiis for the NCCLS recommentate Q o organize and test methodology were acceptable.
Reproducibility testing of 10 organisms at each site on three separate days in triplicate Reproductionity testing of 10 organisms areast illity of MIC results of 100% for all three sites.
The results of the clinical testing, reproducibility testing and QC performance testing The results of the childed tosting, reproductions) comment "Class II Special supports Substantial Equiraler as Simonorolal Susceptibility Test (AST) Systems; Guidance for Industry and FDA.
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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 wings or feathers. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA", which is arranged in a circular fashion around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 7 - 2004
Ms. Linda K. Dillon R&D Manager BD Diagnostic Systems Pasco Laboratories 12750 W. 42nd Avenue Wheat Ridge, CO 80033-2440
Re: K042331
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: August 23, 2004 Received: August 30, 2004
Dear Ms. Dillon:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 31 xxx, presidentially equivalent (for the indications felerenced above and nave decembined by marketed predicate devices marketed in interstate for use stated in the encrosule) to regally manat date of the Medical Device Amendments, or to commerce prior to May 20, 1976, the excordance with the provisions of the Federal Food, Drug, devices that have tech recuire approval of a premarket approval application (PMA). and Cosmetic Act (Fee) that do not require subject to the general controls provisions of the Act. The 1 ou may, mercrore, market the act include requirements for annual registration, listing of general controls provisions of tactice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (600 a00 - 5) irols. Existing major regulations affecting your device it may be subject to such additional controllar controller.
can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA can be lound in This 21, Occareents concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised hat I Dri 3 issualite or a cevice complies with other requirements of the Act that FDA has made a decommanding administered by other Federal agencies. You must of any I cutures and regarants and regarants ancluding, but not limited to: registration and listing (21 comply with an the Het brequire.nems 801 and 809); and good manufacturing practice CI K Part 807), laboring in the quality systems (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) I his letter will anow you to begin maketing your aven equivalence of your device to a legally premarket nothleation. The PDA intellig of backanda vour 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, If you destic specific information and advertising of your device, please contact the Office of or questions on the promotion and Safety at (301) 594-3084. Also, please note the In Viro Diagliostic Device Development and store to premarket notification" (21 CFR Part 807.97). regulation entitied, "Misoranums of responsibilities under the Act from the You may outdil other general mormational 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,
Salartys
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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Page 1 of 1
510(k) Number (if known): K042331
Device Name: PASCO MIC and MIC/ID Panels – 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 Pasco MIC and MICHD pareis are used to qualitian. Or head in 3 a battery of antimicrobial agents growing aerobic and tabalicative andertification of those organisms.
This 510(k) notification is for the addition of the antimicrobial Telithromycin at concentrations of This 510(K) notification is for the addition of the antiness and white be active in vitro against 0.015 - 4 mcgmi to Pasco Panels. Telithonyon has been enom to Beach of the FDA-approved package insert for this antimicrobic.
Active In Vitro and in Clinical Infectious Against:
Aerobic Gram-positive microorganisms
Aerobic Grain-positive imetoorganisms and erythromycin susceptible isolates only)
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 Diagnostic Devices (OIVD)
Liddie Lu- Poole
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K04233
§ 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).