(57 days)
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 the antimicrobial Gemifloxacin at concentrations of 0.015 - 4 mcg/ml to Pasco Panels. Gemifloxacin 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-negative microorganisms Klebsiella pneumoniae Active In Vitro but their clinical significance is unknown Aerobic Gram-positive microorganisms Staphylococcus aureus (methicillin-susceptible strains only) Aerobic Gram-negative microorganisms Acinetobacter lwoffi Klebsiella oxytoca Proteus vulgaris
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 information provided describes the acceptance criteria and the study conducted for the Pasco MIC and MIC/ID Panels with the addition of Gemifloxacin.
Here's the breakdown as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Essential Agreement (EA) | Acceptable (e.g., >90-95%) | 99.7% |
| Major Errors (M) | Zero | No major errors observed |
| Very Major Errors (VM) | Zero | No very major errors observed |
| Category Agreement (CA) | Acceptable (e.g., >90-95%) | 99.3% |
| Minor Discrepancies | Acceptable; within EA | 5 random minor discrepancies (all within EA) |
| QC Endpoints (S. aureus ATCC 29213, E. faecalis ATCC 29212, E. coli ATCC 25922, P. aeruginosa ATCC 27853) | Acceptable | Acceptable |
| Inter-site Reproducibility (MIC results) | Acceptable | 99.6% |
| Intra-site Reproducibility (MIC results) | Acceptable | 100% (two sites), 99% (one site) |
Note: The specific numerical acceptance criteria (e.g., a precise percentage for EA or CA) are not explicitly stated in the provided text. However, "acceptable" and the absence of major/very major errors imply that the reported performance met the pre-defined thresholds for regulatory approval.
2. Sample Sizes Used for the Test Set and Data Provenance
- Sample Size (Test Set): 615 isolates (challenge and clinical Enterobacteriaceae and Acinetobacter sp.)
- Data Provenance: The isolates included "challenge strains, fresh clinical isolates, stock clinical isolates and QC strains." The study was conducted at "three test sites." The text does not specify the country of origin but implies a multi-site clinical evaluation. It is a prospective or concurrent evaluation as it compares the Pasco methodology to a reference methodology.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- This information is not provided in the given text. The ground truth (reference methodology) is mentioned, but details about the experts involved in establishing it are absent.
4. Adjudication Method for the Test Set
- This information is not provided in the given text.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted as the device is an automated antimicrobial susceptibility test panel, not an interpretive imaging device requiring human readers.
6. Standalone Performance
- Yes, a standalone (algorithm only) performance was done. The device's performance (Essential Agreement, Category Agreement, etc.) was directly compared against a reference methodology without human intervention in the interpretation of the core MIC values.
7. Type of Ground Truth Used
- The ground truth used was established by a "reference methodology". The text doesn't specify the exact nature of this reference methodology (e.g., specific manual dilution methods, another FDA-approved AST system, etc.), but it is implied to be a gold standard for antimicrobial susceptibility testing.
8. Sample Size for the Training Set
- This information is not provided in the given text. The document focuses on the validation of the device, not its development or training phase.
9. How the Ground Truth for the Training Set Was Established
- This information is not provided in the given text, as details on the training set are absent.
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K03/727
JUL 3 0 2003
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510(k) SUMMARY
(page 1 of 3)
| DATE: | May 23, 2003 |
|---|---|
| CONTACT PERSON: | Linda K. DillonChuck LakelPasco Laboratories12750 West 42nd 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: K030933, May 1, 2003 RE: Moxifloxacin: K030620, April 14, 2003 RE: Gatifloxacin: K011116. April 24, 2001 RE: ESBL Confirmatory Test: K010508. April 23, 2001 RF: 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.
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
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510(k) SUMMARY (page 2 of 3)
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 OC strains were tested concurrently using both Pasco methodology and reference methodology in panels that contained Gemifloxacin at concentrations ranging from 0.015 - 4 mcg/ml. Testing was conducted at three test sites.
Test results of 615 challenge and clinical Enterobacteriaceae and Acinetobacter spon demonstrated an Essential Agreement (EA) of 99.7%. No major (M) or very major (VM) errors were observed. Category Agreement (CA) was acceptable at 99.3% with 5 random minor discrepancies, all of which were within EA.
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510(k) SUMMARY
(page 3 of 3)
QC endpoints for the NCCLS recommended QC organisms (S. aureus ATCC 29213, E. faecalis ATCC 29212, E. coli ATCC 25922 and P. aeruginosa ATCC 27853) from panels using both the reference and test methodology were acceptable.
Reproducibility testing of 10 organisms at each site on three separate days in triplicate demonstrated inter-site reproducibility of MIC results of 99.6%. Intra-site reproducibility of MIC results was 100% for two sites and 99% for one site.
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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Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL 3 0 2003
Ms. Linda K. Dillon R&D Manager BD Diagnostic Systems Pasco Laboratories 12750 W. 42nd Avenue Wheat Ridge, CO 80033-2440
Re: K031727
Trade/Device Name: PASCO MIC and MIC/ID Panels Gemifloxacin, 0.015-4 ug/ml Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Regulatory Class: Class II Product Code: JWY Dated: May 23, 2003 Received: June 3, 2003
Dear Ms. Dillon:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 vour 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 can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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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). Other general information on your responsibilities under the Act may be obtained 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,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
6
1,031727
510(k) Number (if known):
Device Name: PASCO MIC and MIC/ID Panels
Indications For Use: Inclusion of Gemifloxacin
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 the antimicrobial Gemifloxacin at concentrations of 0.015 - 4 mcg/ml to Pasco Panels. Gemifloxacin 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-negative microorganisms Klebsiella pneumoniae
Active In Vitro but their clinical significance is unknown
Aerobic Gram-positive microorganisms Staphylococcus aureus (methicillin-susceptible strains only)
Sagafth 7/29/03
Division Sign-Off
Office of In Vitro Diagnostic Device
Aerobic Gram-negative microorganisms
Acinetobacter lwoffi Klebsiella oxytoca Proteus vulgaris
KO31727 510(k).
Evaluation and Safery
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CRF 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
§ 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).