(66 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 antimicrobial Ertapenem at concentrations of 0.03 - 32 mcg/ml to Pasco Panels. Ertapenem 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 Staphylococcus aureus (methicillin-susceptible strains only)
Aerobic Gram-negative microorganisms Escherichia coli Klebsiella pneumoniae
Active In Vitro but their clinical significance is unknown
Aerobic Gram-negative microorganisms
Citrobacter freundii Citrobacter koseri Enterobacter aerogenes Enterobacter cloacae Klebsiella oxytoca (excluding ESBL producing strains) Morganella morganii Proteus mirabilis Proteus vulgaris Serratia marcescens
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. Varving 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.
1. Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Essential Agreement, EA) | Reported Device Performance (EA) | Acceptance Criteria (Category Agreement, CA) | Reported Device Performance (CA) |
|---|---|---|---|
| ≥ 90% for Staphylococci spp. | 98.3% | ≥ 90% with no very major or major errors for methicillin-susceptible Staphylococci spp. | 100% (no very major or minor errors) |
| ≥ 90% for Enterobacteriaceae | 99.6% | ≥ 90% with acceptable minor discrepancies for Enterobacteriaceae | 99.4% (5 random minor discrepancies, all within EA) |
Note: The acceptance criteria for Essential Agreement (EA) and Category Agreement (CA) are implicitly derived from the context of "acceptable" and the high percentages reported, aligning with typical AST performance standards. The document explicitly states "Category Agreement (CA) was acceptable at 99.4% with 5 random minor discrepancies, all of which were within EA." and "No major (M) or very major (VM) errors were observed" for Enterobacteriaceae, indicating these are key performance indicators for acceptance.
2. Sample Size and Data Provenance for Test Set:
- Sample Size:
- Staphylococci spp.: 410 challenge and clinical strains
- Enterobacteriaceae: 574 challenge and clinical strains
- QC organisms: 10 organisms for reproducibility testing across 3 sites, each tested in triplicate on 3 separate days. (Total 90 tests per site for reproducibility).
- Data Provenance: The study used "challenge strains, fresh clinical isolates, stock clinical isolates and QC strains." The data was collected at "three test sites." The specific country of origin is not mentioned, but the submission is to the U.S. FDA, implying relevance to the U.S. market. The use of "fresh clinical isolates" suggests prospective collection for those samples, while "stock clinical isolates" implies a mix of retrospective and potentially prospective uses. "Challenge strains" and "QC strains" are typically laboratory-maintained strains.
3. Number and Qualifications of Experts for Ground Truth:
The document does not explicitly state the number of experts used to establish ground truth or their specific qualifications (e.g., "radiologist with 10 years of experience"). However, for antimicrobial susceptibility testing, the "reference methodology" (presumably a standard such as broth microdilution or agar dilution as per NCCLS guidelines) serves as the ground truth. This reference methodology is typically performed by trained microbiologists or laboratory personnel following established protocols.
4. Adjudication Method for Test Set:
The document does not describe an explicit adjudication method (like 2+1 or 3+1). The "reference methodology" is considered the standard against which the Pasco panels are compared. Discrepancies are reported (e.g., 5 random minor discrepancies for Enterobacteriaceae), and the agreement (Essential and Category) is calculated based on direct comparison to the reference method. There's no indication of a separate expert review or adjudication process for conflicting results between the test device and the reference method, beyond standard laboratory quality control.
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 in diagnostic imaging where human readers interpret results with and without AI assistance. This submission describes an in vitro diagnostic device (Antimicrobial Susceptibility Test) where the output is typically an objective measurement (MIC) or category (S/I/R), not an interpretation that varies significantly between human readers in the same way an imaging study would. The study focuses on comparing the device's performance against a reference laboratory method.
6. Standalone Performance Study:
Yes, a standalone study was done. The document describes the performance of the Pasco MIC and MIC/ID Panels directly against a "reference methodology." The results for Essential Agreement, Category Agreement, and reproducibility are reported for the device itself, without human-in-the-loop assistance for interpretation beyond reading the visible growth or color changes as per the package insert instructions.
7. Type of Ground Truth Used:
The ground truth used was the reference methodology for antimicrobial susceptibility testing. The text states: "Challenge strains, fresh clinical isolates, stock clinical isolates and QC strains were tested concurrently using both Pasco methodology and reference methodology..." This implies a standard, accepted laboratory method (e.g., broth microdilution or agar dilution as per NCCLS guidelines) as the gold standard for determining the true MIC and susceptibility category.
8. Sample Size for the Training Set:
The document does not specify a separate training set sample size or clearly delineate it from the test set. For in vitro diagnostic devices like AST panels, the "training set" in the context of an algorithm or AI is not typically applicable in the same way as for imaging devices. The "training" for such devices often involves optimizing the panel design, reagent concentrations, and interpretation rules during product development, which is usually done on a larger, internal set of diverse isolates, but this is not reported as a separate "training set" in the 510(k) summary. The clinical testing described primarily serves as validation (test set).
9. How Ground Truth for the Training Set Was Established:
As no distinct "training set" is explicitly mentioned, the method for establishing its ground truth is not detailed. However, if any internal development or optimization involved using ground truth, it would almost certainly have been established using similar reference methodology as described for the validation (test set).
{0}------------------------------------------------
JUN 1 2 2003
2
510(k) SUMMARY
(page 1 of 3)
| DATE: | April 4, 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: 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.
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
{1}------------------------------------------------
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. Varving 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 contained Ertapenem at concentrations ranging from 0.03 - 32 mcg/ml. Testing was conducted at three test sites.
Test results from 410 challenge and clinical Staphylococci spp. demonstrated an Essential Agreement (EA) of 98.3%. For the methicillin-susceptible Staphylococci spp., the Category agreement (CA) was 100% with no very major or minor errors noted.
Test results of 574 challenge and clinical Enterobacteriaceae demonstrated an Essential Agreement (EA) of 99.6%. No major (M) or very major (VM) errors were observed. Category Agreement (CA) was acceptable at 99.4% with 5 random minor discrepancies, all of which were within EA.
{2}------------------------------------------------
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 100%. Intra-site reproducibility of MIC results was also 100% for all 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.
{3}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the text "Public Health Service". The text is in a simple, sans-serif font and is left-aligned. The words are stacked on a single line. The text is likely part of a document or sign.
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular emblem with the department's name encircling an abstract symbol in the center. The symbol consists of four curved lines that resemble stylized human figures or waves, stacked on top of each other.
JUN 1 2 2003
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Linda K. Dillon R&D Manager BD Diagnostics Systems Pasco Laboratories 12750 W. 42nd Avenue Wheat Ridge, CO 80033-2440
K031103 Re:
Trade/Device Name: PASCO MIC and MIC/ID Panels Ertapenem, 0.03-32 µg/ml Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Regulatory Class: Class II Product Code: JWY Dated: April 4, 2003 Received: May 14, 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 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 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 (OS) regulation (21 CFR Part 820).
{4}------------------------------------------------
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). 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
{5}------------------------------------------------
Page 1 of 1
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: PASCO MIC and MIC/ID Panels
Indications For Use: Inclusion of Ertapenem
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 antimicrobial Ertapenem at concentrations of 0.03 - 32 mcg/ml to Pasco Panels. Ertapenem 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 Staphylococcus aureus (methicillin-susceptible strains only)
Aerobic Gram-negative microorganisms Escherichia coli Klebsiella pneumoniae
Active In Vitro but their clinical significance is unknown
Aerobic Gram-negative microorganisms
Citrobacter freundii Citrobacter koseri Enterobacter aerogenes Enterobacter cloacae Klebsiella oxytoca (excluding ESBL producing strains) Morganella morganii Proteus mirabilis Proteus vulgaris Serratia marcescens
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) al additional la F-Padle
Division Sign-Off
Concurrence of CDRH, Office of Device Evaluation (ODE)
Office of In Vitro Diagnostic Device
Evaluation and Safety
| Prescription Use (Per 21 CRF 801.109) | 510(k) |
|---|---|
| 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).