(85 days)
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 Cefepime to Pasco panels at concentrations of 0.03 to 64 mcg/ml for use in determining the susceptibility of Enterobacter spp., E. col, K. pneumoniae, P. mirabilis, P. aeruginosa and methicillin susceptible strains of S. aureus. Clinical testing of S. pneumoniae has not been performed with the Pasco system.
Varying concentrations of antimicrobial agents (usually in twofold dilutions) are dispensed into the Pasco 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 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.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device Name: Pasco MIC and MIC/ID Panels (with the addition of Cefepime)
Device Type: Antimicrobial Susceptibility Test
1. Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance (Gram-Negative Isolates) | Reported Device Performance (Gram-Positive Isolates) |
|---|---|---|
| Essential Agreement (EA) | Initial: 98.2% Retest: 99.4% | Initial: 100% |
| Very Major (VM) Error | 1 VM error on initial testing (Klebsiella pneumoniae), resolved upon retest | None observed |
| Category Agreement (CA) | 97.3% (9 random minor errors) | 88.1% (29 random minor errors) |
| Major Errors | Not explicitly stated for Gram-negative, but implied acceptable given overall performance and no mention of significant major errors. | None observed |
| QC Endpoints within Recommended Ranges | Yes (reference and Pasco panels) | Yes (reference and Pasco panels) |
| Reproducibility (within +/- 1 dilution) | 98.8% | 98.8% (assuming this applies to both) |
2. Sample Size and Data Provenance:
- Test Set Sample Size: Not explicitly stated as a numerical value for patients or isolates. The text mentions "CDC challenge strains and clinical isolates."
- For Gram-negative isolates: Performance is described for specific organisms like Enterobacter spp., E. coli, K. pneumoniae, P. mirabilis, and P. aeruginosa.
- For Gram-positive isolates: Performance is described for methicillin-susceptible strains of S. aureus.
- Data Provenance: The study was performed at "two sites." The country of origin is not specified, but given the context of a 510(k) summary submitted to the FDA, it is highly likely to be the United States. The study used "CDC challenge strains and clinical isolates," indicating a prospective collection of isolates for comparative testing.
3. Number of Experts and Qualifications:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. It's implied that "comparative testing" against a "reference panel" was performed, which usually involves trained microbiologists or laboratory personnel, but their specific qualifications or experience levels are not detailed.
4. Adjudication Method:
- Adjudication Method: Not explicitly stated. The text mentions "resolved upon retest" for the single Very Major error, suggesting some form of re-evaluation or confirmatory testing. However, a formal adjudication process (like 2+1 or 3+1 by independent experts) for discordant results is not described.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
- MRMC Study: No. This study is evaluating the performance of an in vitro diagnostic device (antimicrobial susceptibility panel) against a reference method, not the effectiveness of AI assistance on human readers. Therefore, an MRMC study and effect size of human readers with/without AI assistance are not applicable.
6. Standalone (Algorithm Only) Performance:
- Standalone Performance: Not applicable in the context of an in vitro diagnostic device like an antimicrobial susceptibility panel. The device itself is the "standalone" component being tested against a reference standard. There isn't an "algorithm" being evaluated independently of its human-in-the-loop application in the same way as an AI-powered image analysis tool. The results presented are the performance of the Pasco panels themselves.
7. Type of Ground Truth Used:
- Ground Truth: The ground truth was established by a reference panel or reference method. The text states, "Comparative testing of the Pasco test panel to a reference panel was performed." This implies that the results from the established reference method were considered the true susceptibility results against which the Pasco panel's performance was measured.
8. Sample Size for the Training Set:
- Training Set Sample Size: Not applicable. This document describes a clinical validation study for a medical device (an in-vitro diagnostic panel), not a machine learning model. The device itself is a physical laboratory test, not a software algorithm that requires a "training set" in the machine learning sense. The "training" for such devices typically involves manufacturing controls and calibration processes, not data ingestion for model optimization.
9. How Ground Truth for the Training Set Was Established:
- Ground Truth for Training Set: Not applicable, as there is no "training set" in the context of a machine learning model. The development of the Pasco panels would have involved standard microbiological and manufacturing quality control procedures to ensure the accuracy of the antimicrobial concentrations and reagents.
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PASCO LABORATORIES, 12750 WEST FORTY-SECOND AVEN
WHEAT RIDGE, COLORADO 8003
Image /page/0/Picture/2 description: The image shows a handwritten sequence of numbers and letters, followed by a circled number. The sequence "K974362" is written in a slightly messy, cursive style. Below and to the right of this sequence, the number "2" is enclosed in a circle. The writing appears to be done with a dark ink or marker on a white surface.
FEB | 2 |998
510(k) SUMMARY (page 1 of 2)
| DATE: | November 13, 1997 |
|---|---|
| CONTACT PERSON: | Linda K. Dillon |
| TRADE NAME OF DEVICE: | Pasco MIC and MIC/ID Panels |
| COMMON NAME: | Antimicrobial Susceptibility Test |
| CLASSIFICATION NAME: | Class II Antimicrobial SusceptibilityTest Microbiology Panel #83 |
SUBSTANTIAL EQUIVALENCE:
In review of previous 510(k) notifications for the Pasco MIC and MIC/ID panels (most recently K972567, August 20,1997 RE: Sparfloxacin; K971951, August 15, 1997 RE: Levofloxacin; 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 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.
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510(k) SUMMARY
(3)
(page 2 of 2)
DESCRIPTION OF THE DEVICE:
Varying concentrations of antimicrobial agents (usually in twofold dilutions) are dispensed into the Pasco 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 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 blochemical identification of those organisms.
SUMMARY/CONCLUSION OF SUBSTANTIAL EQUIVALENCE TESTING: Test panels containing Cefepime at concentrations ranging from 64 to 0.03 mcq/ml were prepared in-house at Pasco using routine manufacturing procedures. Comparative testing of the Pasco test panel to a reference panel was performed at two sites using CDC challenge strains and clinical isolates.
Test results of the gram-negative isolates demonstrated acceptable Essential Agreement (EA) of 98.2% on initial testing and 99.4 % after retesting. One Very Major (VM) error was observed on initial testing of Klebsiella pneumoniae, however this was resolved upon retest. Category Agreement (CA) was 97.3% with nine random minor errors noted.
Test results of the gram-positive isolates demonstrated acceptable Essential Agreement (EA) of 100% on initial testing. No Major or Very Major errors were observed. Category Agreement (CA) was 88.1% with twenty nine random errors noted.
QC endpoints from both the reference and Pasco panels throughout testing were within the recommended acceptable ranges listed in the product information and NCCLS. Reproducibility testing at each site demonstrated 98.8% within the acceptable plus or minus 1 dilution.
The results of the clinical testing, reproducibility testing and QC performance testing supports Substantial Equivalence as outlined in the FDA draft document "Review Criteria For Assessment Of Antimicrobial Susceptibility Devices" (May 1991).
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Image /page/2/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 its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged around the circumference of the circle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FFB 1 2 1998
Ms. Linda K. Dillon Technical Manager Pasco Laboratories, Inc. 12750 West Forty-Second Avenue Wheat Ridge, Colorado 80033
Re: K974362 Trade Name: Pasco MIC and MIC/ID Panels Regulatory Class: II Product Code: JWY Dated: November 13, 1997 Received: November 19, 1997
Dear Ms. Dillon:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (EDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.
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Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely vours.
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Device Name:
PASCO MIC and MIC/ID Panels; Inclusion of Cefepime
Indication 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 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 Cefepime to Pasco panels at concentrations of 0.03 to 64 mcg/ml for use in determining the susceptibility of Enterobacter spp., E. col, K. pneumoniae, P. mirabilis, P. aeruginosa and methicillin susceptible strains of S. aureus. Clinical testing of S. pneumoniae has not been performed with the Pasco system.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON AMOTHER PAGE IF NEEDED )
Concurrence of CDRH, Office of Device Evaluation (ODE)
V Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use (Optional Format 1-2-96)
Flo Hain 2/10/98
Division Sign-OH) Division of Clinical Laboratory Devices
OR
510(k) Number .
§ 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).