(84 days)
PASCO MIC AND MIC/ID PANELS are used for quantitatively measuring (with the exception of the Breakpoint/D 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 Clindamycin to Pasco panels at concentrations of 0.015-2 mcg/ml for use in determining the susceptibility of S. pneumoniae and non-pneumococcal streptococci.
Varying concentrations of antimicrobial agents (usually in two-fold 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 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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Pasco MIC and MIC/ID Panels (Clindamycin):
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (from FDA draft document "Review Criteria For Assessment Of Antimicrobial Susceptibility Devices" - May 1991) | Reported Device Performance (Clindamycin) |
|---|---|
| Essential Agreement (EA) for S. pneumoniae strains: Acceptable | 90.3% |
| Major (M) Errors for S. pneumoniae strains: Not observed | No Major Errors |
| Very Major (VM) Errors for S. pneumoniae strains: Not observed | No Very Major Errors |
| Minor Errors for S. pneumoniae strains: Not observed (likely implied acceptable if within EA) | No Minor Errors |
| Category Agreement (CA) for S. pneumoniae strains: Not explicitly stated as a numerical criteria, but 100% with 1 random minor error was observed. | 100% (with 1 random minor error within EA) |
| Essential Agreement (EA) for non-pneumococcal streptococci strains: Acceptable | 97.8% |
| Major (M) Errors for non-pneumococcal streptococci strains: Not observed | No Major Errors |
| Very Major (VM) Errors for non-pneumococcal streptococci strains: Not observed | No Very Major Errors |
| Minor Errors for non-pneumococcal streptococci strains: Not observed | No Minor Errors |
| Category Agreement (CA) for non-pneumococcal streptococci strains: Not explicitly stated as a numerical criteria, but 100% with no random minor errors was observed. | 100% (with no random minor errors) |
| Overall Essential Agreement for streptococci: Not explicitly stated, but 93.8% was reported. | 93.8% |
| QC Endpoints for S. pneumoniae ATCC 49619: Within recommended NCCLS acceptable range | Within recommended NCCLS acceptable range |
| Reproducibility: Not explicitly stated as a numerical criteria, but "100% within the acceptable plus or minus 1 dilution" was observed. | 100% within the acceptable plus or minus 1 dilution |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Sizes:
- S. pneumoniae strains: 101
- Non-pneumococcal streptococci strains: 130
- QC organism (S. pneumoniae ATCC 49619): used throughout testing (number of individual tests not specified, but likely repeated measurements)
- Reproducibility testing: 12 organisms at each of two sites, with 7 organisms producing on-scale endpoints.
- Data Provenance: The study was conducted using "CDC challenge strains and clinical isolates," suggesting a mix of standardized laboratory strains and real-world patient samples. The testing was performed at "two sites." The country of origin is not explicitly stated, but given the FDA submission, it is highly likely to be the USA. The study appears to be prospective comparative testing, as new panels were prepared and then tested against a reference panel.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
The document does not provide information on the number or qualifications of experts used to establish the ground truth. Ground truth in antimicrobial susceptibility testing for a device like this would typically involve a reference method (e.g., broth microdilution or agar dilution) interpreted by trained laboratory personnel.
4. Adjudication Method for the Test Set:
The document does not specify an adjudication method. In this context, it's less about expert adjudication of discrepancies (as might be seen in image interpretation) and more about the comparison of results from the investigational device against the established reference method standard. Discrepancies would be categorized as Major, Very Major, or Minor errors based on predefined criteria, rather than a human adjudication process.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
A MRMC comparative effectiveness study was not performed. This type of study is more common for diagnostic devices that rely on human interpretation (e.g., radiology AI). The Pasco device is an automated in vitro diagnostic for antimicrobial susceptibility, so human reader performance with and without AI assistance is not applicable.
6. Standalone Performance:
Yes, a standalone performance study was done. The entire summary of substantial equivalence testing describes the performance of the Pasco panels (the algorithm/device) compared to a reference standard. The metrics like Essential Agreement, Major/Very Major/Minor errors, Category Agreement, QC endpoints, and Reproducibility are all measures of the device's standalone performance.
7. Type of Ground Truth Used:
The ground truth used was based on comparison to a reference panel. Specifically, "Comparative testing of the Pasco test panel to a reference panel was performed." In microbiology, this usually implies a validated, standard antimicrobial susceptibility testing method (e.g., a CLSI-compliant broth microdilution method) as the gold standard for determining the true MIC and category.
8. Sample Size for the Training Set:
The document does not mention a training set. This is a traditional microbiology device (panels with antimicrobial agents), not a machine learning or AI-driven diagnostic device that typically requires a large training dataset for model development. The "device" here refers to the pre-prepared panels, and its performance is evaluated against established methods.
9. How the Ground Truth for the Training Set Was Established:
As there is no mention of a training set (see point 8), this question is not applicable.
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SEP 1 6 1999
199214
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510(k) SUMMARY (page 1 of 2)
| DATE: | June 18, 1999 |
|---|---|
| CONTACT PERSON: | Linda K. DillonChuck Lakel |
| TRADE NAME OF DEVICE: | Pasco MIC and MIC/ID Panels |
| COMMON NAME: | Antimicrobial Susceptibility Test |
| CLASSIFICATION NAME: | Class II Antimicrobial Susceptibility Test Microbiology Panel#83 |
SUBSTANTIAL EQUIVALENCE:
In review of previous 510(k) notifications for the Pasco MIC and MIC/ID panels (most recently: K982235, July 30, 1998 RE: Minocycline; K982156, July 29, 1998 RE: Cefdinir; K980955 May 18, 1998 RE: Trovafloxacin; K974362, February 12, 1998 RE: Cefepime; K973317, November 14, 1997 RE: Cefpodoxime: K973695, November 5, 1997 RE: Meropenem; 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.
DESCRIPTION OF THE DEVICE:
Varying concentrations of antimicrobial agents (usually in two-fold 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 panels are then observed for visible growth or color changes as described in the package insert.
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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/D 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:
Test panels containing Clindamycin at concentrations ranging from 2-0.015 mcg/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 101 S. pneumoniae strains demonstrated acceptable Essential Agreement (EA) of 90.3%. No major (M), very major (VM) or minor errors were observed. Category agreement (CA) was 100% with 1 random minor error (within EA). Test results of the 130 nonpneumococcal streptococci strains demonstrated acceptable Essential Agreement (EA) of 97.8%. No major (M), very major (VM) or minor errors were observed. Category Agreement (CA) was 100% with no random minor errors. The overall Essential Agreement for streptococci was 93,8%.
QC endpoints for the QC organism S. pneumoniae ATCC 49619 from both the reference and Pasco panels throughout testing were within the recommended NCCLS acceptable range.
Reproducibility testing of 12 organisms at each site provided 7 organisms with on-scale endpoints. Overall reproducibility data demonstrated 100% within the acceptable plus or minus 1 dilution.
The results of the clinical testing, reproducibility testing and OC 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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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP 1 6 1999
Ms. Linda K. Dillon Technical Manager Pasco Laboratories, Inc. 12750 West Forty-Second Avenue Wheat Ridge, Colorado 80033
Re: K992143
Trade Name: Pasco MIC and MIC/ID Panels (Clindamycin) Regulatory Class: II Product Code: JWY Dated: June 18, 1999 Received: June 24, 1999
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 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). 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 requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) 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 yours,
Steven Autman
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 Clindamycin
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 Clindamycin to Pasco panels at concentrations of 0.015-2 mcg/ml for use in determining the susceptibility of S. pneumoniae and non-pneumococcal streptococci.
P.M. Poole Acting for DR Dubois, Ph.D.
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K99 2143
Prescription Use (Per 21 CFR 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).