(50 days)
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No
The summary describes a traditional antimicrobial susceptibility testing method using established technology and does not mention any AI or ML components.
No
This device is for determining the susceptibility of bacterial pathogens to antimicrobial agents and for biochemical identification of those organisms, which is a diagnostic function, not a therapeutic one.
Yes
The device is described as measuring the susceptibility of bacterial pathogens to antimicrobial agents and determining their biochemical identification, which are diagnostic processes.
No
The device description explicitly states "Pasco MIC panels make use of established technology to quantitatively measure the susceptibility of rapidly growing aerobic and facultative anaerobic bacterial pathogens," implying a physical panel or system is involved, not just software. The focus is on the addition of a specific antimicrobial agent to these panels, which are physical components used in laboratory testing.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the 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 describes a test performed in vitro (outside the body) on biological samples (bacterial pathogens) to provide information about a patient's condition (susceptibility to antibiotics and identification of the organism).
- Device Description: The description mentions "quantitatively measure the susceptibility of rapidly growing aerobic and facultative anaerobic bacterial pathogens," which aligns with the definition of an IVD.
- Performance Studies: The performance studies involve testing bacterial strains and comparing results to reference panels and published standards, which is typical for validating an IVD.
The information provided clearly indicates that this device is designed to be used in vitro to diagnose or provide information about a patient's health status by analyzing biological samples.
N/A
Intended Use / Indications 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 Sparfloxacin to Pasco panels at concentrations of 0.03 to 8 mcg/ml for determining the susceptibility of bacterial pathogens with the exception of Haemophilus and S. Pneumoniae.
Product codes (comma separated list FDA assigned to the subject device)
JWY
Device Description
The Pasco MIC panels make use of established technology to guantitatively measure the susceptibility of rapidly growing aerobic and facultative anaerobic bacterial pathogens.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
QC performance testing at two laboratories through 25 consecutive days of testing. Endpoint results from the Pasco panels were compared to those from the reference panels and results from both panels were compared to published NCCLS recommended QC ranges. Test results of the five recommended NCCLS strains (S. aureus ATCC 29213, E. faecalis ATCC 29212, P. aeruginosa ATCC 27853 and E. coli ATCC 25922).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The safety and efficacy of this product was determined by conducting QC performance testing at two laboratories through 25 consecutive days of testing. Endpoint results from the Pasco panels were compared to those from the reference panels and results from both panels were compared to published NCCLS recommended QC ranges. Test results of the five recommended NCCLS strains (S. aureus ATCC 29213, E. faecalis ATCC 29212, P. aeruginosa ATCC 27853 and E. coli ATCC 25922) confirmed 100% Essential Agreement in Which the Pasco endpoints either agreed exactly with or were within plus or minus one dilution of the reference panels. Additionally, MIC results from both the reference and the Pasco test panels were within the NCCLS recommended QC ranges published for Sparfloxacin.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
100% Essential Agreement
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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).
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Image /page/0/Picture/1 description: The image shows a sequence of handwritten digits and letters. The sequence reads 'K972567'. The characters are written in a simple, slightly irregular style, giving them a casual appearance.
SUMMARY OF SAFETY AND EFFECTIVENESS
The Pasco MIC panels make use of established technology to guantitatively measure the susceptibility of rapidly growing aerobic and facultative anaerobic bacterial pathogens. The safety and efficacy of this product was determined by conducting QC performance testing at two laboratories through 25 consecutive days of testing. Endpoint results from the Pasco panels were compared to those from the reference panels and results from both panels were compared to published NCCLS recommended QC ranges.
Test results of the five recommended NCCLS strains (S. aureus ATCC 29213, E. faecalis ATCC 29212, P. aeruginosa ATCC 27853 and
E. coli ATCC 25922) confirmed 100% Essential Agreement in Which the Pasco endpoints either agreed exactly with or were within plus or minus one dilution of the reference panels. Additionally, MIC results from both the reference and the Pasco test panels were within the NCCLS recommended QC ranges published for Sparfloxacin.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 circle's perimeter.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Linda K. Dillon Technical Manager Pasco Laboratories, Inc. 12750 West Forty-Second Wheat Ridge, Colorado 80033
AUG 200 1997 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
K972567 Re: Trade Name: Pasco MIC and MIC/ID Panels Regulatory Class: II Product Code: JWY Dated: June 27, 1997 Received: July 1, 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 requirements, 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 (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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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 Butman
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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ATTACHMENT 1 Page 1 of 1
Device Name:
PASCO MIC and MIC/ID Panels; Inclusion of SPARFLOXACIN
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 Sparfloxacin to Pasco panels at concentrations of 0.03 to 8 mcg/ml for determining the susceptibility of bacterial pathogens with the exception of Haemophilus and S. Pneumoniae.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED )
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V (Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
Wilhelm, Moritz, des Aichenbuhler
(Division Sign-On)
Division of Clinical Laboratory Devices
510(k) Number K972567