(40 days)
Not Found
Not Found
No
The summary describes a traditional antimicrobial susceptibility testing (AST) system and does not mention any AI or ML components.
No
The device is used for measuring the susceptibility of bacterial pathogens to antimicrobial agents and for biochemical identification, not for treating or rehabilitating diseases.
Yes
The device quantitatively measures the susceptibility of bacterial pathogens to antimicrobial agents and determines their biochemical identification, which are diagnostic purposes for identifying and characterizing infections.
No
The provided text describes a device that uses "panels" for measuring susceptibility and identification of bacteria. This strongly suggests a physical laboratory device or kit, not a software-only solution. The lack of any mention of software, algorithms, or digital processing further supports this conclusion.
Yes, this device is an IVD (In Vitro Diagnostic).
The intended use clearly states that the Pasco MIC and MIC/ID panels are used for:
- Quantitatively measuring the susceptibility of bacterial pathogens to antimicrobial agents. This involves testing samples (likely bacterial cultures) outside of the body to determine how they react to different drugs.
- Determining the biochemical identification of those organisms. This also involves laboratory testing of samples to identify the specific type of bacteria.
These activities fall squarely under the definition of In Vitro Diagnostics, which are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases, conditions, or infections. In this case, the samples are bacterial pathogens isolated from patients.
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 Meropenem to Pasco panels at concentrations of 0.03 to 32 mcg/ml for use in determining the susceptibility of K. pneumoniae, E. coli and P. aeruginosa. Clinical testing with Haemophilus sp., Viridans group streptococci and S. pneumoniae with Meropenem has not been performed with the Pasco system.
Product codes
JWY
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized human figure with three heads in profile, stacked on top of each other. The figure is positioned to the right of the text, which reads "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" in a circular arrangement around the figure.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV - 5 1997
Linda K. Dillon Technical Manager Pasco Laboratories, Inc. 12750 West Forty-Second Avenue Wheat Ridge, Colorado 80033
K973695 Re:
Trade Name: Pasco MIC and MIC/ID Panels/meropenem Regulatory Class: II Product Code: JWY Dated: September 23, 1997 Received: September 26, 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 (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.
1
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
2
Device Name:
PASCO MIC and MIC/ID Panels; Inclusion of MEROPENEM
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 Meropenem to Pasco panels at concentrations of 0.03 to 32 mcg/ml for use in determining the susceptibility of K. pneumoniae, E. coli and P. aeruginosa. Clinical testing with Haemophilus sp., Viridans group streptococci and S. pneumoniae with Meropenem has not been performed with the Pasco system.
Ken Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices 510(k) Number 17 7
Prescription Use √ (Per 21 CFR 801.109) OR
Over-The Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)