(61 days)
Not Found
Not Found
No
The summary describes a diagnostic test plate and automated readers, but there is no mention of AI, ML, or related concepts. The reading is described as manual or automatic, which typically refers to optical or other automated detection methods, not AI/ML interpretation.
No
This device is an in vitro diagnostic product designed to detect ESBLs in bacterial isolates. It does not provide any therapeutic benefit to a patient, but rather aids in diagnosis.
Yes
The "Intended Use / Indications for Use" section explicitly states that the product "is an in vitro diagnostic product."
No
The device is described as an "in vitro diagnostic product" and a "test plate," which are physical components used in laboratory testing. While it mentions potential automatic reading on hardware (Sensititre® ARIS or Autoreader), the core device itself is a physical test plate containing antimicrobials, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The Sensititre ESBL confirmatory test plate is an in vitro diagnostic product for detection of ESBL's in clinical isolates of Klebsiella pneumoniae, Klebsiella oxytoca and Escherichia coli."
N/A
Intended Use / Indications for Use
The Sensititre ESBL confirmatory test plate is an in vitro diagnostic product for detection of ESBL's in clinical isolates of Klebsiella pneumoniae, Klebsiella oxytoca and Escherichia coli. Test results can be read either manually or automatically on a Sensititre® ARIS or Autoreader.
This 510(K) is for ESBL Confirmatory Test Plate for Klebsiella pneumoniae, Klebsiella oxytoca, and Escherichia coli containing the following antimicrobials as per the NCCLS reference standard (M7):
Ceftazimdime: 0.06-128 Ceftazidime/clavulanic acid: 0.06/4-128/4 Cefotaxime: 0.06-64 Cefotaxime/clavulanic acid: 0.06/4-64/4
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter.
JUL 16 2003
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Cynthia C. Knapp Director Lab Services TREK Diagnostic System 982 Keynote Circle, Suite 6 Cleveland, Ohio 44131
K031545 Re:
Trade/Device Name: ESBL Confirmatory Test Plate Ceftazimdime, Ceftazidime/clavulanic acid, Cefotaxime,
Cefotaxime/ clavulanic acid
Regulation Number: 21 CFR 866.1640
Regulation Name: Antimicrobial Susceptibility Test Regulatory Class: Class II Product Code: JWY Dated: May 16, 2003 Received: May 20, 2003
Dear Ms. Knapp:
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. Iisting 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 (QS) regulation (21 CFR Part 820).
1
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
2
510 (k) Number (If known):
O31545
Device Name: ESBL Confirmatory Test Plate
Indications For Use:
The Sensititre ESBL confirmatory test plate is an in vitro diagnostic product for detection of ESBL's in clinical isolates of Klebsiella pneumoniae, Klebsiella oxytoca and Escherichia coli. Test results can be read either manually or automatically on a Sensititre® ARIS or Autoreader.
This 510(K) is for ESBL Confirmatory Test Plate for Klebsiella pneumoniae, Klebsiella oxytoca, and Escherichia coli containing the following antimicrobials as per the NCCLS reference standard (M7):
Ceftazimdime: 0.06-128 Ceftazidime/clavulanic acid: 0.06/4-128/4 Cefotaxime: 0.06-64 Cefotaxime/clavulanic acid: 0.06/4-64/4
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| Division Sign-Off | 7/10/03 | |
| Office of In Vitro Diagnostic Device | ||
| Evaluation and Safety | ||
| 510(k) | K031545 | |
| Prescription Use | ||
| (Per 21 CFR 801.109 | OR | Over-The-Counter Use |