(88 days)
Not Found
Not Found
No
The summary describes a susceptibility testing system for antibiotics and does not mention any AI or ML components.
No
The device is described as an in vitro diagnostic product for susceptibility testing, not a device used for treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the Sensititre system "is an in vitro diagnostic product for clinical susceptibility testing."
No
The device description is not provided, but the intended use describes an "in vitro diagnostic product" and a "Susceptibility System" which strongly suggests a physical laboratory system involving hardware components for testing. The addition of a drug (Daptomycin) to a "MIC panel" further supports this.
Yes, this device is an IVD (In Vitro Diagnostic).
The very first sentence of the "Intended Use / Indications for Use" section explicitly states: "The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of gram positive organisms."
N/A
Intended Use / Indications for Use
The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of gram positive organisms.
This 510(k) is for the addition of Daptomycin in the dilution range of 0.03 -64 µg/ml to the Sensititre 18 - 24 hour MIC panel for testing gram positive isolates. The approved primary "Indications for Use" and clinical significance of Daptomycin is for: Staphylococcus aureus (including methicillin-resistant strains),Enterococcus faecalis (vancomycin-susceptible strains only), Streptococcus agalactiae and Steptococcus pyogenes. In vitro data, without clinical correlation is provided for: Staphylococcus epidermidis (including methicillin-resistant strains) Enterococcus faecalis ( vancomycin-resistant strains), Enterococcus faecium (including vancomycin-resistant strains)and Staphylococcus haemolyticus.
Product codes
JWY, LRG
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
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the circumference. Inside the circle is a stylized image of an eagle or bird with outstretched wings, represented by three curved lines.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB - 3 2004
Ms. Cindy Knapp Director of Lab Services Trek Diagnostic Systems, Inc. 982 Keynote Circle - Suite 6 Cleveland, OH 44131
Re: K033522
Trade/Device Name: Susceptibility Test Panel for Daptomycin 0.03-64 us/ml Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: Class II Product Code: JWY; LRG Dated: January 5, 2004 Received: January 8, 2004
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, 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 (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). You may obtain other general information on your responsibilities under the Act 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 vours.
Saqartys
Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): K033522
Device Name: Susceptibility Test Panel for Daptomycin 0.03-64μg/ml
Indications For Use:
The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of gram positive organisms.
This 510(k) is for the addition of Daptomycin in the dilution range of 0.03 -64 µg/ml to the Sensititre 18 - 24 hour MIC panel for testing gram positive isolates. The approved primary "Indications for Use" and clinical significance of Daptomycin is for: Staphylococcus aureus (including methicillin-resistant strains),Enterococcus faecalis (vancomycin-susceptible strains only), Streptococcus agalactiae and Steptococcus pyogenes. In vitro data, without clinical correlation is provided for: Staphylococcus epidermidis (including methicillin-resistant strains) Enterococcus faecalis ( vancomycin-resistant strains), Enterococcus faecium (including vancomycin-resistant strains)and Staphylococcus haemolyticus.
× Prescription Use
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Naas at 2/3/04
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
KO33522 510(k)_