(151 days)
Not Found
Not Found
No
The summary describes a susceptibility testing plate and system for determining the minimum inhibitory concentration (MIC) of an antibiotic (Ceftaroline) against specific bacteria. The description focuses on the chemical and biological aspects of the test and does not mention any computational or algorithmic components that would suggest the use of AI or ML. The "Not Found" entries for sections typically associated with AI/ML (e.g., "Mentions AI, DNN, or ML", "Description of the training set") further support this conclusion.
No
The device is an in vitro diagnostic product used for susceptibility testing of bacterial isolates, not a product for treating or diagnosing a disease in a living patient.
Yes
The text explicitly states that the Sensititre HP MIC Susceptibility plate and the Sensititre 18-24 hour MIC Susceptibility System are "in vitro diagnostic product[s] for clinical susceptibility testing."
No
The device is described as an in vitro diagnostic product involving susceptibility plates and a susceptibility system, which are physical components used for testing. The 510(k) is for the addition of a drug (Ceftaroline) to these physical plates/panels. There is no mention of software as the primary or sole component.
Yes, the device described is an IVD (In Vitro Diagnostic).
The text explicitly states:
- "The Sensititre HP MIC Susceptibility plate is an in vitro diagnostic product for clinical susceptibility testing of fastidious isolates."
- "The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of non-fastidious isolates."
These statements directly identify the devices as in vitro diagnostic products.
N/A
Intended Use / Indications for Use
The Sensititre HP MIC Susceptibility plate with Ceftaroline (0.015-32ug/ml) and the Sensititre 18-24 hour MIC susceptibility System Test Panel with Ceftaroline (0.015-64ug/ml) are intended for use with the Sensititre MIC or BP Susceptibility System.
The Sensititre HP MIC Susceptibility plate is an in vitro diagnostic product for clinical susceptibility testing of fastidious isolates. The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of non-fastidious isolates.
This 510(k) is for the addition of Ceftaroline in the dilution range of 0.015-32μg/ml to the Sensititre HP MIC Susceptibility plate for testing Haemophilus influenzae and the Sensititre 18 - 24 hour MIC panel in the dilution range of 0.015-64μg/ml for testing gram negative isolates.
The approved primary "Indications for Use" and clinical significance of Ceftaroline is for:
Facultative Gram-negative Microorganisms:
Escherichia coli
Klebsiella pneumoniae
Klebsiella oxytoca
Haemophilus influenzae
In vitro data, without clinical correlation is provided for:
Facultative Gram-Negative Microorganisms:
Citrobacter koseri
Citrobacter freundii
Enterobacter cloacae
Enterobacter aerogenes
Moraxella catarrhalis
Morganella morganii
Proteus mirabilis
Ceftaroline is not active against Gram negative bacteria producing extended spectrum beta-lactamases (ESBLS) from the TEM, SHV or CTX-M families, serine carbapenemases (such as KPC), class 8 metallobeta-lactamases or class C (AmpC cephalosporinases).
Product codes
JWY, LRG
Device Description
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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
Not Found
Key Metrics
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
TREK Diagnostic Systems, Ltd. C/o Cindy Knapp Director of US Regulatory and Global Clinical Affairs 982 Keynote Circle, Suite 6 Cleveland OH 44131
NOV - 8 2011
Re: K111615
Trade/Device Name: Sensititre® 18-24 hour Susceptibility MIC Plates Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: Class II Product Code: JWY, LRG Dated: November 2, 2011 Received: November 4, 2011
Dear Cindy 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 class II (Special Controls), 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The
1
Page 2 - Ms. Knapp
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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jail C. Harper
Sally Hojvat Director
Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known):
Device Name: Sensititre® HP MIC Susceptibility Plate with Ceftaroline (0.015-32µg/ml) and The Sensititre® 18 - 24 hour MIC Susceptibility System Test Panel with Ceftaroline (0.015-64ug/ml)
Indications for Use: The Sensititre HP MIC Susceptibility plate with Ceftaroline (0.015-32ug/ml) and the Sensititre 18-24 hour MIC susceptibility System Test Panel with Ceftaroline (0.015-64ug/ml) are intended for use with the Sensititre MIC or BP Susceptibility System.
The Sensititre HP MIC Susceptibility plate is an in vitro diagnostic product for clinical susceptibility testing of fastidious isolates._The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of non-fastidious isolates.
This 510(k) is for the addition of Ceftaroline in the dilution range of 0.015-32μg/ml to the Sensititre HP MIC Susceptibility plate for testing Haemophilus influenzae and the Sensititre 18 - 24 hour MIC panel in the dilution range of 0.015-64μg/ml for testing gram negative isolates.
The approved primary "Indications for Use" and clinical significance of Ceftaroline is for:
Facultative Gram-negative Microorganisms:
Escherichia coli Klebsiella pneumoniae Klebsiella oxytoca Haemophilus influenzae
In vitro data, without clinical correlation is provided for:
Facultative Gram-Negative Microorganisms:
Citrobacter koseri Citrobacter freundii Enterobacter cloacae Enterobacter aerogenes Moraxella catarrhalis Morganella morganii Proteus mirabilis
Ceftaroline is not active against Gram negative bacteria producing extended spectrum beta-lactamases (ESBLS) from the TEM, SHV or CTX-M families, serine carbapenemases (such as KPC), class 8 metallobeta-lactamases or class C (AmpC cephalosporinases).
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
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Pole
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K111615