(61 days)
Not Found
Not Found
No
The summary describes a standard in vitro diagnostic susceptibility testing system and does not mention any AI or ML components or functionalities.
No.
The device is an in vitro diagnostic product used for clinical susceptibility testing, which provides information for diagnosis and treatment decisions but does not directly treat or prevent diseases.
Yes
The "Intended Use / Indications for Use" section explicitly states that it is an "in vitro diagnostic product for clinical susceptibility testing".
No
The device description explicitly states "Susceptibility Test Panel," which is a physical, in vitro diagnostic product, not software. The 510(k) is for the addition of a specific antibiotic (Cefdinir) to this physical panel.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The Sensititre 18 hour MIC or Breakpoint Susceptibility system is an in vitro diagnostic product for clinical susceptibility testing of gram negative and gram positive organisms."
N/A
Intended Use / Indications for Use
The Sensititre 18 hour MIC or Breakpoint Susceptibility system is an in vitro diagnostic product for clinical susceptibility testing of gram negative and gram positive organisms.
This 510(k) is for the addition of Cefdinir in the dilution range of 0.06 - 64 ug/ml to the Sensititre 18 - 24 hour MIC panel for testing non-fastidious gram negative isolates. There are no approved primary "Indications for Use" and the clinical significance of Cefdinir is unknown when evaluating Enterobacteriaceae or any other non-fastidious gram negative rods. In vitro data, without clinical correlation is provided for Citrobacter diversus, Escherichia coli, Klebsiella pneumoniae, and Proteus mirabilis. Cefdinir is inactive against Pseudomonas and Enterobacter species.
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB 1 6 1999
Cynthia C. Knapp Director Lab Services AccuMed International, Inc. 29299 Clemens Road, Suite 1-K Westlake, OH 44145
Re: K984489 Trade Name: Sensititre 18-24 Hour Susceptibility Plates Regulatory Class: II Product Code: JWY Dated: December 15, 1998 Received: December 17, 1998
Dear Ms. Knapp:
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 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). 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.
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 Sutman
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
10(k) Number (if known): K984489
Device Name: Susceptibility Test Panel
Indications For Use:
The Sensititre 18 hour MIC or Breakpoint Susceptibility system is an in vitro diagnostic product for clinical susceptibility testing of gram negative and gram positive organisms.
This 510(k) is for the addition of Cefdinir in the dilution range of 0.06 - 64 ug/ml to the Sensititre 18 - 24 hour MIC panel for testing non-fastidious gram negative isolates. There are no approved primary "Indications for Use" and the clinical significance of Cefdinir is unknown when evaluating Enterobacteriaceae or any other non-fastidious gram negative rods. In vitro data, without clinical correlation is provided for Citrobacter diversus, Escherichia coli, Klebsiella pneumoniae, and Proteus mirabilis. Cefdinir is inactive against Pseudomonas and Enterobacter species.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH. Office of Device Evaluation (ODE)
Woody Dubose
Division of Clinical Laboratory Devices 510(k) Number_K 98 44 89
Prescription Use Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96) .