(62 days)
Not Found
Not Found
No
The summary describes a traditional antimicrobial susceptibility test disc and does not mention any AI or ML terms or functionalities.
No
The device is used for in-vitro susceptibility testing of microorganisms, not for treating a disease or condition in a living organism.
Yes
This device, an Antimicrobial Susceptibility Test Disc, is used for "semi-quantitative susceptibility testing" of microorganisms, which is a method to determine how susceptible bacteria are to antibiotics. This process is a form of diagnosis as it helps identify effective treatments for infections, which is a diagnostic purpose.
No
The device description clearly states "Antimicrobial Susceptibility Test Discs," which are physical components used in laboratory testing, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "semi-quantitative susceptibility testing by agar diffusion test procedure of rapidly growing micro-organisms." This process involves testing biological samples (micro-organisms) outside of the body to determine their susceptibility to antimicrobial agents. This is a core function of in vitro diagnostics.
- Device Description: The device is described as "Antimicrobial Susceptibility Test Discs," which are components used in laboratory testing procedures.
The definition of an IVD generally includes devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. While the description doesn't explicitly state the specimens are from humans, the context of testing micro-organisms for susceptibility to antimicrobial agents strongly implies a clinical or public health application involving human samples.
N/A
Intended Use / Indications for Use
Antimicrobial Susceptibility Test Discs are indicated for the semi-quantitative susceptibility testing by agar diffusion test procedure of rapidly growing micro-organisms. These include : Enterobacteriacae and Enterococcus spp., and by modified procedures, Haemophilus influenzae.
Product codes
JTN
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 866.1620 Antimicrobial susceptibility test disc.
(a)
Identification. An antimicrobial susceptibility test disc is a device that consists of antimicrobic-impregnated paper discs used to measure by a disc-agar diffusion technique or a disc-broth elution technique the in vitro susceptibility of most clinically important bacterial pathogens to antimicrobial agents. In the disc-agar diffusion technique, bacterial susceptibility is ascertained by directly measuring the magnitude of a zone of bacterial inhibition around the disc on an agar surface. The disc-broth elution technique is associated with an automated rapid susceptibility test system and employs a fluid medium in which susceptibility is ascertained by photometrically measuring changes in bacterial growth resulting when antimicrobial material is eluted from the disc into the fluid medium. 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 is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized image of an eagle with three heads, representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circle around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Andy Hollingsworth Quality Systems Manager Oxoid Limited Wade Road Basingstoke Hants RG24 8PW England
JUL - 3 1997
Re: K971633
Trade Name: Piperacillin/Tazobactam Antimicrobial Susceptibility Test Regulatory Class: II Product Code: JTN Dated: June 10, 1997 Received: June 12, 1997
Dear Mr. Hollingsworth:
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, Paris 800 to 895. A substantially equivalent deterniuation assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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
510(K) Submission for Oxoid Antimicrobial Susceptibility Test Disc
PIPERACILLIN / TAZOBACTAM
OXOID LTD
510(K) Number : K971633
Device Name : Oxoid Piperacillin/Tazobactam Susceptibility Test Disc
Indication for Use :
Antimicrobial Susceptibility Test Discs are indicated for the semi-quantitative susceptibility testing by agar diffusion test procedure of rapidly growing micro-organisms. These include : Enterobacteriacae and Enterococcus spp., and by modified procedures, Haemophilus influenzae.
The technical product insert details the Quality Control organisms to be use with this disc.
Arlen Penhos
(Division Sign-O Division of Clinical L 510(k) Number.
\✓ For prescription use
Image /page/2/Picture/12 description: The image shows a black and white drawing of a round object. The object is mostly black, but there are many small white dots scattered throughout. The object appears to be textured, and it is not perfectly round.