(50 days)
Not Found
Not Found
No
The 510(k) summary describes a susceptibility testing plate for determining the minimum inhibitory concentration (MIC) of an antibiotic against specific bacteria. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the provided text. The focus is on the addition of a new antibiotic to an existing panel.
No
The device is described as an "in vitro diagnostic device for the quantitative determination of susceptibility." This indicates it is used for diagnosis, not for treating a condition, making it a diagnostic device rather than a therapeutic one.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "is an in vitro diagnostic device for the quantitative determination of susceptibility".
No
The device description is not found, but the intended use clearly describes an "in vitro diagnostic device" which is a physical plate used for susceptibility testing. This is a hardware component, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"The Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility plate is an in vitro diagnostic device for the quantitative determination of susceptibility of Streptococcus pneumoniae and Haemophilus influenzae."
N/A
Intended Use / Indications for Use
The Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility plate is an in vitro diagnostic product for the quantitative determination of antimicrobial agent susceptibility of Haemophilus influenzae and Streptococcus pneumoniae. This 510(k) is for the addition of Linezolid in the dilution range of 0.25 - 32 µgml to the Sensititre Haemophilus/Streptococcus pneumoniae MIC panel for testing Streptococcus pneumoniae and Haemophilus influenzae isolates. The approved primary "Indications for Use" for Streptococcus pneumoniae (penicillin-resistant strains) and Haemophilus influenzae remains unchanged. Clinical significance of Enterococcus faecalis and Enterococcus faecium is not established. Clinical correlation is provided for: Streptococcus pneumoniae (penicillin-resistant strains).
Product codes
JWY
Device Description
Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility Plates
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 seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three lines representing its wings and body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 2 9 2001
Ms. Cynthia C. Knapp Director Lab Services Trek Diagnostic Systems, Inc. 29299 Clemens Road, Suite 1-K Westlake, OH 44145
K012151 Re:
Trade/Device Name: Sensititre™ Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility Plates Regulation Number: 21 CFR 866.1640 Regulatory Class: II
Product Code: JWY Dated: July 10, 2001 Received: July 10, 2001
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 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, Parts 800 to 895. A substantially equivalent determination 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.
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Page 2 -
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 notheation. The I Dri imalig of baction 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 1 If you desire specific darices jagnostic devices), please contact the Office of Compliance at additionally 607.10 for in This clegitestions on the promotion and advertising of your device, (301) 594-4560. Additionary, 10. quest at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Information on your responsibilities and er Assistance at its toll-free number (800) 638-2041 or Manufacturers International and Collisanter Fixsware da gov/cdrb/dsma/dsmamain.html".
(301) 443-6597 or at its internet address "http://www.fda.gov/cdrb/dsma/dsmamain.html".
Sincerely yours,
Steven Butman
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) Number (If known): Yolal Si
Device Name: Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility Plates.
Indications For Use:
The Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility plate is an in The Sensiture Haemopinius/Sucptococcus phoundomio (Streptococcus pneumoniae and Haemophilus influenzae.
This 510(k) is for the addition of Linezolid in the dilution range of 0.25 - 32 µgml to the This 510(K) is for the adultion of Encezond in the and for testing Streptococcus
Sensititre Haemophilus/Streptococcus pneumoniae MIC panel for testing Streptococcus Sensititre Haemophilus Streptococcus picanoneae isolates. The approved primary "Indications for pneumoniae and Haemopilius innuctize isources. The scoccus pneumonide (penicillin-Ose" and cinneal significance of Enterprise of Entical correlation is provided for: Streptococcus pneumoniae (penicillin- resistant strains)
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Freddie Warren Poole
Division Sign-Off) Division of Clinical Laboratory Devices
510(k) Number K012151
Prescription Use (Per 21 CFR 801.109
OR
Over-The-Counter Use_