(35 days)
This query cannot be answered from the provided text as it does not contain the necessary information about "Predicate Device(s) K/DEN number".
No
The provided text describes a susceptibility plate for bacterial identification and antibiotic resistance testing. There is no mention of AI or ML in the intended use or any other section.
No
The device is a susceptibility plate used to determine the effectiveness of antibiotics against specific bacteria, which is for diagnostic purposes, not therapeutic treatment of a disease.
No
The document describes a Susceptibility Plate used for determining antibiotic susceptibility, which is a method for drug resistance testing, not a diagnostic test for identifying a disease or condition.
No
The device description is not provided, but the intended use clearly describes a physical susceptibility plate (Sensititre® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC Susceptibility plate) used for testing bacterial susceptibility to antibiotics. This indicates a hardware component is central to the device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states that the device is a "MIC Susceptibility plate". Susceptibility testing is a laboratory procedure performed in vitro (outside the body) to determine the effectiveness of antimicrobial agents against specific microorganisms. This is a core function of an In Vitro Diagnostic device.
Furthermore, the text describes the device's use with various Streptococcus species and Haemophilus influenzae, which are microorganisms. The purpose is to assess their susceptibility to antibiotics like cefepime and ceftriaxone. This process of analyzing biological samples (in this case, bacterial cultures) to provide information for diagnosis, treatment, or prevention of disease is the definition of an IVD.
N/A
Intended Use / Indications for Use
The Sensititre® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC Susceptibility plate is and I he Sellstitle= Huemophilus influence&oldid=91888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888 Streptococcus species.
This 510(k) is for the addition of Streptococcus spps to cefepime (0.12 - 8 ug/mL), ceftrianone (0.06-2 I I IIIS SIV(K) is for the addition of Shippoooooal vipps Sensitite® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC Susceptibility Plates .
oneumonde (HF) MIC Susceptionity Frates -
Viridans group streptococci. Streptococcus pneumoniae, Streptococcus pyogenes With activity against: Streptococcus agalactiae " " Sheptococcas agatachas for use" and clinical significance of ceftriaxone is for
Viridans group streptococci.
Streptococcus pneumoniae,
Streptococcus pyogenes
The following in vitro data are available but their clinical significance is unknown:
Streptococcus agalactiae
" "Streptococcas ugadestions for use" and clinical significance of chloramphenicol is for: Streptococcus pneumoniae
Streptococcus spp.
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
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three branches intertwined. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 1 3 2006
Ms. Cynthia C. Knapp Director Lab Services TREK Diagnostic Systems, Inc. 982 Keynote Circle, Suite 6 Cleveland, OH 44131
Re: K062681
Trade/Device Name: Sensititre® Haemophilus inflenzae/Streptococcus pneumoniae (HP) MIC susceptibility plates, for Cefepime (0.12-8 ug/ml), Chlomaphenicol (4-16 ug/ml) Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobiał Susceptibility Test Powder
Regulatory Class: Class II Product Code: JWY, LRG Dated: September 5, 2006 Received: September 8, 2006
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, Orug 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 (1 vire, 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
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 (240)276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 yours,
Sally anton
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): KOレ 26 8 )
Device Name: Sensititre® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC Susceptibility Plates. Cefepime (0.12-8μg/ml), Ceftriaxone (0.06-2 μg/ml), Chloramphenicol (4-16 μg/ml)
Indications For Use:
Indications For Use.
The Sensititre® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC Susceptibility plate is and I he Sellstitle= Huemophilus influence&oldid=918888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888 Streptococcus species.
This 510(k) is for the addition of Streptococcus spps to cefepime (0.12 - 8 ug/mL), ceftrianone (0.06-2 I I IIIS SIV(K) is for the addition of Shippoooooal vipps Sensitite® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC Susceptibility Plates .
oneumonde (HF) MIC Susceptionity Frates -
Viridans group streptococci. Streptococcus pneumoniae, Streptococcus pyogenes With activity against: Streptococcus agalactiae " " Sheptococcas agatachas for use" and clinical significance of ceftriaxone is for
Viridans group streptococci.
Streptococcus pneumoniae,
Streptococcus pyogenes
The following in vitro data are available but their clinical significance is unknown:
Streptococcus agalactiae
" "Streptococcas ugadestions for use" and clinical significance of chloramphenicol is for: Streptococcus pneumoniae
Streptococcus spp.
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
ic Devices (OIVD)
Office of In Vitro Diagnostic Device
Evaluation and Safety
510062 K062681