(28 days)
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Not Found
No
The document describes a standard in vitro diagnostic susceptibility plate and does not mention any AI or ML components.
No.
The device is an in vitro diagnostic product for susceptibility testing, not a therapeutic device designed to treat or prevent disease.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the product is an "in vitro diagnostic product for clinical susceptibility testing," which directly indicates its use in diagnosis.
No
The device description clearly states it is a "Sensititre® Haemophilus/Streptococcus pneumoniae (HP) MIC Plates," which are physical plates used for in vitro diagnostic testing, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The Sensitite Haemophilus / Streptococcus pneumoniae (HP) MIC Susceptibility plate is an in vitro diagnostic product for clinical susceptibility testing of Haemophilus / Streptococcus pneumoniae."
This statement directly identifies the device as an in vitro diagnostic product.
N/A
Intended Use / Indications for Use
The Sensitite Haemophilus / Streptococcus pneumoniae (HP) MIC Susceptibility plate is an in vitro diagnostic product for clinical susceptibility testing of Haemophilus / Streptococcus pneumoniae . This 510(k) is for the addition of Gemifloxacin in the dilution range of 0.001 - 16 ug/ml to the Sensititre Haemophilus / Streptococcus pneumoniae (HP) MIC Susceptibility plate MIC panel for testing Haemophilus / Streptococcus pneumoniae isolates. The approved primary " Indications for Use" and clinical significance of Gemifloxacin is for: Streptococcus pneumoniae and Haemophilus Influenzae.
Product codes
JWY, LRG
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/0/Picture/2 description: The image is a black and white logo. The logo is circular and contains a stylized image of an eagle. The eagle is facing to the right. The words "HUMAN SERVICES - USA" are written around the top of the circle.
AUG 2 9 2003
od and Drug Administ 2098 Gaither Road Rockville MD 20850
Ms. Cynthia C. Knapp Director Lab Services TREK Diagnostic Systems, Inc. 29299 Clemens Road, Suite 1-K Westlake, OH 44145
Re: K032382
Trade/Device Name: Sensititre® Haemophilus/Streptococcus pneumoniae (HP) MIC Plates Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: Class II Product Code: JWY, LRG Dated: July 28, 2003 Received: August 1, 2003
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, 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 either class II (Special Controls) or class III (PMA), 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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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 (301) 594-3084. 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.
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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KO32382 510 (k) Number (If known): __________________________________________________________________________________________________________________________________________________
Device Name: Haemophilus / Streptococcus pneumoniae (HP) MIC Susceptibility plate
Indications For Use:
The Sensitite Haemophilus / Streptococcus pneumoniae (HP) MIC Susceptibility plate is an in vitro diagnostic product for clinical susceptibility testing of Haemophilus / Streptococcus pneumoniae .
This 510(k) is for the addition of Gemifloxacin in the dilution range of 0.001 - 16 ug/ml to the Sensititre Haemophilus / Streptococcus pneumoniae (HP) MIC Susceptibility plate MIC panel for testing Haemophilus / Streptococcus pneumoniae isolates. The approved primary " Indications for Use" and clinical significance of Gemifloxacin is for: Streptococcus pneumoniae and Haemophilus Influenzae.
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off
8/28/03
Office of In Vitro Diagnostic Device Evaluation and Safety
| 510(k) | K032382 |
|---|---|
| -------- | --------- |
| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---|---|---|
| --------------------------------------- | ---- | ---------------------- |