(193 days)
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None
No
The document describes a standard in vitro diagnostic susceptibility plate 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 helps in identifying suitable treatments but is not used to treat or prevent disease directly.
Yes
The text explicitly states "The Sensititre HP MIC Susceptibility plate is an in vitro diagnostic product for clinical susceptibility testing".
No
The device description explicitly states it is a "Sensititre Haemophilus / Streptococcus pneumoniae (HP) MIC plates," which are physical laboratory plates used for susceptibility testing. This indicates a hardware component is central to the device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use / Indications for Use: The description explicitly states it is an "in vitro diagnostic product for clinical susceptibility testing." This is the primary characteristic of an IVD.
- Device Description: The device is a "Sensititre HP MIC Susceptibility plate," which is a laboratory tool used to test biological samples (bacterial isolates) outside of the body.
- Purpose: The purpose is to determine the susceptibility of bacterial isolates to an antibiotic (Tedizolid), which is a diagnostic process performed in a laboratory setting.
The information provided clearly indicates that this device is intended for use in a laboratory to perform diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
The Sensititre HP MIC Susceptibility plate is an in vitro diagnostic product for clinical susceptibility testing of fastidious isolates. This 510(k) is for the newly approved Tedizolid for the dilution range of 0.002-4ug/ml to the Sensititre HP MIC Susceptibility plate for testing Streptococcus spp. The approved primary "Indications for Use" and clinical significance for Streptococcus spp. is for the following species: Streptococcus pyogenes Streptococcus agalactiae Streptococcus anginosus
Product codes
JWY, LRG, LTT
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
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Anatomical Site
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Indicated Patient Age Range
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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
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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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
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 October 27, 2015
THERMO FISHER SCIENTIFIC CYNTHIA KNAPP DIRECTOR OF CLINICAL OPERATIONS 1 THERMO FISHER WAY OAKWOOD VILLAGE OH 44014-6
Re: K142338
Trade/Device Name: Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Plates with Tedizolid in the dilution range of 0.002-4 ug/ml Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: II Product Code: JWY. LRG, LTT Dated: February 11, 2015 Received: February 12, 2015
Dear Ms. Knapp:
This letter corrects our substantially equivalent letter of March 2, 2015.
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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
1
CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Ribhi Shawar -S
For Uwe Scherf, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K142338
Device Name
Sensititre Haemophilus / Streptococcus pneumoniae (HP) MIC plates with Tedizolid in the dilution range of 0.002-4ug/ml
Indications for Use (Describe)
The Sensititre HP MIC Susceptibility plate is an in vitro diagnostic product for clinical susceptibility testing of fastidious isolates.
This 510(k) is for the newly approved Tedizolid for the dilution range of 0.002-4ug/ml to the Sensititre HP MIC Susceptibility plate for testing Streptococcus spp.
The approved primary "Indications for Use" and clinical significance for Streptococcus spp. is for the following species: Streptococcus pyogenes Streptococcus agalactiae Streptococcus anginosus
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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