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

Device Description

Sensititre Haemophilus / Streptococcus pneumoniae (HP) MIC plates with Tedizolid in the dilution range of 0.002-4ug/ml

AI/ML Overview

Summary of Acceptance Criteria and Device Performance for K142338:

Device Name: Sensititre Haemophilus / Streptococcus pneumoniae (HP) MIC Plates with Tedizolid in the dilution range of 0.002-4ug/ml

Device Description:
The Sensititre HP MIC Susceptibility plate is an in vitro diagnostic product designed for clinical susceptibility testing of fastidious isolates, specifically for Streptococcus spp. This 510(k) approval expands its use to include Tedizolid in the dilution range of 0.002-4ug/ml for testing Streptococcus pyogenes, Streptococcus agalactiae, and Streptococcus anginosus.

Study Overview:
This document is a 510(k) premarket notification approval letter, not a detailed study report. Therefore, it does not contain the specific performance data, sample sizes, or ground truth establishment methods typically found in a clinical study description. The letter confirms the device's substantial equivalence to legally marketed predicate devices, implying that the submitted data met the FDA's requirements for demonstrating equivalent performance.

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is an FDA approval letter, specific acceptance criteria and detailed device performance are not explicitly stated in a table format within the provided text. However, for antimicrobial susceptibility testing (AST) devices, typical acceptance criteria relate to:

Essential Agreement (EA): The percentage of isolates for which the MIC of the new device is within one doubling dilution of the reference method's MIC.
Categorical Agreement (CA): The percentage of isolates for which the new device assigns the same susceptibility category (Susceptible, Intermediate, Resistant) as the reference method.
Minor Errors: Discrepancies where the new device classifies an isolate as Intermediate when the reference is Susceptible or Resistant, or vice versa.
Major Errors (ME): Discrepancies where the new device classifies an isolate as Susceptible when the reference is Resistant.
Very Major Errors (VME): Discrepancies where the new device classifies an isolate as Resistant when the reference is Susceptible.

Based on the typical requirements for 510(k) clearances for AST devices, the implied acceptance criteria would involve meeting specific thresholds for EA, CA, and acceptable rates of ME and VME against a reference method (e.g., CLSI broth microdilution). The fact that the device received 510(k) clearance indicates that these criteria were met.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size for Test Set: Not specified in the provided document.
Data Provenance: Not specified in the provided document. For 510(k) submissions, data often comes from multi-site clinical trials, which could include various countries. The retrospective or prospective nature of the data is also not mentioned.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

Number of Experts: Not specified.
Qualifications of Experts: Not specified. For AST, the "ground truth" is typically established by laboratory testing using a recognized reference method (e.g., CLSI broth microdilution) performed by trained microbiologists, rather than clinical experts like radiologists.

4. Adjudication Method for the Test Set:

Adjudication Method: Not applicable/not specified. For AST devices, discrepancies are usually resolved by re-testing or by a pre-defined algorithm comparing results to a gold standard reference method, not typically by expert adjudication in the same way as an imaging diagnosis.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Was an MRMC study done? No. This type of study is not relevant for an antimicrobial susceptibility test device, as there are no "readers" in the context found in imaging or diagnostic pathology.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Was a standalone study done? Yes, in essence. An AST device like the Sensititre HP MIC plate provides a direct result (MIC value) from the laboratory assay. The performance data submitted for 510(k) clearance would represent this "standalone" performance against a reference method. Human interpretation is involved in reading the MIC endpoint on the plate, but the performance evaluation is based on the device's ability to produce accurate MIC values.

7. Type of Ground Truth Used:

Type of Ground Truth: The ground truth for AST devices is typically established through a reference method (e.g., Clinical and Laboratory Standards Institute (CLSI) recommended broth microdilution method). This method is considered the gold standard for determining the minimum inhibitory concentration (MIC) of an antimicrobial agent against an isolate.

8. Sample Size for the Training Set:

Sample Size for Training Set: Not applicable/not specified. AST devices are usually based on a direct measurement of bacterial growth inhibition at various concentrations, not on machine learning algorithms trained on large datasets. Therefore, a "training set" in the AI sense is not relevant. The device development would involve optimizing the assay itself.

9. How the Ground Truth for the Training Set Was Established:

How Ground Truth for Training Set was Established: Not applicable. As explained above, there isn't a "training set" in the conventional AI sense for this type of device. The development process would involve extensive laboratory work to ensure the accuracy and reliability of the MIC readings across a range of bacterial isolates and Tedizolid concentrations, using CLSI or similar reference methods to confirm results.

Summary

{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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Regulation Number and Section

§ 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).