The Sensititre Haemophilus influenzae/Streptococcus pneumoniae plates are in vitro diagnostic products for clinical susceptibility testing of Haemophilus influenzae, Streptococcus pneumoniae and Streptococcus species.

Sensititre® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC Susceptibility Plates with Dtest (containing erythromycin at 1 µg/ml and clindamycin at 0.5µg/ml) broth test for Streptococcus pneumoniae and Streptococcus spp.-β-Hemolytic Group is an in vitro diagnostic product for clinical susceptibility testing.

The Dtest for broth microdilution test is for manual read detection of inducible clindamycin resistance in Streptococcus pyogenes and Streptococcus agalactiae resistant to erythromycin (MICs ≥ 1 µg/mL) and susceptible or intermediate to clindamycin (MICs ≤ 0.25 µg/mL or 0.5 µg/mL), and to determine absence of inducible clindamycin resistance in Streptococcus pneumoniae. The performance of this test for the detection of inducible clindamycin resistance in isolates of S. pneumoniae has not been established.

With S. pyogenes and S. agalactiae, a Dtest (1/0.5 ug/ml) positive (growth) test, determined by manual read, should be reported as inducible clindamycin resistance.

Device Description

Sensititre® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC Susceptibility Plates with Dtest (containing erythromycin at 1 ug/mL and clindamycin at 0.5 ug/mL) broth test for Streptococcus pneumoniae and Streptococcus spp.-β-Hemolytic Group is an in vitro diagnostic product for clinical susceptibility testing.

AI/ML Overview

This document is an FDA 510(k) clearance letter for a medical device called "Sensititre Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC Susceptibility Plates with Dtest". This type of document mainly focuses on the regulatory clearance for marketing the device based on its substantial equivalence to a predicate device. It typically does not contain detailed information about the specific studies, acceptance criteria, or performance metrics in the way a clinical study report or a scientific paper would.

Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not available in the provided text.

Here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance:

Not available in the provided text. The document states that the FDA reviewed the premarket notification and determined the device is "substantially equivalent" to legally marketed predicate devices. This indicates that the device met the regulatory bar for substantial equivalence, but it doesn't quantify specific acceptance criteria or performance numbers (e.g., sensitivity, specificity, accuracy).

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

Not available in the provided text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

Not applicable/Not available. This device is an in vitro diagnostic for antimicrobial susceptibility testing. The "ground truth" would typically come from a reference method (e.g., a recognized standard for MIC determination), not from human expert interpretation of images or other subjective data. The document does not specify how the ground truth for any comparison studies was established.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable/Not available. Adjudication methods are typically used when there's subjective interpretation by multiple human readers, which is not the primary mode of operation for this type of in vitro diagnostic device.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable/Not available. This device is an antimicrobial susceptibility test, not an AI-powered image analysis or diagnostic aid for human readers. Therefore, an MRMC study and AI assistance improvement effect size are not relevant here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Likely yes, but details are not provided. For an in vitro diagnostic device like this, the "standalone" performance is essentially how well the plate works on its own to determine susceptibility. The document implies that data was submitted to demonstrate its performance, but it doesn't give specifics. The Dtest component is designed for "manual read detection," so there is a human-in-the-loop for that specific interpretation, but the overall MIC determination is a direct result of the chemical reactions on the plate.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not explicitly stated, but inferred to be a reference method for antimicrobial susceptibility testing. For such devices, ground truth is typically established by parallel testing with a recognized reference method for determining minimum inhibitory concentrations (MICs), such as agar dilution or broth microdilution using a standard methodology.

8. The sample size for the training set:

Not available in the provided text. (Note: This type of device does not typically have a "training set" in the machine learning sense, but rather a set of clinical and challenge isolates used for performance evaluation during development and validation.)

9. How the ground truth for the training set was established:

Not available in the provided text. (Similar to point 7, it would be by a reference method.)

Summary of available information from the text:

Device Name: Sensititre® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC Susceptibility Plates with Dtest
Regulation Name: Antimicrobial susceptibility test powder
Regulatory Class: II
Product Code: JWY, LTT, LTW
Indications for Use: In vitro diagnostic products for clinical susceptibility testing of Haemophilus influenzae, Streptococcus pneumoniae, and Streptococcus species. The Dtest specifically for manual read detection of inducible clindamycin resistance in Streptococcus pyogenes and Streptococcus agalactiae, and to determine the absence of inducible clindamycin resistance in Streptococcus pneumoniae.
FDA Determination: Substantially equivalent to legally marketed predicate devices.

Why this information is missing:

This document is an official FDA communication granting clearance, not a scientific publication detailing the underlying studies. The FDA clearance process focuses on whether the submitted data demonstrates that the new device is "substantially equivalent" to an existing, legally marketed device (the predicate). While studies are conducted to support this claim, their detailed methodologies, acceptance criteria, and specific performance outcomes are typically contained in the 510(k) submission itself, which is not fully public in this correspondence.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

THERMO FISHER SCIENTIFIC CYNTHIA KNAPP DIRECTOR OF CLINICAL OPERATIONS 1 THERMO FISHER WAY OAKWOOD VILLAGE OH 44146

August 1, 2014

Re: K133847

Trade/Device Name: Sensititre Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC Susceptibility Plates with Dtest (containing erythromycin at 1ug/mL and clindamvcin at 0.5 ug/mL) Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: II Product Code: JWY, LTT, LTW Dated: July 24, 2014 Received: July 25, 2014

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. 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 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

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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/Resourcesfor You/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,

Uwe Scherf - S for

Sally Hojvat, M.Sc., PhD. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K133847

Device Name

Sensitite® Haemophilus influenza/Streptococus pneumoniae (HP) MIC Susceptibility plates with Dtest (containing erythromyin at 1 ug/mL and clindamycin at 0.5 ug/mL)

Indications for Use (Describe)

Sensititie® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC Susceptibility Plates with Dtest (containing erythromycin at 1 µg/ml and clindamycin at 0.5µg/ml) broth test for Streptococcus pneumoniae and Streptococus spp.-9-Hemolytic Group is an in vitro diagnostic product for clinical susceptibility testing.

The Dtest for broth microdilution test is for manual read detection of inducible clindamycin resistance in Streptococcus pyogenes and Streptococcus agalactiae resistant to erythromycin (MICs ≥ 1 µg/mL) and susceptible or intermediate to clindamycin (MICs ≤ 0.25 µg/mL or 0.5 µg/mL), and to determine absence of inducible clindamycin resistance in Streptococus pneumoniae. The performance of this test for the detection of inducible clindamycin resistance in isolates of S. pneumoniae has not been established.

With S. pyogenes and S. agalactiae, a Dtest (1/0.5 ug/ml) positive (growth) test, determined by manual read, should be reported as inducible clindamycin resistance.

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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FOR FDA USE ONLY

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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).