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The Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility plate is an in vitro diagnostic product for clinical susceptibility testing of Streptococcus pneumoniae and Haemophilus influenzae.

This 510(k) is for the removal of the statement in our package insert under Plate Reading and Interpretation of Results: "The panel may only be read manually." Replace this with: "The panel may be autoread or manually read when testing S. pneumoniae and manually read with Haemophilus." The Sensititre Haemophilus/Streptococcus pneumoniae MIC panel is for testing Streptococcus pneumoniae and Haemophilus influenzae isolates.

Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility Plates.

The provided text is a 510(k) premarket notification approval letter for the Sensititre™ Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility Plates. This letter approves an amendment to the indications for use, specifically regarding the method of reading the susceptibility plates (manual vs. autoread).

However, the provided document does not contain the acceptance criteria or the study details proving the device meets those criteria, as requested in the prompt. The document is a regulatory approval letter based on information submitted in a 510(k) application, but it does not reproduce the detailed study information itself.

Therefore, I cannot provide the requested information based on the given text. The text only states that the FDA has reviewed the submission and found the device substantially equivalent to legally marketed predicate devices. The specifics of the performance testing, acceptance criteria, sample sizes, ground truth establishment, or expert qualifications are not present in this regulatory approval letter.

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