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The BD BACTEC Plus PRIME Aerobic/F blood culture medium is used in a qualitative procedure for the aerobic culture and recovery of microorganisms (bacteria and yeast) from blood. The principal use of this medium is with the BD BACTEC fluorescent series instruments.

The sample to be tested is inoculated into one or more vials which are inserted into the BACTEC fluorescent series instrument for incubation and periodic reading. Each vial contains a chemical sensor which can detect increases in CO2 produced by the growth of microorganisms. The sensor is monitored by the instrument every ten minutes for an increase in its fluorescence, which is proportional to the amount of CO2 present. A positive reading indicates the presumptive presence of viable microorganisms in the vial. Detection is limited to microorganisms that will grow in a particular type of medium.

Resins have been described for the treatment of blood specimens both prior to and after their inoculation into culture media. Resins have been incorporated into BACTEC culture media to enhance recovery of organisms without a need for special processing.

Here's an analysis of the provided text regarding the BD BACTEC Plus PRIME Aerobic/F medium:

Key Takeaway: This document is a 510(k) summary for a medical device (blood culture medium) seeking FDA clearance. It's a "substantial equivalence" claim, meaning the device is compared to a legally marketed predicate device rather than a ground-up demonstration of safety and effectiveness as in a PMA. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are framed within this comparison to the predicate device. The performance data focuses on demonstrating that the new device performs equivalently or, in some cases, better than the predicate.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by achieving performance that is not significantly different or clinically equivalent to the predicate device, or statistically better where a difference is desirable (like antimicrobial neutralization).

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