(32 days)
ParaCon II / Fecal Concentrator II is a filtration device that is intended for use in the separation of intestinal parasites from: fecal debris in preserved fecal specimens.
Fecal specimens that have been preserved in preservatives such as formalin, sodium acetate-acetic acid-formalin, merthiolate-formalin, or modified polyvinyl alcohol, and which are contained in 30 ml transport vials, may be mated to the ParaCon II / Fecal Concentrator II filtration device and inverted in order to separate fecal debris from the specimen.
The filtered specimen may then be concentrated by centrifugation, and observed microscopically.
ParaCon II / Fecal Concentrator II is a filtration device.
The provided text is a 510(k) premarket notification letter from the FDA to Para Scientific, Inc. regarding their ParaCon II / Fecal Concentrator II device. This document is a regulatory approval letter and does not contain the acceptance criteria, study details, or performance data typically found in a scientific study or a detailed technical submission for a medical device.
Therefore, I cannot provide the requested information. The letter only confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed based on its stated indications for use. It doesn't include the specific study details that would demonstrate how acceptance criteria were met.
§ 866.2900 Microbiological specimen collection and transport device.
(a)
Identification. A microbiological specimen collection and transport device is a specimen collecting chamber intended for medical purposes to preserve the viability or integrity of microorganisms in specimens during storage of specimens after their collection and during their transport from the collecting area to the laboratory. The device may be labeled or otherwise represented as sterile. The device aids in the diagnosis of disease caused by pathogenic microorganisms.(b)
Classification. Class I (general controls). The device, when solely intended for use in the collection of concentrated parasites from specimens and transport, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.