(196 days)
The Sensititre AP90 panel is an in vitro diagnostic product intended to be used in conjunction with the Sensititre system for the automated identification of clinically significant gram positive organisms. This 510(k) is for gram positive identification.
The Sensititre AP90 panel is an in vitro diagnostic product. The panel has a 4 by 8 layout of reagents repeated 3 times across the plate. Reagents include UREA, ESCULIN, ARGININE, FR13, FR16, RHAMNOSE, FR15, MANNITOL, FR14, TREHALOSE, FR17, MALTOSE, FR18, FR19, FR20, FR21, FR22, FR23, GLYCEROL, FR24, FR25, GLUCOSE, SUCROSE, FR26, FR27, B-METHYL GLUCOSIDE, FR28, FR29, SORBITOL, FR30, FR32, FR31. FR indicates Fluorescent reagent. The Urease test requires an oil overlay.
The provided text is a 510(k) premarket notification letter from the FDA regarding the "Gram Positive Autoidentification Plates, Sensititre AP90" device. While it authorizes the marketing of the device and lists the intended use and organisms for testing, it does not contain the detailed acceptance criteria or a study summary proving the device meets said criteria.
The letter is a regulatory approval document stating that the device is substantially equivalent to a previously marketed device. It does not elaborate on the performance studies that led to this determination. Without access to the actual 510(k) submission (K972576), it's impossible to provide the specific information requested about acceptance criteria and the study details.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based solely on the provided text. The text refers to the device being "substantially equivalent" to predicate devices, which implies that its performance would be expected to be similar, but it doesn't detail the specific performance metrics or studies.
§ 866.2660 Microorganism differentiation and identification device.
(a)
Identification. A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.