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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.

INTENDED USE: The BBLCRYSTAL™ Gram Positive (GP) Identification (ID) System is a miniaturized identification method employing modified conventional, fluorogenic, and chromogenic substrates. It is intended for the identification of frequently isolated aerobic gram-positive bacteria from clinical specimens. INDICATIONS FOR USE: Use of the BBLCRYSTAL™ Gram Positive Identification System is indicated when the aerobic gram-positive organisms described in the attached table have been isolated in pure culture from clinical specimens in a clinical laboratory, and identification of the microorganisms is desired.

The main component of the BBLCRYSTAL™ GP ID System is the BBLCRYSTAL GP panel assembly, consisting of the CRYSTAL base and lid. The BBLCRYSTAL lid consists of 29 dehydrated biochemical/chromogenic/ fluorogenic substrates and one fluorogenic negative control, on the ends of plastic prongs. The CRYSTAL base consists of 30 matching wells; its design allows inoculation of all 30 wells in a single step by pouring the suspension of pure culture into the target area and tilting the base. The test inoculum rehydrates the dried substrates and initiates test reactions. The pure culture suspension is prepared by picking several small colonies of the same morphology from media such as Trypticase® Soy Agar with 5% Sheep Blood or Columbia Agar with 5% Sheep Blood, or alternatively selective media such as Phenylethyl Alcolol Agar with 5% Sheep Blood or Columbia CNA Agar with 5% Sheep Blood. A standardized suspension of this culture is prepared in the BBLCRYSTAL™ ANR, GP, RGP, N/H ID Inoculum Fluid provided. The suspension is added to the target area of the panel base, which the use then rocks back and forth to inoculate all the wells contained in the base. After the base/lid assembly has been incubated for 4 hours at 35-37°C, the assembly is placed on the BBLCRYSTAL Panel Viewer and the color reactions are visually compared to the BBLCRYSTAL GP Color Chart provided. Each reaction is scored as a positive (+) or negative (-) and recorded on the BBLCRYSTAL GP Report Form. After all results are read, a 10-digit numerical profile is calculated by assigning a value of 4, 2, or 1 to each positive reaction. (Negative reactions are scored as "O".) The values for each column are then added together to obtain the 10 digit Profile Number. The BBLCRYSTAL ID System Electronic Codebook is loaded into the user's PC and the appropriate database is selected. Then the Profile Number and results of any off-line tests are entered, and the Codebook gives one of the following three results: - (a) a definitive ID; - (b) a tie between two or more species; or - no ID possible with data submitted. (c) In the case of a definitive ID or a tie between two or more potential ID's, the user can access the statistics for that ID as well as background information for the species identified.

is intended for use in conjunction with the Vitek® System for the automated identification of clinically significant streptococci, staphylococci, and a selected group of Gram positive bacilli.

The VITEK® Gram Positive Identification Card containing new claims for the identification of Enterococcus casseliflavus Enterococcus gallinarum Enterococcus hirae