BBLCRYSTAL GRAM-POSITIVE ID SYSTEM

{0} K9101968 FEB - 4 1997 May 17, 1996 SUMMARY OF SAFETY AND EFFECTIVENESS SUBMITTED BY: Virginia C. Weinknecht Becton Dickinson Microbiology Systems P O Box 243 Cockeysville, MD 21030-0243 NAME OF DEVICE: Trade Name: BBLCRYSTAL™ Gram Positive ID System Common Name/Description: Miniaturized Microorganism ID System Classification Name: Microbiology - Discs, Strips, and Reagents, Microorganism Differentiation PREDICATE DEVICES: BioMerieux Vitek, Inc., API Staph (K813614) BioMerieux Vitek, Inc., API 20 Strep (K813610) BioMerieux Vitek, Inc., API Coryne (K910304) DEVICE DESCRIPTION: 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. B-1 {1} TABLE B-1: Taxa List for BBLCRYSTAL™ Gram Positive Identification System <table><tr><td>Actinomyces pyogenes<br/>Aerococcus species (includes A. urinae and A. viridans)<br/>Aerococcus urinae<br/>Aerococcus viridans<br/>Alloiococcus otitidis¹<br/>Arcanobacterium haemolyticum¹<br/>Bacillus brevis<br/>Bacillus cereus<br/>Bacillus circulans<br/>Bacillus coagulans<br/>Bacillus licheniformis<br/>Bacillus megaterium<br/>Bacillus pumilus<br/>Bacillus species (includes B. brevis, B. circulans, B. coagulans, B. licheniformis, B. megaterium, B. pumilus and B. sphaericus, P. alvei, P. macerans)<br/>Bacillus sphaericus<br/>Bacillus subtilis<br/>Corynebacterium aquaticum<br/>Corynebacterium bovis<br/>Corynebacterium diptheriae (includes C. diptheriae ssp. grevis, C. diptheriae ssp. mitis and C. diptheriae ssp. intermedius)<br/>Corynebacterium genitalium<br/>Corynebacterium jeikeium<br/>Corynebacterium kutscheri<br/>Corynebacterium propinquum<br/>Corynebacterium pseudodiphtheriticum<br/>Corynebacterium pseudogenitalium<br/>Corynebacterium pseudotuberculosis<br/>Corynebacterium ranale group<br/>Corynebacterium species (includes C. aquaticum, C. bovis, C. kutscheri, C. propinquum, c. pseudodiphtheriticum, C. pseudotuberculosis, C. ranale group, C. striatum and C. ulcerans)<br/>Corynebacterium striatum<br/>Corynebacterium ulcerans<br/>Enterococcus avium<br/>Enterococcus casseliflavus/gelinarum<br/>Enterococcus durans<br/>Enterococcus faecalis<br/>Enterococcus faecium<br/>Enterococcus hirae<br/>Enterococcus raffinosus<br/>Enterococcus solitarius<br/>Erysipelothrix rhusiopathiae<br/>Gardnerella vaginalis<br/>Gemella haemolysans<br/>Gemella morbillorum<br/>Gemella species (includes G. haemolysans, and G. morbillorum)<br/>Globicatella sanguis<br/>Helcococcus kunzii</td><td>Lactococcus garvieae<br/>Lactococcus lactis ssp. cremoris<br/>Lactococcus lactis ssp. hordniae<br/>Lactococcus lactis ssp. lactis<br/>Lactococcus raffinolactis<br/>Lactococcus species (includes L. lactis ssp. cremoris, L. lactis ssp. hordniae, L. lactis ssp. lactis and L. raffinolactis)<br/>Leuconostoc citreum<br/>Leuconostoc lactis<br/>Leuconostoc mesenteroides ssp. mesenteroides<br/>Leuconostoc pseudomesenteroides<br/>Leuconostoc species (includes L. citreum, L. lactis, L. mesenteroides ssp. mesenteroides and L. pseudomesenteroides)<br/>Listeria grayi¹<br/>Listeria ivanovii ssp. ivanovii<br/>Listeria monocytogenes<br/>Listeria murrayi<br/>Micrococcus kristinae<br/>Micrococcus luteus<br/>Micrococcus lyiae<br/>Micrococcus roseus<br/>Micrococcus sedentarius<br/>Micrococcus species (includes M. kristinae, M. luteus, M. lyiae, M. roseus, M. sedentarius)<br/>Oerskovia species (includes O. turbata, and O. xanthineolytica)<br/>Peanibacillus alvei<br/>Peanibacillus macerans<br/>Pediococcus demnosus<br/>Pediococcus pervulus<br/>Pediococcus pantosaceus<br/>Pediococcus species (includes P. demnosus, P. pervulus, and P. pentosaceus)<br/>Rhodococcus equi<br/>Rothia dentocariosa¹<br/>Staphylococcus aureus<br/>Staphylococcus auricularis<br/>Staphylococcus auricularis (includes S. capitis ssp. capitis and S. capitis ssp. ureolyticus)<br/>Staphylococcus caprae<br/>Staphylococcus carnosus<br/>Staphylococcus cohnii (includes S. cohnii ssp. cohnii and S. cohnii ssp. ureolyticum)<br/>Staphylococcus cohnii ssp. cohnii<br/>Staphylococcus cohnii ssp. ureolyticum<br/>Staphylococcus epidermidis<br/>Staphylococcus equorum<br/>Staphylococcus felis<br/>Staphylococcus gallinarum<br/>Staphylococcus haemolyticus<br/>Staphylococcus hominis<br/>Staphylococcus intermedius</td><td>Staphylococcus kloosii<br/>Staphylococcus lundus<br/>Staphylococcus lugdunensis<br/>Staphylococcus pasteuri¹<br/>Staphylococcus saccharolyticus<br/>Staphylococcus saprophyticus<br/>Staphylococcus schleiferi (includes S. schleiferi ssp. cagulans and S. schleiferi ssp. schleiferi)<br/>Staphylococcus sciuri<br/>Staphylococcus silvum<br/>Staphylococcus silvum ssp. scleroides<br/>Staphylococcus silvum ssp. scleroides ssp. scleroides ssp. scleroides ssp. scleroides ssp. scleroides ssp. scleroides ssp. scleroides ssp. scleroides ssp. scleroides ssp. ssp. scleroides ssp. ssp. ssp. ssp. ssp. ssp. ssp. ssp. ssp. ssp. ssp. ssp. ssp. ssp. ssp. ssp. ssp. ssp. ssp. ssp. ssp. ssp. ssp. ssp. ssp. ssp. ssp. ssp. ssp. ssp. ssp. ssp. ssp. ssp. ssp. ssp. ssp. ssp. ssp. ssp. ssp. ssp. ssp. ssp. ssp. ssp. ssp. ssp. ssp. ssp. ssp. ssp. ssp. ssp. ssp. ssp. ssp. ssp. ssp. ssp. ssp. ssp. ssp. ssp. ssp. ssp. ssp. {2} B-3 # PRODUCT DESCRIPTION: 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 "0".) 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 (c) no ID possible with data submitted. 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. {3} In the case where no ID is possible, the Codebook suggests that the user perform a purity check of the test isolate. If culture purity has been confirmed, then it is likely that (i) the test isolate is producing atypical Crystal reactions (which may also be caused by procedural errors), (ii) the test species is not part of the intended taxa, or (iii) the system is unable to identify the test isolate with the required level of confidence. Once user error has been ruled out, the Codebook suggests that additional testing must be done to establish an identification. ## PERFORMANCE DATA: ### Clinical Correlation: In a study conducted at four clinical laboratories, the performance of the BBLCRYSTAL Gram Positive ID System was evaluated against a combination of the API Staph, API 20 Strep, and API Coryne Identification Systems, and conventional methodologies. Fresh, routine isolates arriving in the clinical laboratory, as well as previously identified isolates of the clinical trial sites' choice were utilized in the study. A total of 735 gram positive aerobic isolates were tested; 90% (668/735) of these isolates were correctly identified (including supplemental testing) using the BBLCRYSTAL™ GP ID System; 7.6% (56/735) were incorrectly identified; and 1.5% (11/735) yielded a "No Identification" result. ### Reproducibility: At the same four clinical laboratories, reproducibility of the BBLCRYSTAL™ GP ID System was established by testing ten (10) Quality Control strains in triplicate on three days. Evaluations were performed of individual and overall reproducibility of substrate reactions, of QC organism reactions, and of inter- and intra-laboratory reproducibility. Overall reproducibility was calculated as 96.7%. Reproducibility of individual substrate reactions ranged from 79.2 to 100%; individual QC organism reaction reproducibility ranged from 91.4 to 99.8%; and individual site reproducibility from 95.5 to 97.8%. B-4