COBAS CORE IMMUNOCHEMISTRY SYSTEM

{0} K962231 Roche Roche Diagnostic Systems A Member of the Roche Group AUG 30 1996 Roche Diagnostic Systems, Inc. Branchburg Township 1080 US Highway 202 Somerville, New Jersey 08876-3771 Direct Mail Fax # 510(k) Summary Roche COBAS Core II Immunochemistry System In accordance with the Safe Medical Devices Act of 1990, a 510(k) summary as outlined in 21 CFR 807.92 is provided herewith. ## I. Identification of 510(k) Sponsor: Roche Diagnostic Systems, Inc. a subsidiary of Hoffmann-La Roched, Inc. Branchburg Township 1080 US Highway 202 Somerville, NJ 08876-3771 510(k) Submission dated June 7, 1996 ## II. Description of the Device/Statement of Intended Use: The COBAS Core II Immunochemistry System is an *in vitro* diagnostic analyzer intended for enzyme immunoassay procedures. The instrument performs initial sample measurement and pipetting, timed addition of assay reagents, incubation and shaking of assay tubes, aspiration of used reagents and washing of coated polystyrene assay beads and photometric measurement of the chromogen / enzyme reaction. ## III. Identification of the legally marketed device to which the 510(k) sponsor claims equivalence: The COBAS Core II Immunochemistry System is substantially equivalent to the currently marketed Roche COBAS Core Immunochemistry System (K921180). 9 282 {1} 3 283 # IV. Summary of the technological characteristics of the new device in comparison to those of the predicate. ## Similarities to predicate - Both instruments are intended for automation of the currently marketed Roche COBAS Core assays: - COBAS Core Ferritin (K920829)  COBAS Core TSH (K930776) - COBAS Core Prolatin (K930305)  COBAS Core T4 (K932605) - COBAS Core FSH (K930304)  COBAS Core T3 (K932608) - COBAS Core LH (K930306)  COBAS Core Free T4 (K932607) - COBAS Core IgE (K930890)  COBAS Core Free T3 (K942676) - Both instruments perform the same basic operations, which are, sample handling, pipetting, dilution, incubation, bead washing, measurement and data management. - Both instruments utilize the coated bead technology and photometric measurement. ## Differences to predicate device The differences in the above mentioned devices consist hardware and software changes in the following areas: | Area of Change | COBAS Core I | COBAS Core II | | --- | --- | --- | | Barcode Reader | Infra Red Reader | Laser Barcode Scanner | | Rack Platform | 6 positions for samples and reagents | 14 positions for samples and reagents | | Test /Sample Racks Identity | Binary Rack Coding | Barcode Label ID | | Rack Locking Device | Racks could be unlocked during processing | Racks are mechanically locked when in use | | Pipetting Syringes | Module on left side of instrument | Module moved to the right side of the instrument with no modification to the tube length or syringes | | Operating Software | Internally developed software | Internally developed software embedded in Microsoft Windows NT | | Microprocessor | CPU 186 | PC-486 DX33 Real Time CPU 186 Hard Disk - 350 MB RAM - 16 MB Diskette - 1.44 MB floppy disk drive 3.5" | {2} V. Breif discussion of the clinical and nonclinical tests relied on for a determination of substantial equivalence: To demonstrate equivalence in performance characteristics, three representative assays were evaluated for precision and accuracy. The three assays are: - COBAS Core LH - COBAS Core FSH - COBAS Core Ferritin Precision Study Four internal reference sera and the kit control were tested to evaluate the within-run and run-to-run reproducibility of the COBAS Core II analyzer. For within-run precision the samples were tested seven times in triplicate. For the run-to run precision the same samples were tested in duplicate in 10 independent runs. Except for one serum with a very low LH level, all CV's are far below 10%. The precision range found for the COBAS Core II correspond to the values determined for the COBAS Core I. Correlation Study The correlation of the COBAS Core I and COBAS Core II was evaluated using 137 randomly selected clinical samples run in duplicate on both analyzers. The results of Core I and Core II were compared using linear regression analysis. For all three assays, the calculated slopes were $1.000 \pm 0.014$ with a correlation coefficient > 0.995.