Attachment B.docx

Attachment B Salient Characteristics

· Reagents shall be FDA approved.

· Reagents, consumables, and supplies shall be the same as currently validated for use on the Optilite analyzer:

· LK016.OPT.A, Freelite Kappa

· LK018.OPT.A, Freelite Lambda

· NK045.OPT.A, Ceruloplasmin

· IK703, WASHING SOLUTION (20ml)

· IK704, WASHING SOLUTION (100ml)

· IK705, TUBING MAINTENANCE SOLUTION

· IK702, TENCELLTM Cuvettes

· 989220, 0.5 Sample Cups

· IK709, Optilite Sample Diluent 1

· IK710, Optilite Sample Diluent 2

· Requirements for using cuvettes, sample cups and reagents:

· Do not reuse or substitute. Binding Site Laboratories cannot accept responsibility for system performance and assay results when consumables are reused or have been manufactured by anyone other than Binding Site Laboratories.

· Do not substitute. Binding Site Laboratories manufactures substances and components to rigidly controlled quality standards. Substitution of materials may affect Binding Site System performance, assay results, safety, and equipment life.

· Freelite Kappa reagent shall have a measuring range of 0.6-63500 mg/L

· Freelite Lambda reagent shall have a measuring range of 1.3-139000 mg/L

· Ceruloplasmin reagent shall have a measuring range of 0.04-1.64 g/L

· Free Kappa and Free Lambda reagent shall come in a comprehensive kit with calibrators, controls, and liquid latex regent to perform 100 free kappa or 100 free lambda assays. The contents of the kit shall be stable for up to 3 months at 2-8°C after opening.

· Ceruloplasmin reagent shall come in a comprehensive kit with calibrators, controls and liquid regent to perform 50 assays. The regent in the kit shall be stable for up to 3 months, the calibrator shall be stable for up to 7 days and the quality control should be stable for up to 30 days at 2-8°C after opening.