CBI 7520 READER

{0} K961183 AUG - 2 1996 Attachment 7 # 510(K) SUMMARY ## CBI 7520 Microplate Reader ### Submitter's Name, Address, Telephone and Fax Number, And Contact Person Columbia Bioscience, Inc. 182 Thomas Johnson Drive Suite 205 Frederick, Maryland 21702 Contact: - Norman Jenkins - Columbia Bioscience, Inc. - 182 Thomas Johnson Drive - Suite 205 - Frederick, Maryland 21702 Phone: (301) 941-7971 Facsimile: (410) 995-0508 ### Name of the Device CBI 7520 Microplate Reader ### Common or Usual Name Microplate reader ### Predicate Devices 1. Anthos 2001 Microplate Reader (K894270); 2. Anthos ht2 Microplate Reader (K931907) 3. Anthos 2010 Microplate Reader (K9xxxxx); {1} 15 # Intended Use The CBI 7520 Microplate Reader is intended to be used as a general purpose microplate photometer for clinical use. # Principles of Operation The CBI 7520 and its predicate devices all share the same principle of operation. Briefly, each device provides a light source which is focused to provide illumination of wells in a microtiter plate. A corresponding silicon-photodiodes measures the amount of light absorbed by the sample as the light passes through the microplate well. The respective well absorbance measurements is used by the data reduction software to yield a specific well absorbance value which in turn can yield a qualitative or quantitative assay result. Thus, the CBI 7520 and its predicate devices have similar principles of operation. # Technical Characteristics The CBI 7520 microplate reader and the predicate readers employ an automatic transport mechanism to bring the individual microplate wells into position for reading. The devices all employ Tungsten halogen lamp as the light source. All three devices use silicon-photodiodes to measure the light absorbance. # Summary of the Basis for the Finding of Substantial Equivalence The CBI 7520 for the measurement of light absorbance is equivalent to the predicate devices for its intended use. There is no substantial difference between the CBI 7520 and its predicate devices in performance or technical characteristics. The CBI 7520 has the same intended use, indications for use, and the same principles of operation for its indications for use as the predicate devices.