← Product Code [JJQ](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJQ) · K961183 # CBI 7520 READER (K961183) _Columbia Bioscience, Inc. · JJQ · Aug 2, 1996 · Clinical Chemistry · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJQ/K961183 ## Device Facts - **Applicant:** Columbia Bioscience, Inc. - **Product Code:** [JJQ](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJQ.md) - **Decision Date:** Aug 2, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.2300 - **Device Class:** Class 1 - **Review Panel:** Clinical Chemistry ## Indications for Use The CBI 7520 Microplate Reader is intended to be used as a general purpose microplate photometer for clinical use. ## Device Story CBI 7520 Microplate Reader; general purpose photometer for clinical laboratory use. Input: light transmitted through microtiter plate wells. Operation: Tungsten halogen lamp light source; silicon-photodiode sensors measure light absorbance per well; automatic transport mechanism positions wells. Output: absorbance values processed by software to yield qualitative or quantitative assay results. Used in clinical settings by laboratory personnel. Benefits: enables automated, high-throughput measurement of clinical assays. ## Clinical Evidence Bench testing only; no clinical data presented. Equivalence established via comparison of technical characteristics and principles of operation. ## Technological Characteristics Tungsten halogen lamp light source; silicon-photodiode detectors; automatic microplate transport mechanism. Standalone benchtop photometer. Data reduction software performs absorbance calculations. ## Regulatory Identification A colorimeter, a photometer, or a spectrophotometer for clinical use is an instrument intended to measure radiant energy emitted, transmitted, absorbed, or reflected under controlled conditions. The device may include a monochromator to produce light of a specific wavelength. ## Predicate Devices - Anthos 2001 Microplate Reader ([K894270](/device/K894270.md)) - Anthos ht2 Microplate Reader ([K931907](/device/K931907.md)) - Anthos 2010 Microplate Reader (K9xxxxx) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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. --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJQ/K961183](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJQ/K961183) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com