← Product Code [JJS](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJS) · K961355 # MULTICHECK (K961355) _Radiometer America, Inc. · JJS · Jun 14, 1996 · Clinical Chemistry · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJS/K961355 ## Device Facts - **Applicant:** Radiometer America, Inc. - **Product Code:** [JJS](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJS.md) - **Decision Date:** Jun 14, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.1660 - **Device Class:** Class 1 - **Review Panel:** Clinical Chemistry ## Indications for Use Multicheck™ with metabolite is intended for checking the precision and accuracy of Radiometer and non-Radiometer analyzers for pH/Blood Gases, Oximetry, Electrolytes, and Glucose and Lactate. ## Device Story Multicheck™ with metabolite; four-level quality control system; 30 ampoules per box, 2 mL solution per ampoule. Used in clinical laboratory settings to verify performance of blood gas, oximetry, electrolyte, glucose, and lactate analyzers. Healthcare professionals use control results to assess analyzer precision and accuracy, ensuring reliable patient diagnostic data. ## Clinical Evidence No clinical data; bench testing only. ## Technological Characteristics Four-level aqueous quality control solution; contains pH, blood gas, oximetry, electrolyte, glucose, and lactate analytes. Packaged in 2 mL ampoules. ## Regulatory Identification A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls. ## Predicate Devices - Multicheck™ ([K952725](/device/K952725.md)) ## 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} RADIOMETER AMERICA INC. K961355 Exhibit VII MEDICAL DIVISION 811 SHARON DRIVE, WESTLAKE, OHIO 44145-1598 800-736-0600, 216-871-8900 FAX 216-892-8117 JUN 14 1996 SUBJECT: 510(k) SUMMARY FROM: Donald L. Baker Director of Marketing and Regulatory Affairs Radiometer America, Inc. 810 Sharon Drive Westlake, Ohio 44145 (216)871-8900, Ext287 or 1-800-736-0600 Fax (216)871-8117 DATE: April 1, 1996 PRODUCT: Trade Name - Multicheck™ Common Name - Quality Control Classification Name - Controls for Blood Gas (assayed and unassayed) PREDICATE DEVICE: Multicheck™ PRODUCT DESCRIPTION: Multicheck™ with metabolite is a four level quality control system consisting of part numbers S5530, S5540, S5550, and S5560. Each level consists of 30 ampoules per box, 2 mL solution per ampoule. INTENDED USE: Multicheck™ with metabolite is intended for checking the precision and accuracy of Radiometer and non-Radiometer analyzers for pH/Blood Gases, Oximetry, Electrolytes, and Glucose and Lactate. TECHNOLOGICAL CHARACTERISTICS VERSUS PREDICATE DEVICE: Multicheck™ with metabolite is technologically similar to Multicheck™ with glucose. SUBSTANTIAL EQUIVALENCE: Multicheck™ with metabolite is substantially equivalent in features and characteristics to the current Multicheck (K952725) marketed by RadiometerAmerica Inc. The only difference is the addition of the lactate analyte. --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJS/K961355](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJS/K961355) **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