← Product Code [JJS](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJS) · K961354 # QUALICHECK 4 METABOLITE(S3630,S3640,S3650,S3660) (K961354) _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/K961354 ## 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 Qualicheck 4 Metabolite is intended for checking the precision and accuracy of Radiometer and non-Radiometer analyzers for pH/Blood Gases, Electrolytes, Glucose and Lactate. ## Device Story Qualicheck 4 Metabolite is a four-level quality control system; supplied as 2 mL ampoules. Used by laboratory personnel to verify performance of blood gas, electrolyte, glucose, and lactate analyzers. System provides known reference values to assess analyzer precision and accuracy; enables clinical decision-making based on validated instrument performance. ## Clinical Evidence No clinical data; bench testing only. ## Technological Characteristics Four-level quality control solution; 2 mL ampoules. Analyte composition includes pH, blood gases, electrolytes, glucose, and lactate. Designed for use with Radiometer and non-Radiometer analyzers. ## 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 - Qualicheck 4 Glucose ([K952637](/device/K952637.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} K961354 RADIOMETER AMERICA INC. Exhibit VII MEDICAL DIVISION 811 SHARON DRIVE, WESTLAKE, OHIO 44145-1588 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 - Qualicheck™4 Metabolite Common Name - Quality Control Classification Name - Controls for Blood Gas (assayed and unassayed) PREDICATE DEVICE: Qualicheck 4 Glucose PRODUCT DESCRIPTION: Qualicheck 4 Metabolite is a four level quality control system consisting of part numbers S3630, S3640, S3650, and S3660. Each level consists of 30 ampoules per box, 2 mL solution per ampoule. INTENDED USE: Qualicheck 4 Metabolite is intended for checking the precision and accuracy of Radiometer and non-Radiometer analyzers for pH/Blood Gases, Electrolytes, Glucose and Lactate. TECHNOLOGICAL CHARACTERISTICS VERSUS PREDICATE DEVICE: Qualicheck 4 Metabolite is technologically similar to Qualicheck 4 Glucose. SUBSTANTIAL EQUIVALENCE: Qualicheck 4 Metabolite is substantially equivalent in features and characteristics to the current Qualicheck 4 Glucose (K952637) 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/K961354](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJS/K961354) **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. 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