← Product Code [JGS](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JGS) · K962334 # EML105 ELECTROLYTE METABOLITE ANALYZER (K962334) _Radiometer America, Inc. · JGS · Oct 24, 1996 · Clinical Chemistry · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JGS/K962334 ## Device Facts - **Applicant:** Radiometer America, Inc. - **Product Code:** [JGS](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JGS.md) - **Decision Date:** Oct 24, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.1665 - **Device Class:** Class 2 - **Review Panel:** Clinical Chemistry ## Indications for Use EML105 is a stand alone, electrolyte metabolite analyzer that measures Na⁺, K⁺, Ca²⁺, Cl⁻, glucose and lactate on whole blood and urine. It can be interfaced with an ABL analyzer 500/510/520 to become an ABL System 605/615/625 for the measurement of pH/Blood gases, electrolytes, metabolites and co-oximetry. ## Device Story Automated electrolyte metabolite analyzer; measures Na⁺, K⁺, Ca²⁺, Cl⁻, glucose, lactate in whole blood/urine; analysis time ~54 seconds. Standalone unit (40x35x40 cm, 22 kg) or integrated with ABL 500/510/520 analyzers to form ABL System 605/615/625. Used in clinical settings; operated by laboratory personnel. Provides quantitative analyte concentrations to assist clinicians in metabolic/electrolyte status assessment. ## Clinical Evidence Bench testing only; no clinical data provided. ## Technological Characteristics Automated electrolyte/metabolite analyzer; ion-specific electrode technology; dimensions 40cm x 35cm x 40cm; weight 22kg; standalone or networked via interface with ABL 500/510/520 series. ## Regulatory Identification A sodium test system is a device intended to measure sodium in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. ## Predicate Devices - EML105 ([K952621](/device/K952621.md)) - YSI 2300 ## Reference Devices - ABL analyzer 500/510/520 ## 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} OCT 24 1996 RADIOMETER AMERICA INC. EXHIBIT VI MEDICAL DIVISION 811 SHARON DRIVE, WESTLAKE, OHIO 44145-1588 800-736-0600, 216-871-8900 FAX 216-892-8117 K962334 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, Ext. 287 or 1-800-736-0600 Fax (216)871-8117 DATE: June 3, 1996 PRODUCT: Trade Name - EML105 Common Name - Electrolyte Metabolite Analyzer Classification Name - Electrolyte Ion Specific PREDICATE DEVICE: EML105 and YSI 2300 PRODUCT DESCRIPTION: EML105 is an automated electrolyte metabolite analyzer that is 40 cm x 35 cm x 40 cm (WHD) and weighs 22 kg. It measures on whole blood and urine in approximately 54 seconds. INTENDED USE: EML105 is a stand alone, electrolyte metabolite analyzer that measures Na⁺, K⁺, Ca²⁺, Cl⁻, glucose and lactate on whole blood and urine. It can be interfaced with an ABL analyzer 500/510/520 to become an ABL System 605/615/625 for the measurement of pH/Blood gases, electrolytes, metabolites and co-oximetry. TECHNOLOGICAL CHARACTERISTICS VERSUS PREDICATE DEVICE: EML105 (with lactate) is technologically similar to the current version EML105. SUBSTANTIAL EQUIVALENCE: EML105 with lactate is substantially equivalent in features and characteristics to the current version EML105 marketed by Radiometer America Inc. (K952621). The only difference is the addition of the lactate analyte. Like the current version of EML105, the EML105 with lactate can be interfaced with an ABL analyzer to form an ABL System 605, 615 or 625. The predicate device for the lactate analyte is YSI 2300. --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JGS/K962334](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JGS/K962334) **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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