EML105 ELECTROLYTE METABOLITE ANALYZER

K962334 · Radiometer America, Inc. · JGS · Oct 24, 1996 · Clinical Chemistry

Device Facts

• Record ID: K962334
• Device Name: EML105 ELECTROLYTE METABOLITE ANALYZER
• Applicant: Radiometer America, Inc.
• Product Code: JGS · Clinical Chemistry
• Decision Date: Oct 24, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1665
• Device Class: Class 2

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.

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.

Indications for Use

Indicated for measurement of Na⁺, K⁺, Ca²⁺, Cl⁻, glucose, and lactate in whole blood and urine samples.

Regulatory Classification

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)
• YSI 2300

Reference Devices

• ABL analyzer 500/510/520

Submission Summary (Full Text)

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OCT 24 1996

RADIOMETER AMERICA INC.

EXHIBIT VI

MEDICAL DIVISION

811 SHARON DRIVE, WESTLAKE, OHIO 44145-1588
800-736-0600, 216-871-8900
FAX [phone]

K962334

SUBJECT: 510(k) SUMMARY

FROM: Donald L. Baker
Director of Marketing and Regulatory Affairs
Radiometer America Inc.
810 Sharon Drive
Westlake, Ohio 44145
[phone], Ext. 287 or 1-800-736-0600
Fax [phone]

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.