(129 days)
EML105 is a stand alone, electrolyte metabolite analyzer that measures Na , K+, Ca2+, CI, 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.
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.
This document is a 510(k) summary for a medical device called EML105, an electrolyte metabolite analyzer. It describes the device, its intended use, and claims substantial equivalence to a previously marketed device (EML105) and a predicate device (YSI 2300) for the new lactate analyte.
However, the provided text does not contain any information regarding acceptance criteria, study methodologies, device performance data, sample sizes, ground truth establishment, or expert involvement. It is solely a regulatory submission summary outlining the device's characteristics and its predicate devices.
Therefore, I cannot provide the requested information in the format specified. The document lacks the detailed study results and performance metrics needed to answer your questions.
{0}------------------------------------------------
RADIOMETER AMERICA INC.
MEDICAL DIVISION
EXHIBIT VI
811 SHARON DRIVE, WESTLAKE, OHIO 441 ROO-738-0800, 216
21
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+, CI, 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
EML105 (with lactate) is technologically similar to the current version EML105. DEVICE:
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.
§ 862.1665 Sodium test system.
(a)
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.(b)
Classification. Class II.