(129 days)
EML105, YSI 2300
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No
The summary describes a standard automated electrolyte and metabolite analyzer and does not mention any AI or ML capabilities.
No.
The device is an analyzer that measures electrolytes and metabolites in blood and urine, which is a diagnostic function, not a therapeutic one.
Yes
The device is an "electrolyte metabolite analyzer that measures Na, K+, Ca2+, CI, glucose and lactate on whole blood and urine," which is used to measure specific substances in biological samples to identify potential health issues or monitor conditions. This type of measurement is fundamental to diagnosing medical conditions.
No
The device description clearly states the physical dimensions and weight of the EML105, indicating it is a physical hardware device, not software only.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device "measures Na , K+, Ca2+, CI, glucose and lactate on whole blood and urine." These are biological samples taken from the body, and the measurements are used for diagnostic purposes.
- Device Description: The description confirms it's an "automated electrolyte metabolite analyzer," which aligns with the function of an IVD device used to analyze components of biological samples.
The fact that it analyzes components of whole blood and urine for diagnostic purposes is the key indicator that it falls under the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
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Device 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
EML105, YSI 2300
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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.