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510(k) Data Aggregation
K Number
K093834Device Name
CRIT-LINE ANEMIA MANAGEMENT SOFTWARE
Manufacturer
HEMA METRICS, LLC
Date Cleared
2010-09-29
(289 days)
Product Code
MSQ, JQP
Regulation Number
866.3110Why did this record match?
Applicant Name (Manufacturer) :
HEMA METRICS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Crit-Line Anemia Management software is a database application used to record, track and trend patient data as pertains to the management of anemia, and provide a dosage recommendation.
Device Description
The CLAM software is a database application that records, tracks, trends, and analyzes patient data (Hematocrit, Oxygen Saturation, and Hemoglobin) along with current ESA dose in order to effectively manage anemia. During dialysis treatment, the CLAM downloads initial, real-time Hematocrit (HCT), Oxygen Saturation (SaO2), and Hemoglobin (Hb) data from the Crit Line blood monitor. The CLAM software trends this patient data along with current Erythropoiesis Stimulating Agent (ESA) dosage to determine the patient's Hb levels, the need (if any) for ESA dosing, and to track patient's response to treatment. The CLAM software uses a proprietary algorithm to calculate a recommendation for ESA dosage based on patient data trends and current ESA dose in order to establish and maintain predetermined patient Hb levels. The CLAM proprietary algorithm used to determine ESA dosing for anemia treatment is based on the current manual algorithm. In addition, the CLAM software generates and prints patient reports for review and record keeping. The CLAM software resides on a host computer separate from the Crit Line units and acquires real-time data from the clinic's Crit Line monitors via wireless radio signal or by a serial cable.
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