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510(k) Data Aggregation
K Number
K183176Device Name
Endotoxin Activity Assay (EAA)
Manufacturer
Spectral Medical Inc.
Date Cleared
2019-03-12
(116 days)
Product Code
NGS
Regulation Number
866.3210Why did this record match?
Applicant Name (Manufacturer) :
Spectral Medical Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EAA™ is a rapid in vitro diagnostic test that utilizes a specific monoclonal antibody to measure the endotoxin activity in EDTA whole blood specimens. The information, when used in conjunction with other clinical information and other relevant diagnostic tests aids in the risk assessment of patients in the ICU for progression to severe sepsis. Patients tested on their first day of admission to the ICU where the endotoxin activity (EA) value is ≥ 0.60, are three times more likely to develop severe sepsis within the next three days than subjects whose EA values are < 0.40 and should be closely monitored for such occurrence.
Device Description
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K Number
K170790Device Name
SAM CRRT Unit, SAM Cassette CRRT
Manufacturer
Spectral Medical Inc.
Date Cleared
2017-12-13
(272 days)
Product Code
KDI
Regulation Number
876.5860Why did this record match?
Applicant Name (Manufacturer) :
Spectral Medical Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The S.A.M CRRT Unit is intended for:
* Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload.
* Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kilograms or more with diseases where removal of plasma components is indicated.
For all treatments performed utilizing the S.A.M CRRT Unit, use of the treatment device must be carried out as per the manufacturers' specifications.
All treatments administered via the S.A.M unit must be prescribed by a physician and are intended in the environment of the Intensive Care Unit or Emergency Department of the hospital.
Rx Only.
The S.A.M Cassette CRRT is intended for single use in continuous renal replacement and therapeutic plasma exchange therapies using the S.A.M CRRT Unit. The S.A.M Cassette for CRRT is indicated for patients weighing 20 kg or more. Rx Only.
Device Description
The S.A.M CRRT Unit is a software controlled device that performs the following functions:
- Primes the SAM disposable cassette automatically.
- Pumps blood through the blood flow path of the disposable cassette.
- Delivers anticoagulant into the blood flow path.
- Pumps sterile infusion solutions into the blood flow path of the disposable according to therapy in use.
- Pumps sterile dialysate into the fluid compartment of the filter in CRRT therapies.
- Controls the patient fluid removal or plasma loss according to the therapy in use.
- Monitors the system and alerts the operator to abnormal situations through alarms.
The S.A.M CRRT Unit has a touchscreen interface that provides operating instructions to the user. The system is used in conjunction with the S.A.M Cassette tubing set.
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