K961335 · Mallinckrodt Sensor Systems, Inc. · CHL · Jun 28, 1996 · Clinical Chemistry
Device Facts
Record ID
K961335
Device Name
GEM PREMIER PLUS MODEL 5500
Applicant
Mallinckrodt Sensor Systems, Inc.
Product Code
CHL · Clinical Chemistry
Decision Date
Jun 28, 1996
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 862.1120
Device Class
Class 2
Indications for Use
The GEM Premier Plus is designed for use by health care professionals to rapidly analyze patient whole blood samples at the point of care, in a clinical setting.
Device Story
Small (12" x 10" x 16.5") blood gas and electrolyte analyzer; point-of-care use by non-laboratory medical personnel. Input: 200uL whole blood sample via disposable reagent cartridge. Operation: self-calibrating system; sensors, pump tubing, and waste contained in cartridge. Output: measured pO2, pCO2, pH, Na+, K+, iCa++, hematocrit; calculated HCO3, TCO2, Base Excess, O2 Sat. Results provided in 104 seconds. Clinical utility: rapid diagnostic feedback for critical care decision-making.
Clinical Evidence
Clinical testing conducted at five sites by healthcare professionals with limited training. Comparison study between GEM Premier Plus and predicate GEM Premier using patient blood samples. Results demonstrated substantial equivalence in performance.
Technological Characteristics
Dimensions: 12" x 10" x 16.5". Disposable reagent cartridge contains sensors, calibration solutions, pump tubing, and waste. Compliance: UL 544 and IEC 1010-1.
Indications for Use
Indicated for health care professionals to perform rapid analysis of whole blood samples for blood gas and electrolyte parameters in clinical point-of-care settings.
Regulatory Classification
Identification
A blood gases (PCO2 , PO2 ) and blood pH test system is a device intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. Measurements of blood gases (PCO2 , PO2 ) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.
Predicate Devices
GEM® Premier Blood Gas and Electrolyte Analyzer
Submission Summary (Full Text)
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K961335
# Section 2 510(k) Summary and Certification
JUN 28 1996
Contact person: Andrew C. Taylor
Director of Research and Development
Tel: (313) 973 7000
Fax: (313) 973 1368
Date: April 5, 1996
Device Name: GEM® Premier Plus
Blood Gas and Electrolyte Analyzer
Predicate Device: GEM® Premier
Blood Gas and Electrolyte Analyzer
Description:
The GEM Premier Plus is a small (12" x 10" x 16.5") Blood Gas and Electrolyte Analyzer designed for use by non-laboratory medical personnel at the point of care. The device, along with its disposable reagent cartridge is capable of measuring pO2, pCO2, pH, Na+, K+, iCa++ and hematocrit from a single 200uL blood sample in 104 seconds. The device will also calculate the following derived parameters - HCO3, TCO2, Base Excess, O2 Sat. The system is self calibrating with all calibration solutions, sensors, pump tubing and waste bag contained within a disposable cartridge.
Intended Use:
The GEM Premier Plus is designed for use by health care professionals to rapidly analyze patient whole blood samples at the point of care, in a clinical setting.
Technological Characteristics vs. Predicate Device:
The measurement technology used in the GEM Premier Plus is identical to that used in the predicate device, the GEM Premier
Non Clinical Tests to Support Equivalence Determination
The GEM Premier has been tested and found to comply with UL 544 and IEC1010-1
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## Clinical Tests to Support Equivalence Determination
The GEM Premier Plus was tested at five clinical sites and compared to the predicate device, the GEM Premier. All tests were performed by health care professionals with limited training in the use of blood gas and electrolyte analyzers. Patient samples were run on both the GEM Premier Plus and the GEM Premier instruments.
## Conclusions Drawn From Clinical Tests
The results from the clinical tests demonstrated that the GEM Premier Plus and the predicate device, the GEM Premier were substantially equivalent in performance.
The manufacturer states that the device is safe and effective for its intended use as a Critical Care Blood Gas and Electrolyte Analyzer when operated per the GEM Premier Plus labeling.
