GEM PREMIER PLUS MODEL 5500

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

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.

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: [phone]
Fax: [phone]

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.