GEM Premier 3000

K161818 · Instrumentation Laboratory CO · CGA · Sep 14, 2016 · Clinical Chemistry

Device Facts

Record IDK161818
Device NameGEM Premier 3000
ApplicantInstrumentation Laboratory CO
Product CodeCGA · Clinical Chemistry
Decision DateSep 14, 2016
DecisionSESE
Submission TypeSpecial
Regulation21 CFR 862.1345
Device ClassClass 2

Indications for Use

The GEM Premier 3000 is a portable system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting. The instrument provides quantitative measurements of whole blood pH, pCO2, pO2, Na+, K+, Ca++, Glucose, Lactate and Hct. These parameters along with derived parameters aid in the diagnosis of a patient's acid/base status, oxygen delivery capacity, and electrolyte and metabolite balance.

Device Story

Portable whole blood analyzer for point-of-care or central laboratory use; operated by healthcare professionals. Device uses potentiometry (pH, pCO2, Na+, K+, Ca++), amperometry (pO2, glucose, lactate), and conductivity (hematocrit) to analyze blood samples. System provides quantitative measurements and derived parameters to aid clinical diagnosis of acid/base status, oxygen delivery, and electrolyte/metabolite balance. Output displayed on touch screen for immediate clinical decision-making. Subject device updates operating system from Linux Fedora Core 7 to Fedora Core 21 and replaces single-board computer due to component obsolescence.

Clinical Evidence

No clinical data. Verification and validation were performed via bench testing to confirm that the software and hardware updates met predetermined acceptance criteria and did not introduce new hazards.

Technological Characteristics

Portable analyzer; potentiometric, amperometric, and conductivity sensing principles. Hardware includes Seco Q7-BT Rel. 2.0 module with Intel Atom E3800 processor. Software runs on Linux Fedora Core 21. Dimensions: 17"(H) x 12"(W) x 12"(D); Weight: 29.5 lbs. User interface: menu-driven touch screen. Sample introduction: aspiration.

Indications for Use

Indicated for use by healthcare professionals to analyze whole blood samples for pH, pCO2, pO2, Na+, K+, Ca++, Glucose, Lactate, and Hct in clinical settings to aid in diagnosis of acid/base status, oxygen delivery capacity, and electrolyte/metabolite balance.

Regulatory Classification

Identification

A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Special Controls

*Classification.* Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Predicate Devices

Related Devices

Submission Summary (Full Text)

{0} SPECIAL 510(k): Device Modification OIR Decision SUMMARY To: THE FILE RE: DOCUMENT NUMBER k161818 This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary): 1. The name and 510(k) number of the SUBMITTER'S previously cleared device: GEM Premier 3000 (k052121). 2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use). 3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed. This change was for the following item(s): - An update in the operating system from Linux Fedora Core 7, Software V6.2.5 to Linus Fedora Core 21, Software V6.3.0. - Single Board Computer from Win Enterprises 90140 Intel Pentium® M® / Celeron® M processor, 400MHz - ETX Module to Seco Q7-BT Rel. 2.0 Module with the Intel® Atom™ E3800 4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and device performance and specifications. 5. A Design Control Activities Summary which includes: a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as {1} specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device. 2
Innolitics

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