GEM PREMIER 3000

K052121 · Instrumentation Laboratory CO · CGA · Oct 21, 2005 · Clinical Chemistry

Device Facts

• Record ID: K052121
• Device Name: GEM PREMIER 3000
• Applicant: Instrumentation Laboratory CO
• Product Code: CGA · Clinical Chemistry
• Decision Date: Oct 21, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 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

GEM Premier 3000 is a portable point-of-care analyzer for whole blood samples; operated by healthcare professionals in clinical settings. Device measures pH, pCO2, pO2, Na+, K+, Ca++, Glucose, Lactate, and Hct; provides quantitative results to aid diagnosis of acid/base status, oxygen delivery, and electrolyte/metabolite balance. Modification involves software update to extend reportable ranges for Glucose (5-500 mg/dL) and Lactate (0.2-15 mmol/L). System utilizes Intelligent Quality Management (iQM). Output used by clinicians for rapid patient assessment.

Clinical Evidence

Bench testing only. Performance testing conducted to validate the extended reportable range for Glucose and Lactate parameters following the V5.5 software update. No clinical data provided.

Technological Characteristics

Portable whole blood analyzer; electrochemical sensing principle. Software-controlled; includes Intelligent Quality Management (iQM). Parameters: pH, pCO2, pO2, Na+, K+, Ca++, Glucose, Lactate, Hct.

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 to aid in diagnosis of acid/base status, oxygen delivery capacity, and electrolyte/metabolite balance in clinical settings.

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

• GEM Premier 3000 (K052121)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

OIVD Review Memorandum

To: THE FILE

Re: k 052121 Instrumentation Laboratory GEM Premier 3000

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. (For a preamendments device, a statement to this effect has been provided.)
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.
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 to extend the reportable range claim for the Glucose and Lactate parameters on the GEM Premier 3000 with the release of V5.5 software on the GEM Premier 3000 based on additional performance testing. There are no changes to the algorithm or operating principle for these parameters. No changes were made to the product's Indication for Use.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, immunoassay technology, test protocol, performance, assay principle, cutoff level and reagents.

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
c) A declaration of conformity with design controls. The declaration of conformity should include:

i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and
ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.

6. A Truthful and Accurate Statement, a 510(k) Summary and the Indications for Use Enclosure (and Class III Summary for Class III devices).

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 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.