GEM Premier 3000

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

Device Facts

• Record ID: K161818
• Device Name: GEM Premier 3000
• Applicant: Instrumentation Laboratory CO
• Product Code: CGA · Clinical Chemistry
• Decision Date: Sep 14, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Intended 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

• GEM Premier 3000 (k052121)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

INSTRUMENTATION LABORATORY CO. NIKITA MALLADI REGULATORY AFFAIRS SPECIALIST II 180 HARTWELL ROAD BEDFORD MA 01730

September 14, 2016

Re: K161818 Trade/Device Name: GEM Premier 3000 Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: CGA, CHL, JGS, CEM, JFP, KHP, KFG Dated: August 12, 2016 Received: August 15, 2016

Dear Nikita Malladi:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

# Katherine Serrano -S

For:

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) k161818

Device Name GEM Premier 3000

#### Indications for Use (Describe)

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.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| | <span> <span style="font-size:16px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
| | <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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# 510(k) Summary

This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92.

| Submitter's Information | Instrumentation Laboratory (IL) Co.<br>180 Hartwell Road<br>Bedford, MA 01730, USA |
|-------------------------|------------------------------------------------------------------------------------|
|-------------------------|------------------------------------------------------------------------------------|

| Contact Person | Nikita Malladi<br>Regulatory Affairs Specialist II<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
|----------------|----------------------------------------------------------------------------------------------------------------------------|
|----------------|----------------------------------------------------------------------------------------------------------------------------|

| Preparation Date | September 12, 2016 |
|------------------|--------------------|
|------------------|--------------------|

| Device Trade Names | GEM Premier 3000 |
|--------------------|------------------|
|--------------------|------------------|

| Predicate Device | GEM Premier 3000 | K052121 |
|------------------|------------------|---------|
|------------------|------------------|---------|

| Regulatory Information | | | | | |
|------------------------|-----------------------|---------------------------------------------|-------|-----------------|-------|
| Analyte | Regulation<br>Section | Regulatory Description | Class | Product<br>Code | Panel |
| pH, pCO2, pO2 | 862.1120 | Blood Gases (pCO2, pO2) and Blood pH system | II | CHL | 75 |
| Sodium | 862.1665 | Sodium test system | II | JGS | |
| Potassium | 862.1600 | Potassium test system | II | CEM | |
| Ionized Calcium | 862.1145 | Calcium test system | II | JFP | |
| Glucose | 862.1345 | Glucose test system | II | CGA | |
| Lactate | 862.1450 | Lactic acid test system | I | KHP | |
| Hematocrit | 864.5600 | Automated hematocrit instrument | II | GKF | 81 |

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### Device Description

The GEM Premier 3000 is designed as a portable system for use by health care professionals to rapidly analyze whole blood samples, in central laboratory or point-of-care clinical settings. The instrument provides both measured and calculated results for blood gases, hematocrit, electrolytes, glucose, and lactate.

# Indications for Use / Intended 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.

## Reason for Submission

This Special 510(k) is being submitted to update the operating system from Linux Fedora Core 7 to Linux Fedora Core 21 for GEM Premier 3000 Instruments. The operating system is being updated to accommodate a change in the single-board computer due to obsolescence.

The submission meets the criteria for a Special 510(k) based on the following:

- No change in indications for use or intended use
- No change in operating principle
- No change to labeled performance claims
- No change to data reduction software
- No change to fluidic design
- No change to GEM cartridges or CVP material

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| Comparison to Predicate | | |
|---------------------------|--------------------------------------------------------------------------------------------|--------------------------------------------------------|
| Item | Predicate (K052121) | Updated Device Subject of this Submission |
| Similarities | | |
| Trade Names | GEM Premier 3000 | Same |
| Indications for Use | See above | Same |
| Intended User | Central Laboratory and Point-of-Care | Same |
| Blood Gas Measurement | Potentiometry: pH and pCO2<br>Amperometry: pO2 | Same |
| Electrolyte Measurement | Potentiometry: Na+, K+, Ca++ | Same |
| Metabolite Measurement | Amperometry: Glucose and Lactate | Same |
| Hematocrit Measurement | Conductivity | Same |
| Sample Introduction | Aspiration | Same |
| Test Principle | Potentiometry: pH, pCO2, Na+, K+, Ca++ Amperometry: pO2, Glu, Lac Conductivity: Hematocrit | Same |
| Sample Type | Whole blood for all analytes | Same |
| Dimensions | GEM3000 - 17 (H) x 12 (W) x 12 (D)" | Same |
| Weight | GEM3000 – 29.5 pounds | Same |
| User Interface | Menu Driven Touch Screen | Same |
| Sample Introduction | Aspiration | Same |
| Controls | In conjunction with iQM:<br>GEM CVP 1, GEM CVP 2,<br>GEM CVP 3 and GEM CVP 4 | Same |
| Differences | | |
| Software | GEM Premier 3000 V6.2.5 | GEM Premier 3000 V6.3.0 |
| Operating System Software | Linux Fedora Core 7 | Linux Fedora Core 21 |
| Single Board Computer | Win Enterprises 90140 Intel Pentium® M® / Celeron® M processor, 400MHz - ETX Module | Seco Q7-BT Rel. 2.0 Module with the Intel® Atom™ E3800 |

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| Declaration of Conformance to<br>Design Controls | As required by the risk analysis, all verification and validation activities were<br>performed and the results demonstrated that the predetermined<br>acceptance criteria were met. |
|--------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Verification and Validation<br>Summary | Software verification and validation was performed according as defined in<br>the GEM Premier 3000 V6.3.0 Project Software Verification Plan (Document<br>No. L0024004020, See Section 32) and in accordance with the Software<br>Design Verification Procedure. Software Validation was performed as<br>defined in the GEM 3X00 Software Design and Development Plan for SBC<br>Project (Document No. L0024003937, See Section 30).<br>Testing verified that the SW V6.3.0 change meets requirements and that no<br>new hazards have been introduced. This is documented in the GEM<br>Premier 3000 V6.3.0 Software Verification report (Document No.<br>L0024004116, See Section 33), and the GEM Premier 3000 V6.3.0 Software<br>Validation Assessment (Document No. L0024005866, See Section 35). |
| Conclusion | Based on the shared indications for use, operating principle and<br>performance claims, the GEM Premier 3000 with software V6.3.0 running<br>on the Linux Fedora Core 21 operating system can be concluded to be<br>substantially equivalent to the cleared and currently marketed predicate<br>device, GEM Premier 3000. |