GEM PREMIER 4000 WITH IQM, MODEL 4000; GEM CVP 1 AND 2 WITH CO-OX; GEM CVP 3 AND 4 HEMATOCRIT

K061974 · Instrumentation Laboratory CO · CHL · Sep 15, 2006 · Clinical Chemistry

Device Facts

• Record ID: K061974
• Device Name: GEM PREMIER 4000 WITH IQM, MODEL 4000; GEM CVP 1 AND 2 WITH CO-OX; GEM CVP 3 AND 4 HEMATOCRIT
• Applicant: Instrumentation Laboratory CO
• Product Code: CHL · Clinical Chemistry
• Decision Date: Sep 15, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1120
• Device Class: Class 2

Intended Use

The GEM Premier 4000 is a portable critical care system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of pH, pCO2, pO2, Na+, K+, Cl-, Ca++, glucose, lactate, hematocrit and CO-Oximetry (tHb, O2Hb, MetHb, HHb) parameters. These parameters, along with derived parameters, aid in the diagnosis of a patient's acid/base status, electrolyte and metabolite balance and oxygen delivery capacity. Intelligent Quality Management (iQM) is used as the quality control and assessment system for the GEM Premier 4000 system. iQM is an active quality process control program designed to provide continuous monitoring of the analytical process with real-time, automatic error detection, automatic correction of the system and automatic documentation of all corrective actions, replacing the use of traditional external quality controls. As part of this program, GEM CVP 1 and 2 (Calibration Valuation Product) with CO-Ox and GEM CVP 3 and 4 Hematocrit are external solutions intended to complete the calibration process and final accuracy assessment of the iQM cartridge calibration after initial warm-up. The reported values for the four levels of GEM CVP (two levels for pH, blood gases, electrolytes, metabolites and CO-Oximetry; two levels for hematocrit) must meet specifications before the iQM cartridge can be used for patient sample measurements. Once the cartridge calibration is verified, the internal iQM program monitors the status of the system during the cartridge use life.

Device Story

Portable critical care system; analyzes whole blood samples at point-of-care or central lab; measures pH, blood gases, electrolytes, glucose, lactate, hematocrit, and CO-Oximetry parameters. Uses potentiometric, amperometric, conductometric, and spectrophotometric sensors. Features Intelligent Quality Management (iQM) system; provides continuous monitoring of analytical process; performs real-time automatic error detection, correction, and documentation; replaces traditional external quality controls. Requires GEM CVP external solutions for initial calibration verification. Healthcare professionals use output to diagnose acid/base status, electrolyte/metabolite balance, and oxygen delivery capacity.

Clinical Evidence

In-house and field site testing performed. No specific clinical trial data provided in summary; substantial equivalence supported by performance testing comparing subject device to predicate devices.

Technological Characteristics

Potentiometric, amperometric, conductivity, and spectrophotometric sensing. Portable form factor. iQM software for automated quality control. Uses external CVP solutions for calibration verification.

Indications for Use

Indicated for use by healthcare professionals to analyze whole blood samples for pH, blood gases, electrolytes, metabolites, hematocrit, and CO-Oximetry parameters to aid in diagnosis of acid/base status, electrolyte/metabolite balance, and oxygen delivery capacity in clinical and laboratory 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

• IL Synthesis (K963800)
• GEM Premier 3000 (K052121)
• IL 682 CO-Oximeter (K945677)

Submission Summary (Full Text)

{0}------------------------------------------------

K061974

## 510(k) Summary GEM Premier 4000 with iQM and GEM CVP

#### Submitted by:

Instrumentation Laboratory Co. 113 Hartwell Avenue Lexington, MA 02421

#### Contact Person:

Carol Marble, Regulatory Affairs Director 781-861-4467 Phone: [phone] Fax: [e-mail] E-mail:

#### Summary Prepared:

July 11, 2006

#### Device Trade Names:

- GEM® Premier 4000 with iQM® (Intelligent Quality Management) .
- GEM CVP 1 and 2 (Calibration Valuation Product) with CO-Ox .
- GEM CVP 3 and 4 (Calibration Valuation Product) Hematocrit .

#### Regulatory Information:

- GEM Premier 4000 with iQM (Intelligent Quality Management) .

| Description | CFR Section | Device Class | Product Code |
|---------------------------------|-------------|--------------|--------------|
| Blood gases and blood pH | 862.1120 | Class II | CHL |
| Sodium test system | 862.1665 | Class II | JGS |
| Potassium test system | 862.1600 | Class II | CEM |
| Calcium test system | 862.1145 | Class II | JFP |
| Chloride test system | 862.1170 | Class II | CGZ |
| Glucose test system | 862.1345 | Class II | CGA |
| Lactic acid test system | 862.1450 | Class I | KHP |
| Automated hematocrit instrument | 864.5600 | Class II | GKF |
| Carboxyhemoglobin assay | 864.7425 | Class II | GHS |
| Automated hemoglobin system | 864.5620 | Class II | GKR |

- GEM CVP 1 and 2 (Calibration Valuation Product) with CO-Ox .

| Description | CFR Section | Device Class | Product Code |
|--------------------------|-------------|--------------|--------------|
| Quality Control Material | 862.1660 | Class I | JJY |

#### GEM CVP 3 and 4 (Calibration Valuation Product) Hematocrit .

| Description | CFR Section | Device Class | Product Code |
|--------------------|-------------|--------------|--------------|
| Hematocrit Control | 864.8625 | Class II | GLK |

Section 5

SEP 15 2006

Page 1 of 2

{1}------------------------------------------------

# 510(k) Summary GEM Premier 4000 with iQM and GEM CVP

#### Predicate Devices:

| Description | 510(k) | Analytes |
|----------------------------------------|---------|-------------------------------------------------------------------------------|
| GEM 3000 with iQM and GEM CVP | K052121 | pH, blood gases, electrolytes (except chloride), glucose, lactate, hematocrit |
| IL Synthesis with traditional QC | K963800 | Chloride |
| IL 682 CO-Oximeter with traditional QC | K945677 | CO-Oximeter parameters |

### Device Description and Indications for Use:

The GEM Premier 4000 is a portable critical care system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of pH, pCO2 pO2, Na . K , CI , Ca * , glucose, lactate, hematocrit and CO-Oximetry (tHb, O2Hb, MetHb, HHb) parameters. These parameters, along with derived parameters, aid in the diagnosis of a patient's acid/base status, electrolyte and metabolite balance and oxygen delivery capacity.

Intelligent Quality Management (iQM) is used as the quality control and assessment system for the GEM Premier 4000 system. iOM is an active quality process control program designed to provide continuous monitoring of the analytical process with real-time, automatic error detection, automatic correction of the system and automatic documentation of all corrective actions, replacing the use of traditional external quality controls.

As part of this program, GEM CVP 1 and 2 (Calibration Product) with CO-Ox and GEM CVP 3 and 4 Hematocrit are external solutions intended to complete the calibration process and final accuracy assessment of the iQM cartridge calibration after initial warm-up. The reported values for the four levels of GEM CVP (two levels for pH, blood gases, electrolytes, metabolites and CO-Oximetry; two levels for hematocrit) must meet specifications before the iQM cartidge can be used for patient sample measurements. Once the cartridge calibration is verified, the internal iQM program monitors the status of the system during the cartridge use life.

## Statement of Technological Characteristics of the Device Compared to Predicate Device:

In-house and field site testing supports that the GEM Premier 4000 with iOM in conjunction with GEM CVP 1 and 2 with CO-Ox and GEM CVP 3 and 4 Hematocrit is not materially different from the above listed predicate devices in performance, safety and effectiveness or intended use. The operating principles for the different analytes are the same between the GEM Premier 4000 and the predicates:

| Operating Principle | Analyte(s) |
|---------------------|------------------------------|
| Potentiometric | pH, pCO2, Na+, K+, Cl-, Ca++ |
| Amperometric | pO2, Glucose, Lactate |
| Conductivity | Hematocrit |
| Spectrophotometry | CO-Oximeter parameters |

Page 2 of 2

{2}------------------------------------------------

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle with its wings spread, rendered in a thick, black line. The eagle is positioned to the right of a circular arrangement of text. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" and is arranged around the upper half of the circle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Carol Marble Regulatory Affairs Director Instrumentation Laboratory Co. 113 Hartwell Avenue Lexington, MA 02421

SEP 1 5 2006

k061974 Re:

Trade/Device Name: GEM® Premier 4000 with iQM® (Intelligent Quality Management) GEM CVP 1 and 2 (Calibration Valuation Product) with CO-Ox GEM CVP 3 and 4 (Calibration Valuation Product) Hematocrit Regulation Number: 21 CFR 862.1120 Regulation Name: Blood gases (Pco2, Po2) and blood Ph test system Regulatory Class: Class II Product Code: CHL, JGS, CEM, JFP, CGZ, CGA, KHP, GKF, GHS, GKR, JJY, GLK, GLY Dated: July 11, 2006 Received: July 12, 2006

Dear Ms. Marble:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21. Code of Federal Regulations (CFR), Parts 800 to 895. 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

{3}------------------------------------------------

Page 2 -

CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Carol C. Benson for

Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

## Indications for Use Statement

### 510(k) Number (if known): k061974

#### GEM® Premier 4000 with iQM® (Intelligent Quality Management) Device Name: GEM CVP 1 and 2 (Calibration Valuation Product) with CO-Ox GEM CVP 3 and 4 (Calibration Valuation Product) Hematocrit

#### Indications for Use:

The GEM Premier 4000 is a portable critical care system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of pH, pCO2, pO2, Nat, K+, Cl , Ca+, glucose, lactate, hematocrit and CO-Oximetry (tHb, O2Hb, MetHb, HHb) parameters. These parameters, along with derived parameters, aid in the diagnosis of a patient's acid/base status, electrolyte and metabolite balance and oxygen delivery capacity.

Intelligent Quality Management (iQM) is used as the quality control and assessment system for the GEM Premier 4000 system. iQM is an active quality process control program designed to provide continuous monitoring of the analytical process with real-time, automatic error detection, automatic correction of the system and automatic documentation of all corrective actions, replacing the use of traditional external quality controls.

As part of this program, GEM CVP 1 and 2 (Calibration Valuation Product) with CO-Ox and GEM CVP 3 and 4 Hematocrit are external solutions intended to complete the calibration process and final accuracy assessment of the iQM cartridge calibration after initial warm-up. The reported values for the four levels of GEM CVP (two levels for pH, blood gases, electrolytes, metabolites and CO-Oximetry; two levels for hematocrit) must meet specifications before the iQM cartridge can be used for patient sample measurements. Once the cartridge calibration is verified, the internal iQM program monitors the status of the system during the cartridge use life.

で Over-The-Counter Use Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Amy Daugherty for Carol Benson
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

K061974

Section 4

GEM Premier 4000 with iQM and GEM CVP 510(k)