GEM PREMIER 3000

K992834 · Instrumentation Laboratory CO · CHL · Nov 24, 1999 · Clinical Chemistry

Device Facts

• Record ID: K992834
• Device Name: GEM PREMIER 3000
• Applicant: Instrumentation Laboratory CO
• Product Code: CHL · Clinical Chemistry
• Decision Date: Nov 24, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1120
• Device Class: Class 2

Intended Use

The GEM Premier 3000, which is an upgraded version of the existing GEM Premier Plus (K961335), 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++, and Hct. These parameters along with derived parameters Base Excess, HCO3, TCO2 and sO2 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 clinical use; operated by healthcare professionals. Device accepts whole blood samples; performs quantitative measurements of pH, pCO2, pO2, Na+, K+, Ca++, and Hct; calculates derived parameters including Base Excess, HCO3, TCO2, and sO2. Output provided to clinicians to aid diagnosis of acid/base status, oxygen delivery, and electrolyte/metabolite balance. Facilitates rapid clinical decision-making at point of care.

Clinical Evidence

Bench testing only. Precision evaluated using 60 replicates across 7 instruments (n=420) for pH, pCO2, pO2, Na+, K+, Ca++, and Hct. Method comparison performed against predicate devices using 80-130 clinical samples (arterial, venous, heart bypass, liver transplant) and healthy volunteer samples. Results showed high correlation (r=0.9548 to 0.9990) and statistical similarity across all measured parameters.

Technological Characteristics

Portable blood gas/electrolyte analyzer. Uses electrochemical sensors for pH, pCO2, pO2, Na+, K+, and Ca++. Automated hematocrit measurement. System provides quantitative analysis of whole blood samples.

Indications for Use

Indicated for use by healthcare professionals to analyze whole blood samples in clinical settings for patients requiring assessment of acid/base status, oxygen delivery capacity, and electrolyte/metabolite balance. No specific age or gender restrictions provided.

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)
• Manual spun hematocrit

Reference Devices

• GEM Premier Plus (K961335)

Submission Summary (Full Text)

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# Section 3 GEM Premier 3000 - 510(k) Summary (Summary of Safety and Effectiveness)

#### Submitted by:

Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02421 Phone: [phone] Fax:

### Contact Person:

Carol Marble. Regulatory Affairs Manager Phone: [phone] / Fax: [phone]

### Summary Prepared:

August 20, 1999

### Name of the device:

GEM Premier 3000

### Classification name(s):

| 75CHL | Electrode measurement, blood-gases (PCO2, PO2) and blood pH | Class II |
|----------|-------------------------------------------------------------|----------|
| 862.1120 | Blood-Gases (PCO2, PO2) and blood pH test system | |
| 75JGS | Electrode, ion specific, sodium | Class II |
| 862.1665 | Sodium test system | |
| 75CEM | Electrode, ion specific, potassium | Class II |
| 862.1600 | Potassium test system | |
| 75JFO | Electrode, ion specific, calcium | Class II |
| 862.1145 | Calcium test system | |
| 81GKF | Instrument, hematocrit, automated | Class II |
| 864.5600 | Automated hematocrit instrument | |

### Identification of predicate device(s):

IL Synthesis (except for hematocrit, which used manual spun hematocrit) K963800

### Description of the device/intended use(s):

The GEM Premier 3000, which is an upgraded version of the existing GEM Premier Plus (K961335), 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++, and Hct. These parameters along with derived parameters Base Excess, HCO3, TCO2 and sO2 aid in the diagnosis of a patient's acid/base status, oxygen delivery capacity, and electrolyte and metabolite balance.

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

The GEM Premier 3000 is substantially equivalent in performance, intended use, safety and effectiveness to the IL Synthesis (predicate device) for the quantitative measurements of whole blood pH, pCO2, pO2, Na+, K+ and Ca++, and to manual spun hematocrit (predicate device) for Hct.

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### Summary of performance data:

### Precision

Blood gas precision data were generated by using three levels of controls (GEM Check Plus) for pH, pCO2, pO3, Na+, K+, Ca++ and two levels of controls (GEM critCheck) for hematocrit. Control levels were run in replicates of 4 once a day for 14 days (twice on Day 1) for a total of 60 replicates on each of 7 different IL GEM 3000 instruments (total n=420). The table below shows the combined within run and total %CV of the seven instruments. NOTE: SD is used for pH since differences are so small that %CV would be misleading.

| Level 1 | | | Level 2 | | | Level 3 | | | |
|------------------|--------|-------------------|----------------|--------|-------------------|----------------|--------|-------------------|----------------|
| Parameter | Mean | Within<br>Run %CV | Total<br>%CV | Mean | Within<br>Run %CV | Total<br>%CV | Mean | Within<br>Run %CV | Total<br>%CV |
| pH | 7.0886 | 0.0066<br>(SD) | 0.0180<br>(SD) | 7.4276 | 0.0038<br>(SD) | 0.0049<br>(SD) | 7.6263 | 0.0040<br>(SD) | 0.0082<br>(SD) |
| pCO₂<br>(mmHg) | 66.02 | 1.95 | 2.82 | 36.37 | 2.37 | 2.45 | 16.79 | 2.89 | 3.76 |
| pO₂<br>(mmHg) | 64.42 | 2.14 | 2.77 | 103.69 | 0.86 | 1.63 | 155.65 | 0.82 | 1.20 |
| Na+<br>(mmol/L) | 118.55 | 0.63 | 0.98 | 135.51 | 0.42 | 0.72 | 152.61 | 0.63 | 1.18 |
| K+<br>(mmol/L) | 2.32 | 1.92 | 2.04 | 3.782 | 0.62 | 0.92 | 6.143 | 0.57 | 0.83 |
| Ca++<br>(mmol/L) | 0.753 | 2.16 | 2.68 | 1.071 | 0.94 | 1.50 | 1.387 | 0.88 | 1.30 |
| Hct<br>(%) | 24.34 | 1.18 | 1.43 | 43.93 | 1.11 | 1.57 | NA | NA | NA |

### Method Comparison

The method comparison data included arterial, venous, heart bypass and liver transplant blood samples from hospital patients using heparinized syringes and from healthy volunteers using heparinized vacutainer tubes. All samples were analyzed on the GEM Premier 3000 using an IL Synthesis as the predicate device with the exception of the hematocrit parameter, which used manual spun hematocrit as the predicate device. The GEM Premier 3000 was shown to be statistically similar to the predicate devices for the parameters listed below:

| Parameter | n | Slope | Intercept | r | Sample Range |
|---------------|-----|--------|-----------|--------|--------------|
| pH | 128 | 1.0660 | -0.4754 | 0.9931 | 7.10 - 7.60 |
| pCO₂ (mmHg) | 130 | 0.9721 | 2.1653 | 0.9935 | 24.6 - 99.6 |
| pO₂ (mmHg) | 128 | 0.9977 | 1.3552 | 0.9990 | 32 - 538 |
| Na+ (mmol/L) | 85 | 1.0181 | -3.9552 | 0.9820 | 110 - 182 |
| K+ (mmol/L) | 84 | 0.9474 | 0.0736 | 0.9987 | 1.20 - 14.60 |
| Ca++ (mmol/L) | 80 | 0.9756 | 0.0202 | 0.9927 | 0.73 - 4.01 |
| Hct (%) | 117 | 1.0841 | -3.4184 | 0.9548 | 16.0 - 54.0 |

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized graphic of three wavy lines, which are meant to represent the human form.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV 2 4 1999

Ms. Carol Marble Manager, Regulatory Affairs Instrumentation Laboratory Company 101 Hartwell Avenue Lexington, Massachusetts 02421-3125

Re: K992834 Trade Name: GEM Premier 3000 Regulatory Class: II Product Code: CHL, JGS, CEM, JFO, GKF Dated: November 11, 1999 Received: November 12, 1999

Dear Ms. Marble:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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#### Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Putman

Steven I. Gutman, M.D, M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement

510(k) Number (if known): K992834

Device Name: GEM Premier 3000

### Indications for Use:

The GEM Premier 3000, which is an upgraded version of the existing GEM Premier Plus (K961335), 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++, and Hct. These parameters along with derived parameters Base Excess, HCO2, TCO2 and sO2 aid in the diagnosis of a patient's acid/base status, oxygen delivery capacity, and electrolyte and metabolite balance.

Seun Cooper

(Division Sign-Off)
Division of Clin 'aboratory ices
510(k) Numbe: K 9942834

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.019)

Over-The-Counter Use

GEM Premier 3000 510(k)

OR