Stat Profile Prime ABG Analyzer System

K151982 · Nova Biomedical Corporation · CHL · Sep 10, 2015 · Clinical Chemistry

Device Facts

• Record ID: K151982
• Device Name: Stat Profile Prime ABG Analyzer System
• Applicant: Nova Biomedical Corporation
• Product Code: CHL · Clinical Chemistry
• Decision Date: Sep 10, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1120
• Device Class: Class 2

Indications for Use

The Stat Profile Prime ABG Analyzer System is intended for in vitro diagnostic use by health care professionals in clinical laboratory settings and for point-of-care usage for the quantitative determination of pH, PCO2, and PO2 in heparinized whole blood. PCO2, PO2, pH: Whole blood measurement of certain gases in whole blood, or pH of whole blood, is used in the diagnosis and treatment of life-threatening acid-base disturbances.

Device Story

Stat Profile Prime ABG Analyzer is a small, portable blood gas analyzer for clinical laboratory and point-of-care use. It utilizes a replaceable micro-sensor card containing integrated sensors for pH, PCO2, and PO2. Whole blood samples (50 µL minimum) are aspirated from syringes, tubes, or capillary devices via a peristaltic pump and sampling probe. The device uses traditional electrode technology for PO2 and ion-selective electrode technology for pH and PCO2. After analysis, samples are automatically flushed into a waste bag within a disposable calibrator cartridge. The system includes internal/external liquid QC and an onboard Quality Management System. Healthcare professionals (respiratory therapists, nurses) operate the device to obtain rapid blood gas measurements, which are used to inform clinical decisions regarding acid-base status and patient treatment.

Clinical Evidence

Clinical POC study conducted at 3 sites (CVICU, MICU, PCU) with 52 personnel (respiratory therapists/nurses). Compared results from POC personnel against trained healthcare professionals using 188 syringe and 127 capillary specimens. Results showed high correlation (r=0.997-1.000) across all parameters. Total imprecision evaluated using external QC materials over 20 runs; %CV for pH was <0.1%, PCO2 1.3-4.7%, and PO2 2.8-5.0%.

Technological Characteristics

Small blood gas analyzer using integrated micro-sensor card technology. pH measured via hydrogen ion selective membrane; PCO2 via modified pH sensor; PO2 via amperometric sensor. Dimensions/form factor designed for point-of-care portability. Consumables include disposable micro-sensor card and calibrator cartridge with waste collection. Connectivity includes onboard Quality Management System. Sterilization/materials not specified beyond disposable cartridge design.

Indications for Use

Indicated for healthcare professionals in clinical labs and point-of-care settings for quantitative determination of pH, PCO2, and PO2 in heparinized whole blood to diagnose and treat life-threatening acid-base disturbances in critically ill patients with metabolic and pulmonary diseases.

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

• Stat Profile® Prime ABG Analyzer System (K142220)

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE

A. 510(k) Number:
k151982

B. Purpose for Submission:
Modification of a previously cleared device (k142220) – modify the intended use of the device to include Point-of-Care use

C. Measurand:
pH, PCO2, and PO2

D. Type of Test:
Quantitative: Traditional electrode technology to measure blood PO2; Ion selective electrode technology to measure blood pH, PCO2.

E. Applicant:
Nova Biomedical Corporation

F. Proprietary and Established Names:
Stat Profile Prime ABG Analyzer System

G. Regulatory Information:
| Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| CHL | II | 862.1120, Blood Gases (pCO2, pO2) and Blood pH system | 75-Chemistry |

H. Intended Use:
1. Intended use(s):
See indications for use below.
2. Indication(s) for use:

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The Stat Profile Prime ABG Analyzer System is intended for in vitro diagnostic use by health care professionals in clinical laboratory settings and for point-of-care usage for the quantitative determination of pH, PCO2, and PO2 in heparinized whole blood.

PCO2, PO2, pH: Whole blood measurement of certain gases in whole blood, or pH of whole blood, is used in the diagnosis and treatment of life-threatening acid-base disturbances.

3. Special conditions for use statement(s):

For prescription use only.

For clinical laboratory and point-of-care use.

4. Special instrument requirements:

Stat Profile Prime ABG Analyzer System.

I. Device Description:

The Stat Profile Prime ABG Analyzer is a small blood gas analyzer for laboratory and point-of-care use. The sensors and flow path have been integrated into one replaceable micro-sensor card, which is replaced periodically according to usage. The product, consumables, installation instructions and packaging are designed for easy customer installation. Whole blood specimens are aspirated into the analyzer's micro-sensor card from syringes, tubes, or capillary blood collection devices using a peristaltic pump and a sampling probe. The disposable micro-sensor card contains the analytical flow-path and all of the measurement sensors (pH, PCO2, PO2). Once the analysis measurement is complete, the whole blood specimen is automatically flushed out of the micro-sensor card flow-path and into a self-contained waste collection bag contained within the disposable calibrator cartridge.

The Stat Profile Prime ABG Analyzer has multiple quality control options. Both traditional internal and external liquid QC will be available, as well as an onboard Quality Management System (QMS). The Stat Profile Prime ABG Analyzer has two primary sample modes: syringe and capillary modes. The minimum sample size for both analysis modes is 50 µL.

J. Substantial Equivalence Information:

1. Predicate device name(s):

Stat Profile Prime ABG Analyzer

2. Predicate 510(k) number(s):

k142220

3. Comparison with predicate:

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| Similarities and Differences | | | |
| --- | --- | --- | --- |
| Item | Predicate Device: Stat Profile Prime ABG Analyzer (k142220) | | Candidate Device: Stat Profile Prime ABG Analyzer (k151982) |
| Intended use | For in vitro diagnostics use for the determination of pH, PO2, and PCO2 in heparinized whole blood by health care professionals | | Same |
| Configuration | 2 level calibration standards per analyte, and reference solution | | Same |
| Packaging | Liquid in Mylar bags inside cardboard container. Includes a waste collection bag. Self-contained, disposable packaging. | | Same |
| Settings for use | Clinical laboratories | | Clinical laboratories and point-of-care settings. |
| Measuring range | pH | 6.500-8.000 | Same |
| | PCO2 | 3.0-200 mmHg | |
| | PO2 | 5-765 mmHg | |

# K. Standard/Guidance Document Referenced (if applicable):

CLSI EP05-A2, Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline-Second Edition

CLSI EP09-A2, Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline-Second Edition

# L. Test Principle:

pH is measured using a hydrogen ion selective membrane. One side of the membrane is in contact with a solution of constant pH. The other side is in contact with a solution of unknown pH. A change in potential develops which is proportional to the pH difference of these solutions. This change in potential is measured against a reference electrode of constant potential.

PCO2 is measured with a modified pH sensor. Carbon dioxide in the unknown solution makes contact with a hydrogen ion selective membrane CO2 diffuses across the membrane into a thin layer of bicarbonate buffer in response to partial pressure difference. This solution then becomes equilibrated with the external gas pressure of the fluid in contact with the outer surface of the membrane. CO2 in the solution becomes hydrated producing carbonic acid

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which results in a change in hydrogen ion activity. The measured potential is related to the logarithm of PCO2 content of the sample after compensation of the measured potential of the pH sensor.

PO2 is measured amperometrically by the generation of a current at the sensor surface. As oxygen diffuses through a gas permeable membrane, the oxygen molecules are reduced at the cathode, consuming 4 electrons for every molecule of oxygen reduced. This flow of electrons is then measured by the sensor and is directly proportional to the partial pressure of oxygen.

## M. Performance Characteristics (if/when applicable):

### 1. Analytical performance:

#### a. Precision/Reproducibility:

The within run precision study was performed at three point-of-care (POC) sites, including a cardiovascular intensive care unit (CVICU), a medical intensive care unit (MICU) and a pulmonary care unit (PCU) by a total of 52 POC personnel, comprised of 35 respiratory therapy and 17 nursing POC personnel. The study was performed by analyzing 20 replicates of 3 levels of Stat Profile Prime External Quality Control material (levels 1-3) on a Stat Profile Prime ABG analyzer at each POC site. All three sites produced similar results. Representative within run precision results are summarized in tables below:

One representative POC (site 1): Within Run Precision with Controls (N=20)

| Within Run Precision - Level 1 | | | |
| --- | --- | --- | --- |
| Parameter | Mean | SD | CV% |
| pH | 7.154 | 0.003 | 0.04 |
| PCO2 (mmHg) | 59.5 | 0.5 | 0.8 |
| PO2 (mmHg) | 62.3 | 1.8 | 2.9 |
| Within Run Precision - Level 2 | | | |
| pH | 7.368 | 0.002 | 0.03 |
| PCO2 (mmHg) | 41.6 | 0.5 | 1.2 |
| PO2 (mmHg) | 97.6 | 1.9 | 2.0 |
| Within Run Precision - Level 3 | | | |
| pH | 7.568 | 0.003 | 0.04 |
| PCO2 (mmHg) | 24.3 | 0.4 | 1.6 |
| PO2 (mmHg) | 136.6 | 3.1 | 2.3 |

A total imprecision study was performed at different point-of-care (POC) sites by different POC personnel by analyzing 3 levels of Stat Profile Prime External Quality Control material (levels 1-3) in duplicate for 20 days for a total of 40 measurements on each of three Stat Profile Prime ABG Analyzers. All three sites produced similar results. The total imprecision data from one representative POC site is shown in the table below:

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Total Imprecision from one representative POC Site (N=40)

| Total Imprecision Data - Level 1 | | | | | |
| --- | --- | --- | --- | --- | --- |
| Parameter | Pooled Mean | Within Run SD | Within Run %CV | Total SD | Total %CV |
| pH | 7.150 | 0.003 | 0.041 | 0.003 | 0.049 |
| PCO2 (mmHg) | 60.7 | 0.6 | 1.0 | 1.1 | 1.8 |
| PO2 (mmHg) | 61.7 | 1.8 | 2.9 | 2.9 | 4.7 |
| Total Imprecision Data - Level 2 | | | | | |
| pH | 7.366 | 0.001 | 0.020 | 0.004 | 0.049 |
| PCO2 (mmHg) | 41.4 | 0.3 | 0.8 | 0.8 | 1.8 |
| PO2 (mmHg) | 99.5 | 1.5 | 1.5 | 2.3 | 2.3 |
| Total Imprecision Data - Level 3 | | | | | |
| pH | 7.561 | 0.005 | 0.072 | 0.008 | 0.100 |
| PCO2 (mmHg) | 25.5 | 0.6 | 2.4 | 1.3 | 4.9 |
| PO2 (mmHg) | 137.6 | 2.0 | 1.5 | 3.3 | 2.4 |

The combined-site total imprecision results from all 3 sites are summarized in the tables below:

Total impression with external quality control materials $(\mathrm{N} = 120)$

| Combined Total Imprecision Data - Level 1 | | | | | |
| --- | --- | --- | --- | --- | --- |
| Parameter | Pooled Mean | Within Run SD | Within Run %CV | Total SD | Total %CV |
| pH | 7.152 | 0.004 | 0.056 | 0.005 | 0.070 |
| PCO2 (mmHg) | 61.3 | 0.8 | 1.3 | 1.7 | 2.7 |
| PO2 (mmHg) | 64.0 | 1.6 | 2.5 | 3.2 | 5.0 |
| Combined Total Imprecision Data - Level 2 | | | | | |
| pH | 7.367 | 0.002 | 0.027 | 0.003 | 0.041 |
| PCO2 (mmHg) | 41.1 | 0.4 | 1.0 | 0.6 | 1.5 |
| PO2 (mmHg) | 101.7 | 1.4 | 1.4 | 3.0 | 2.9 |
| Combined Total Imprecision Data - Level 3 | | | | | |
| pH | 7.560 | 0.006 | 0.079 | 0.007 | 0.093 |
| PCO2 (mmHg) | 25.5 | 0.8 | 3.1 | 1.2 | 4.7 |
| PO2 (mmHg) | 139.8 | 1.7 | 1.2 | 4.0 | 2.8 |

b. Linearity/assay reportable range:

The linearity study has been previously reviewed in k142220.

c. Traceability, Stability, Expected values (controls, calibrators, or methods):

The traceability of the pH standards and reagents, and the traceability of the PCO2/PO2 controls and reagents have been previously reviewed in k142220.

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The stability and value assignment for the calibrators, internal and external controls have been previously reviewed in k142220.

d. Detection limit:

The detection limit study has been previously reviewed in k142220.

e. Analytical specificity:

The analytical specificity study has been previously reviewed in k142220.

f. Assay cut-off:

Not applicable.

2. Comparison studies:

a. Method comparison with predicate device:

Method comparison study for all analytes was previously cleared in k142220 for clinical laboratory use only. In order to add Point-of-Care claim, sponsor has conducted POC study using the intended POC operators at the intended use sites to demonstrate that POC operators could generate equivalent results as the clinical laboratory professionals. A method comparison study was performed at 3 POC sites by a total of 52 different POC personnel (35 respiratory therapist and 17 nurses) using the analyzer's syringe mode method. Approximately 188 Lithium heparin whole blood gas specimens from syringes were analyzed to compare the whole blood results obtained by trained laboratory personnel vs respiratory therapy POC personnel on the same specimens. No more than 12.7% of samples for each analyte were altered in order to adequately span the measuring range. Each of the three sites produced similar method comparison data. Syringe mode method comparison study data is shown below from one representative POC site and the three combined POC sites:

Syringe Mode: POC vs. Laboratory Professionals, one representative POC site

| Parameter | n | Whole Blood Range tested | Slope | Intercept | r |
| --- | --- | --- | --- | --- | --- |
| pH | 62 | 6.897-7.726 | 1.001 | -0.012 | 0.999 |
| PCO2 (mmHg) | 62 | 4.3-193.0 | 0.996 | 1.023 | 0.999 |
| PO2 (mmHg) | 62 | 11.8-700.1 | 0.987 | 0.843 | 1.000 |

Syringe Mode: Combined all 3 POC sites

| Parameter | n | Whole Blood Range tested | Slope | Intercept | r |
| --- | --- | --- | --- | --- | --- |
| pH | 188 | 6.785-7.767 | 0.997 | 0.018 | 0.999 |
| PCO2 (mmHg) | 188 | 4.3-193.0 | 1.001 | 1.063 | 0.998 |
| PO2 (mmHg) | 188 | 11.8-755.3 | 1.015 | -0.939 | 1.000 |

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Another method comparison study was performed at 3 POC sites by a total of 52 different POC personnel (35 respiratory therapists and 17 nurses) using the analyzer's capillary mode method. Approximately 127 heparinized blood gas specimens from capillary tubes were run to compare the whole blood results obtained by trained laboratory personnel vs POC personnel on the same specimens. No more than 9.5% of samples for each analyte were altered in order to adequately span the measuring range. Each of the three sites produced similar method comparison data. The capillary mode method comparison study data from one representative POC site and data from the three combined POC sites is shown in the tables below:

Capillary Mode: POC vs Laboratory Professionals, one representative POC site

| Parameter | n | Whole Blood Range tested | Slope | Intercept | r |
| --- | --- | --- | --- | --- | --- |
| pH | 43 | 6.903-7.737 | 1.005 | -0.035 | 0.999 |
| PCO2 (mmHg) | 43 | 3.2-182.5 | 0.989 | 1.21 | 0.998 |
| PO2 (mmHg) | 43 | 16.2-649.9 | 1.037 | -1.553 | 1.000 |

Capillary Mode: Combined all 3 POC sites

| Parameter | n | Whole Blood Range tested | Slope | Intercept | r |
| --- | --- | --- | --- | --- | --- |
| pH | 127 | 6.791-7.737 | 0.993 | 0.047 | 0.998 |
| PCO2 (mmHg) | 127 | 3.2-192.2 | 0.984 | 1.347 | 0.997 |
| PO2 (mmHg) | 127 | 13.1-672.9 | 1.041 | -2.761 | 0.999 |

b. Matrix comparison:
Not applicable.

3. Clinical studies:
a. Clinical Sensitivity:
Not applicable.
b. Clinical specificity:
Not applicable.
c. Other clinical supportive data (when a. and b. are not applicable):
Not applicable.

4. Clinical cut-off:
Not applicable.

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5. Expected values/Reference range:

| Parameter | Reference Range |
| --- | --- |
| pH1,2,3 | 7.35-7.45 |
| PCO21,2,3 | 35-45 mmHg |
| PO21,2,3 | 83-108 mmHg |

References:

1. Statland, Bernard. 1987. Clinical Decisions Levels for Lab Tests, Medical Economics Books.
2. Burtis, Carl A. and Ashwood, Edward R., ed. 1994. Tietz Textbook of Clinical Chemistry. Philadelphia, PA: W. B. Saunders Co.
3. Burtis, Carl A. Ashwood, Edward R., Burns, David R., 2011. Tietz Textbook of Clinical Chemistry and Molecular Diagnostics. $5^{th}$ ed, Philadelphia, PA: W. B. Saunders Co.

N. Proposed Labeling:

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10, and 21 CFR Part 801.109(b)(1) to indicate For In Vitro Diagnostic Use and Prescription Use Only.

O. Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.