Stat Profile Prime Plus Analyzer System

K200204 · Nova Biomedical Corporation · GGZ · Apr 6, 2020 · Hematology

Device Facts

• Record ID: K200204
• Device Name: Stat Profile Prime Plus Analyzer System
• Applicant: Nova Biomedical Corporation
• Product Code: GGZ · Hematology
• Decision Date: Apr 6, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7500
• Device Class: Class 2

Indications for Use

The Stat Profile® Prime Plus Analyzer System is indicated for use by healthcare professionals in clinical laboratory settings and for point-of-care usage for quantitative determination of Hematocrit, Oxygen Saturation, Total Hemoglobin, Oxygenhemoglobin, Carboxyhemoglobin, Methemoglobin, and Deoxyhemoglobin in heparinized arterial and venous whole blood. Hematocrit (Hct) measurements of the packed red blood cell volume are used to distinguish normal from abnormal states, such as anemia and erythrocytosis. Oxygen Saturation (sO₂) measurements are used to assess the oxygenation of the hemoglobin and the adequacy of tissue oxygenation in the evaluation of pulmonary function. Measurements are also used to diagnose and treat cyanosis. Total Hemoglobin (tHb) measurements are used in the evaluation of chronic and acute anemia as well as the oxygen transport capability of the hemoglobin. Oxyhemoglobin (O₂Hb) measurements are used to assess pulmonary function in combination with Deoxyhemoglobin and are also used in the diagnosis and treatment of cyanosis. Carboxyhemoglobin (COHb) measurements are used to determine if and to what level carbon monoxide has been inhaled by the patient. High levels of carbon monoxide can lead to tissue anoxia and death. Methemoglobin (MetHb) measurements are used to determine congenital methemoglobinemia or determine the ingestion of nitrates, chlorates, or any other drug or chemical that can cause methemoglobin formation. High levels of methemoglobin can lead to cyanosis and death. Deoxyhemoglobin (HHb) measurements are used to assess pulmonary function in combination with Oxygenhemoglobin.

Device Story

Stat Profile® Prime Plus Analyzer System; small automatic blood gas analyzer for clinical laboratory and point-of-care (POC) use. Inputs: lithium heparinized arterial/venous whole blood (135 μL). Principle: Hct via impedance sensor; sO₂, tHb, O₂Hb, COHb, MetHb, HHb via spectrophotometric optical absorbance. System includes analyzer, sensor cartridges, calibrator packs, and internal/external quality control materials. Operator identifies specimens via barcode scanner or touchscreen. Output: quantitative analyte concentrations displayed on screen/printed. Used by clinicians/POC personnel to assess pulmonary function, anemia, cyanosis, and carbon monoxide/methemoglobin levels. Supports clinical decision-making regarding oxygen transport and tissue oxygenation.

Clinical Evidence

Clinical POC study conducted at 3 sites (CTICU, ED, RT Lab) with 75 personnel. Method comparison (n=322-437) against lab standards showed high correlation (r=0.9923-0.9993) and slopes near 1.0. Precision studies (n=10 replicates) demonstrated low imprecision (Total %CV 0.0-2.3% across levels). No clinical safety issues reported.

Technological Characteristics

Small automatic blood gas analyzer. Sensing: impedance (Hct) and spectrophotometric (sO₂, tHb, O₂Hb, COHb, MetHb, HHb). Configuration: two sensor cartridge slots (Primary/Auxiliary). Connectivity: barcode scanner, touchscreen, onboard thermal printer. Power: electrical. Safety: IEC 61010-1, IEC 60601-1-2.

Indications for Use

Indicated for healthcare professionals in clinical labs and point-of-care settings for quantitative measurement of Hct, SO2, tHb, O2Hb, COHb, MetHb, and HHb in heparinized arterial and venous whole blood. Used to assess anemia, erythrocytosis, pulmonary function, tissue oxygenation, cyanosis, carbon monoxide exposure, and methemoglobinemia.

Regulatory Classification

Identification

A whole blood hemoglobin assay is a device consisting or reagents, calibrators, controls, or photometric or spectrophotometric instrumentation used to measure the hemoglobin content of whole blood for the detection of anemia. This generic device category does not include automated hemoglobin systems.

Special Controls

*Classification.* Class II (special controls). An acid hematin intended for use with whole blood hemoglobin assays is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

Predicate Devices

• Stat Profile® Prime Plus Analyzer System (k180186)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

ASSAY ONLY

## I Background Information:

A 510(k) Number

k200204

B Applicant

Nova Biomedical Corporation

C Proprietary and Established Names

Stat Profile® Prime Plus Analyzer System

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| GGZ | Class II | 21 CFR 864.7500 - Whole Blood Hemoglobin Assays | HE - Hematology |
| GHS | Class II | 21 CFR 864.7425 - Carboxyhemoglobin assay | HE - Hematology |
| GKK | Class II | 21 CFR 864.7500 - Whole blood hemoglobin assays | HE - Hematology |
| GKR | Class II | 21 CFR 864.5620 - Automated hemoglobin system | HE - Hematology |
| JPI | Class II | 21 CFR 864.6400 - Hematocrit measuring device | HE - Hematology |

## II Submission/Device Overview:

### A Purpose for Submission:

Modification of a previously cleared device (k180186) – modify the intended use of the device to include Point-of-Care (POC) use.

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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B Measurand:
Hematocrit (Hct), Oxygen Saturation (sO₂), Total Hemoglobin (tHb), Oxygenhemoglobin (O₂Hb), Carboxyhemoglobin (COHb), Methemoglobin (MetHb), and Deoxyhemoglobin (HHb)

C Type of Test:
Hct: quantitative, impedance sensor
sO₂, tHb, O₂Hb, COHb, MetHb, HHb: quantitative, spectrophotometric

III Intended Use/Indications for Use:

A Intended Use(s):
See Indications for Use below.

B Indication(s) for Use:
The Stat Profile® Prime Plus Analyzer System is indicated for use by healthcare professionals in clinical laboratory settings and for point-of-care usage for quantitative determination of Hematocrit, Oxygen Saturation, Total Hemoglobin, Oxygenhemoglobin, Carboxyhemoglobin, Methemoglobin, and Deoxyhemoglobin in heparinized arterial and venous whole blood.

Hematocrit (Hct) measurements of the packed red blood cell volume are used to distinguish normal from abnormal states, such as anemia and erythrocytosis.

Oxygen Saturation (sO₂) measurements are used to assess the oxygenation of the hemoglobin and the adequacy of tissue oxygenation in the evaluation of pulmonary function. Measurements are also used to diagnose and treat cyanosis.

Total Hemoglobin (tHb) measurements are used in the evaluation of chronic and acute anemia as well as the oxygen transport capability of the hemoglobin.

Oxyhemoglobin (O₂Hb) measurements are used to assess pulmonary function in combination with Deoxyhemoglobin and are also used in the diagnosis and treatment of cyanosis.

Carboxyhemoglobin (COHb) measurements are used to determine if and to what level carbon monoxide has been inhaled by the patient. High levels of carbon monoxide can lead to tissue anoxia and death.

Methemoglobin (MetHb) measurements are used to determine congenital methemoglobinemia or determine the ingestion of nitrates, chlorates, or any other drug or chemical that can cause methemoglobin formation. High levels of methemoglobin can lead to cyanosis and death.

Deoxyhemoglobin (HHb) measurements are used to assess pulmonary function in combination with Oxygenhemoglobin.

C Special Conditions for Use Statement(s):
Rx - For Prescription Use Only

For clinical laboratory and point of care use.

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D Special Instrument Requirements:

Stat Profile® Prime Plus Analyzer System

IV Device/System Characteristics:

A Device Description:

The Stat Profile® Prime Plus Analyzer System is a small automatic blood gas analyzer for laboratory and point of care setting. It consists of the analyzer, sensor cartridges, calibrator packs, auto-cartridge quality control packs (internal controls), ampiled quality control materials (external controls) and thermal paper for an onboard printer. Specimens may be identified by scanning a barcode or by manually entering the information via the touchscreen.

The Stat Profile® Prime Plus Analyzer has slots to accommodate two sensor cartridges (Primary and Auxiliary). The analyzer will determine the configuration of the system by detecting which sensor cards are installed. The reporting of CO-Oximeter parameters (or not reporting them) will also be determined by the selection of the Sensor Cards, for which there are two options:

- Primary Sensor Card 1 reports the following analytes: pO₂, pCO₂, pH, Na, Cl, K, iCa, iMg, Glu, tBil, Hct, tHb, sO₂, O₂Hb, COHb, MetHb, HHb
- Primary Sensor Card 2 reports the following analytes: pO₂, pCO₂, pH, Na, Cl, K, iCa, iMg, Glu, Hct, tHb, sO₂

B Principle of Operation:

Oxygen saturation (sO₂) represents the percent of hemoglobin bound to oxygen, expressed as a fraction of the amount of hemoglobin capable of binding to oxygen (oxyhemoglobin plus deoxyhemoglobin). As the level of SO₂ changes within a blood sample, the optical absorbance of the whole blood changes.

Hematocrit (Hct) is defined as the percentage of red blood cells to the total blood volume and is measured by the electrical resistance of the blood sample. The hematocrit value is corrected for the concentration of the sodium ion.

Total Hemoglobin (tHb) is measured by optical absorbance, and is the sum of all measured hemoglobin fractions expressed as the amount of hemoglobin in a specified volume of whole blood.

Oxyhemoglobin (O₂Hb) is measured by optical absorbance, and is the combined form of hemoglobin and oxygen.

Carboxyhemoglobin is measured by optical absorbance, and is the combined form of carbon monoxide and hemoglobin.

Methemoglobin is measured by optical absorbance, and is the form of hemoglobin in which the iron has been oxidized from the ferrous to the ferric state.

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Deoxyhemoglobin is measured by optical absorbance, and is the form of hemoglobin that is not combined with oxygen but can easily uptake oxygen in the lungs.

## V Substantial Equivalence Information:

A Predicate Device Name(s):

Stat Profile® Prime Plus Analyzer System

B Predicate 510(k) Number(s):

k180186

C Comparison with Predicate(s):

| Device & Predicate Device(s): | k200204 | k180186 |
| --- | --- | --- |
| Device Trade Name | Stat Profile® Prime Plus Analyzer System | Stat Profile® Prime Plus Analyzer System |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | For the quantitative determination of Hematocrit, Oxygen Saturation, Total Hemoglobin, Oxyhemoglobin, Carboxyhemoglobin, Methemoglobin, and Deoxyhemoglobin in heparinized arterial and venous whole blood. | Same |
| Acceptable Sample Types | Lithium heparin whole blood from syringes and open tubes. | Same |
| Sample Volume | 135 μL | Same |
| General Device Characteristic Differences | | |
| Settings for use | Clinical laboratories and point-of-care settings | Clinical laboratories |

## VI Standards/Guidance Documents Referenced:

IEC 61010-1:2010 – Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use – Part 1: General Requirements.

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IEC 60601-1-2:2014 – Medical Electrical Equipment – Part 1-2: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Electromagnetic Disturbances – Requirements and Tests.

## VII Performance Characteristics (if/when applicable):

### A Analytical Performance:

#### 1. Precision/Reproducibility:

The precision performance of the Stat Profile® Prime Plus Analyzer System for Hct, sO₂, tHb, O₂Hb, COHb, MetHb, and HHb for POC use was established in three separate studies using methods described in CLSI EP5-A2. The studies were conducted at three POC sites: a Cardiothoracic Intensive Care Unit, an Emergency Department and a Respiratory Therapy Lab. Across all three studies, a total of 61 respiratory care, 12 nursing, and 1 exercise physiology POC personnel participated.

#### Within-run precision using controls

A three site POC within-run precision (repeatability) study of the Stat Profile® Plus Analyzer System for Hct, SO₂, tHb, O₂Hb, COHb, MetHb, and HHb was conducted by testing three levels of quality control material and/or two levels of linearity materials. At each site, the samples were assayed in replicates of 20 using one analyzer for a total of three Stat Profile® Plus Analyzer Systems and 60 measurements per sample. All three POC sites produced similar results. Representative within-run precision results from one site are summarized in the tables below:

| Hct (%) | |
| --- | --- |
| Mean | SD |
| 61 | 0.7 |
| 38 | 0.3 |
| 26 | 0.6 |
| 29 | 0.2 |
| 46 | 0.004 |
| sO2 (%) | |
| --- | --- |
| Mean | SD |
| 48 | 0.9 |
| 78 | 0.01 |
| 90 | 0.5 |
| tHb (g/dL) | | |
| --- | --- | --- |
| Mean | SD | %CV |
| 20.0 | 0.1 | 0.7 |
| 12.8 | 0.1 | 0.9 |
| 6.4 | 0.1 | 1.7 |

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| O2Hb (%) | | |
| --- | --- | --- |
| Mean | SD | %CV |
| 21.0 | 0.4 | 2.0 |
| 47.3 | 0.1 | 0.3 |
| 80.1 | 0.1 | 0.1 |
| COHb (%) | | |
| --- | --- | --- |
| Mean | SD | %CV |
| 29.0 | 0.3 | 0.9 |
| 21.7 | 0.2 | 1.0 |
| 6.6 | 0.1 | 1.6 |
| MetHb (%) | | |
| --- | --- | --- |
| Mean | SD | %CV |
| 27.4 | 0.1 | 0.4 |
| 17.5 | 0.3 | 1.7 |
| 5.0 | 0.2 | 4.0 |
| HHb (%) | | |
| --- | --- | --- |
| Mean | SD | %CV |
| 22.6 | 0.2 | 0.9 |
| 13.5 | 0.1 | 0.9 |
| 8.4 | 0.2 | 1.9 |

Within-run precision using whole blood

A three site POC within-run precision (repeatability) study of the Stat Profile® Plus Analyzer System for Hct, $\mathrm{sO}_2$ , tHb, $\mathrm{O}_2\mathrm{Hb}$ , COHb, MetHb, and HHb was conducted by testing five levels of analytes in native whole blood samples and two levels of analytes in altered whole blood samples. At each site, the samples were assayed in replicates of 10 using one analyzer for a total of three Stat Profile® Plus Analyzer Systems and 30 measurements per sample. A minimum of two operators at each site for a total of 9 operators conducted the testing. The results from each site are presented in the tables below.

Hct $(\%)$

| Site | Mean | SD |
| --- | --- | --- |
| 1 | 46.5 | 0.71 |
| | 46.6 | 0.52 |
| | 43.9 | 0.57 |
| | 30.0 | 0.47 |
| | 35.2 | 0.42 |
| | 44.7 | 0.82 |
| | 43.6 | 0.52 |
| 2 | 48.4 | 1.43 |
| | 20.8 | 0.42 |

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| Site | Mean | SD |
| --- | --- | --- |
| 3 | 46 | 0.00 |
| | 48.8 | 0.79 |
| | 48 | 0.00 |
| | 38.9 | 0.32 |
| | 44 | 0.47 |
| | 44.1 | 0.32 |

sO₂ (%)

| Site | Mean | SD |
| --- | --- | --- |
| 1 | 50.0 | 0.94 |
| | 66.4 | 0.70 |
| | 92.3 | 0.48 |
| | 92.5 | 0.53 |
| | 93.8 | 0.42 |
| | 97.1 | 0.32 |
| | 99.0 | 0.00 |
| 2 | 80.0 | 0.00 |
| | 89.4 | 0.7 |
| | 92.5 | 0.53 |
| | 95.9 | 0.32 |
| | 98.9 | 0.32 |
| | 99.4 | 0.52 |
| | 99.4 | 0.52 |
| 3 | 44.0 | 0.00 |
| | 53.6 | 0.97 |
| | 85.1 | 0.32 |
| | 91.0 | 0.00 |
| | 95.1 | 0.32 |
| | 95.9 | 0.32 |
| | 97.9 | 0.32 |

tHb (g/dL)

| Site | Mean | SD | %CV |
| --- | --- | --- | --- |
| 1 | 16.2 | 0.05 | 0.3 |
| | 16.1 | 0.05 | 0.3 |
| | 14.9 | 0.05 | 0.3 |
| | 8.4 | 0.08 | 0.9 |
| | 10.3 | 0.09 | 0.9 |
| | 15.6 | 0.19 | 1.2 |

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| Site | Mean | SD | %CV |
| --- | --- | --- | --- |
| | 15.4 | 0.16 | 1.0 |
| 2 | 15 | 0.31 | 2.1 |
| | 7.2 | 0.22 | 3.0 |
| | 16.2 | 0.05 | 0.3 |
| | 16.1 | 0.05 | 0.3 |
| | 8.2 | 0.05 | 0.6 |
| | 11 | 0.12 | 1.1 |
| | 14.7 | 0.08 | 0.5 |
| 3 | 14.4 | 0.05 | 0.3 |
| | 17 | 0.00 | 0.00 |
| | 16.5 | 0.07 | 0.4 |
| | 11.5 | 0.07 | 0.6 |
| | 14 | 0.12 | 0.8 |
| | 14.8 | 0.07 | 0.5 |
| | 15.8 | 0.37 | 2.4 |

O₂Hb (%)

| Site | Mean | SD | %CV |
| --- | --- | --- | --- |
| 1 | 49.6 | 0.48 | 1.0 |
| | 64.5 | 0.73 | 1.1 |
| | 66.9 | 0.35 | 0.5 |
| | 78.9 | 0.27 | 0.3 |
| | 91.8 | 0.53 | 0.6 |
| | 95.5 | 0.28 | 0.3 |
| | 98.3 | 0.21 | 0.2 |
| 2 | 60.50 | 1.01 | 1.7 |
| | 78.60 | 0.30 | 0.4 |
| | 85.00 | 0.65 | 0.8 |
| | 90.40 | 0.45 | 0.5 |
| | 93.90 | 0.48 | 0.5 |
| | 94.40 | 0.17 | 0.2 |
| | 97.70 | 0.13 | 0.1 |
| 3 | 42.6 | 0.31 | 0.7 |
| | 44.0 | 0.00 | 0.00 |
| | 52.8 | 0.86 | 1.6 |
| | 66.8 | 0.92 | 1.4 |
| | 76.1 | 0.26 | 0.3 |
| | 83.1 | 0.46 | 0.6 |
| | 94.1 | 0.46 | 0.5 |

COHb (%)

| Site | Mean | SD | %CV |
| --- | --- | --- | --- |
| 1 | 0.38 | 0.08 | 20.8 |
| | 0.38 | 0.08 | 20.8 |
| | 0.95 | 0.33 | 34.8 |

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| Site | Mean | SD | %CV |
| --- | --- | --- | --- |
| | 1.10 | 0.16 | 14.8 |
| | 1.92 | 0.19 | 10.1 |
| | 14.3 | 0.27 | 1.9 |
| | 15.4 | 0.20 | 1.3 |
| 2 | 1.08 | 0.17 | 15.7 |
| | 1.28 | 0.25 | 19.5 |
| | 1.53 | 0.27 | 17.6 |
| | 1.60 | 0.19 | 11.9 |
| | 4.11 | 0.17 | 4.0 |
| | 4.74 | 0.15 | 3.2 |
| | 17.40 | 0.21 | 1.2 |
| 3 | 0.38 | 0.06 | 15.8 |
| | 0.39 | 0.09 | 23.1 |
| | 0.70 | 0.34 | 48.6 |
| | 0.73 | 0.24 | 32.9 |
| | 0.80 | 0.24 | 30.0 |
| | 15.8 | 0.26 | 1.7 |
| | 16.2 | 0.31 | 1.9 |

MetHb (%)

| Site | Mean | SD | %CV |
| --- | --- | --- | --- |
| 1 | 0.42 | 0.09 | 21.9 |
| | 0.43 | 0.08 | 19.2 |
| | 0.43 | 0.09 | 22.1 |
| | 0.44 | 0.08 | 19.2 |
| | 0.62 | 0.23 | 36.3 |
| | 0.79 | 0.14 | 18.3 |
| | 13.23 | 0.23 | 1.71 |
| 2 | 0.38 | 0.08 | 21.0 |
| | 0.54 | 0.08 | 14.8 |
| | 0.58 | 0.09 | 15.5 |
| | 0.71 | 0.07 | 9.8 |
| | 0.81 | 0.22 | 27.2 |
| | 0.88 | 0.15 | 17.0 |
| | 21.50 | 1.06 | 4.9 |
| 3 | 0.77 | 0.12 | 15.6 |
| | 0.80 | 0.08 | 10.0 |
| | 0.90 | 0.14 | 15.6 |
| | 1.00 | 0.08 | 8.0 |
| | 1.20 | 0.11 | 9.2 |
| | 1.40 | 0.12 | 8.6 |
| | 13.60 | 0.79 | 5.8 |

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HHb (%)

| Site | Mean | SD | %CV |
| --- | --- | --- | --- |
| 1 | 0.9 | 0.19 | 21.6 |
| | 2.7 | 0.14 | 5.4 |
| | 4.5 | 0.18 | 4.0 |
| | 6.5 | 0.19 | 2.9 |
| | 7.4 | 0.44 | 5.9 |
| | 32.9 | 0.69 | 2.1 |
| | 49.0 | 0.38 | 0.8 |
| 2 | 0.48 | 0.08 | 16.6 |
| | 0.50 | 0.11 | 22.0 |
| | 0.61 | 0.18 | 29.5 |
| | 4.00 | 0.36 | 9.2 |
| | 7.20 | 0.37 | 5.1 |
| | 10.10 | 0.60 | 6.0 |
| | 19.60 | 0.18 | 0.9 |
| 3 | 2.30 | 0.16 | 6.9 |
| | 3.41 | 0.14 | 4.0 |
| | 4.30 | 0.14 | 3.2 |
| | 7.38 | 0.14 | 1.9 |
| | 14.70 | 0.51 | 3.4 |
| | 46.00 | 0.87 | 1.9 |
| | 54.50 | 0.33 | 0.6 |

## Total precision

A three site POC total precision study of the Stat Profile® Prime Plus Analyzer for Hct, sO₂, tHb, O₂Hb, COHb, MetHb, and HHb was conducted using three levels of QC materials and one Stat Profile® Plus Analyzer System per site. For each run, each sample was run in duplicate each day for a total of 20 days for a total of 40 results per site. The results were analyzed per site for within-run precision (repeatability) and for total precision (combined within-run and run-to-run). All three POC sites produced similar results. Representative results from one site are summarized in the tables below:

| Analyte | Mean | Within-Run SD | Total SD |
| --- | --- | --- | --- |
| Hct (%) | 61 | 0.7 | 0.8 |
| | 38 | 0.3 | 0.3 |
| | 27 | 0.5 | 0.5 |
| Analyte | Mean | Within-Run SD | Total SD |
| --- | --- | --- | --- |
| sO₂ (%) | 48 | 0.6 | 0.7 |
| | 78 | 0.3 | 0.4 |
| | 91 | 0.5 | 0.4 |

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| Analyte | Mean | Within-Run SD | Within-Run %CV | Total SD | Total %CV |
| --- | --- | --- | --- | --- | --- |
| tHb (g/dL) | 19.7 | 0.2 | 0.9 | 0.2 | 1.1 |
| | 12.9 | 0.1 | 1.0 | 0.2 | 1.5 |
| | 6.3 | 0.1 | 1.6 | 0.1 | 2.1 |
| Analyte | Mean | Within-Run SD | Within-Run %CV | Total SD | Total %CV |
| --- | --- | --- | --- | --- | --- |
| O2Hb (%) | 20.9 | 0.3 | 1.5 | 0.4 | 2.0 |
| | 47.3 | 0.2 | 0.3 | 0.4 | 0.9 |
| | 80.2 | 0.1 | 0.1 | 0.2 | 0.3 |
| Analyte | Mean | Within-Run SD | Within-Run %CV | Total SD | Total %CV |
| --- | --- | --- | --- | --- | --- |
| COHb (%) | 29.1 | 0.2 | 0.7 | 0.2 | 0.9 |
| | 21.7 | 0.1 | 0.7 | 0.3 | 1.2 |
| | 6.5 | 0.1 | 2.0 | 0.1 | 2.2 |
| Analyte | Mean | Within-Run SD | Within-Run %CV | Total SD | Total %CV |
| --- | --- | --- | --- | --- | --- |
| MetHb (%) | 27.7 | 0.1 | 0.4 | 0.1 | 0.4 |
| | 18.4 | 0.2 | 1.1 | 0.2 | 1.2 |
| | 5.8 | 0.1 | 2.2 | 0.1 | 2.3 |
| Analyte | Mean | Within-Run SD | Within-Run %CV | Total SD | Total %CV |
| --- | --- | --- | --- | --- | --- |
| HHb (%) | 22.7 | 0.1 | 0.5 | 0.1 | 0.6 |
| | 13.2 | 0.2 | 1.2 | 0.2 | 1.2 |
| | 7.9 | 0.1 | 1.5 | 0.1 | 1.7 |

2. Linearity:

Previously established in k180186.

3. Analytical Specificity/Interference:

Previously established in k180186.

4. Assay Reportable Range:

Previously established in k180186.

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| Analyte | Measurement Range |
| --- | --- |
| Hct (%) | 12 – 70 |
| sO2(%) | 30 – 100 |
| tHb (g/dL) | 5.0 – 25.0 |
| O2Hb (%) | 1.8 – 100 |
| COHb (%) | 0.3 – 60 |
| MetHb (%) | 0.3 – 60 |
| HHb (%) | 0.4 – 40 |

5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):

Previously established in k180186.

6. Detection Limit:

Previously established in k180186.

7. Assay Cut-Off:

Not applicable.

## B Comparison Studies:

1. Method Comparison with Predicate Device:

The accuracy performance of the Stat Profile® Prime Plus Analyzer System for Hct, sO₂, tHb, O₂Hb, COHb, MetHb, and HHb was established with a method comparison study by assessing agreement with the predicate device. The method comparison studies were conducted at three POC sites: a Cardiothoracic Intensive Care Unit, an Emergency Department, and a Respiratory Therapy Lab. Samples of lithium heparinized arterial and venous whole blood were analyzed in singlicate using three Stat Profile® Prime Plus analyzers (one at each site). Across all sites, specimen handling and analysis was performed by 65 POC operators over a period of 20 testing days. In order to cover the claimed measuring range for each analyte, less than 10% of samples for each analyte were altered. The results obtained by POC operators were compared to the results obtained by trained healthcare professionals from the same whole blood specimens testing with the predicate device. Each of the three sites produced similar method comparison data. Linear regression analysis for venous and arterial whole blood results with all POC sites combined is presented in the table below.

| Analyte | N | Range | Slope | Intercept | r |
| --- | --- | --- | --- | --- | --- |
| Hct (%) | 417 | 18 - 69 | 0.999 | 0.132 | 0.993 |
| sO2(%) | 398 | 30 - 100 | 1.008 | -0.966 | 0.998 |
| tHb (g/dL) | 416 | 5 - 24.2 | 1.004 | -0.006 | 0.992 |
| O2Hb (%) | 422 | 7.1 - 98.4 | 1.007 | -0.864 | 0.998 |
| COHb (%) | 425 | 0.3 - 50.5 | 1.002 | -0.001 | 0.999 |
| MetHb (%) | 437 | 0.3 - 56.7 | 1.004 | 0.001 | 0.999 |
| HHb (%) | 322 | 0.4 - 39.7 | 1.012 | 0.088 | 0.996 |

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2. Matrix Comparison:

Not applicable. The only acceptable sample type for this device is lithium heparin whole blood.

C Clinical Studies:

1. Clinical Sensitivity:

Not applicable.

2. Clinical Specificity:

Not applicable.

3. Other Clinical Supportive Data (When 1. And 2. Are Not Applicable):

Not applicable.

D Clinical Cut-Off:

Not applicable.

E Expected Values/Reference Range:

Reference ranges for Hct, sO₂, tHb, O₂Hb, COHb, MetHb, and HHb on the Stat Profile® Prime Plus Analyzer System are cited from the literature:

| Analyte | Reference ranges |
| --- | --- |
| Hct | Male: 39 – 49%
Female: 35 – 45% |
| sO₂ (Arterial Whole Blood) | 95 – 98% |
| tHb | Male: 14.0 – 17.8 g/dL
Female: 12.0 – 15.6 g/dL |
| O₂Hb (Arterial Whole Blood) | 94 – 97% |
| COHb (Nonsmoking) | 0.0 – 1.5% |
| MetHb | 0.0 – 1.5% |
| HHb | 0.0 – 5.0% |

References:

Statland, Bernard, Clinical Decision Levels for Lab Tests, Medical Economics Books, 1987.

Burtis, Carl A. and Ashwood, Edward R., ed. 1994. Tietz Textbook of Clinical Chemistry, W. B. Saunders Co. Philadelphia, PA.

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Williams, W.J., Beutler, E., Ersley, A.J., and Rundles, R.W., Hematology, Second Edition. McGraw-Hill Co, 1977.

Zijlstra, W.G. and van Kampem, E.J., “Spectrophotometry of Hemoglobin and Hemoglobin Derivatives,” Advances in Clinical Chemistry, Vol. 23: pp 199-257. 1983.

Kost, G.T., “The Significance of Ionized Calcium in Cardiac and Critical Care,” Arch. Pathol. Lab Med. Vol. 117: pp 890-896. 1993.

Tietz, Norbert W., ed. 1983. Clinical Guide to Laboratory Tests, W. B. Saunders Co., Philadelphia, PA.

## VIII Proposed Labeling:

The labeling supports the finding of substantial equivalence for this device.

## IX Conclusion:

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

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