ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT
Device Facts
| Record ID | K123953 |
|---|---|
| Device Name | ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT |
| Applicant | Alfa Wassermann Diagnostic Technologies, Inc. |
| Product Code | KHS · Clinical Chemistry |
| Decision Date | May 2, 2013 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1160 |
| Device Class | Class 2 |
Intended Use
The ACE Carbon Dioxide (CO2-LC) Reagent is intended for the quantitative determination of carbon dioxide concentration in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance. This test is intended for use in clinical laboratories and physician office laboratories. For in vitro diagnostic use only. The ACE Direct Bilirubin Reagent is intended for the quantitative determination of direct bilirubin concentration in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic, hematological and metabolic disorders, including hepatitis and gall bladder block. This test is intended for use in clinical laboratories and physician office laboratories. For in vitro diagnostic use only. The ACE Total Bilirubin Reagent is intended for the quantitative determination of total bilirubin concentration in serum and lithium heparin plasma using the ACE, ACE Alera and ACE Axcel Clinical Chemistry System. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells is used in the diagnosis and treatment of liver, hemolytic, hematological and metabolic disorders, including hepatitis and gall bladder block. This test is intended for use in clinical laboratories and physician office laboratories. For in vitro diagnostic use only. The ACE Magnesium Reagent is intended for the quantitative determination of magnesium in serum and lithium heparin plasma using the ACE, ACE Alera and ACE Axcel Clinical Chemistry Systems. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium). This test is intended for use in clinical laboratories and physician office laboratories. For in vitro diagnostic use only.
Device Story
Reagents for quantitative photometric analysis of CO2, direct bilirubin, total bilirubin, and magnesium; used on ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Input: serum or lithium heparin plasma samples. Operation: CO2 uses coupled enzymatic reaction (PEPC/MD) measuring absorbance decrease at 408 nm; Bilirubin assays use diazotized sulfanilic acid forming azobilirubin measured at 554 nm; Magnesium uses xylidyl blue-1 in alkaline medium forming red complex. Output: quantitative concentration values. Used in clinical labs/POLs by trained operators. Results assist clinicians in diagnosing acid-base imbalances, liver/metabolic disorders, and magnesium level abnormalities.
Clinical Evidence
Bench testing only. Precision studies (within-run and total) performed on ACE, ACE Alera, and ACE Axcel systems across multiple concentrations. Matrix comparison studies (serum vs. plasma) showed high correlation (r > 0.98) and slope near 1.0. Linearity and interference studies confirmed performance within specified ranges. Point-of-care (POL) precision and method comparison studies at 3 sites confirmed comparability to in-house results.
Technological Characteristics
Photometric clinical chemistry reagents. CO2: enzymatic (PEPC/MD). Bilirubin: diazo method. Magnesium: xylidyl blue-1 colorimetric. Form factor: liquid ready-to-use or kit-based reagents. Analyzers: ACE, ACE Alera, ACE Axcel. Traceability: NIST SRM 351 (CO2), 916 (Total Bili), 909 (Mg).
Indications for Use
Indicated for quantitative determination of CO2, direct bilirubin, total bilirubin, and magnesium in serum and lithium heparin plasma. Used for diagnosis/treatment of acid-base balance disorders, liver, hemolytic, hematological, metabolic disorders (hepatitis, gall bladder block), hypomagnesemia, and hypermagnesemia. Intended for clinical and physician office laboratories.
Regulatory Classification
Identification
A bicarbonate/carbon dioxide test system is a device intended to measure bicarbonate/carbon dioxide in plasma, serum, and whole blood. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.
Predicate Devices
- Alfa Wassermann ACE Carbon Dioxide (CO2-LC) Reagent, ACE Direct Bilirubin Reagent, ACE Total Bilirubin Reagent, and ACE Magnesium Reagent (k931786)
Related Devices
- K113435 — ACE CARBON DIOXIDE(CO2-LC) REAGENT, ACE DIRECT BILIRUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT · Alfa Wassermann · Jul 2, 2012
- K080810 — EASYRA BILIRUBIN DIRECT AND TOTAL REAGENT, PHOSPHORUS INORGANIC REAGENT AND IRON AND MAGNESIUM REAGENT · Medica Corp. · Dec 10, 2008
Submission Summary (Full Text)
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. K123953
# 510(k) SUMMARY
·
·
MAY 2 2013
| 510(k) Owner: | Alfa Wassermann Diagnostic Technologies, LLC<br>4 Henderson Drive<br>West Caldwell, NJ 07006 | | |
|------------------------|----------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|--|
| Contact: | Hkatz@AlfaWassermannUS.com<br>Hyman Katz, Ph.D.<br>Phone: 973-852-0158<br>Fax: 973-852-0237 | | |
| Date Summary Prepared: | April 25, 2013 | | |
| Device: | Trade Name: | ACE Carbon Dioxide (CO2-LC) Reagent | |
| | Classification: | Class 2 | |
| | Common/Classification Name: | Enzymatic, Carbon-Dioxide<br>(21 C. F.R. § 862.1160)<br>Product Code KHS | |
| | Trade Name: | ACE Direct Bilirubin Reagent | |
| | Classification: | Class 2 | |
| | Common/Classification Name: | Diazo Colorimetry, Bilirubin<br>(21 C. F.R. § 862.1110)<br>Product Code CIG | |
| | Trade Name: | ACE Total Bilirubin Reagent | |
| | Classification: | Class 2 | |
| | Common/Classification Name: | Diazo Colorimetry, Bilirubin<br>(21 C. F.R. § 862.1110)<br>Product Code CIG | |
| | Trade Name: | ACE Magnesium Reagent | |
| | Classification: | Class 1, reserved | |
| | Common/Classification Name: | Photometric Method, Magnesium<br>(21 C. F.R. § 862.1495)<br>Product Code JGJ | |
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| Predicate<br>Devices: | Alfa Wassermann ACE Carbon Dioxide (CO2-LC) Reagent, ACE Direct Bilirubin<br>Reagent, ACE Total Bilirubin Reagent, and ACE Magnesium Reagent<br>(k931786) | Intended Use: | Indications for Use: |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Descriptions: | In the ACE Carbon Dioxide (CO2-LC) Reagent assay, serum carbon dioxide (in the<br>form of bicarbonate) reacts with phosphoenolpyruvate in the presence of<br>phosphoenolpyruvate carboxylase and magnesium to yield oxaloacetic acid and<br>phosphate. In the presence of malate dehydrogenase, the reduced cofactor is oxidized by<br>oxaloacetic acid. The reduced cofactor absorbs strongly at 408 nm whereas its oxidized<br>form does not. The rate of decrease in absorbance, monitored bichromatically at 408<br>nm/692 nm, is proportional to the carbon dioxide content of the sample.<br><br>In the ACE Direct Bilirubin Reagent assay, sodium nitrite added to sulfanilic acid forms<br>diazotized sulfanilic acid. Bilirubin glucuronide in serum reacts with diazotized<br>sulfanilic acid to form azobilirubin, which absorbs strongly at 554 nm. The increase in<br>absorbance, measured bichromatically at 554 nm/692 nm, one minute after sample addi-<br>tion, is directly proportional to the direct bilirubin concentration.<br><br>In the ACE Total Bilirubin Reagent assay, sodium nitrite, when added to sulfanilic acid,<br>forms diazotized sulfanilic acid. Bilirubin in serum reacts with diazotized sulfanilic acid<br>to form azobilirubin, which absorbs strongly at 554 nm. The inclusion of dimethyl<br>sulfoxide (DMSO) in the reagent as an accelerator causes both direct and indirect<br>bilirubin to react rapidly. The increase in absorbance, measured bichromatically at 554 nm/692 nm, is directly proportional to the total bilirubin concentration in the sample.<br><br>Magnesium ions in serum react with Xylidyl blue-1 in an alkaline medium to produce a<br>red complex which is measured bichromatically at 525 nm/692 nm. The intensity of<br>color produced is directly proportional to the magnesium concentration in the sample.<br>EGTA prevents calcium interference by preferential chelation of calcium present in the<br>sample. A surfactant system is included to remove protein interference. | | The ACE Carbon Dioxide (CO2-LC) Reagent is intended for the quantitative<br>determination of carbon dioxide concentration in <b>serum and lithium heparin plasma</b><br>using the ACE, ACE Alera®, and ACE Axcel Clinical Chemistry Systems.<br>Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of<br>numerous potentially serious disorders associated with changes in body acid-base<br>balance. This test is intended for use in clinical laboratories and physician office<br>laboratories. <i>For in vitro</i> diagnostic use only. |
| | The ACE Direct Bilirubin Reagent is intended for the quantitative determination of<br>direct bilirubin concentration in <b>serum and lithium heparin plasma</b> using the ACE,<br>ACE Alera, and ACE Axcel Clinical Chemistry Systems. Measurements of the levels of<br>bilirubin, an organic compound formed during the normal and abnormal destruction of<br>red blood cells, is used in the diagnosis and treatment of liver, hemolytic, hematological<br>and metabolic disorders, including hepatitis and gall bladder block. This test is intended<br>for use in clinical laboratories and physician office laboratories. <i>For in vitro</i> diagnostic<br>use only | | |
| | The ACE Total Bilirubin Reagent is intended for the quantitative determination of total<br>bilirubin concentration in <b>serum and lithium heparin plasma</b> using the ACE, ACE<br>Alera and ACE Axcel Clinical Chemistry System. Measurements of the levels of<br>bilirubin, an organic compound formed during the normal and abnormal destruction of<br>red blood cells is used in the diagnosis and treatment of liver, hemolytic, hematological<br>and metabolic disorders, including hepatitis and gall bladder block. This test is intended<br>for use in clinical laboratories and physician office laboratories. <i>For in vitro</i> diagnostic<br>use only. | | |
| | The ACE Magnesium Reagent is intended for the quantitative determination of<br>magnesium in <b>serum and lithium heparin plasma</b> using the ACE, ACE Alera and<br>ACE Axcel Clinical Chemistry Systems. Magnesium measurements are used in the<br>diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of<br>magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium).<br>This test is intended for use in clinical laboratories and physician office laboratories. <i>For<br/>in vitro</i> diagnostic use only. | | |
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| Technological<br>Characteristics: | The ACE Carbon Dioxide (CO2-LC) Reagent consists of a single reagent bottle. The<br>reagent contains Phosphoenolpyruvate, nicotinamide adenine dinucleotide, analog,<br>reduced, phosphoenol pyruvate carboxylase and malate dehydrogenase. |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The ACE Direct Bilirubin Reagent is composed of two reagent bottles (Direct Bilirubin<br>Reagent and Sodium Nitrite Reagent). The reagents contain Sulfanilic Acid,<br>hydrochloric acid, and sodium nitrite. |
| | The ACE Total Bilirubin Reagent is composed of two reagent bottles (Total Bilirubin<br>Reagent and Sodium Nitrite Reagent). The reagents contain sulfanilic acid, hydrochloric<br>Acid, DMSO and sodium Nitrite. |
| | The ACE Magnesium Reagent is composed of a single reagent bottle. The reagent<br>contains Xylidyl blue-1 and EGTA. |
. . .
| Device<br>Comparison<br>with Predicate | Comparison of similarities and differences with predicate<br>device<br>ACE Carbon Dioxide (CO2-LC) Reagent | | |
|----------------------------------------|------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|----------------------------------|
| | CO2-LC | Candidate Device | Predicate<br>K9317<br>(ACE CO2 |
| | Intended Use | The ACE Carbon Dioxide (CO2-LC) Reagent is<br>intended for the quantitative determination of carbon<br>dioxide concentration. | Same |
| | Platforms | ACE, ACE Alera®, and ACE Axcel Clinical Chemistry<br>Systems | ACE Clinical<br>Chemistry System |
| | Method | Photometric | Same |
| | Calibration Stability | 7 days | Same |
| | On-Board Stability | 14 days | Same |
| | Sample Type | Serum and lithium heparin plasma | Serum |
| | Sample Volume | 6 µL | Same |
| | Reaction Volume | 156 µL | Same |
| | Expected Values | 23 - 29 mEq/L | Same |
| | Measuring Range | 4 - 50 mEq/L | Same |
| | Sample Stability | Separated from cells, carbon dioxide is stable for 7 | Same |
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| Device<br>Comparison<br>with Predicate | ACE Direct Bilirubin Reagent | | |
|----------------------------------------|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|
| | Direct Bilirubin | Candidate Device | Predicate Device<br>K931786<br>(ACE Direct<br>Bilirubin) |
| | Intended Use/<br>Indications for Use | The ACE Direct Bilirubin Reagent is intended for the<br>quantitative determination of direct bilirubin<br>concentration. | Same |
| | Platforms | ACE, ACE Alera®, and ACE Axcel Clinical<br>Chemistry Systems | ACE Clinical<br>Chemistry System |
| | Method | Photometric | Same |
| | Calibration Stability | 30 days | Same |
| | On-Board Stability | 30 days | Same |
| | Sample Type | Serum and lithium heparin plasma | Serum |
| | Sample Volume | 20 µL | Same |
| | Reaction Volume | 355 µL | Same |
| | Expected Values | <0.2 mg/dL | Same |
| | Measuring Range | 0.1 - 14.0 mg/dL | Same |
| | Sample Stability | Samples must be stored away from sunlight or<br>fluorescent lights because bilirubin is subject to<br>photodegradation. Specimens may be stored at 4-8°C<br>for 7 months or 6 months at -20°C. | Same |
| | Total Bilirubin | ACE Total Bilirubin Reagent<br>Candidate Device | Predicate Device .<br>K931786<br>(ACE Total<br>Bilirubin) |
| | Intended Use/<br>Indications for Use | The ACE Total Bilirubin Reagent is intended for the<br>quantitative determination of total bilirubin<br>concentration. | Same |
| | Platforms | ACE, ACE Alera®, and ACE Axcel Clinical<br>Chemistry Systems | ACE Clinical<br>Chemistry System |
| | Method | Photometric | Same |
| | Calibration Stability | 30 Days | Same |
| | On-Board Stability | 30 Days | Same |
| | Sample Type | Serum and lithium heparin plasma | Serum |
| | Sample Volume | 20 µL | Same |
| | Reaction Volume | 380 µL | Same |
| | Expected Values | 0.3 - 1.2 mg/dL | Same |
| | Measuring Range | 0.2 - 40.0 mg/dL | Same |
| | Sample Stability | Samples must be stored away from sunlight or | Same |
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| Device<br>Comparison<br>with Predicate | Magnesium | Candidate Device | Predicate Device<br>K931786<br>(ACE Magnesium) |
|----------------------------------------|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|
| | Intended Use/<br>Indications for Use | ACE Magnesium Reagent is intended for the<br>quantitative determination of magnesium. | Same |
| | Platforms | ACE, ACE Alera®, and ACE Axcel Clinical<br>Chemistry Systems | ACE Clinical<br>Chemistry System |
| | Method | Photometric | Same |
| | Calibration Stability | 30 Day | Same |
| | On-Board Stability | 30 Days | Same |
| | Sample Type | Serum and lithium heparin plasma | Serum |
| | Sample Volume | 3 µL | Same |
| | Reaction Volume | 488 µL | Same |
| | Expected Values | 1.6 - 2.6 mg/dL | Same |
| | Measuring Range | 0.4 - 6.1 mg/dL | Same |
| | Sample Stability | Serum magnesium is stable for 7 days at 4-8°C and<br>1 year at -20 °C if the serum is separated from the<br>erythrocytes. | Same |
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#### Performance Data:
.
In-House Precision -Serum vs.
Plasma
# Performance data for the Alfa Wassermann ACE Reagents run on the Alfa Wassermann ACE, ACE Alera and ACE Axcel Clinical Chemistry Systems
#### In-House Precision: Serum vs. Plasma - ACE CO2-LC Reagent
| | | | Precision (SD, %CV) | | | | | | | | |
|-----------------|-------------|---------------|---------------------|---------------|---------------|---------------|---------------|---------------|---------------|--|--|
| CO2-LC<br>mEq/L | ACE<br>Mean | Within-Run | Total | Alera<br>Mean | Within-Run | Total | Axcel<br>Mean | Within-Run | Total | | |
| Serum<br>Low | 24.0 | 0.27,<br>1.1% | 1.34,<br>5.6% | 24.6 | 0.61,<br>2.5% | 1.85,<br>7.5% | 23.9 | 0.48,<br>2.0% | 1.56,<br>6.5% | | |
| Serum<br>Mid | 34.1 | 0.72,<br>1.2% | 1.22,<br>3.6% | 35.7 | 0.41,<br>1.2% | 1.17,<br>3.3% | 34.3 | 0.52,<br>1.5% | 1.26,<br>3.7% | | |
| Serum<br>High | 45.6 | 0.57,<br>2.8% | 2.7,<br>3.2% | 47.0 | 0.55,<br>1.2% | 2.7,<br>3.2% | 45.4 | 0.25,<br>0.6% | 1.19,<br>2.6% | | |
| Plasma<br>Low | 22.9 | 0.29,<br>1.3% | 0.86,<br>3.8% | 23.3 | 0.71,<br>3.0% | 1.43,<br>6.1% | 23.1 | 0.29,<br>1.3% | 0.86,<br>3.8% | | |
| Plasma<br>Mid | 33.7 | 0.41,<br>1.2% | 1.85,<br>5.5% | 34.8 | 0.34,<br>1.0% | 1.77,<br>5.1% | 33.8 | 0.24,<br>0.7% | 1.69,<br>5.0% | | |
| Plasma<br>High | 45.6 | 0.46,<br>1.0% | 1.14,<br>2.5% | 46.9 | 0.46,<br>1.0% | 1.10,<br>2.4% | 45.3 | 0.47,<br>1.0% | 1.05,<br>2.3% | | |
#### In-House Precision: Serum vs. Plasma – ACE Direct Bilirubin Reagent
| Direct<br>Bilirubin<br>mg/dL | ACE | | | Alera | | | Axcel | | |
|------------------------------|------|----------------|----------------|-------|----------------|----------------|-------|----------------|----------------|
| | Mean | Within-Run | Total | Mean | Within-Run | Total | Mean | Within-Run | Total |
| Serum<br>Low | 0.2 | 0.04,<br>24.5% | 0.05,<br>30.0% | 0.2 | 0.03,<br>16.0% | 0.04,<br>20.1% | 0.1 | 0.02,<br>12.5% | 0.02,<br>14.0% |
| Serum<br>Mid | 4.7 | 0.04,<br>0.9% | 0.06,<br>1.2% | 4.7 | 0.06,<br>1.4% | 0.10,<br>2.2% | 4.7 | 0.08,<br>1.6% | 0.08,<br>1.6% |
| Serum<br>High | 8.4 | 0.05,<br>0.6% | 0.09,<br>1.1% | 8.3 | 0.06,<br>0.8% | 0.09,<br>1.1% | 8.3 | 0.13,<br>1.5% | 0.14,<br>1.7% |
| Plasma<br>Low | 0.1 | 0.03,<br>26.6% | 0.03,<br>26.6% | 0.1 | 0.03,<br>23.4% | 0.05,<br>35.4% | 0.1 | 0.02, 16.6% | 0.02,<br>19.7% |
| Plasma<br>Mid | 4.8 | 0.04,<br>0.8% | 0.05,<br>1.1% | 4.8 | 0.08,<br>1.7% | 0.13,<br>2.8% | 4.8 | 0.11,<br>2.4% | 0.11,<br>2.4% |
| Plasma<br>High | 8.5 | 0.09,<br>1.1% | 0.14,<br>1.6% | 8.5 | 0.06,<br>0.7% | 0.10,<br>1.1% | 8.5 | 0.16,<br>1.9% | 0.20,<br>2.3% |
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#### In-House Precision: Serum vs. Plasma – ACE Total Bilirubin Reagent
#### Performance Data:
In-House Precision -Serum vs. Plasma
.
| Total<br>Bilirubin<br>mg/dL | ACE<br>Mean | Within-<br>Run | Total | | Alera<br>Mean | Within-<br>Run | Total | | Axcel<br>Mean | Within-<br>Run | Total |
|-----------------------------|-------------|----------------|----------------|--|---------------|----------------|----------------|--|---------------|----------------|----------------|
| Precision (SD, %CV) | | | | | | | | | | | |
| Serum<br>Low | 0.3 | 0.07,<br>21.3% | 0.07,<br>21.3% | | 0.3 | 0.04,<br>11.0% | 0.05,<br>15.7% | | 0.3 | 0.04,<br>13.4% | 0.04,<br>13.9% |
| Serum<br>Mid | 13.3 | 0.13,<br>1.0% | 0.13,<br>1.0% | | 13.0 | 0.14,<br>1.1% | 0.14,<br>1.1% | | 13.3 | 0.13,<br>1.0% | 0.13,<br>1.0% |
| Serum<br>High | 26.1 | 0.18,<br>0.7% | 0.21,<br>0.8% | | 25.5 | 0.12,<br>0.5% | 0.12,<br>0.5% | | 26.1 | 0.11,<br>0.4% | 0.17,<br>0.7% |
| Plasma<br>Low | 0.2 | 0.04,<br>20.3% | 0.05,<br>21.3% | | 0.2 | 0.06,<br>23.7% | 0.07,<br>29.4% | | 0.2 | 0.04,<br>20.6% | 0.05,<br>23.9% |
| Plasma<br>Mid | 13.2 | 0.11,<br>0.8% | 0.12,<br>0.9% | | 13.0 | 0.13,<br>1.0% | 0.14,<br>1.1% | | 13.2 | 0.06,<br>0.5% | 0.07,<br>0.5% |
| Plasma<br>High | 26.2 | 0.15,<br>0.6% | 0.17,<br>0.6% | | 25.6 | 0.12,<br>0.5% | 0.18,<br>0.7% | | 26.1 | 0.13,<br>0.5% | 0.14,<br>0.5% |
# In-House Precision: Serum vs. Plasma -- ACE Magnesium Reagent
| | | | Precision (SD, %CV) | | | | | | |
|--------------------|-------------|----------------|---------------------|---------------|----------------|---------------|---------------|----------------|---------------|
| Magnesium<br>mg/dL | ACE<br>Mean | Within-<br>Run | Total | Alera<br>Mean | Within-<br>Run | Total | Axcel<br>Mean | Within<br>-Run | Total |
| Serum<br>Low | 2.0 | 0.10,<br>5.1% | 0.12,<br>5.9% | 2.1 | 0.06,<br>3.1% | 0.09,<br>4.3% | 1.9 | 0.07,<br>3.6% | 0.08,<br>4.3% |
| Serum<br>Mid | 3.7 | 0.09,<br>2.5% | 0.11,<br>3.0% | 3.8 | 0.06,<br>1.7% | 0.07,<br>1.8% | 3.7 | 0.09,<br>2.6% | 0.09,<br>2.6% |
| Serum<br>High | 5.6 | 0.05,<br>1.0% | 0.10,<br>1.7% | 5.6 | 0.08,<br>1.4% | 0.09,<br>1.6% | 5.5 | 0.08,<br>1.4% | 0.09,<br>1.7% |
| Plasma<br>Low | 1.7 | 0.08,<br>4.7% | 0.11,<br>6.2% | 1.7 | 0.06,<br>3.5% | 0.07,<br>4.1% | 1.7 | 0.04,<br>2.4% | 0.11,<br>6.8% |
| Plasma<br>Mid | 3.5 | 0.09,<br>2.7% | 0.10,<br>2.8% | 3.5 | 0.09,<br>2.4% | 0.09,<br>2.6% | 3.4 | 0.09,<br>2.8% | 0.13,<br>3.7% |
| Plasma<br>High | 5.3 | 0.04,<br>0.9% | 0.10,<br>1.9% | 5.4 | 0.09,<br>1.6% | 0.10,<br>1.8% | 5.3 | 0.05,<br>1.0% | 0.09,<br>1.8% |
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| Performance<br>Data: | | | Performance data for the Alfa Wassermann ACE Reagents run on the |
|-------------------------------------|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| In-House | | | Alfa Wassermann ACE, ACE Alera and ACE Axcel Clinical Chemistry |
| Matrix | | | Systems |
| Comparison -<br>Serum vs.<br>Plasma | | | In-House Matrix Comparison: Serum vs. Plasma – ACE CO2-LC Reagent |
| | System | Range | Results - Serum vs. Plasma |
| | ACE<br>53 pairs | 4.9-47.9 mEq/L | Slope: 1.031<br>Intercept: -1.03<br>Correlation: 0.9922<br>Std. Error Est: 1.13<br>Confidence Interval Slope: 0.995 to 1.067<br>Confidence Interval Intercept: -2.11 to 0.04 |
| | ACE Alera<br>54 pairs | 4.7-48.2 mEq/L | Slope: 1.000<br>Intercept: -0.09<br>Correlation: 0.9955<br>Std. Error Est: 0.86<br>Confidence Interval Slope: 0.974 to 1.027<br>Confidence Interval Intercept: -0.81 to 0.64 |
| | ACE Axcel<br>51 pairs | 5.5-47.9 mEq/L | Slope: 0.988<br>Intercept: -0.35<br>Correlation: 0.9889<br>Std. Error Est: 1.12<br>Confidence Interval Slope: 0.946 to 1.031<br>Confidence Interval Intercept: -1.29 to 0.60 |
| | | | In-House Matrix Comparison: Serum vs. Plasma – ACE Direct Bilirubin Reagent |
| | System | Range | Results - Serum vs. Plasma |
| | ACE<br>102 pairs | 0.1-10.8 mg/dL | Slope: 1.021<br>Intercept: 0.00<br>Correlation: 0.9982<br>Std. Error Est: 0.10<br>Confidence Interval Slope: 1.009 to 1.033<br>Confidence Interval Intercept: -0.02 to 0.03 |
| | ACE Alera<br>101 pairs | 0.1-11.0 mg/dL | Slope: 1.005<br>Intercept: 0.01<br>Correlation: 0.9978<br>Std. Error Est: 0.11<br>Confidence Interval Slope: 0.992 to 1.018<br>Confidence Interval Intercept: -0.02 to 0.03 |
| | ACE Axcel<br>56 pairs | 0.1-13.1 mg/dL | Slope: 1.004<br>Intercept: 0.00<br>Correlation: 0.9983<br>Std. Error Est: 0.16<br>Confidence Interval Slope: 0.988 to 1.020<br>Confidence Interval Intercept: -0.04 to 0.05 |
| System | Range | Results - Serum vs. Plasma | |
| ACE<br>102 pairs | 0.1-37.2 mg/dL | Slope: 1.017<br>Intercept: 0.01<br>Correlation: 0.9996<br>Std. Error Est: 0.15<br>Confidence Interval Slope: 1.011 to 1.022<br>Confidence Interval Intercept: -0.03 to 0.04 | |
| ACE Alera<br>102 pairs | 0.2-36.7 mg/dL | Slope: 1.020<br>Intercept: 0.00<br>Correlation: 0.9993<br>Std. Error Est: 0.20<br>Confidence Interval Slope: 1.012 to 1.028<br>Confidence Interval Intercept: -0.05 to 0.04 | |
| ACE Axcel<br>56 pairs | 0.2-35.5 mg/dL | Slope: 1.008<br>Intercept: 0.00<br>Correlation: 0.9995<br>Std. Error Est: 0.22<br>Confidence Interval Slope: 1.000 to 1.017<br>Confidence Interval Intercept: -0.06 to 0.07 | |
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and the comments of the comments of the comments of
| ACE<br>101 pairs | 1.2-5.8 mg/dL | Correlation: 0.9765<br>Std. Error Est: 0.19<br>Confidence Interval Slope: 0.902 to 0.994<br>Confidence Interval Intercept: -0.02 to 0.18 |
|------------------------|---------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ACE Alera<br>101 pairs | 1.0-5.9 mg/dL | Slope: 0.986<br>Intercept: 0.05<br>Correlation: 0.9817<br>Std. Error Est: 0.15<br>Confidence Interval Slope: 0.948 to 1.024<br>Confidence Interval Intercept: -0.06 to 0.10 |
| ACE Axcel<br>55 pairs | 1.2-5.8 mg/dL | Slope: 0.986<br>Intercept: 0.025<br>Correlation: 0.9892<br>Std. Error Est: 0.125<br>Confidence Interval Slope: 0.947 to 1.026<br>Confidence Interval Intercept: -0.61 to 0.111 |
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| Performance Data:<br>Precision - POL | POL - Precision studies at 3 POC sites for ACE Alera Clinical Chemistry System<br>(ACE system was also tested concurrently and comparable precision was obtained | | | | | | | DBILI | | | ACE Result<br>mg/dL SD, %CV | | | ACE Alera Result<br>mg/dL SD, %CV | | | | |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|------------------|------------------|---------------|------|------------------|------------------|---------------|----------|-----------------------------|--------|------------------|-----------------------------------|-------|------------------|------------------|-------|
| | | CO2_LC | | | ACE Result | | | ACE Alera Result | | | Lab | Sample | Mean | Within-Run | Total | Mean | Within-Run | Total |
| Lab | Sample | Mean | | | mEq/L SD, %CV | Mean | | | mEq/L SD, %CV | In-House | 1 | 1.0 | 0.03 SD<br>2.90% | 0.03 SD<br>2.90% | 1.0 | 0.05 SD<br>5.10% | 0.05 SD<br>5.40% | |
| | | | Within-Run | Total | | | Within-Run | Total | | POL 1 | 1 | 0.9 | 0.04 SD<br>4.20% | 0.05 SD<br>4.90% | 0.9 | 0.04 SD<br>4.80% | 0.05 SD<br>5.40% | |
| In-House | 1 | 21.2 | 0.33 SD<br>1.60% | 0.63 SD<br>3.00% | | 21.1 | 0.43 SD<br>2.00% | 0.81 SD<br>3.90% | | POL 2 | 1 | 0.9 | 0.03 SD<br>3.30% | 0.05 SD<br>5.20% | 0.9 | 0.02 SD<br>2.50% | 0.02 SD<br>2.50% | |
| POL 1 | 1 | 20.3 | 0.68 SD<br>3.30% | 0.88 SD<br>4.30% | | 22.3 | 0.28 SD<br>1.30% | 0.67 SD<br>3.00% | | POL 3 | 1 | 0.9 | 0.03 SD<br>3.50% | 0.03 SD<br>3.50% | 0.9 | 0.00 SD<br>0.00% | 0.00 SD<br>0.00% | |
| POL 2 | 1 | 23 | 0.55 SD<br>2.40% | 1.54 SD<br>6.70% | | 22.4 | 0.59 SD<br>2.60% | 0.84 SD<br>3.80% | | In-House | 2 | 5.0 | 0.05 SD<br>1.00% | 0.07 SD<br>1.30% | 4.9 | 0.07 SD<br>1.50% | 0.09 SD<br>1.90% | |
| POL 3 | 1 | 22.3 | 0.42 SD<br>1.90% | 1.10 SD<br>4.90% | | 24.3 | 0.37 SD<br>1.50% | 1.53 SD<br>6.30% | | POL 1 | 2 | 4.9 | 0.09 SD<br>1.80% | 0.10 SD<br>2.10% | 4.8 | 0.05 SD<br>1.00% | 0.05 SD<br>1.00% | |
| In-House | 2 | 24.2 | 0.46 SD<br>1.90% | 0.66 SD<br>2.70% | | 24.2 | 0.42 SD<br>1.70% | 0.77 SD<br>3.20% | | POL 2 | 2 | 4.8 | 0.07 SD<br>1.50% | 0.12 SD<br>2.50% | 4.8 | 0.07 SD<br>1.50% | 0.08 SD<br>1.70% | |
| POL 1 | 2 | 24.9 | 0.77 SD<br>3.10% | 1.38 SD<br>5.60% | | 25.6 | 0.32 SD<br>1.30% | 0.63 SD<br>2.40% | | POL 3 | 2 | 4.7 | 0.10 SD<br>2.10% | 0.11 SD<br>2.40% | 4.9 | 0.10 SD<br>2.00% | 0.10 SD<br>2.00% | |
| POL 2 | 2 | 26.2 | 0.43 SD<br>1.70% | 1.92 SD<br>7.40% | | 26 | 0.24 SD<br>0.90% | 1.00 SD<br>3.90% | | In-House | 3 | 8.0 | 0.18 SD<br>2.30% | 0.18 SD<br>2.30% | 7.8 | 0.20 SD<br>2.60% | 0.20 SD<br>2.60% | |
| POL 3 | 2 | 25.9 | 0.34 SD<br>1.30% | 1.08 SD<br>4.20% | | 27.8 | 0.29 SD<br>1.10% | 1.60 SD<br>5.80% | | POL 1 | 3 | 7.9 | 0.16 SD<br>2.00% | 0.17 SD<br>2.20% | 7.9 | 0.06 SD<br>0.80% | 0.07 SD<br>0.90% | |
| In-House | 3 | 27.3 | 0.49 SD<br>1.80% | 0.65 SD<br>2.40% | | 27 | 0.43 SD<br>1.60% | 0.83 SD<br>3.10% | | POL 2 | 3 | 7.7 | 0.10 SD<br>1.30% | 0.16 SD<br>2.00% | 7.8 | 0.04 SD<br>0.60% | 0.10 SD<br>1.30% | |
| POL 1 | 3 | 30.4 | 0.73 SD<br>2.40% | 1.75 SD<br>5.80% | | 28.4 | 0.39 SD<br>1.40% | 0.94 SD<br>3.30% | | POL 3 | 3 | 7.7 | 0.09 SD<br>1.20% | 0.12 SD<br>1.50% | 8.0 | 0.08 SD<br>1.00% | 0.08 SD<br>1.10% | |
| POL 2 | 3 | 29.6 | 0.62 SD<br>2.10% | 1.88 SD<br>6.40% | | 29.3 | 0.48 SD<br>1.60% | 0.94 SD<br>3.20% | | | | | | | | | | |
| POL 3 | 3 | 29.5 | 0.26 SD<br>0.90% | 1.08 SD<br>3.60% | | 30.7 | 0.29 SD<br>1.00% | 1.60 SD<br>5.20% | | | | | | | | | | |
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#### Performance Data at POL:
Precision -
POL
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| | | | TBILI | | ACE Result<br>mg/dL SD, %CV | | | ACE Alera Result<br>mg/dL SD, %CV | | |
|------------------------------------------------|--|--|----------|--------|-----------------------------|------------------|------------------|-----------------------------------|------------------|------------------|
| Performance<br>Data at POL:<br>Precision - POL | | | Lab | Sample | Mean | Within-Run | Total | Mean | Within-Run | Total |
| | | | In-House | 1 | 1.2 | 0.04 SD<br>3.40% | 0.04 SD<br>3.70% | 1.2 | 0.05 SD<br>4.20% | 0.05 SD<br>4.50% |
| | | | POL 1 | 1 | 1.2 | 0.07 SD<br>5.50% | 0.07 SD<br>5.80% | 1.2 | 0.04 SD<br>3.20% | 0.04 SD<br>3.70% |
| | | | POL 2 | 1 | 1.1 | 0.05 SD<br>4.00% | 0.07 SD<br>6.40% | 1.2 | 0.06 SD<br>4.90% | 0.06 SD<br>5.00% |
| | | | POL 3 | 1 | 1.1 | 0.04 SD<br>3.40% | 0.05 SD<br>4.40% | 1.1 | 0.05 SD<br>4.80% | 0.06 SD<br>5.20% |
| | | | In-House | 2 | 11.5 | 0.20 SD<br>1.70% | 0.20 SD<br>1.80% | 11.3 | 0.23 SD<br>2.00% | 0.24 SD<br>2.10% |
| | | | POL 1 | 2 | 11.2 | 0.05 SD<br>0.50% | 0.42 SD<br>3.70% | 11.4 | 0.07 SD<br>0.70% | 0.09 SD<br>0.80% |
| | | | POL 2 | 2 | 11.3 | 0.05 SD<br>0.50% | 0.15 SD<br>1.30% | 11.3 | 0.17 SD<br>1.50% | 0.17 SD<br>1.50% |
| | | | POL 3 | 2 | 10.9 | 0.09 SD<br>0.80% | 0.11 SD<br>1.00% | 11.2 | 0.09 SD<br>0.80% | 0.09 SD<br>0.80% |
| | | | In-House | 3 | 20.9 | 0.24 SD<br>1.10% | 0.27 SD<br>1.30% | 20.6 | 0.27 SD<br>1.30% | 0.35 SD<br>1.70% |
| | | | POL 1 | 3 | 20.0 | 0.24 SD<br>1.20% | 0.24 SD<br>1.20% | 20.7 | 0.11 SD<br>0.50% | 0.12 SD<br>0.60% |
| | | | POL 2 | 3 | 20.3 | 0.21 SD<br>1.00% | 0.42 SD<br>2.10% | 20.5 | 0.11 SD<br>0.50% | 0.15 SD<br>0.70% |
| | | | POL 3 | 3 | 19.9 | 0.24 SD<br>1.20% | 0.26 SD<br>1.30% | 20.3 | 0.28 SD<br>1.40% | 0.28 SD<br>1.40% |
| | | | MG | | ACE Result<br>mg/dL SD, %CV | | | ACE Alera Result<br>mg/dL SD, %CV | | |
| | | | Lab | Sample | Mean | Within-Run | Total | Mean | Within-Run | Total |
| | | | In-House | 1 | 1.7 | 0.05 SD<br>3.30% | 0.09 SD<br>5.70% | 1.7 | 0.05 SD<br>3.00% | 0.07 SD<br>4.50% |
| | | | POL 1 | 1 | 1.7 | 0.05 SD<br>3.30% | 0.11 SD<br>6.30% | 1.7 | 0.07 SD<br>4.20% | 0.10 SD<br>5.90% |
| | | | POL 2 | 1 | 1.8 | 0.08 SD<br>4.60% | 0.09 SD<br>5.00% | 1.5 | 0.09 SD<br>6.00% | 0.13 SD<br>8.40% |
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| Performance<br>Data at POL:<br>Precision -<br>POL | | | | | | | | |
|---------------------------------------------------|--------------|---|-----|------------------|------------------|-----|------------------|------------------|
| | In-<br>House | 2 | 3.7 | 0.09 SD<br>2.50% | 0.12 SD<br>3.30% | 3.6 | 0.07 SD<br>2.00% | 0.09 SD<br>2.50% |
| | POL 1 | 2 | 3.7 | 0.05 SD<br>1.30% | 0.11 SD<br>3.00% | 3.8 | 0.11 SD<br>2.80% | 0.13 SD<br>3.60% |
| | POL 2 | 2 | 3.7 | 0.07 SD<br>1.90% | 0.13 SD<br>3.50% | 3.5 | 0.10 SD<br>2.90% | 0.18 SD<br>5.20% |
| | POL 3 | 2 | 3.6 | 0.09 SD<br>2.50% | 0.10 SD<br>2.80% | 3.7 | 0.08 SD<br>2.10% | 0.13 SD<br>3.60% |
| | In-<br>House | 3 | 5.6 | 0.10 SD<br>1.80% | 0.14 SD<br>2.60% | 5.5 | 0.05 SD<br>1.00% | 0.10 SD<br>1.80% |
| | POL 1 | 3 | 5.7 | 0.09 SD<br>1.60% | 0.11 SD<br>1.90% | 5.8 | 0.08 SD<br>1.40% | 0.12 SD<br>2.10% |
| | POL 2 | 3 | 5.6 | 0.09 SD<br>1.60% | 0.17 SD<br>3.10% | 5.4 | 0.10 SD<br>1.90% | 0.26 SD<br>4.80% |
| | POL 3 | 3 | 5.5 | 0.06 SD<br>1.10% | 0.08 SD<br>1.40% | 5.5 | 0.05 SD<br>0.90% | 0.09 SD<br>1.60% |
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## Performance Data: Method
# POL – Method Comparison for ACE Clinical Chemistry System
Comparison -POL on ACE
| Reagent | Statistic | In-House ACE (x) vs. POL 1 ACE (y) | In-House ACE (x) vs. POL 2 ACE (y) | In-House ACE (x) vs. POL 3 ACE (y) |
|---------------------|-----------------|------------------------------------|------------------------------------|------------------------------------|
| CO2-LC | n | 46 | 45 | 45 |
| | Range | 3.6 to 42.5 | 3.6 to 46.2 | 3.6 to 46.2 |
| | Regression | $y = 0.963x - 0.71$ | $y = 0.976x + 1.29$ | $y = 0.984x + 0.42$ |
| | Correlation | 0.9710 | 0.9530 | 0.9908 |
| | Std. Error Est. | 1.38 | 2.10 | 0.94 |
| | CI Slope | 0.893 to 1.034 | 0.884 to 1.069 | 0.943 to 1.025 |
| | CI Intercept | -2.34 to 0.92 | -0.91 to 3.49 | -0.56 to 1.40 |
| Direct<br>Bilirubin | n | 49 | 49 | 49 |
| | Range | 0.1 to 12.4 | 0.1 to 12.4 | 0.1 to 12.4 |
| | Regression | $y = 1.022x + 0.04$ | $y = 1.003x + 0.11$ | $y = 1.012x + 0.06$ |
| | Correlation | 0.9986 | 0.9985 | 0.9984 |
| | Std. Error Est. | 0.14 | 0.14 | 0.14 |
| | CI Slope | 1.006 to 1.038 | 0.987 to 1.019 | 0.995 to 1.029 |
| | CI Intercept | 0.00 to 0.08 | 0.07 to 0.15 | 0.02 to 0.11 |
| Total<br>Bilirubin | n | 48 | 50 | 49 |
| | Range | 0.2 to 39.3 | 0.2 to 39.3 | 0.2 to 39.3 |
| | Regression | $y = 0.979x + 0.00$ | $y = 1.000x + 0.04$ | $y = 1.000x + 0.01$ |
| | Correlation | 0.9995 | 0.9998 | 0.9998 |
| | Std. Error Est. | 0.27 | 0.18 | 0.17 |
| | CI Slope | 0.970 to 0.989 | 0.994 to 1.006 | 0.994 to 1.006 |
| | CI Intercept | -0.08 to 0.08 | -0.01 to 0.09 | -0.05 to 0.06 |
| Magnesium | n | 51 | 52 | 51 |
| | Range | 0.6 to 6.1 | 0.6 to 6.1 | 0.6 to 6.1 |
| | Regression | $y = 0.970x + 0.12$ | $y = 0.975x + 0.16$ | $y = 1.026x - 0.04$ |
| | Correlation | 0.9902 | 0.9927 | 0.9925 |
| | Std. Error Est. | 0.13 | 0.11 | 0.12 |
| | CI Slope | 0.931 to 1.009 | 0.941 to 1.008 | 0.989 to 1.062 |
| | CI Intercept | 0.03 to 0.21 | 0.08 to 0.23 | -0.13 to 0.04 |
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| | POL – Method Comparison (performed at POC sites) for ACE Alera Clinical<br>Chemistry System against the predicate device tested in-house | | | |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|-----------------------------------------|-----------------------------------------|
| Reagent | Statistic | In-House ACE (x) vs.<br>POL 1 Alera (y) | In-House ACE (x) vs.<br>POL 2 Alera (y) | In-House ACE (x) vs.<br>POL 3 Alera (y) |
| CO2-LC | n | 45 | 45 | 46 |
| | Range | 2.0 to 46.0 | 2.0 to 46.0 | 2.0 to 46.0 |
| | Regression | $y = 0.984x + 0.15$ | $y = 0.972x + 0.57$ | $y = 0.987x + 0.10$ |
| | Correlation | 0.9903 | 0.9767 | 0.9790 |
| | Std. Error Est. | 0.95 | 1.45 | 1.38 |
| | CI Slope | 0.941 to 1.026 | 0.908 to 1.037 | 0.926 to 1.049 |
| | CI Intercept | -0.81 to 1.12 | -0.90 to 2.05 | -1.30 to 1.50 |
| Direct<br>Bilirubin | n | 51 | 51 | 51 |
| | Range | 0.1 to 12.4 | 0.1 to 12.4 | 0.1 to 12.4 |
| | Regression | $y = 0.995x + 0.09$ | $y = 0.969x + 0.11$ | $y = 0.991x + 0.10$ |
| | Correlation | 0.9991 | 0.9984 | 0.9990 |
| | Std. Error Est. | 0.10 | 0.14 | 0.11 |
| | CI Slope | 0.983 to 1.007 | 0.953 to 0.985 | 0.979 to 1.004 |
| | CI Intercept | 0.05 to 0.12 | 0.07 to 0.15 | 0.06 to 0.13 |
| Total Bilirubin | n | 50 | 50 | 50 |
| | Range | 0.2 to 39.4 | 0.2 to 39.4 | 0.2 to 39.4 |
| | Regression | $y = 1.020x + 0.02$ | $y = 0.957x + 0.07$ | $y = 0.981x + 0.01$ |
| | Correlation | 0.9998 | 0.9991 | 0.9998 |
| | Std. Error Est. | 0.18 | 0.34 | 0.16 |
| | CI Slope | 1.013 to 1.026 | 0.945 to 0.968 | 0.976 to 0.987 |
| | CI Intercept | -0.03 to 0.08 | -0.03 to 0.17 | -0.04 to 0.06 |
| Magnesium | n | 50 | 50 | 50 |
| | Range | 0.7 to 5.9 | 0.7 to 5.9 | 0.7 to 5.9 |
| | Regression | $y = 1.010x + 0.00$ | $y = 1.004x - 0.11$ | $y = 0.990x - 0.07$ |
| | Correlat…
