ACE ALBUMIN REAGENT, ACE TOTAL PROTEIN REAGENT, ACE CALCIUM-ARSENAZO REAGENT AND ACE PHOSPHORUS REAGENT
Device Facts
| Record ID | K131488 |
|---|---|
| Device Name | ACE ALBUMIN REAGENT, ACE TOTAL PROTEIN REAGENT, ACE CALCIUM-ARSENAZO REAGENT AND ACE PHOSPHORUS REAGENT |
| Applicant | Alfa Wassermann Diagnostics Technologies, LLC |
| Product Code | CIX · Clinical Chemistry |
| Decision Date | Aug 19, 2013 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1035 |
| Device Class | Class 2 |
Intended Use
ACE Albumin Reagent is intended for the quantitative determination of albumin concentration in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. ACE Total Protein Reagent is intended for the quantitative determination of total protein concentration in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Total protein measurements are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. ACE Calcium-Arsenazo Reagent is intended for the quantitative determination of calcium concentration in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. ACE Inorganic Phosphorus U.V. Reagent is intended for the quantitative determination of inorganic phosphorus concentration in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Measurements of inorganic phosphorus are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases and vitamin D imbalance. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
Device Story
Reagent system for clinical chemistry analyzers (ACE, ACE Alera, ACE Axcel). Inputs: serum or lithium heparin plasma samples. Principle: photometric colorimetric assays (Albumin: Bromcresol green; Total Protein: Biuret; Calcium: Arsenazo III; Phosphorus: Phosphomolybdate). Device measures absorbance at specific wavelengths (bichromatic) to determine analyte concentration proportional to color intensity. Used in clinical/physician office labs by trained personnel. Output: quantitative concentration values used by clinicians to diagnose/monitor liver, kidney, bone, and metabolic diseases. Benefits: rapid, automated diagnostic testing for patient management.
Clinical Evidence
Bench testing only. Performance evaluated via in-house precision (within-run and total SD/%CV) and matrix comparison (serum vs. plasma) across ACE, ACE Alera, and ACE Axcel systems. Matrix comparison studies (n=48-102 pairs per reagent/system) showed high correlation (r=0.9798-0.9950) and slopes near 1.0. Linearity and detection limits (LoB, LoD, LoQ) established for ACE Alera. Interference testing confirmed no significant impact from icterus, hemolysis, lipemia, or ascorbic acid at specified concentrations.
Technological Characteristics
Photometric reagent kits. Albumin: Bromcresol green/acetate buffer. Total Protein: Copper sulfate, sodium potassium tartrate, potassium iodide, sodium hydroxide. Calcium: Arsenazo III. Phosphorus: Ammonium molybdate, sulfuric acid. Analyzers use bichromatic measurement at specific wavelengths (e.g., 629/692 nm for Albumin). Standalone reagent bottles for use on automated clinical chemistry systems.
Indications for Use
Indicated for quantitative determination of albumin, total protein, calcium, and inorganic phosphorus in serum and lithium heparin plasma for patients requiring diagnostic assessment of liver, kidney, bone, metabolic, or nutritional disorders. Intended for use in clinical or physician office laboratories.
Regulatory Classification
Identification
An albumin test system is a device intended to measure the albumin concentration in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.
Predicate Devices
- Alfa Wassermann ACE and ACE Axcel Clinical Chemistry Systems and ACE Reagents (K930104, K113253, K113374)
Related Devices
- K113374 — ACE ALBUMIN REAGENT ACE TOTAL PROTEIN REAGENT ACE CALCIUM-ARSENAZO REAGENT ACE PHOSPHORUS U.V. REAGENT · Alfa Wassermann Diagnostic Technologies, Inc. · Jul 13, 2012
- K123322 — ACE BUN/UREA REAGENT, ACE CREATININE REAGENT, ACE URIC ACID REAGENT, ACE CK REAGENT · Alfa Wassermann Diagnostics Technologies, LLC · May 21, 2013
- K060434 — ABX PENTRA ALBUMIN CP, ABX PENTRA MICRO-ALBUMIN CP, ABX PENTRA TOTAL PROTEIN CP, ABX PENTRA MULTICAL · Horiba Abx · Jun 5, 2007
- K200898 — Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Urea Nitrogen, Medicon Hellas Glucose, Medicon Hellas Total Bilirubin, Medicon Hellas Direct Bilirubin · Medicon Hellas S.A · Sep 21, 2021
Submission Summary (Full Text)
{0}------------------------------------------------
K131488
| 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 | | AUG 1 9 2013 |
| Date Summary Prepared: | July 12, 2013 | | |
| Device: | Trade Name: | ACE Albumin Reagent | |
| | Classification: | Class 2 | |
| | Common/Classification Name: | Bromcresol Green Dye-Binding, Albumin<br>(21 C.F.R. § 862.1035)<br>Product Code CIX | |
| | Trade Name: | ACE Total Protein Reagent | |
| | Classification: | Class 2 | |
| | Common/Classification Name: | Biuret (Colorimetric), Total Protein<br>(21 C.F.R. § 862.1635)<br>Product Code CEK | |
| | Trade Name: | ACE Calcium-Arsenazo Reagent | |
| | Classification: | Class 2 | |
| | Common/Classification Name: | Azo Dye, Calcium<br>(21 C.F.R. § 862.1445)<br>Product Code CJY | |
| | Trade Name: | ACE Inorganic Phosphorus U.V. Reagent | |
| | Classification: | Class 1 | |
| | Common/Classification Name: | Phosphomolybdate (Colorimetric), Inorganic<br>Phosphorus<br>(21 C.F.R. § 862.1580)<br>Product Code CEO | |
| Predicate Devices: | Manufacturer for reagent system predicates:<br>Alfa Wassermann ACE and ACE Axcel Clinical Chemistry Systems and ACE<br>Reagents (K930104, K113253, K113374) | | |
{1}------------------------------------------------
| Device<br>Descriptions: | In the ACE Albumin Reagent assay, Bromcresol green binds specifically to albumin to<br>form a green colored complex, which is measured bichromatically at 629 nm/692 nm.<br>The intensity of color produced is directly proportional to the albumin concentration in<br>the sample.<br><br>In the ACE Total Protein Reagent assay, cupric ions react with the peptide bonds of<br>proteins under alkaline conditions to form a violet colored complex, which is measured<br>bichromatically at 544 nm/692 nm. The intensity of color produced is directly<br>proportional to the total protein concentration in the sample.<br><br>In the ACE Calcium-Arsenazo Reagent assay, calcium reacts with Arsenazo III in an<br>acidic solution to form a blue-purple colored complex, which is measured<br>bichromatically at 647 nm/692 nm. The intensity of color produced is directly<br>proportional to the calcium concentration in the sample.<br><br>In the ACE Inorganic Phosphorus U.V. Reagent assay, under acidic conditions,<br>inorganic phosphorus in serum reacts with ammonium molybdate to form an unreduced<br>phosphomolybdate complex, which absorbs strongly at 340 nm. The increase in<br>absorbance, measured bichromatically at 340 nm/378 nm, is directly proportional to the<br>amount of phosphorus in the sample. |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | Indications for Use:<br><br>ACE Albumin Reagent is intended for the quantitative determination of albumin<br>concentration in serum and lithium heparin plasma using the ACE, ACE Alera, and<br>ACE Axcel Clinical Chemistry Systems. Albumin measurements are used in the<br>diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.<br>This test is intended for use in clinical laboratories or physician office laboratories. For<br><i>in vitro</i> diagnostic use only.<br><br>ACE Total Protein Reagent is intended for the quantitative determination of total<br>protein concentration in serum and lithium heparin plasma using the ACE, ACE Alera,<br>and ACE Axcel Clinical Chemistry Systems. Total protein measurements are used in<br>the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone<br>marrow as well as other metabolic or nutritional disorders. This test is intended for use<br>in clinical laboratories or physician office laboratories. For <i>in vitro</i> diagnostic use only.<br><br>ACE Calcium-Arsenazo Reagent is intended for the quantitative determination of<br>calcium concentration in serum and lithium heparin plasma using the ACE, ACE Alera,<br>and ACE Axcel Clinical Chemistry Systems. Calcium measurements are used in the<br>diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal<br>disease and tetany (intermittent muscular contractions or spasms). This test is intended<br>for use in clinical laboratories or physician office laboratories. For <i>in vitro</i> diagnostic<br>use only. |
| | ACE Inorganic Phosphorus U.V. Reagent is intended for the quantitative determination<br>of inorganic phosphorus concentration in serum and lithium heparin plasma using the<br>ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Measurements of<br>inorganic phosphorus are used in the diagnosis and treatment of various disorders.<br>including parathyroid gland and kidney diseases and vitamin D imbalance. This test is<br>intended for use in clinical laboratories or physician office laboratories. For in vitro<br>diagnostic use only. |
| Technological<br>Characteristics: | ACE Albumin Reagent consists of a single reagent bottle. The reagent contains<br>Bromcresol green and acetate buffer. |
| | ACE Total Protein Reagent consists of a single reagent bottle. The reagent contains<br>copper sulfate, sodium potassium tartrate, potassium iodide and sodium hydroxide. |
| | ACE Calcium-Arsenazo Reagent consists of a single reagent bottle. The Reagent<br>contains Arsenazo III. |
| | ACE Inorganic Phosphorus U.V. Reagent consists of a single reagent bottle. The<br>reagent contains ammonium molybdate and sulfuric acid. |
.
{2}------------------------------------------------
·
{3}------------------------------------------------
| | Comparison of similarities and differences with predicate device | | |
|----------------------------------------|------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|-----------------------------------------------------------|
| Device Comparison<br>with Predicate | ACE Albumin Reagent | | |
| ALB | Candidate Device | Predicate Device<br>K930104<br>(ACE ALB) | |
| Intended Use/<br>Indications for Use | The ACE Albumin Reagent is intended<br>for the quantitative determination of<br>albumin concentration. | Same | |
| Platforms | ACE, ACE Alera®, and ACE Axcel<br>Clinical Chemistry Systems | ACE Clinical Chemistry System | |
| Method | Photometric | Same | |
| Calibration<br>Stability | 30 days | Same | |
| On-Board Stability | 30 Days | Same | |
| Sample Type | Serum and lithium heparin plasma | Serum | |
| Sample Volume | 3 µL | Same | |
| Reaction Volume | 463 µL | Same | |
| Expected Values | 3.5 – 5.2 g/dL | Same | |
| Measuring Range | 0.1 – 7.6 g/dL | Same | |
| Sample Stability | Specimen stable at 4°C for up to 72 hours<br>and frozen at -20°C for 6 months or<br>indefinitely at -70°C. | Same | |
| | Calcium-Arsenazo | Candidate Device | Predicate Device<br>K930104<br>(ACE Calcium-Arsenazo) |
| Device<br>Comparison<br>with Predicate | Intended Use/<br>Indications for Use | ACE Calcium-Arsenazo Reagent is<br>intended for the quantitative<br>determination of calcium. | Same |
| | Platforms | ACE, ACE Alera®, and ACE Axcel<br>Clinical Chemistry Systems | ACE Clinical Chemistry System |
| | Method | Photometric | Same |
| | Calibration<br>Stability | 30 Days | Same |
| | On-Board Stability | 30 Days | Same |
| | Sample Type | Serum and lithium heparin plasma | Serum |
| | Sample Volume | 3 µL | Same |
| | Reaction Volume | 318 µL | Same |
| | Expected Values | 8.5 - 10.2 mg/dL | Same |
| | Measuring Range | 0.2 - 16.5 mg/dL | Same |
| | Sample Stability | Specimen stable for 7 days at 20-25°C, 3<br>weeks at 4-8°C, and 8 months at -20°C | Same |
| | | ACE Inorganic Phosphorus U.V. Reagent | |
| | Inorganic<br>Phosphorus | Candidate Device | Predicate Device<br>K930104<br>(ACE Inorganic Phosphorus) |
| | Intended Use/<br>Indications for Use | ACE Inorganic Phosphorus U.V.<br>Reagent is intended for the<br>quantitative determination of | Same |
| | | inorganic phosphorus. | |
| | Platforms | ACE, ACE Alera®, and ACE Axcel<br>Clinical Chemistry Systems | ACE Clinical 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 | 3 µL | Same |
| | Reaction Volume | 218 µL | Same |
| | Expected Values | 2.7 - 4.5 mg/dL | Same |
| | Measuring Range | 0.4-21 mg/dL | Same |
{4}------------------------------------------------
·
{5}------------------------------------------------
## 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 Albumin Reagent | | | | | | | | | | |
|------------------------------------------------------------|---------------------|----------------|------------|---------------|----------------|------------|---------------|----------------|------------|--|
| | | | | | | | | | | |
| | Precision (SD, %CV) | | | | | | | | | |
| Albumin<br>g/dL | ACE<br>Mean | Within-<br>Run | Total | Alera<br>Mean | Within-<br>Run | Total | Axcel<br>Mean | Within-<br>Run | Total | |
| Serum Low | 4.1 | 0.05, 1.3% | 0.07, 1.6% | 4.1 | 0.04, 0.9% | 0.04, 1.1% | 4.1 | 0.02, 0.5% | 0.04, 1.0% | |
| Plasma Low | 3.8 | 0.06, 1.7% | 0.06, 1.7% | 3.7 | 0.03, 0.8% | 0.05, 1.4% | 3.7 | 0.06, 1.6% | 0.06, 1.6% | |
| Serum Mid | 5.4 | 0.08, 1.6% | 0.10, 1.8% | 5.3 | 0.05, 1.0% | 0.06, 1.1% | 5.3 | 0.03, 0.6% | 0.03, 0.6% | |
| Plasma Mid | 5.0 | 0.05, 1.0% | 0.07, 1.4% | 5.0 | 0.08, 1.7% | 0.08, 1.7% | 4.9 | 0.04, 0.9% | 0.05, 1.1% | |
| Serum High | 6.5 | 0.07, 1.1% | 0.11, 1.6% | 6.5 | 0.05, 0.8% | 0.08, 1.3% | 6.4 | 0.06, 1.0% | 0.09, 1.3% | |
| Plasma High | 6.2 | 0.09, 1.5% | 0.10, 1.7% | 6.1 | 0.08, 1.3% | 0.10, 1.6% | 6.1 | 0.05, 0.9% | 0.08, 1.3% | |
#### In-House Precision: Serum vs. Plasma - ACE Total Protein Reagent
| Precision (SD, %CV) | | | | | | | | | |
|--------------------------|-------------|----------------|------------|---------------|----------------|------------|---------------|----------------|------------|
| Total<br>Protein<br>g/dL | ACE<br>Mean | Within-<br>Run | Total | Alera<br>Mean | Within-<br>Run | Total | Axcel<br>Mean | Within-<br>Run | Total |
| Serum Low | 6.7 | 0.06, 1.0% | 0.07, 1.0% | 6.7 | 0.05, 0.7% | 0.05, 0.8% | 6.8 | 0.08, 1.1% | 0.09, 1.3% |
| Plasma Low | 7.2 | 0.06, 0.9% | 0.06, 0.9% | 7.1 | 0.08, 1.1% | 0.09, 1.2% | 7.2 | 0.05, 0.8% | 0.07, 0.9% |
| Serum Mid | 8.4 | 0.11, 1.3% | 0.11, 1.3% | 8.4 | 0.08, 1.0% | 0.08, 1.0% | 8.4 | 0.07, 0.8% | 0.11, 1.4% |
| Plasma Mid | 8.8 | 0.04, 0.5% | 0.06, 0.7% | 8.7 | 0.06, 0.7% | 0.1, 1.2% | 8.8 | 0.07, 0.8% | 0.08, 0.9% |
| Serum High | 10.1 | 0.07, 0.7% | 0.08, 0.8% | 10.0 | 0.07, 0.7% | 0.09, 0.9% | 10.1 | 0.07, 0.7% | 0.09, 0.9% |
| Plasma High | 10.3 | 0.13, 1.3% | 0.14, 1.4% | 10.2 | 0.11, 1.1% | 0.14, 1.3% | 10.4 | 0.08, 0.8% | 0.10, 1.0% |
#### In-House Precision: Serum vs. Plasma - ACE Calcium-Arsenazo Reagent
| Precision (SD, %CV) | | | | | | | | | |
|-------------------------------|-------------|----------------|------------|---------------|----------------|------------|---------------|----------------|------------|
| Calcium-<br>Arsenazo<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 Low | 9.3 | 0.12, 1.3% | 0.25, 2.7% | 9.3 | 0.09, 0.9% | 0.22, 2.4% | 9.3 | 0.08, 0.8% | 0.17, 1.8% |
| Plasma Low | 8.4 | 0.04, 0.5% | 0.2, 2.4% | 8.3 | 0.10, 1.2% | 0.17, 2.0% | 8.3 | 0.08, 0.9% | 0.11, 1.4% |
| Serum Mid | 11.7 | 0.18, 1.6% | 0.2, 1.7% | 11.6 | 0.14, 1.2% | 0.14, 1.2% | 11.6 | 0.1, 0.9% | 0.11, 0.9% |
| Plasma Mid | 10.7 | 0.19, 1.7% | 0.20, 1.9% | 10.7 | 0.13, 1.2% | 0.15, 1.4% | 10.7 | 0.12, 1.2% | 0.13, 1.2% |
| Serum High | 13.9 | 0.20, 1.4% | 0.2, 1.4% | 13.8 | 0.19, 1.4% | 0.19, 1.4% | 13.8 | 0.09, 0.7% | 0.11, 0.8% |
| Plasma High | 13.0 | 0.25, 1.9% | 0.26, 2.0% | 12.9 | 0.13, 1.0% | 0.14, 1.1% | 13.1 | 0.15, 1.2% | 0.18, 1.4% |
{6}------------------------------------------------
| In-House Precision: Serum vs. Plasma - ACE Inorganic Phosphorus Reagent | | | | | | | | | |
|-------------------------------------------------------------------------|-------------|----------------|------------|---------------|----------------|------------|---------------|----------------|------------|
| Precision (SD, %CV) | | | | | | | | | |
| Inorganic<br>Phosphorus<br>U.V.<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 Low | 3.5 | 0.15, 4.4% | 0.17, 5.0% | 3.4 | 0.11, 3.1% | 0.14, 4.0% | 3.5 | 0.11, 3.1% | 0.14, 4.1% |
| Plasma Low | 3.1 | 0.16, 5.1% | 0.18, 5.9% | 3.0 | 0.11, 3.7% | 0.15, 5.0% | 3.1 | 0.15, 5.0% | 0.19, 6.1% |
| Serum Mid | 10.2 | 0.04, 0.3% | 0.05, 0.5% | 9.9 | 0.08, 0.8% | 0.08, 0.8% | 10.2 | 0.04, 0.4% | 0.12, 1.2% |
| Plasma Mid | 9.8 | 0.09, 0.9% | 0.09, 0.9% | 9.6 | 0.07, 0.8% | 0.08, 0.8% | 9.9 | 0.06, 0.6% | 0.12, 1.2% |
| Serum High | 17.0 | 0.26, 1.5% | 0.26, 1.6% | 16.6 | 0.22, 1.3% | 0.22, 1.3% | 17.3 | 0.28, 1.6% | 0.30, 1.7% |
| Plasma High | 16.7 | 0.23, 1.4% | 0.24, 1.4% | 16.3 | 0.24, 1.5% | 0.29, 1.8% | 16.9 | 0.30, 1.8% | 0.32, 1.9% |
.
{7}------------------------------------------------
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 Matrix Comparison: Serum vs. Plasma – ACE Albumin Reagent
| System | Range | Results - Serum vs. Plasma | |
|-----------------------|--------------|--------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|
| ACE<br>55 pairs | 0.3-6.8 g/dL | Slope:<br>Intercept:<br>Correlation:<br>Std. Error Est:<br>Confidence Interval Slope:<br>Confidence Interval Intercept: | 0.991<br>0.03<br>0.9874<br>0.19<br>0.948 to 1.034<br>-0.15 to 0.20 |
| ACE Alera<br>56 pairs | 0.3-6.8 g/dL | Slope:<br>Intercept:<br>Correlation:<br>Std. Error Est:<br>Confidence Interval Slope:<br>Confidence Interval. Intercept: | 1.002<br>-0.01<br>0.9905<br>0.17<br>0.964 to 1.040<br>-0.15 to 0.14 |
| ACE Axcel<br>56 pairs | 0.7-6.7 g/dL | Slope:<br>Intercept:<br>Correlation:<br>Std. Error Est:<br>Confidence Interval Slope:<br>Confidence Interval Intercept: | 0.956<br>0.20<br>0.9850<br>0.20<br>0.911 to 1.001<br>0.04 to 0.37 |
#### In-House Matrix Comparison: Serum vs. Plasma – ACE Total Protein Reagent
| System | Range | Results - Serum vs. Plasma |
|-----------|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ACE | 0.5-12.3 g/dL<br>56 pairs | Slope: 1.001<br>Intercept: 0.12<br>Correlation: 0.9798<br>Std. Error Est: 0.40<br>Confidence Interval Slope: 0.946 to 1.056<br>Confidence Interval Intercept: -0.24 to 0.48 |
| ACE Alera | 0.5-12.0 g/dL<br>56 pairs | Slope: 0.999<br>Intercept: 0.14<br>Correlation: 0.9840<br>Std. Error Est: 0.35<br>Confidence Interval Slope: 0.950 to 1.047<br>Confidence Interval Intercept: -0.18 to 0.46 |
| ACE Axcel | 0.5-13.9 g/dL<br>81 pairs | Slope: 0.994<br>Intercept: 0.34<br>Correlation: 0.9885<br>Std. Error Est: 0.26<br>Confidence Interval Slope: 0.961 to 1.028<br>Confidence Interval Intercept: 0.12 to 0.57 |
{8}------------------------------------------------
Performance Data: In-House
#### Precision -Serum vs.
Plasma
#### In-House Matrix Comparison: Serum vs. Plasma – ACE Calcium-Aresnazo Reagent
| System | Range | Results - Serum vs. Plasma | | |
|-----------------|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ACE<br>56 pairs | 1.0-13.7 mg/dL | Slope: 1.006<br>Intercept: -0.01<br>Correlation: 0.9824<br>Std. Error Est: 0.39<br>Confidence Interval Slope: 0.955 to 1.058<br>Confidence Interval Intercept: -0.46 to 0.45 | | |
| | ACE Alera<br>56 pairs | 1.0-13.7 mg/dL | Slope: 1.008<br>Intercept: -0.06<br>Correlation: 0.9793<br>Std. Error Est: 0.43<br>Confidence Interval Slope: 0.952 to 1.064<br>Confidence Interval Intercept: -0.55 to 0.42 | |
| | | ACE Axcel<br>81 pairs | 0.7-15.0 mg/dL | Slope: 0.978<br>Intercept: 0.33<br>Correlation: 0.9911<br>Std. Error Est: 0.23<br>Confidence Interval Slope: 0.949 to 1.007<br>Confidence Interval Intercept: 0.06 to 0.60 |
#### In-House Matrix Comparison: Serum vs. Plasma - ACE Inorganic Phosphorus Reagent
| System | Range | Results - Serum vs. Plasma |
|------------------------|----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ACE<br>100 pairs | 1.3-19.3 mg/dL | Slope: 1.042<br>Intercept: -0.26<br>Correlation: 0.9927<br>Std. Error Est: 0.33<br>Confidence Interval Slope: 1.017 to 1.067<br>Confidence Interval Intercept: -0.38 to -0.14 |
| ACE Alera<br>102 pairs | 1.3-19.3 mg/dL | Slope: 1.049<br>Intercept: -0.28<br>Correlation: 0.9928<br>Std. Error Est: 0.33<br>Confidence Interval Slope: 1.024 to 1.074<br>Confidence Interval Intercept: -0.40 to -0.16 |
| ACE Axcel<br>56 pairs | 0.5-19.8 mg/dL | Slope: 0.999<br>Intercept: 0.04<br>Correlation: 0.9950<br>Std. Error Est: 0.34<br>Confidence Interval Slope: 0.972 to 1.027<br>Confidence Interval Intercept: -0.12 to 0.20 |
{9}------------------------------------------------
| POL - Precision for ACE and ACE Alera Clinical Chemistry Systems<br>(Note: Refer to previously cleared submission k113374 for ACE Axcel POL data) | | | | | | | | |
|---------------------------------------------------------------------------------------------------------------------------------------------------|----------------|--------|------|----------------------------|--------------|------|----------------------------------|--------------|
| Performance Data:<br>In-House<br>Matrix<br>Comparison –<br>Serum vs.<br>Plasma | Albumin<br>Lab | Sample | Mean | ACE Result<br>g/dL SD, %CV | | Mean | ACE Alera Result<br>g/dL SD, %CV | |
| | | | | Within-Run | Total | | Within-Run | Total |
| | In-House | 1 | 3.5 | 0.05<br>1.4% | 0.07<br>2.0% | 3.5 | 0.02<br>0.6% | 0.04<br>1.1% |
| | POL 1 | 1 | 3.5 | 0.04<br>1.3% | 0.04<br>1.3% | 3.5 | 0.05<br>1.4% | 0.06<br>1.7% |
| | POL 2 | 1 | 3.5 | 0.06<br>1.7% | 0.07<br>2.0% | 3.6 | 0.05<br>1.4% | 0.05<br>1.5% |
| | POL 3 | 1 | 3.5 | 0.08<br>2.3% | 0.08<br>2.4% | 3.5 | 0.05<br>1.6% | 0.05<br>1.6% |
| | In-House | 2 | 5.0 | 0.06<br>1.2% | 0.06<br>1.2% | 5.0 | 0.05<br>1.0% | 0.05<br>1.1% |
| | POL 1 | 2 | 4.9 | 0.06<br>1.2% | 0.07<br>1.4% | 5.0 | 0.08<br>1.7% | 0.09<br>1.9% |
| | POL 2 | 2 | 4.9 | 0.03<br>0.6% | 0.06<br>1.2% | 5.0 | 0.06<br>1.2% | 0.08<br>1.6% |
| | POL 3 | 2 | 4.9 | 0.06<br>1.2% | 0.09<br>1.9% | 4.9 | 0.03<br>0.6% | 0.03<br>0.7% |
| | In-House | 3 | 6.2 | 0.11<br>1.9% | 0.13<br>2.1% | 6.2 | 0.06<br>1.0% | 0.07<br>1.1% |
| | POL 1 | 3 | 6.1 | 0.07<br>1.1% | 0.07<br>1.2% | 6.2 | 0.07<br>1.1% | 0.10<br>1.6% |
| | POL 2 | 3 | 6.1 | 0.10<br>1.6% | 0.12<br>1.9% | 6.2 | 0.06<br>1.0% | 0.07<br>1.1% |
| | POL 3 | 3 | 6.1 | 0.10<br>1.7% | 0.11<br>1.8% | 6.1 | 0.08<br>1.3% | 0.08<br>1.4% |
{10}------------------------------------------------
| | | | | ACE Result | | | ACE Alera Result | | |
|-----------------------------------------------------------------------------------|------------------|----------|--------|------------|--------------|-------|------------------|--------------|-------|
| Performance<br>Data:<br>In-House<br>Matrix<br>Comparison -<br>Serum vs.<br>Plasma | Total<br>Protein | Lab | Sample | Mean | g/dL SD, %CV | | Mean | g/dL SD, %CV | |
| | | | | | Within-Run | Total | | Within-Run | Total |
| | | In-House | 1 | 5.3 | 0.05 | 0.06 | 5.3 | 0.08 | 0.10 |
| | | | | | 0.9% | 1.2% | | 1.5% | 1.8% |
| | | POL 1 | 1 | 5.3 | 0.13 | 0.13 | 5.5 | 0.07 | 0.10 |
| | | | | | 2.5% | 2.5% | | 1.4% | 1.8% |
| | | POL 2 | 1 | 5.3 | 0.08 | 0.16 | 5.2 | 0.07 | 0.15 |
| | | | | | 1.5% | 3.1% | | 1.3% | 2.8% |
| | | POL 3 | 1 | 5.6 | 0.10 | 0.12 | 5.6 | 0.07 | 0.12 |
| | | | | | 1.7% | 2.1% | | 1.4% | 2.2% |
| | | In-House | 2 | 8.3 | 0.10 | 0.12 | 8.3 | 0.10 | 0.11 |
| | | | | | 1.2% | 1.4% | | 1.2% | 1.4% |
| | | POL 1 | 2 | 8.2 | 0.08 | 0.11 | 8.4 | 0.09 | 0.10 |
| | | | | | 1.0% | 1.4% | | 1.1% | 1.2% |
| | | POL 2 | 2 | 8.3 | 0.06 | 0.18 | 8.4 | 0.10 | 0.11 |
| | | | | | 0.7% | 2.1% | | 1.2% | 1.4% |
| | | POL 3 | 2 | 8.6 | 0.04 | 0.10 | 8.2 | 0.09 | 0.14 |
| | | | | | 0.5% | 1.1% | | 1.1% | 1.7% |
| | | In-House | 3 | 11.2 | 0.14 | 0.17 | 11.3 | 0.14 | 0.15 |
| | | | | | 1.3% | 1.5% | | 1.3% | 1.4% |
| | | POL 1 | 3 | 11.2 | 0.14 | 0.17 | 11.3 | 0.14 | 0.14 |
| | | | | | 1.3% | 1.5% | | 1.2% | 1.2% |
| | | POL 2 | 3 | 11.2 | 0.09 | 0.20 | 11.5 | 0.09 | 0.16 |
| | | | | | 0.8% | 1.8% | | 0.8% | 1.4% |
| | | POL 3 | 3 | 11.4 | 0.22 | 0.23 | 11.1 | 0.26 | 0.31 |
| | | | | | 1.9% | 2.0% | | 2.3% | 2.8% |
{11}------------------------------------------------
| | | | | ACE Result | | | ACE Alera Result | |
|--|----------------------|--------|------|-----------------|-----------------|------|------------------|-----------------|
| | Calcium-<br>Arsenazo | | | mg/dL SD, %CV | | | mg/dL SD, %CV | |
| | Lab | Sample | Mean | Within-Run | Total | Mean | Within-Run | Total |
| | In-House | 1 | 7.0 | 0.12 SD<br>1.7 | 0.17 SD<br>2.4 | 6.9 | 0.08 SD<br>1.2% | 0.15 SD<br>2.1% |
| | POL 1 | 1 | 7.0 | 0.14 SD<br>2.0% | 0.15 SD<br>2.1% | 6.9 | 0.07 SD<br>1.0% | 0.19 SD<br>2.7% |
| | POL 2 | 1 | 7.0 | 0.16 SD<br>2.3% | 0.17 SD<br>2.4% | 7.0 | 0.19 SD<br>2.7% | 0.19 SD<br>2.7% |
| | POL 3 | 1 | 7.0 | 0.16 SD<br>2.3% | 0.17 SD<br>2.4% | 7.0 | 0.14 SD<br>1.9% | 0.14 SD<br>1.9% |
| | In-House | 2 | 10.7 | 0.21 SD<br>2.0% | 0.21 SD<br>2.0% | 10.5 | 0.05 SD<br>0.5% | 0.06 SD<br>0.6% |
| | POL 1 | 2 | 10.6 | 0.06 SD<br>0.6% | 0.06 SD<br>0.6% | 10.5 | 0.09 SD<br>0.9% | 0.33 SD<br>3.2% |
| | POL 2 | 2 | 10.5 | 0.12 SD<br>1.2% | 0.15 SD<br>1.5% | 10.6 | 0.21 SD<br>1.9% | 0.22 SD<br>2.1% |
| | POL 3 | 2 | 10.5 | 0.10 SD<br>1.0% | 0.11 SD<br>1.0% | 10.6 | 0.16 SD<br>1.5% | 0.16 SD<br>1.5% |
| | In-House | 3 | 13.6 | 0.11 SD<br>0.8% | 0.26 SD<br>1.9% | 13.5 | 0.17 SD<br>1.3% | 0.20 SD<br>1.5% |
| | POL 1 | 3 | 13.6 | 0.14 SD<br>1.1% | 0.20 SD<br>1.5% | 13.4 | 0.14 SD<br>1.1% | 0.34 SD<br>2.5% |
| | POL 2 | 3 | 13.5 | 0.32 SD<br>2.3% | 0.37 SD<br>2.7% | 13.6 | 0.21 SD<br>1.5% | 0.23 SD<br>1.7% |
| | POL 3 | 3 | 13.6 | 0.16 SD<br>1.2% | 0.17 SD<br>1.2% | 13.6 | 0.14 SD<br>1.0% | 0.18 SD<br>1.3% |
・
:
{12}------------------------------------------------
| Performance Data:<br>Precision - POL | POL - Precision for ACE and ACE Alera Clinical Chemistry Systems | | | | | | |
|--------------------------------------|------------------------------------------------------------------|------|-----------------------------|------------------------|------|-----------------------------|------------------------|
| Inorganic<br>Phosphorus<br>U.V. | | | ACE Result | | | ACE Alera Result | |
| Lab | Sample | Mean | mg/dL SD, %CV<br>Within-Run | mg/dL SD, %CV<br>Total | Mean | mg/dL SD, %CV<br>Within-Run | mg/dL SD, %CV<br>Total |
| In-House | 1 | 2.7 | 0.08 SD<br>3.0% | 0.08 SD<br>3.0% | 2.8 | 0.06 SD<br>2.1% | 0.06 SD<br>2.1% |
| POL 1 | 1 | 2.7 | 0.03 SD<br>1.2% | 0.05 SD<br>1.9% | 2.7 | 0.04 SD<br>1.4% | 0.10 SD<br>3.8% |
| POL 2 | 1 | 2.6 | 0.06 SD<br>2.3% | 0.09 SD<br>3.6% | 2.5 | 0.02 SD<br>0.9% | 0.11 SD<br>4.4% |
| POL 3 | 1 | 2.8 | 0.06 SD<br>2.1% | 0.10 SD<br>3.5% | 2.9 | 0.05 SD<br>1.9% | 0.07 SD<br>2.4% |
| In-House | 2 | 7.0 | 0.07 SD<br>1.0% | 0.09 SD<br>1.3% | 7.1 | 0.07 SD<br>0.9% | 0.09 SD<br>1.3% |
| POL 1 | 2 | 7.0 | 0.04 SD<br>0.6% | 0.07 SD<br>1.1% | 7.1 | 0.07 SD<br>0.9% | 0.18 SD<br>2.5% |
| POL 2 | 2 | 6.7 | 0.08 SD<br>1.2% | 0.14 SD<br>2.1% | 6.7 | 0.07 SD<br>1.1% | 0.22 SD<br>3.2% |
| POL 3 | 2 | 7.2 | 0.04 SD<br>0.6% | 0.07 SD<br>1.0% | 7.4 | 0.10 SD<br>1.4% | 0.13 SD<br>1.7% |
| In-House | 3 | 11.1 | 0.14 SD<br>1.2% | 0.18 SD<br>1.6% | 11.3 | 0.09 SD<br>0.8% | 0.11 SD<br>0.9% |
| POL 1 | 3 | 11.1 | 0.13 SD<br>1.2% | 0.14 SD<br>1.3% | 11.3 | 0.16 SD<br>1.4% | 0.27 SD<br>2.4% |
| POL 2 | 3 | 10.9 | 0.12 SD<br>1.1% | 0.21 SD<br>1.9% | 10.6 | 0.15 SD<br>1.4% | 0.21 SD<br>1.9% |
| POL 3 | 3 | 11.4 | 0.13 SD<br>1.1% | 0.18 SD<br>1.6% | 11.7 | 0.11 SD<br>0.9% | 0.14 SD<br>1.2% |
.
.
{13}------------------------------------------------
| Performance<br>Data:<br>Precision -<br>POL | POL – Method Comparison for ACE Clinical Chemistry System | | | | |
|--------------------------------------------|-----------------------------------------------------------|------------------|------------------------------------------|------------------------------------------|------------------------------------------|
| | Reagent | Statistic | ACE In-House (x) vs.<br>ACE<br>POL 1 (y) | ACE In-House (x) vs.<br>ACE<br>POL 2 (y) | ACE In-House (x) vs.<br>ACE<br>POL 3 (y) |
| | Albumin | n | 50 | 50 | 50 |
| | | Range (g/dL) | 1.0 to 6.4 | 1.0 to 6.4 | 1.0 to 6.4 |
| | | Regression | $y = 0.983x + 0.03$ | $y = 0.992x - 0.01$ | $y = 1.006x - 0.03$ |
| | | Correlation | 0.9934 | 0.9965 | 0.9971 |
| | | Std. Error Est. | 0.10 | 0.08 | 0.07 |
| | | CI Slope | 0.950 to 1.016 | 0.968 to 1.016 | 0.984 to 1.028 |
| | | CI Intercept | -0.11 to 0.17 | -0.11 to 0.09 | -0.12 to 0.06 |
| | Total Protein | n | 51 | 51 | 51 |
| | | Range (g/dL) | 0.9 to 13.6 | 0.9 to 13.6 | 0.9 to 13.6 |
| | | Regression | $y = 1.008x + 0.02$ | $y = 1.007x + 0.06$ | $y = 1.029x + 0.01$ |
| | | Correlation | 0.9957 | 0.9976 | 0.9960 |
| | | Std. Error Est. | 0.15 | 0.11 | 0.15 |
| | | CI Slope | 0.981 to 1.035 | 0.987 to 1.027 | 1.003 to 1.056 |
| | | CI Intercept | -0.17 to 0.22 | -0.08 to 0.20 | -0.18 to 0.20 |
| | Calcium-Arsenazo | n | 50 | 50 | 50 |
| | | Range (mg/dL) | 1.9 to 13.7 | 1.9 to 13.7 | 1.9 to 13.7 |
| | | Regression | $y = 1.004x - 0.07$ | $y = 1.002x - 0.17$ | $y = 0.981x + 0.09$ |
| | | Correlation Std. | 0.9915 | 0.9944 | 0.9951 |
| | | Error Est. CI | 0.26 | 0.21 | 0.19 |
| | | Slope | 0.966 to 1.042 | 0.971 to 1.033 | 0.953 to 1.009 |
| | | CI Intercept | -0.42 to 0.27 | -0.45 to 0.11 | -0.17 to 0.34 |
| | Inorganic<br>Phosphorus<br>U.V. | n | 50 | 48 | 50 |
| | | Range (mg/dL) | 1.0 to 18.4 | 1.0 to 18.4 | 1.0 to 18.4 |
| | | Regression | $y = 0.966x + 0.13$ | $y = 1.007x - 0.10$ | $y = 0.975x + 0.11$ |
| | | Correlation Std. | 0.9991 | 0.9982 | 0.9987 |
| | | Error Est. CI | 0.12 | 0.16 | 0.14 |
| | | Slope | 0.954 to 0.978 | 0.989 to 1.025 | 0.960 to 0.989 |
| | | CI Intercept | 0.07 to 0.19 | -0.18 to -0.01 | 0.04 to 0.19 |
{14}------------------------------------------------
| Performance<br>Data: | POL - Method Comparison for ACE Alera Clinical Chemistry System | | | | |
|----------------------|-----------------------------------------------------------------|------------------|------------------------------------------|------------------------------------------|------------------------------------------|
| Precision -<br>POL | Reagent | Statistic | ACE In-House (x) vs. ACE Alera POL 1 (y) | ACE In-House (x) vs. ACE Alera POL 2 (y) | ACE In-House (x) vs. ACE Alera POL 3 (y) |
| | | n | 50 | 50 | 50 |
| | | Range (g/dL) | 1.0 to 6.4 | 1.0 to 6.4 | 1.0 to 6.4 |
| | | Regression | y= $1.004x - 0.03$ | y= $1.005x - 0.05$ | y = $0.982x + 0.01$ |
| | Albumin | Correlation | 0.9949 | 0.9960 | 0.9967 |
| | | Std. Error Est. | 0.09 | 0.08 | 0.07 |
| | | CI Slope | 0.975 to 1.034 | 0.979 to 1.031 | 0.959 to 1.005 |
| | | Cl Intercept | -0.15 to 0.10 | -0.16 to 0.06 | -0.09 to 0.11 |
| | | n | 51 | 51 | 51 |
| | | Range (g/dL) | 0.9 to 13.6 | 0.9 to 13.6 | 0.9 to 13.6 |
| | | Regression | y= $0.998x + 0.16$ | y = $1.027x - 0.06$ | y = $0.979x + 0.24$ |
| | Total Protein | Correlation | 0.9969 | 0.9962 | 0.9964 |
| | | Std. Error Est. | 0.13 | 0.14 | 0.14 |
| | | CI Slope | 0.976 to 1.020 | 1.002 to 1.053 | 0.955 to 1.003 |
| | | CI Intercept | 0.00 to 0.33 | -0.24 to 0.13 | 0.07 to 0.42 |
| | | n | 50 | 50 | 50 |
| | | Range (mg/dL) | 1.9 to 13.7 | 1.9 to 13.7 | 1.9 to 13.7 |
| | | Regression | y = $0.992x - 0.09$ | y = $1.007x - 0.11$ | y = $1.008x - 0.08$ |
| | Calcium-<br>Arsenazo | Correlation Std. | 0.9904 | 0.9929 | 0.9929 |
| | | Error Est. Cl | 0.27 | 0.23 | 0.23 |
| | | Slope | 0.952 to 1.032 | 0.972 to 1.042 | 0.973 to 1.043 |
| | | CI Intercept | -0.46 to 0.27 | -0.43 to 0.21 | -0.40 to 0.23 |
| | | n | 50 | 50 | 50 |
| | | Range (mg/dL) | 1.0 to 18.4 | 1.0 to 18.4 | 1.0 to 18.4 |
| | Inorganic<br>Phosphorus<br>U.V. | Regression | y = $1.015x + 0.14$ | y = $0.960x + 0.12$ | y = $0.984x + 0.05$ |
| | | Correlation Std. | 0.9992 | 0.9986 | 0.9991 |
| | | Error Est. Cl | 0.12 | 0.14 | 0.12 |
| | | Slope | 1.003 to 1.027 | 0.945 to 0.974 | 0.972 to 0.996 |
| | | Cl Intercept | 0.08 to 0.20 | 0.05 to 0.19 | -0.01 to 0.11 |
{15}------------------------------------------------
# Performance Data:
Method Comparison -POL on ACE
## Performance data for the Alfa Wassermann ACE Reagents run on the Alfa Wassermann ACE Alera Clinical Chemistry Systems
# Detection Limits - ACE Alera Clinical Chemistry System
| ACE Alera | ALB<br>(g/dL) | TP<br>(g/dL) | CA<br>(mg/dL) | PHOS<br>(mg/dL) |
|-----------|---------------|--------------|---------------|-----------------|
| LoB | 0.08 | 0.08 | 0.09 | 0.25 |
| LoD | 0.09 | 0.13 | 0.11 | 0.35 |
| LoQ | 0.09 | 0.20 | 0.23 | 0.35 |
#### Linearity - ACE Alera Clinical Chemistry System
| ACE<br>Reagents | Low Level<br>Tested | Upper Level<br>Tested | Linear to: | Linear Regression<br>Equation |
|-----------------|---------------------|-----------------------|------------|----------------------------------|
| ALB | 0.1 g/dL | 7.6 g/dL | 7.6 g/dL | y = 0.980x + 0.01<br>r2 = 0.9982 |
| TP | 0.2 g/dL | 15.1 g/dL | 15.1 g/dL | y=0.991x + 0.04<br>r2 = 0.9979 |
| CA | 0.3 g/dL | 16.5 mg/dL | 16.5 mg/dL | y=0.992x +0.27<br>r2 = 0.9990 |
| PHOS | 0.2 mg/dL | 21 mg/dL | 21 mg/dL | y=1.001x +0.03<br>r2 = 0.9995 |
{16}------------------------------------------------
### Performance Data:
## ACE Alera
#### Interferences - ACE Alera Clinical Chemistry System
| Interferents<br>on ACE Alera | No Significant Interference at or below: | | | |
|------------------------------|------------------------------------------|------------|------------|------------|
| | ALB | TP | CA | PHOS |
| Icterus | 60 mg/dL | 56.8 mg/dL | 58.8 mg/dL | 11.5 mg/dL |
| Hemolysis | 250 mg/dL | 250 mg/dL | 1000 mg/dL | 250 mg/dL |
| Lipemia | 1000 mg/dL | 929 mg/dL | 1000 mg/dL | 306 mg/dL |
| Ascorbic Acid | 6 mg/dL | 6 mg/dL | 6 mg/dL | 6 mg/dL |
## Precision - ACE Alera Clinical Chemistry System
| on-ACE Alera | | Precision (SD, %CV) | | |
|---------------|------------|---------------------|------------|------------|
| | | Mean | Within-Run | Total |
| ALB<br>g/dL | Serum Low | 2.6 | 0.03, 1.3% | 0.05, 2.0% |
| | Serum Mid | 3.4 | 0.07, 1.9% | 0.09, 2.5% |
|…
