ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON REAGENT, ACE LDH-L REAGENT
Device Facts
| Record ID | K131975 |
|---|---|
| Device Name | ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON REAGENT, ACE LDH-L REAGENT |
| Applicant | Alfa Wassermann Diagnostic Technologies, Inc. |
| Product Code | CFJ · Clinical Chemistry |
| Decision Date | Oct 2, 2013 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1440 |
| Device Class | Class 2 |
Intended Use
The ACE Direct Total Iron-Binding Capacity (TIBC) Reagent is intended for the quantitative determination of total iron-binding capacity in serum using the ACE Alera Clinical Chemistry System. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia. This test is intended for use in clinical laboratories and physician office laboratories. For in vitro diagnostic use only. The ACE Total Iron Reagent is intended for the quantitative determination of iron in serum using the ACE Alera Clinical Chemistry System. Iron (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia, hemochromatosis (a disease associated with widespread deposit in the tissues of two iron-containing pigments, hemosiderin and hemofuscin, and characterized by pigmentation of the skin), and chronic renal disease. This test is intended for use in clinical laboratories and physician office laboratories. For in vitro diagnostic use only. The ACE LDH-L Reagent is intended for the quantitative determination of lactate dehydrogenase activity in serum using the ACE Alera Clinical Chemistry System. Lactate dehydrogenase measurements are used in the diagnosis and treatment of liver diseases such as acute viral hepatitis, cirrhosis, and metastatic carcinoma of the liver, cardiac diseases such as myocardial infarction, and tumors of the lung or kidneys. This test is intended for use in clinical laboratories and physician office laboratories. For in vitro diagnostic use only.
Device Story
Reagents for ACE Alera Clinical Chemistry System; perform quantitative photometric analysis of serum samples. TIBC assay: uses chromazurol B, cetrimide, and ferric chloride; measures absorbance decrease at 647 nm. Iron assay: uses ferrozine; measures violet complex at 554/692 nm. LDH-L assay: enzymatic conversion of L-lactate and NAD to pyruvate and NADH; measures NADH increase at 340 nm. Used in clinical/physician office labs by trained personnel. Output provides analyte concentration/activity levels to assist clinicians in diagnosing anemia, iron disorders, liver/cardiac diseases, and tumors. Benefits include rapid, automated diagnostic testing.
Clinical Evidence
Bench testing only. Precision/reproducibility evaluated per CLSI EP05-A2 (N=76 per level in-house; N=20 per level at 3 POL sites). Linearity evaluated per CLSI EP06-A (r^2 > 0.998). Method comparison to predicates performed per CLSI EP09-A2 (n=48-58 samples per analyte, r^2 > 0.996). Interference testing per CLSI EP07-A2. LoD/LoQ determined per CLSI EP17-A.
Technological Characteristics
Photometric/enzymatic reagents. TIBC: chromazurol B, cetrimide, ferric chloride, sodium bicarbonate. Iron: hydroxylamine hydrochloride, ferrozine, surfactant. LDH-L: L-lactic acid, NAD. Platform: ACE Alera Clinical Chemistry System. Connectivity: standalone instrument. Sterilization: N/A (reagents).
Indications for Use
Indicated for quantitative determination of TIBC, iron, and LDH-L in serum for diagnosis/treatment of anemia, hemochromatosis, chronic renal disease, liver diseases (e.g., hepatitis, cirrhosis), and cardiac diseases (e.g., myocardial infarction). Intended for use in clinical and physician office laboratories.
Regulatory Classification
Identification
A lactate dehydrogenase test system is a device intended to measure the activity of the enzyme lactate dehydrogenase in serum. Lactate dehydrogenase measurements are used in the diagnosis and treatment of liver diseases such as acute viral hepatitis, cirrhosis, and metastatic carcinoma of the liver, cardiac diseases such as myocardial infarction, and tumors of the lung or kidneys.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
Predicate Devices
- Alfa Wassermann ACE Direct TIBC Reagent (K930104)
- ACE Total Iron Reagent (K944911)
- ACE LDH-L Reagent (K931786)
Related Devices
- K030528 — ATAC IRON REAGENT, ATAC TIBC COLUMN KIT AND IRON CALIBRATOR (500 UG/DL) · Clinical Data · Jun 17, 2003
- K972363 — IL TEST IRON · Instrumentation Laboratory CO · Aug 15, 1997
Submission Summary (Full Text)
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K131975
### 510(k) Summary
| 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 | | OCT 0 2 2013 |
| Date Summary Prepared: | September 26, 2013 | | | |
| Device: | Trade Name: | ACE Direct Total Iron-Binding Capacity (TIBC)<br>Reagent | | |
| | Classification: | Class 1 | | |
| | Common/Classification Name: | Direct Total Iron-Binding Capacity (TIBC)<br>(21 C.F.R. § 862.1415)<br>Product Code JMO | | |
| | Trade Name: | ACE Total Iron Reagent | | |
| | Classification: | Class 1 | | |
| | Common/Classification Name: | Photometric Method, Iron (Non-Heme)<br>(21 C.F.R. § 862.1410)<br>Product Code JIY | | |
| | Trade Name: | ACE LDH-L Reagent | | |
| | Classification: | Class 2 | | |
| | Common/Classification Name: | NAD Reduction/NADH Oxidation, Lactate<br>Dehydrogenase<br>(21 C. F.R. § 862.1440)<br>Product Code CFJ | | |
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| Predicate<br>Devices: | Manufacturer for reagent system predicates:<br>Alfa Wassermann ACE Clinical Chemistry System and ACE Reagents (K930104,<br>K944911, K931786) | Intended Use: | Indications for Use: |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Descriptions: | In the ACE Direct Total Iron-Binding Capacity (TIBC) Reagent assay, Direct TIBC<br>Color Reagent, an acidic buffer containing an iron-binding dye and ferric chloride, is<br>added to the serum sample. The low pH of Direct TIBC Color Reagent releases iron from<br>transferrin. The iron then forms a colored complex with the dye. The colored complex at<br>the end of the first step represents both the serum iron and excess iron already present in<br>Direct TIBC Color Reagent. Direct TIBC Buffer, a neutral buffer, is then added, shifting<br>the pH and resulting in a large increase in the affinity of transferrin for iron. The serum<br>transferrin rapidly binds the iron by abstracting it from the dye-iron complex. The<br>observed decrease in absorbance of the colored dye-iron complex is directly proportional<br>to the total iron-binding capacity of the serum sample. The absorbance is measured at<br>647 nm. | | The ACE Direct Total Iron-Binding (TIBC) Reagent is intended for the quantitative<br>determination of total iron-binding capacity in serum using the ACE Alera Clinical<br>Chemistry System. Iron-binding capacity measurements are used in the diagnosis and<br>treatment of anemia. This test is intended for use in clinical laboratories and physician<br>office laboratories. For <i>in vitro</i> diagnostic use only. |
| | In the ACE Total Iron Reagent assay, transferrin-bound iron in serum is released at an<br>acidic pH and reduced from ferric to ferrous ions. These ions react with ferrozine to form<br>a violet colored complex, which is measured bichromatically at 554 nm/692 nm. The<br>intensity of color produced is directly proportional to the serum iron concentration. | | The ACE Total Iron Reagent is intended for the quantitative determination of iron in<br>serum using the ACE Alera Clinical Chemistry System. Iron (non-heme) measurements<br>are used in the diagnosis and treatment of diseases such as iron deficiency anemia,<br>hemochromatosis (a disease associated with widespread deposit in the tissues of two<br>iron-containing pigments, hemosiderin and hemofuscin, and characterized by<br>pigmentation of the skin), and chronic renal disease. This test is intended for use in<br>clinical laboratories and physician office laboratories. For <i>in vitro</i> diagnostic use only. |
| | In the ACE LDH-L Reagent assay, lactate dehydrogenase catalyzes the conversion of L-<br>lactate to pyruvate. Nicotinamide adenine dinucleotide (NAD+) acts as an acceptor for<br>the hydrogen ions released from the L-lactate and is converted to reduced nicotinamide<br>adenine dinucleotide (NADH). NADH absorbs strongly at 340 nm whereas NAD+ does<br>not. Therefore, the rate of conversion of NAD+ to NADH can be determined by<br>monitoring the increase in absorbance bichromatically at 340 nm/647 nm. This rate of<br>conversion from NAD+ to NADH is directly proportional to the lactate dehydrogenase<br>activity in the sample. | | The ACE LDH-L Reagent is intended for the quantitative determination of lactate<br>dehydrogenase activity in serum using the ACE Alera Clinical Chemistry System.<br>Lactate dehydrogenase measurements are used in the diagnosis and treatment of liver<br>diseases such as acute viral hepatitis, cirrhosis, and metastatic carcinoma of the liver,<br>cardiac diseases such as myocardial infarction and tumors of the lung or kidneys. This<br>test is intended for use in clinical laboratories and physician office laboratories. For <i>in<br/>vitro</i> diagnostic use only. |
| Technological<br>Characteristics: | The ACE Direct Total Iron-Binding Capacity (TIBC) Reagent is composed of two<br>reagent bottles (Direct TIBC Color Reagent and Direct TIBC Buffer). The Direct TIBC<br>Color Reagent (R1) contains: Chromazurol B, Cetrimide, ferric chloride and<br>acetate buffer. The Direct TIBC Buffer (R2) contains: sodium bicarbonate buffer. | | |
| | The ACE Total Iron Reagent is composed of two reagent bottles (Buffer and Color<br>Reagent). The Buffer (R1) contains: hydroxylamine hydrochloride,<br>acetate buffer (pH 4.5) and surfactant. The Color Reagent (R2) contains: ferrozine and<br>hydroxylamine hydrochloride. | | |
| | The ACE LDH-L Reagent is composed of two reagent bottles (Substrate and Coenzyme<br>Reagent). The reagents contain L-lactic acid and nicotinamide adenine dinucleotide. | | |
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Device Comparison with Predicate
Comparison of similarities and differences with predicate device
ACE Direct Total Iron-Binding Capacity (TIBC) Reagent
| | ACE Direct TIBC Reagent | Candidate Device | Predicate Device k930104 (ACE Direct TIBC Reagent) |
|-----------------------------------|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use/ Indications for Use | | The ACE Direct Total Iron-Binding Capacity (TIBC) Reagent is intended for the quantitative determination of total iron-binding capacity in serum using the ACE Alera Clinical Chemistry System. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia. This test is intended for use in clinical laboratories and physician office laboratories. For <i>in vitro</i> diagnostic use only. | The ACE Direct Total Iron-Binding Capacity (TIBC) Reagent is intended for the quantitative determination of total iron-binding capacity in serum using the ACE Clinical Chemistry System. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia. This test is intended for use in clinical laboratories. For <i>in vitro</i> diagnostic use only. |
| Method | | Photometric | Same |
| Calibration Stability | | 30 days | Same |
| On Board Stability | | 30 days | Same |
| Sample Type | | Serum | Same |
| Sample Volume | | 16 μL | Same |
| Reaction Volume | | 291 μL | Same |
| Expected values | | 250-425 μg/dL | 250-450 μg/dL |
| Measuring range | | 52-700 μg/dL | From the lowest calibrator concentration to 700 μg/dL |
| Sample Stability | | Separated from cells, serum TIBC is stable for 4 days at 18-26°C and 1 week at 2-8°C. | Same |
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| ACE Total Iron<br>Reagent | Candidate Device | Predicate Device<br>k944911<br>: (ACE Total Iron Reagent) |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended<br>Use/Indications for<br>Use | The ACE Total Iron Reagent is intended<br>for the quantitative determination of iron<br>in serum using the ACE Alera Clinical<br>Chemistry System. Iron (non-heme)<br>measurements are used in the diagnosis<br>and treatment of diseases such as iron<br>deficiency anemia, hemochromatosis (a<br>disease associated with widespread<br>deposit in the tissues of two iron-<br>containing pigments, hemosiderin and<br>hemofuscin, and characterized by<br>pigmentation of the skin), and chronic<br>renal disease. This test is intended for use<br>in clinical laboratories and physician<br>office laboratories. For <i>in vitro</i><br>diagnostic use only. | The ACE Total Iron Reagent<br>is intended for the<br>quantitative determination of<br>iron in serum using the ACE<br>Clinical Chemistry System.<br>Iron (non-heme)<br>measurements are used in the<br>diagnosis and treatment of<br>diseases such as iron<br>deficiency anemia,<br>hemochromatosis (a disease<br>associated with widespread<br>deposit in the tissues of two<br>iron-containing pigments,<br>hemosiderin and hemofuscin<br>and characterized by<br>pigmentation of the skin),<br>and chronic renal disease.<br>This test is intended for use<br>in clinical laboratories. For<br><i>in vitro</i> diagnostic use only. |
| Method | Photometric | Same |
| Calibration Stability | 30 days | Same |
| On Board Stability | 30 days | Same |
| Sample Type | Serum | Same |
| Sample Volume | 50 µL | Same |
| Reaction Volume | 335 µL | Same |
| Expected values | Male: 65-175 µg/dL<br>Female: 50-170 µg/dL | Same |
| Measuring range | 9.15-600 µg/dL | 2-600 µg/dL |
| Sample Stability | Separated from cells, serum iron is stable<br>for 7 days at room temperature (20-25°C) | Separated from cells, serum<br>iron is stable for 4 days at<br>room temperature (15-30°C) |
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| ACE LDH-L Reagent | | |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ACE LDH-L Reagent | Candidate Device | Predicate Device<br>k931786<br>(ACE LDH-L Reagent) |
| Intended<br>Use/Indications<br>for Use | The ACE LDH-L Reagent is<br>intended for the quantitative<br>determination of lactate<br>dehydrogenase activity in serum<br>using the ACE Alera Clinical<br>Chemistry System. Lactate<br>dehydrogenase measurements are<br>used in the diagnosis and<br>treatment of liver diseases such as<br>acute viral hepatitis, cirrhosis, and<br>metastatic carcinoma of the liver,<br>cardiac diseases such as<br>myocardial infarction and tumors<br>of the lung or kidneys. This test is<br>intended for use in clinical<br>laboratories and physician<br>office laboratories. For in vitro<br>diagnostic use only. | The ACE LDH-L Reagent is<br>intended for the quantitative<br>determination of lactate<br>dehydrogenase activity in<br>serum using the ACE Clinical<br>Chemistry System. Lactate<br>dehydrogenase measurements<br>are used in the diagnosis and<br>treatment of liver diseases such<br>as acute viral hepatitis,<br>cirrhosis, and metastatic<br>carcinoma of the liver, cardiac<br>diseases such as myocardial<br>infarction and tumors of the<br>lung or kidneys. This test is<br>intended for use in clinical<br>laboratories. For in vitro<br>diagnostic use only. |
| Method | Photometric | Same |
| Calibration Stability | Not a calibrated test | Same |
| On Board Stability | 30 days | Same |
| Sample Type | Serum | Same |
| Sample Volume | 5 µL | Same |
| Reaction Volume | 170 µL | Same |
| Expected values | 100-190 U/L | Same |
| Measuring range | 18-850 U/L | 17-850 U/L |
| Sample Stability | Separated from cells, LDH activity<br>is stable for 7 days at 20-25°C, 4<br>days at 4-8°C and 6 weeks at -20°C.<br>Loss of activity after freezing has<br>also been noted | Separated from cells, LDH<br>activity is stable for 3 days at<br>both 2-8°C and room<br>temperature. Loss of activity<br>after freezing has also been<br>noted. |
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Reportable Range
## Performance data for the Alfa Wassermann ACE Reagents on the Alfa Wassermann ACE Alera Clinical Chemistry System
## Detection Limits - ACE Alera Clinical Chemistry System
| | TIBC | Iron | LDH-L |
|-----|----------|------------|--------|
| LoB | 11 µg/dL | 0 µg/dL | 11 U/L |
| LoD | 24 µg/dL | 1 µg/dL | 18 U/L |
| LoQ | 52 µg/dL | 9.15 µg/dL | 18 U/L |
#### Linearity - ACE Alera Clinical Chemistry System
| Reagent | Low Level<br>Tested | High Level<br>Tested | Linear to: | Linear Regression<br>equation |
|---------|---------------------|----------------------|------------|----------------------------------|
| TIBC | 34 µg/dL | 740 µg/dL | 700 µg/dL | $y = 1.020x + 3.1$ $r² = 0.9981$ |
| Iron | 6 µg/dL | 666 µg/dL | 600 µg/dL | $y = 1.030x + 1.9$ $r² = 0.9986$ |
| LDH-L | 8 U/L | 895 U/L | 850 U/L | $y = 1.050x - 0.7$ $r² = 0.9981$ |
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| Interferent | No Significant Interference at or below: | TIBC | Iron | LDH-L |
|---------------|------------------------------------------|------------|------------|------------|
| Icterus | | 59 mg/dL | 59 mg/dL | 50 mg/dL |
| Hemolysis | | 188 mg/dL* | 125 mg/dL* | <31 mg/dL* |
| Lipemia | | 1000 mg/dL | 125 mg/dL | 1000 mg/dL |
| Ascorbic Acid | | 3 mg/dL | 6 mg/dL | 6 mg/dL |
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| Performance<br>Data: | Precision - ACE Alera Clinical Chemistry System | | | | |
|-------------------------|-------------------------------------------------|------|------|---------------------|------------|
| Precision -<br>In-House | | | | Precision (SD, %CV) | |
| | ACE Alera | | Mean | Within-Run | Total |
| | TIBC<br>µg/dL | Low | 217 | 4.1, 1.9% | 6.7, 3.1% |
| | | Mid | 270 | 3.7, 1.4% | 7.1, 2.6% |
| | | High | 310 | 5.0, 1.6% | 8.6, 2.8% |
| | Iron<br>µg/dL | Low | 62 | 3.2, 5.2% | 4.6, 7.3% |
| | | Mid | 145 | 2.2, 1.5% | 4.2, 2.9% |
| | | High | 226 | 4.1, 1.8% | 5.0, 2.2% |
| | LDH-<br>U/L | 1 | 77 | 3.8, 4.9% | 4.2, 5.5% |
| | | 2 | 119 | 5.1, 4.3% | 5.2, 4.3% |
| | | 3 | 270 | 4.5, 1.7% | 5.8, 2.1% |
| | | 4 | 651 | 12.6, 1.9% | 13.5, 2.1% |
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Method
.
Comparison -In-House
#### Method Comparison - ACE Alera Clinical Chemistry System
#### In-House ACE (x) vs. In-House ACE Alera (y)
| | TIBC | Iron | LDH-L |
|----------------------------|------------------|-----------------|----------------|
| n | 50 | 48 | 58 |
| Range | 59 to 676 µg/dL | 13 to 549 µg/dL | 20 to 799 U/L |
| Slope | 0.987 | 0.993 | 0.997 |
| Intercept | 3.6 | 0.9 | -3.6 |
| Correlation<br>Coefficient | 0.9960 | 0.9995 | 0.9991 |
| Std. Error | 9.2 | 3.6 | 6.8 |
| CI Slope | 0.962 to 1.013 | 0.984 to 1.003 | 0.985 to 1.008 |
| CI Intercept | -7.2 to 14.4 | -0.6 to 2.3 | -6.1 to -1.1 |
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## POL - Precision for ACE and ACE Alera Clinical Chemistry Systems
# Precision -
POL
| Direct TIBC"<br>n=20 | | ACE Result<br>µg/dL SD, %CV | | | ACE Alera Result<br>µg/dL SD, %CV | | |
|----------------------|--------|-----------------------------|--------------|--------------|-----------------------------------|--------------|--------------|
| Lab | Sample | Mean | Within-Run | Total | Mean | Within-Run | Total |
| In-House | 1 | 336 | 2.9<br>0.9% | 5.5<br>1.6% | 330 | 5.1<br>1.5% | 5.8<br>1.8% |
| POL 1 | 1 | 290 | 10.8<br>3.7% | 15.6<br>5.4% | 284 | 8.3<br>2.9% | 9.6<br>3.4% |
| POL 2 | 1 | 275 | 3.5<br>1.3% | 11.4<br>4.1% | 259 | 5.6<br>2.2% | 8.5<br>3.3% |
| POL 3 | 1 | 295 | 5.4<br>1.8% | 5.5<br>1.9% | 276 | 9.1<br>3.3% | 16.7<br>6.0% |
| In-House | 2 | 455 | 5.0<br>1.1% | 8.1<br>1.8% | 450 | 4.9<br>1.1% | 6.8<br>1.5% |
| POL 1 | 2 | 452 | 10.2<br>2.3% | 10.4<br>2.3% | 464 | 6.3<br>1.4% | 6.6<br>1.4% |
| POL 2 | 2 | 442 | 5.9<br>1.3% | 12.5<br>2.8% | 444 | 4.2<br>1.0% | 5.4<br>1.2% |
| POL 3 | 2 | 465 | 4.7<br>1.0% | 5.3<br>1.1% | 453 | 3.2<br>0.7% | 15.5<br>3.4% |
| In-House | 3 | 539 | 9.8<br>1.8% | 12.8<br>2.4% | 530 | 9.4<br>1.8% | 10.8<br>2.0% |
| POL 1 | 3 | 531 | 17.1<br>3.2% | 20.4<br>3.8% | 544 | 8.2<br>1.5% | 8.3<br>1.5% |
| POL 2 | 3 | 530 | 7.4<br>1.4% | 14.1<br>2.7% | 520 | 5.0<br>1.0% | 9.0<br>1.7% |
| POL 3 | 3 | 551 | 4.6<br>0.8% | 5.9<br>1.1% | 533 | 12.6<br>2.4% | 20.2<br>3.8% |
Page 11 of 15
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## POL - Precision for ACE and ACE Alera Clinical Chemistry Systems
## Precision -POL
| Total Iron<br>n=20 | | ACE Result<br>µg/dL SD, %CV | | | ACE Alera Result<br>µg/dL SD, %CV | | |
|--------------------|--------|-----------------------------|-------------|-------------|-----------------------------------|--------------|--------------|
| Lab | Sample | Mean | Within-Run | Total | Mean | Within-Run | Total |
| In-House | 1 | 117 | 1.4<br>1.2% | 2.6<br>2.2% | 119 | 1.8<br>1.5% | 2.5<br>2.1% |
| POL 1 | 1 | 120 | 6.4<br>5.4% | 6.9<br>5.8% | 119 | 2.7<br>2.3% | 3.2<br>2.7% |
| POL 2 | 1 | 120 | 6.3<br>5.3% | 6.6<br>5.5% | 122 | 3.1<br>2.6% | 3.1<br>2.6% |
| POL 3 | 1 | 121 | 4.4<br>3.7% | 4.4<br>3.7% | 116 | 3.2<br>2.8% | 3.4<br>3.0% |
| In-House | 2 | 223 | 2.9<br>1.3% | 5.6<br>2.5% | 222 | 3.8<br>1.7% | 5.1<br>2.3% |
| POL 1 | 2 | 227 | 3.4<br>1.5% | 3.9<br>1.7% | 229 | 2.0<br>0.9% | 2.5<br>1.1% |
| POL 2 | 2 | 227 | 2.6<br>1.1% | 5.1<br>2.2% | 235 | 2.3<br>1.0% | 2.4<br>1.0% |
| POL 3 | 2 | 225 | 1.3<br>0.6% | 1.9<br>0.8% | 229 | 3.4<br>1.5% | 3.9<br>1.7% |
| In-House | 3 | 416 | 8.7<br>2.1% | 9.1<br>2.2% | 412 | 5.2<br>1.3% | 5.7<br>1.4% |
| POL 1 | 3 | 420 | 5.0<br>1.2% | 5.6<br>1.3% | 424 | 4.0<br>0.9% | 4.6<br>1.1% |
| POL 2 | 3 | 423 | 6.6<br>1.6% | 9.3<br>2.2% | 435 | 2.4<br>0.5% | 5.3<br>1.2% |
| POL 3 | 3 | 422 | 5.6<br>1.3% | 6.0<br>1.4% | 428 | 11.1<br>2.6% | 11.1<br>2.6% |
Page 12 of 15
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## Performance
### POL - Precision for ACE and ACE Alera Clinical Chemistry Systems
## Data: Precision -
POL
| LDH-L<br>n=20 | | ACE Result<br>U/L SD, %CV | | | ACE Alera Result<br>U/L SD, %CV | | |
|---------------|--------|---------------------------|--------------|--------------|---------------------------------|--------------|--------------|
| Lab | Sample | Mean | Within-Run | Total | Mean | Within-Run | Total |
| In-House | 1 | 121 | 2.8<br>2.3% | 4.3<br>3.6% | 118 | 2.9<br>2.4% | 5.7<br>4.8% |
| POL 1 | 1 | 113 | 2.1<br>1.9% | 5.4<br>4.8% | 116 | 1.7<br>1.5% | 4.9<br>4.3% |
| POL 2 | 1 | 114 | 2.5<br>2.2% | 6.4<br>5.6% | 118 | 3.0<br>2.5% | 5.1<br>4.3% |
| POL 3 | 1 | 117 | 2.1<br>1.8% | 2.7<br>2.3% | 124 | 3.4<br>2.7% | 4.7<br>3.8% |
| In-House | 2 | 446 | 5.8<br>1.3% | 6.9<br>1.5% | 433 | 4.7<br>1.1% | 6.5<br>1.5% |
| POL 1 | 2 | 433 | 5.8<br>1.3% | 8.1<br>1.9% | 437 | 2.9<br>0.7% | 5.8<br>1.3% |
| POL 2 | 2 | 433 | 4.8<br>1.1% | 5.7<br>1.3% | 449 | 3.7<br>0.8% | 5.2<br>1.2% |
| POL 3 | 2 | 437 | 4.5<br>1.0% | 5.2<br>1.2% | 446 | 5.8<br>1.3% | 6.6<br>1.5% |
| In-House | 3 | 715 | 10.1<br>1.4% | 11.9<br>1.7% | 699 | 5.3<br>0.8% | 8.5<br>1.2% |
| POL 1 | 3 | 699 | 10.0<br>1.4% | 18.0<br>2.6% | 698 | 8.6<br>1.2% | 11.5<br>1.6% |
| POL 2 | 3 | 698 | 12.7<br>1.8% | 12.7<br>1.8% | 726 | 5.4<br>0.8% | 10.0<br>1.4% |
| POL 3 | 3 | 697 | 7.6<br>1.1% | 8.8<br>1.3% | 716 | 14.3<br>2.0% | 16.9<br>2.4% |
Page 13 of 15
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| Performance<br>Data: | POL - Method Comparison for ACE Clinical Chemistry System | | | | |
|--------------------------------------|-----------------------------------------------------------|-----------------|-----------------------------------|-----------------------------------|-----------------------------------|
| Method<br>Comparison -<br>POL on ACE | Reagent | Statistic | In-House (x) vs.<br>ACE POL 1 (y) | In-House (x) vs.<br>ACE POL 2 (y) | In-House (x) vs.<br>ACE POL 3 (y) |
| | TIBC | n | 50 | 50 | 50 |
| | | Range | 59 to 676 | 59 to 676 | 59 to 676 |
| | | Regression | $y = 0.979x + 4.3$ | $y = 0.974x + 8.7$ | $y = 1.006x - 1.4$ |
| | | Correlation | 0.9972 | 0.9966 | 0.9966 |
| | | Std. Error Est. | 7.7 | 8.4 | 8.7 |
| | | CI Slope | 0.958 to 1.000 | 0.951 to 0.998 | 0.982 to 1.030 |
| | | CI Intercept | -4.8 to 13.3 | -1.2 to 18.5 | -11.6 to 8.8 |
| | Iron | n | 48 | 48 | 48 |
| | | Range | 13 to 549 | 13 to 549 | 13 to 549 |
| | | Regression | $y=0.977x - 1.3$ | $y = 0.992x - 0.8$ | $y = 0.992x + 0.9$ |
| | | Correlation | 0.9990 | 0.9994 | 0.9994 |
| | | Std. Error Est. | 5.0 | 3.8 | 3.8 |
| | | CI Slope | 0.964 to 0.990 | 0.982 to 1.003 | 0.982 to 1.002 |
| | | CI Intercept | -3.3 to 0.6 | -2.3 to 0.7 | -0.6 to 2.4 |
| | LDH-L | n | 51 | 51 | 51 |
| | | Range | 74 to 799 | 74 to 799 | 74 to 799 |
| | | Regression | $y = 0.996x + 1.3$ | $y=1.010x - 5.3$ | $y = 0.978x + 7.2$ |
| | | Correlation | 0.9979 | 0.9989 | 0.9989 |
| | | Std. Error Est. | 10.6 | 7.7 | 7.6 |
| | | CI Slope | 0.978 to 1.014 | 0.996 to 1.023 | 0.964 to 0.991 |
| | | CI Intercept | -3.0 to 5.6 | -8.5 to -2.2 | 4.2 to 10.3 |
{14}------------------------------------------------
| Performance<br>Data: | POL – Method Comparison for ACE Alera Clinical Chemistry System | | | | |
|-----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|-----------------------------------------------|-----------------------------------------------|-----------------------------------------------|
| Method<br>Comparison -<br>POL on ACE<br>Alera | Reagent | Statistic | In-House (x)<br>vs.<br>ACE Alera<br>POL 1 (y) | In-House (x)<br>vs.<br>ACE Alera<br>POL 2 (y) | In-House (x)<br>vs.<br>ACE Alera<br>POL 3 (y) |
| | TIBC | n | 50 | 50 | 50 |
| | | Range | 59 to 676 | 59 to 676 | 59 to 676 |
| | | Regression | y = 0.994x + 12.4 | y = 0.973x + 0.1 | y = 1.005x + 9.0 |
| | | Correlation | 0.9934 | 0.9954 | 0.9898 |
| | | Std. Error Est. | 12.0 | 9.8 | 15.1 |
| | | CI Slope | 0.961 to 1.027 | 0.946 to 1.001 | 0.963 to 1.047 |
| |…
