ACE ALBUMIN REAGENT, ACE TOTAL PROTEIN REAGENT, ACE CALCIUM-ARSENAZO REAGENT AND ACE PHOSPHORUS REAGENT

Q: Who is the manufacturer of ACE ALBUMIN REAGENT, ACE TOTAL PROTEIN REAGENT, ACE CALCIUM-ARSENAZO REAGENT AND ACE PHOSPHORUS REAGENT?

Alfa Wassermann Diagnostics Technologies, LLC filed the 510(k) submission for ACE ALBUMIN REAGENT, ACE TOTAL PROTEIN REAGENT, ACE CALCIUM-ARSENAZO REAGENT AND ACE PHOSPHORUS REAGENT (K131488).

Q: What is the FDA product code for ACE ALBUMIN REAGENT, ACE TOTAL PROTEIN REAGENT, ACE CALCIUM-ARSENAZO REAGENT AND ACE PHOSPHORUS REAGENT?

CIX. It is classified under 21 CFR 862.1035 as a Class 2 device in the Clinical Chemistry panel.

Q: What is the regulatory pathway for ACE ALBUMIN REAGENT, ACE TOTAL PROTEIN REAGENT, ACE CALCIUM-ARSENAZO REAGENT AND ACE PHOSPHORUS REAGENT?

510(k) clearance (submission type: Traditional).

Q: Who can help prepare an FDA 510(k) submission like ACE ALBUMIN REAGENT, ACE TOTAL PROTEIN REAGENT, ACE CALCIUM-ARSENAZO REAGENT AND ACE PHOSPHORUS REAGENT?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K131488 · Alfa Wassermann Diagnostics Technologies, LLC · CIX · Aug 19, 2013 · Clinical Chemistry

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

The ACE Albumin Reagent is intended for the quantitative determination of albumin concentration in serum and lithium heparin plasma using the ACE, ACE Alere and ACE Axcel Chemistry Systems. Albumin measurements are used in the diagnosis and treatment of numerous diseased 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. The 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 System. 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. The 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. The 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

Reagents for quantitative photometric/colorimetric analysis of serum and lithium heparin plasma samples; used on ACE, ACE Alera, and ACE Axcel clinical chemistry systems. Reagents react with analytes (albumin, total protein, calcium, phosphorus) to form colored complexes; intensity measured bichromatically. Systems operate in clinical laboratories or physician office laboratories; operated by lab personnel. Output is quantitative concentration value; used by clinicians for diagnosis and treatment monitoring of liver, kidney, bone, and metabolic diseases.

Clinical Evidence

Bench testing only. Precision studies (20-day, n=80; POL studies, n=20) showed total CVs generally <5%. Linearity confirmed across reportable ranges (r² >0.99). Method comparison (n=50-51 per analyte) against predicate showed high correlation (r² >0.99). Matrix comparison (serum vs. lithium heparin plasma) confirmed equivalence. Interference testing performed per CLSI EP07-A2.

Technological Characteristics

Photometric/colorimetric assays. Reagents: Albumin (Bromcresol green), Total Protein (Copper sulfate/tartrate), Calcium (Arsenazo III), Phosphorus (Ammonium molybdate/sulfuric acid). Bichromatic measurement at specific wavelengths (e.g., 629/692 nm, 544/692 nm, 647/692 nm, 340/378 nm). Standalone reagents for use on automated clinical chemistry analyzers. Traceability to NIST SRM 927, 909, 915b, 200, 3139a.

Indications for Use

Indicated for quantitative determination of albumin, total protein, calcium, and inorganic phosphorus in serum and lithium heparin plasma. Used in clinical laboratories or physician office laboratories for diagnosis/treatment of liver, kidney, bone marrow, parathyroid, and metabolic disorders.

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

Submission Summary (Full Text)

{0}------------------------------------------------ K131488 | 510(k) Owner: | Alfa Wassermann Diagnostic Technologies, LLC 4 Henderson Drive West Caldwell, NJ 07006 | | | |------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|--------------| | Contact: | Hkatz@AlfaWassermannUS.com Hyman Katz, Ph.D. Phone: 973-852-0158 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 (21 C.F.R. § 862.1035) Product Code CIX | | | | Trade Name: | ACE Total Protein Reagent | | | | Classification: | Class 2 | | | | Common/Classification Name: | Biuret (Colorimetric), Total Protein (21 C.F.R. § 862.1635) Product Code CEK | | | | Trade Name: | ACE Calcium-Arsenazo Reagent | | | | Classification: | Class 2 | | | | Common/Classification Name: | Azo Dye, Calcium (21 C.F.R. § 862.1445) Product Code CJY | | | | Trade Name: | ACE Inorganic Phosphorus U.V. Reagent | | | | Classification: | Class 1 | | | | Common/Classification Name: | Phosphomolybdate (Colorimetric), Inorganic Phosphorus (21 C.F.R. § 862.1580) Product Code CEO | | | Predicate Devices: | Manufacturer for reagent system predicates: Alfa Wassermann ACE and ACE Axcel Clinical Chemistry Systems and ACE Reagents (K930104, K113253, K113374) | | | {1}------------------------------------------------ | Device Descriptions: | In the ACE Albumin Reagent assay, Bromcresol green binds specifically to albumin to form a green colored complex, which is measured bichromatically at 629 nm/692 nm. The intensity of color produced is directly proportional to the albumin concentration in the sample. In the ACE Total Protein Reagent assay, cupric ions react with the peptide bonds of proteins under alkaline conditions to form a violet colored complex, which is measured bichromatically at 544 nm/692 nm. The intensity of color produced is directly proportional to the total protein concentration in the sample. In the ACE Calcium-Arsenazo Reagent assay, calcium reacts with Arsenazo III in an acidic solution to form a blue-purple colored complex, which is measured bichromatically at 647 nm/692 nm. The intensity of color produced is directly proportional to the calcium concentration in the sample. In the ACE Inorganic Phosphorus U.V. Reagent assay, under acidic conditions, inorganic phosphorus in serum reacts with ammonium molybdate to form an unreduced phosphomolybdate complex, which absorbs strongly at 340 nm. The increase in absorbance, measured bichromatically at 340 nm/378 nm, is directly proportional to the amount of phosphorus in the sample. | |-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use: | Indications for 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. | | Technological Characteristics: | ACE Albumin Reagent consists of a single reagent bottle. The reagent contains Bromcresol green and acetate buffer. | | | ACE Total Protein Reagent consists of a single reagent bottle. The reagent contains copper sulfate, sodium potassium tartrate, potassium iodide and sodium hydroxide. | | | ACE Calcium-Arsenazo Reagent consists of a single reagent bottle. The Reagent contains Arsenazo III. | | | ACE Inorganic Phosphorus U.V. Reagent consists of a single reagent bottle. The reagent contains ammonium molybdate and sulfuric acid. | . {2}------------------------------------------------ · {3}------------------------------------------------ | | Comparison of similarities and differences with predicate device | | | |----------------------------------------|------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|-----------------------------------------------------------| | Device Comparison with Predicate | ACE Albumin Reagent | | | | ALB | Candidate Device | Predicate Device K930104 (ACE ALB) | | | Intended Use/ Indications for Use | The ACE Albumin Reagent is intended for the quantitative determination of albumin concentration. | Same | | | Platforms | ACE, ACE Alera®, and ACE Axcel 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 | 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 and frozen at -20°C for 6 months or indefinitely at -70°C. | Same | | | | Calcium-Arsenazo | Candidate Device | Predicate Device K930104 (ACE Calcium-Arsenazo) | | Device Comparison with Predicate | Intended Use/ Indications for Use | ACE Calcium-Arsenazo Reagent is intended for the quantitative determination of calcium. | Same | | | Platforms | ACE, ACE Alera®, and ACE Axcel 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 | 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 weeks at 4-8°C, and 8 months at -20°C | Same | | | | ACE Inorganic Phosphorus U.V. Reagent | | | | Inorganic Phosphorus | Candidate Device | Predicate Device K930104 (ACE Inorganic Phosphorus) | | | Intended Use/ Indications for Use | ACE Inorganic Phosphorus U.V. Reagent is intended for the quantitative determination of | Same | | | | inorganic phosphorus. | | | | Platforms | ACE, ACE Alera®, and ACE Axcel 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 g/dL | ACE Mean | Within- Run | Total | Alera Mean | Within- Run | Total | Axcel Mean | Within- 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 Protein g/dL | ACE Mean | Within- Run | Total | Alera Mean | Within- Run | Total | Axcel Mean | Within- 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- Arsenazo mg/dL | ACE Mean | Within- Run | Total | Alera Mean | Within- Run | Total | Axcel Mean | Within- 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 Phosphorus U.V. mg/dL | ACE Mean | Within- Run | Total | Alera Mean | Within- Run | Total | Axcel Mean | Within- 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 55 pairs | 0.3-6.8 g/dL | Slope: Intercept: Correlation: Std. Error Est: Confidence Interval Slope: Confidence Interval Intercept: | 0.991 0.03 0.9874 0.19 0.948 to 1.034 -0.15 to 0.20 | | ACE Alera 56 pairs | 0.3-6.8 g/dL | Slope: Intercept: Correlation: Std. Error Est: Confidence Interval Slope: Confidence Interval. Intercept: | 1.002 -0.01 0.9905 0.17 0.964 to 1.040 -0.15 to 0.14 | | ACE Axcel 56 pairs | 0.7-6.7 g/dL | Slope: Intercept: Correlation: Std. Error Est: Confidence Interval Slope: Confidence Interval Intercept: | 0.956 0.20 0.9850 0.20 0.911 to 1.001 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 56 pairs | Slope: 1.001 Intercept: 0.12 Correlation: 0.9798 Std. Error Est: 0.40 Confidence Interval Slope: 0.946 to 1.056 Confidence Interval Intercept: -0.24 to 0.48 | | ACE Alera | 0.5-12.0 g/dL 56 pairs | Slope: 0.999 Intercept: 0.14 Correlation: 0.9840 Std. Error Est: 0.35 Confidence Interval Slope: 0.950 to 1.047 Confidence Interval Intercept: -0.18 to 0.46 | | ACE Axcel | 0.5-13.9 g/dL 81 pairs | Slope: 0.994 Intercept: 0.34 Correlation: 0.9885 Std. Error Est: 0.26 Confidence Interval Slope: 0.961 to 1.028 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 56 pairs | 1.0-13.7 mg/dL | Slope: 1.006 Intercept: -0.01 Correlation: 0.9824 Std. Error Est: 0.39 Confidence Interval Slope: 0.955 to 1.058 Confidence Interval Intercept: -0.46 to 0.45 | | | | | ACE Alera 56 pairs | 1.0-13.7 mg/dL | Slope: 1.008 Intercept: -0.06 Correlation: 0.9793 Std. Error Est: 0.43 Confidence Interval Slope: 0.952 to 1.064 Confidence Interval Intercept: -0.55 to 0.42 | | | | | ACE Axcel 81 pairs | 0.7-15.0 mg/dL | Slope: 0.978 Intercept: 0.33 Correlation: 0.9911 Std. Error Est: 0.23 Confidence Interval Slope: 0.949 to 1.007 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 100 pairs | 1.3-19.3 mg/dL | Slope: 1.042 Intercept: -0.26 Correlation: 0.9927 Std. Error Est: 0.33 Confidence Interval Slope: 1.017 to 1.067 Confidence Interval Intercept: -0.38 to -0.14 | | ACE Alera 102 pairs | 1.3-19.3 mg/dL | Slope: 1.049 Intercept: -0.28 Correlation: 0.9928 Std. Error Est: 0.33 Confidence Interval Slope: 1.024 to 1.074 Confidence Interval Intercept: -0.40 to -0.16 | | ACE Axcel 56 pairs | 0.5-19.8 mg/dL | Slope: 0.999 Intercept: 0.04 Correlation: 0.9950 Std. Error Est: 0.34 Confidence Interval Slope: 0.972 to 1.027 Confidence Interval Intercept: -0.12 to 0.20 | {9}------------------------------------------------ | POL - Precision for ACE and ACE Alera Clinical Chemistry Systems (Note: Refer to previously cleared submission k113374 for ACE Axcel POL data) | | | | | | | | | |---------------------------------------------------------------------------------------------------------------------------------------------------|----------------|--------|------|----------------------------|--------------|------|----------------------------------|--------------| | Performance Data: In-House Matrix Comparison – Serum vs. Plasma | Albumin Lab | Sample | Mean | ACE Result g/dL SD, %CV | | Mean | ACE Alera Result g/dL SD, %CV | | | | | | | Within-Run | Total | | Within-Run | Total | | | In-House | 1 | 3.5 | 0.05 1.4% | 0.07 2.0% | 3.5 | 0.02 0.6% | 0.04 1.1% | | | POL 1 | 1 | 3.5 | 0.04 1.3% | 0.04 1.3% | 3.5 | 0.05 1.4% | 0.06 1.7% | | | POL 2 | 1 | 3.5 | 0.06 1.7% | 0.07 2.0% | 3.6 | 0.05 1.4% | 0.05 1.5% | | | POL 3 | 1 | 3.5 | 0.08 2.3% | 0.08 2.4% | 3.5 | 0.05 1.6% | 0.05 1.6% | | | In-House | 2 | 5.0 | 0.06 1.2% | 0.06 1.2% | 5.0 | 0.05 1.0% | 0.05 1.1% | | | POL 1 | 2 | 4.9 | 0.06 1.2% | 0.07 1.4% | 5.0 | 0.08 1.7% | 0.09 1.9% | | | POL 2 | 2 | 4.9 | 0.03 0.6% | 0.06 1.2% | 5.0 | 0.06 1.2% | 0.08 1.6% | | | POL 3 | 2 | 4.9 | 0.06 1.2% | 0.09 1.9% | 4.9 | 0.03 0.6% | 0.03 0.7% | | | In-House | 3 | 6.2 | 0.11 1.9% | 0.13 2.1% | 6.2 | 0.06 1.0% | 0.07 1.1% | | | POL 1 | 3 | 6.1 | 0.07 1.1% | 0.07 1.2% | 6.2 | 0.07 1.1% | 0.10 1.6% | | | POL 2 | 3 | 6.1 | 0.10 1.6% | 0.12 1.9% | 6.2 | 0.06 1.0% | 0.07 1.1% | | | POL 3 | 3 | 6.1 | 0.10 1.7% | 0.11 1.8% | 6.1 | 0.08 1.3% | 0.08 1.4% | {10}------------------------------------------------ | | | | | ACE Result | | | ACE Alera Result | | | |-----------------------------------------------------------------------------------|------------------|----------|--------|------------|--------------|-------|------------------|--------------|-------| | Performance Data: In-House Matrix Comparison - Serum vs. Plasma | Total 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- 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 1.7 | 0.17 SD 2.4 | 6.9 | 0.08 SD 1.2% | 0.15 SD 2.1% | | | POL 1 | 1 | 7.0 | 0.14 SD 2.0% | 0.15 SD 2.1% | 6.9 | 0.07 SD 1.0% | 0.19 SD 2.7% | | | POL 2 | 1 | 7.0 | 0.16 SD 2.3% | 0.17 SD 2.4% | 7.0 | 0.19 SD 2.7% | 0.19 SD 2.7% | | | POL 3 | 1 | 7.0 | 0.16 SD 2.3% | 0.17 SD 2.4% | 7.0 | 0.14 SD 1.9% | 0.14 SD 1.9% | | | In-House | 2 | 10.7 | 0.21 SD 2.0% | 0.21 SD 2.0% | 10.5 | 0.05 SD 0.5% | 0.06 SD 0.6% | | | POL 1 | 2 | 10.6 | 0.06 SD 0.6% | 0.06 SD 0.6% | 10.5 | 0.09 SD 0.9% | 0.33 SD 3.2% | | | POL 2 | 2 | 10.5 | 0.12 SD 1.2% | 0.15 SD 1.5% | 10.6 | 0.21 SD 1.9% | 0.22 SD 2.1% | | | POL 3 | 2 | 10.5 | 0.10 SD 1.0% | 0.11 SD 1.0% | 10.6 | 0.16 SD 1.5% | 0.16 SD 1.5% | | | In-House | 3 | 13.6 | 0.11 SD 0.8% | 0.26 SD 1.9% | 13.5 | 0.17 SD 1.3% | 0.20 SD 1.5% | | | POL 1 | 3 | 13.6 | 0.14 SD 1.1% | 0.20 SD 1.5% | 13.4 | 0.14 SD 1.1% | 0.34 SD 2.5% | | | POL 2 | 3 | 13.5 | 0.32 SD 2.3% | 0.37 SD 2.7% | 13.6 | 0.21 SD 1.5% | 0.23 SD 1.7% | | | POL 3 | 3 | 13.6 | 0.16 SD 1.2% | 0.17 SD 1.2% | 13.6 | 0.14 SD 1.0% | 0.18 SD 1.3% | ・ : {12}------------------------------------------------ | Performance Data: Precision - POL | POL - Precision for ACE and ACE Alera Clinical Chemistry Systems | | | | | | | |--------------------------------------|------------------------------------------------------------------|------|-----------------------------|------------------------|------|-----------------------------|------------------------| | Inorganic Phosphorus U.V. | | | ACE Result | | | ACE Alera Result | | | Lab | Sample | Mean | mg/dL SD, %CV Within-Run | mg/dL SD, %CV Total | Mean | mg/dL SD, %CV Within-Run | mg/dL SD, %CV Total | | In-House | 1 | 2.7 | 0.08 SD 3.0% | 0.08 SD 3.0% | 2.8 | 0.06 SD 2.1% | 0.06 SD 2.1% | | POL 1 | 1 | 2.7 | 0.03 SD 1.2% | 0.05 SD 1.9% | 2.7 | 0.04 SD 1.4% | 0.10 SD 3.8% | | POL 2 | 1 | 2.6 | 0.06 SD 2.3% | 0.09 SD 3.6% | 2.5 | 0.02 SD 0.9% | 0.11 SD 4.4% | | POL 3 | 1 | 2.8 | 0.06 SD 2.1% | 0.10 SD 3.5% | 2.9 | 0.05 SD 1.9% | 0.07 SD 2.4% | | In-House | 2 | 7.0 | 0.07 SD 1.0% | 0.09 SD 1.3% | 7.1 | 0.07 SD 0.9% | 0.09 SD 1.3% | | POL 1 | 2 | 7.0 | 0.04 SD 0.6% | 0.07 SD 1.1% | 7.1 | 0.07 SD 0.9% | 0.18 SD 2.5% | | POL 2 | 2 | 6.7 | 0.08 SD 1.2% | 0.14 SD 2.1% | 6.7 | 0.07 SD 1.1% | 0.22 SD 3.2% | | POL 3 | 2 | 7.2 | 0.04 SD 0.6% | 0.07 SD 1.0% | 7.4 | 0.10 SD 1.4% | 0.13 SD 1.7% | | In-House | 3 | 11.1 | 0.14 SD 1.2% | 0.18 SD 1.6% | 11.3 | 0.09 SD 0.8% | 0.11 SD 0.9% | | POL 1 | 3 | 11.1 | 0.13 SD 1.2% | 0.14 SD 1.3% | 11.3 | 0.16 SD 1.4% | 0.27 SD 2.4% | | POL 2 | 3 | 10.9 | 0.12 SD 1.1% | 0.21 SD 1.9% | 10.6 | 0.15 SD 1.4% | 0.21 SD 1.9% | | POL 3 | 3 | 11.4 | 0.13 SD 1.1% | 0.18 SD 1.6% | 11.7 | 0.11 SD 0.9% | 0.14 SD 1.2% | . . {13}------------------------------------------------ | Performance Data: Precision - POL | POL – Method Comparison for ACE Clinical Chemistry System | | | | | |--------------------------------------------|-----------------------------------------------------------|------------------|------------------------------------------|------------------------------------------|------------------------------------------| | | Reagent | Statistic | ACE In-House (x) vs. ACE POL 1 (y) | ACE In-House (x) vs. ACE POL 2 (y) | ACE In-House (x) vs. ACE 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 Phosphorus 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 Data: | POL - Method Comparison for ACE Alera Clinical Chemistry System | | | | | |----------------------|-----------------------------------------------------------------|------------------|------------------------------------------|------------------------------------------|------------------------------------------| | Precision - 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- 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 Phosphorus 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 (g/dL) | TP (g/dL) | CA (mg/dL) | PHOS (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 Reagents | Low Level Tested | Upper Level Tested | Linear to: | Linear Regression Equation | |-----------------|---------------------|-----------------------|------------|----------------------------------| | ALB | 0.1 g/dL | 7.6 g/dL | 7.6 g/dL | y = 0.980x + 0.01 r2 = 0.9982 | | TP | 0.2 g/dL | 15.1 g/dL | 15.1 g/dL | y=0.991x + 0.04 r2 = 0.9979 | | CA | 0.3 g/dL | 16.5 mg/dL | 16.5 mg/dL | y=0.992x +0.27 r2 = 0.9990 | | PHOS | 0.2 mg/dL | 21 mg/dL | 21 mg/dL | y=1.001x +0.03 r2 = 0.9995 | {16}------------------------------------------------ ### Performance Data: ## ACE Alera #### Interferences - ACE Alera Clinical Chemistry System | Interferents 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 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% | |…

ACE ALBUMIN REAGENT, ACE TOTAL PROTEIN REAGENT, ACE CALCIUM-ARSENAZO REAGENT AND ACE PHOSPHORUS REAGENT

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ACE ALBUMIN REAGENT, ACE TOTAL PROTEIN REAGENT, ACE CALCIUM-ARSENAZO REAGENT AND ACE PHOSPHORUS REAGENT

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