(88 days)
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.
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.
Here's an analysis of the acceptance criteria and study information for the ACE Albumin Reagent, ACE Total Protein Reagent, ACE Calcium-Arsenazo Reagent, and ACE Inorganic Phosphorus U.V. Reagent, based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
The provided documentation does not explicitly state formal "acceptance criteria" with specific thresholds for each performance metric. However, it presents detailed performance data, particularly precision (within-run and total %CV) and method comparison (regression analysis, correlation coefficient), comparing the new reagents on various ACE clinical chemistry systems (ACE, ACE Alera, ACE Axcel) against existing predicate devices and among themselves. The implied acceptance is that the new reagents perform comparably to, or as effectively as, the predicate devices and demonstrate acceptable precision and linearity for clinical use.
Below is a summary of the reported device performance based on the "In-House Precision" and "In-House Matrix Comparison" tables. Since explicit acceptance criteria are not given, the performance data itself is presented as the evidence of meeting implied clinical utility and equivalence to predicate devices.
ACE Albumin Reagent
| Metric | Acceptance Criteria (Implied) | Reported Performance (Range across ACE, Alera, Axcel systems) |
|---|---|---|
| Precision (%CV) | Clinically acceptable | Serum: Within-Run: 0.5-1.6%, Total: 0.6-1.8%Plasma: Within-Run: 0.8-1.7%, Total: 1.1-1.7% |
| Matrix Comparison (Serum vs. Plasma) | Slope close to 1, Intercept close to 0, High Correlation | Slope: 0.956 - 1.002Intercept: -0.01 - 0.20Correlation: 0.9850 - 0.9905 |
| Linearity | Broad clinical range, r^2 close to 1 | Linear to 7.6 g/dLy = 0.980x + 0.01, r^2 = 0.9982 |
| Detection Limits (ACE Alera) | Low enough for clinical utility | LoB: 0.08 g/dL, LoD: 0.09 g/dL, LoQ: 0.09 g/dL |
| Interferences (ACE Alera) | No significant interference at clinically relevant levels | Icterus: 60 mg/dL, Hemolysis: 250 mg/dL, Lipemia: 1000 mg/dL, Ascorbic Acid: 6 mg/dL |
ACE Total Protein Reagent
| Metric | Acceptance Criteria (Implied) | Reported Performance (Range across ACE, Alera, Axcel systems) |
|---|---|---|
| Precision (%CV) | Clinically acceptable | Serum: Within-Run: 0.7-1.3%, Total: 0.8-1.4%Plasma: Within-Run: 0.5-1.3%, Total: 0.7-1.4% |
| Matrix Comparison (Serum vs. Plasma) | Slope close to 1, Intercept close to 0, High Correlation | Slope: 0.994 - 1.001Intercept: 0.12 - 0.34Correlation: 0.9798 - 0.9885 |
| Linearity | Broad clinical range, r^2 close to 1 | Linear to 15.1 g/dLy=0.991x + 0.04, r^2 = 0.9979 |
| Detection Limits (ACE Alera) | Low enough for clinical utility | LoB: 0.08 g/dL, LoD: 0.13 g/dL, LoQ: 0.20 g/dL |
| Interferences (ACE Alera) | No significant interference at clinically relevant levels | Icterus: 56.8 mg/dL, Hemolysis: 250 mg/dL, Lipemia: 929 mg/dL, Ascorbic Acid: 6 mg/dL |
ACE Calcium-Arsenazo Reagent
| Metric | Acceptance Criteria (Implied) | Reported Performance (Range across ACE, Alera, Axcel systems) |
|---|---|---|
| Precision (%CV) | Clinically acceptable | Serum: Within-Run: 0.7-1.6%, Total: 0.9-2.7%Plasma: Within-Run: 0.5-1.9%, Total: 1.1-2.0% |
| Matrix Comparison (Serum vs. Plasma) | Slope close to 1, Intercept close to 0, High Correlation | Slope: 0.978 - 1.008Intercept: -0.06 - 0.33Correlation: 0.9793 - 0.9911 |
| Linearity | Broad clinical range, r^2 close to 1 | Linear to 16.5 mg/dLy=0.992x +0.27, r^2 = 0.9990 |
| Detection Limits (ACE Alera) | Low enough for clinical utility | LoB: 0.09 mg/dL, LoD: 0.11 mg/dL, LoQ: 0.23 mg/dL |
| Interferences (ACE Alera) | No significant interference at clinically relevant levels | Icterus: 58.8 mg/dL, Hemolysis: 1000 mg/dL, Lipemia: 1000 mg/dL, Ascorbic Acid: 6 mg/dL |
ACE Inorganic Phosphorus U.V. Reagent
| Metric | Acceptance Criteria (Implied) | Reported Performance (Range across ACE, Alera, Axcel systems) |
|---|---|---|
| Precision (%CV) | Clinically acceptable | Serum: Within-Run: 0.3-4.4%, Total: 0.5-5.0%Plasma: Within-Run: 0.9-5.1%, Total: 0.9-6.1% |
| Matrix Comparison (Serum vs. Plasma) | Slope close to 1, Intercept close to 0, High Correlation | Slope: 0.999 - 1.049Intercept: -0.28 - 0.04Correlation: 0.9927 - 0.9950 |
| Linearity | Broad clinical range, r^2 close to 1 | Linear to 21 mg/dLy=1.001x +0.03, r^2 = 0.9995 |
| Detection Limits (ACE Alera) | Low enough for clinical utility | LoB: 0.25 mg/dL, LoD: 0.35 mg/dL, LoQ: 0.35 mg/dL |
| Interferences (ACE Alera) | No significant interference at clinically relevant levels | Icterus: 11.5 mg/dL, Hemolysis: 250 mg/dL, Lipemia: 306 mg/dL, Ascorbic Acid: 6 mg/dL |
2. Sample Sizes Used for the Test Set and Data Provenance
The studies mentioned are "In-House Precision," "In-House Matrix Comparison: Serum vs. Plasma," "POL - Precision," and "POL – Method Comparison."
- In-House Precision (Serum vs. Plasma):
- Sample Size: Not explicitly stated for each "low, mid, high" concentration level, but implies multiple replicates for each level tested across the three systems (ACE, Alera, Axcel). For example, the ACE Alera precision table (pg. 16) shows 3 levels (low, mid, high) for serum, with reported mean, within-run SD, and total SD. Typically, precision studies involve running samples multiple times a day over several days.
- Data Provenance: "In-House" suggests it was conducted by Alfa Wassermann Diagnostic Technologies, LLC, likely at their own facilities. It is a prospective study as they are performing experiments to generate data.
- In-House Matrix Comparison: Serum vs. Plasma:
- Sample Size:
- Albumin: ACE: 55 pairs, ACE Alera: 56 pairs, ACE Axcel: 56 pairs
- Total Protein: ACE: 56 pairs, ACE Alera: 56 pairs, ACE Axcel: 81 pairs
- Calcium-Arsenazo: ACE: 56 pairs, ACE Alera: 56 pairs, ACE Axcel: 81 pairs
- Inorganic Phosphorus: ACE: 100 pairs, ACE Alera: 102 pairs, ACE Axcel: 56 pairs
- Data Provenance: "In-House" suggests it was conducted by Alfa Wassermann Diagnostic Technologies, LLC, likely at their own facilities. The comparison between serum and plasma samples implies these were collected from human subjects. This is a prospective study.
- Sample Size:
- POL (Physician Office Laboratory) - Precision:
- Sample Size: For each reagent and each system (ACE and ACE Alera), there are 3 "samples" (representing different concentration levels) tested at 3 different POL sites. Each sample/site combination has "Within-Run" and "Total" precision reported, implying multiple replicates for each measurement.
- Data Provenance: Conducted at "POL 1," "POL 2," and "POL 3" sites, indicating external collection and testing beyond the manufacturer's immediate facilities. This is a prospective study.
- POL (Physician Office Laboratory) - Method Comparison:
- Sample Size:
- Albumin: 50 samples for each POL site (x3 POLs)
- Total Protein: 51 samples for each POL site (x3 POLs)
- Calcium-Arsenazo: 50 samples for each POL site (x3 POLs)
- Inorganic Phosphorus: 50 samples for POL 1 & 3, 48 samples for POL 2
- Data Provenance: Comparisons between "ACE In-House (x)" and "ACE POL (y)" or "ACE In-House (x)" and "ACE Alera POL (y)". This indicates the data for these studies was collected at both in-house facilities and external Physician Office Laboratories. This is a prospective study design, comparing results from different testing environments.
- Sample Size:
- Detection Limits & Linearity (ACE Alera):
- Sample Size: Not specified for these specific studies, but typically involves a series of diluted and concentrated samples to define the measuring range.
- Data Provenance: In-House, prospective.
- Interference (ACE Alera):
- Sample Size: Not specified, but involves spiking samples with various interferents at different concentrations.
- Data Provenance: In-House, prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
For these types of in vitro diagnostic (IVD) assays, the "ground truth" is typically established by reference methods or validated comparative methods, often using certified calibrators and controls. The documentation does not mention the use of human experts to establish ground truth for the test set in the traditional sense of medical image interpretation (e.g., radiologists interpreting images). Instead, the studies rely on quantitative measurements and statistical comparisons with established methods (the predicate devices or in-house reference measurements) to demonstrate performance. Therefore, no information is provided on the number or qualifications of experts for ground truth establishment.
4. Adjudication Method for the Test Set
Not applicable. As described in point 3, the "ground truth" for these quantitative chemical assays is not established through expert consensus or adjudication in the way it would be for qualitative or interpretive diagnostic devices like medical imaging. Performance is evaluated by statistical comparison of numerical results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
Not applicable. This device consists of chemical reagents for laboratory measurement, not an AI-assisted diagnostic tool interpreted by human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI is not relevant to this submission.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
The performance presented for these reagents is inherently "standalone" in the sense that it reflects the direct analytical performance of the assays on the specified automated clinical chemistry systems. The results are quantitative measurements produced by the device without human interpretation of raw data beyond reading the numerical output. The "without human-in-the-loop" aspect applies here as the device itself performs the measurement and outputs a numerical value of concentration. The method comparison studies demonstrate the standalone performance of the candidate devices compared to predicate devices.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth for these assays is established through reference methods and comparison to legally marketed predicate devices.
- For precision, the "ground truth" for each replicate is assumed to be the true concentration within the sample, and the study assesses the reproducibility of the device in measuring that concentration.
- For method comparison studies (e.g., In-House vs. POL, or ACE vs. ACE Alera), one method's results (often the predicate or an established in-house method) serve as the comparative 'truth' to evaluate the new method's agreement. The reference method would itself be calibrated against known standards.
- For linearity, samples of known, graded concentrations are used.
- For detection limits, the ground truth involves samples with very low, known concentrations.
These are established analytical chemistry principles rather than "expert consensus" or "pathology" in the diagnostic interpretation sense.
8. The Sample Size for the Training Set
The concept of a "training set" is primarily relevant for machine learning or AI algorithms which are iteratively developed and optimized using data. These reagents are chemical assays with a defined photometric measurement principle. While there is a development phase that involves optimizing reagent formulations and instrument parameters, there isn't a "training set" in the computational sense. The data presented here are from formal "verification and validation studies" to demonstrate performance characteristics (precision, linearity, accuracy/comparison, interference, detection limits).
9. How the Ground Truth for the Training Set Was Established
As noted in point 8, the concept of a "training set" is not directly applicable to these chemical reagents. The "ground truth" for establishing and validating the performance of such assays is based on:
- Reference materials/calibrators: Solutions with precisely known concentrations of the analyte (albumin, total protein, calcium, phosphorus) traceable to international standards.
- Validated comparison methods: Measurements made by existing, legally marketed predicate devices or other well-established and accurate laboratory methods.
- Controlled spiking experiments: Adding known amounts of substance to samples to assess recovery, linearity, and interference.
These methods establish the quantitative "truth" against which the performance of the new reagents is measured.
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| 510(k) Owner: | Alfa Wassermann Diagnostic Technologies, LLC4 Henderson DriveWest Caldwell, NJ 07006 | ||
|---|---|---|---|
| Contact: | Hkatz@AlfaWassermannUS.comHyman Katz, Ph.D.Phone: 973-852-0158Fax: 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), InorganicPhosphorus(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 ACEReagents (K930104, K113253, K113374) |
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| DeviceDescriptions: | In the ACE Albumin Reagent assay, Bromcresol green binds specifically to albumin toform 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 inthe sample.In the ACE Total Protein Reagent assay, cupric ions react with the peptide bonds ofproteins under alkaline conditions to form a violet colored complex, which is measuredbichromatically at 544 nm/692 nm. The intensity of color produced is directlyproportional to the total protein concentration in the sample.In the ACE Calcium-Arsenazo Reagent assay, calcium reacts with Arsenazo III in anacidic solution to form a blue-purple colored complex, which is measuredbichromatically at 647 nm/692 nm. The intensity of color produced is directlyproportional 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 unreducedphosphomolybdate complex, which absorbs strongly at 340 nm. The increase inabsorbance, measured bichromatically at 340 nm/378 nm, is directly proportional to theamount of phosphorus in the sample. |
|---|---|
| Intended Use: | Indications for Use:ACE Albumin Reagent is intended for the quantitative determination of albuminconcentration in serum and lithium heparin plasma using the ACE, ACE Alera, andACE Axcel Clinical Chemistry Systems. Albumin measurements are used in thediagnosis and treatment of numerous diseases involving primarily the liver or kidneys.This test is intended for use in clinical laboratories or physician office laboratories. Forin vitro diagnostic use only.ACE Total Protein Reagent is intended for the quantitative determination of totalprotein concentration in serum and lithium heparin plasma using the ACE, ACE Alera,and ACE Axcel Clinical Chemistry Systems. Total protein measurements are used inthe diagnosis and treatment of a variety of diseases involving the liver, kidney, or bonemarrow as well as other metabolic or nutritional disorders. This test is intended for usein clinical laboratories or physician office laboratories. For in vitro diagnostic use only.ACE Calcium-Arsenazo Reagent is intended for the quantitative determination ofcalcium concentration in serum and lithium heparin plasma using the ACE, ACE Alera,and ACE Axcel Clinical Chemistry Systems. Calcium measurements are used in thediagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renaldisease and tetany (intermittent muscular contractions or spasms). This test is intendedfor use in clinical laboratories or physician office laboratories. For in vitro diagnosticuse only. |
| ACE Inorganic Phosphorus U.V. Reagent is intended for the quantitative determinationof inorganic phosphorus concentration in serum and lithium heparin plasma using theACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Measurements ofinorganic phosphorus are used in the diagnosis and treatment of various disorders.including parathyroid gland and kidney diseases and vitamin D imbalance. This test isintended for use in clinical laboratories or physician office laboratories. For in vitrodiagnostic use only. | |
| TechnologicalCharacteristics: | ACE Albumin Reagent consists of a single reagent bottle. The reagent containsBromcresol green and acetate buffer. |
| ACE Total Protein Reagent consists of a single reagent bottle. The reagent containscopper sulfate, sodium potassium tartrate, potassium iodide and sodium hydroxide. | |
| ACE Calcium-Arsenazo Reagent consists of a single reagent bottle. The Reagentcontains Arsenazo III. | |
| ACE Inorganic Phosphorus U.V. Reagent consists of a single reagent bottle. Thereagent contains ammonium molybdate and sulfuric acid. |
.
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| Comparison of similarities and differences with predicate device | |||
|---|---|---|---|
| Device Comparisonwith Predicate | ACE Albumin Reagent | ||
| ALB | Candidate Device | Predicate DeviceK930104(ACE ALB) | |
| Intended Use/Indications for Use | The ACE Albumin Reagent is intendedfor the quantitative determination ofalbumin concentration. | Same | |
| Platforms | ACE, ACE Alera®, and ACE AxcelClinical Chemistry Systems | ACE Clinical Chemistry System | |
| Method | Photometric | Same | |
| CalibrationStability | 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 hoursand frozen at -20°C for 6 months orindefinitely at -70°C. | Same | |
| Calcium-Arsenazo | Candidate Device | Predicate DeviceK930104(ACE Calcium-Arsenazo) | |
| DeviceComparisonwith Predicate | Intended Use/Indications for Use | ACE Calcium-Arsenazo Reagent isintended for the quantitativedetermination of calcium. | Same |
| Platforms | ACE, ACE Alera®, and ACE AxcelClinical Chemistry Systems | ACE Clinical Chemistry System | |
| Method | Photometric | Same | |
| CalibrationStability | 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, 3weeks at 4-8°C, and 8 months at -20°C | Same | |
| ACE Inorganic Phosphorus U.V. Reagent | |||
| InorganicPhosphorus | Candidate Device | Predicate DeviceK930104(ACE Inorganic Phosphorus) | |
| Intended Use/Indications for Use | ACE Inorganic Phosphorus U.V.Reagent is intended for thequantitative determination of | Same | |
| inorganic phosphorus. | |||
| Platforms | ACE, ACE Alera®, and ACE AxcelClinical 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 |
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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) | ||||||||||
| Albuming/dL | ACEMean | Within-Run | Total | AleraMean | Within-Run | Total | AxcelMean | 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) | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| TotalProteing/dL | ACEMean | Within-Run | Total | AleraMean | Within-Run | Total | AxcelMean | 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-Arsenazomg/dL | ACEMean | Within-Run | Total | AleraMean | Within-Run | Total | AxcelMean | 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% |
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| In-House Precision: Serum vs. Plasma - ACE Inorganic Phosphorus Reagent | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Precision (SD, %CV) | |||||||||
| InorganicPhosphorusU.V.mg/dL | ACEMean | Within-Run | Total | AleraMean | Within-Run | Total | AxcelMean | 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% |
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Performance Data: In-House Precision -Serum vs.
Plasma
Performance data for the Alfa Wassermann ACE Reagents run on the Alfa Wassermann ACE, ACE Alera and ACE Axcel Clinical Chemistry Systems
In-House Matrix Comparison: Serum vs. Plasma – ACE Albumin Reagent
| System | Range | Results - Serum vs. Plasma | |
|---|---|---|---|
| ACE55 pairs | 0.3-6.8 g/dL | Slope:Intercept:Correlation:Std. Error Est:Confidence Interval Slope:Confidence Interval Intercept: | 0.9910.030.98740.190.948 to 1.034-0.15 to 0.20 |
| ACE Alera56 pairs | 0.3-6.8 g/dL | Slope:Intercept:Correlation:Std. Error Est:Confidence Interval Slope:Confidence Interval. Intercept: | 1.002-0.010.99050.170.964 to 1.040-0.15 to 0.14 |
| ACE Axcel56 pairs | 0.7-6.7 g/dL | Slope:Intercept:Correlation:Std. Error Est:Confidence Interval Slope:Confidence Interval Intercept: | 0.9560.200.98500.200.911 to 1.0010.04 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/dL56 pairs | Slope: 1.001Intercept: 0.12Correlation: 0.9798Std. Error Est: 0.40Confidence Interval Slope: 0.946 to 1.056Confidence Interval Intercept: -0.24 to 0.48 |
| ACE Alera | 0.5-12.0 g/dL56 pairs | Slope: 0.999Intercept: 0.14Correlation: 0.9840Std. Error Est: 0.35Confidence Interval Slope: 0.950 to 1.047Confidence Interval Intercept: -0.18 to 0.46 |
| ACE Axcel | 0.5-13.9 g/dL81 pairs | Slope: 0.994Intercept: 0.34Correlation: 0.9885Std. Error Est: 0.26Confidence Interval Slope: 0.961 to 1.028Confidence 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 | ||
|---|---|---|---|---|
| ACE56 pairs | 1.0-13.7 mg/dL | Slope: 1.006Intercept: -0.01Correlation: 0.9824Std. Error Est: 0.39Confidence Interval Slope: 0.955 to 1.058Confidence Interval Intercept: -0.46 to 0.45 | ||
| ACE Alera56 pairs | 1.0-13.7 mg/dL | Slope: 1.008Intercept: -0.06Correlation: 0.9793Std. Error Est: 0.43Confidence Interval Slope: 0.952 to 1.064Confidence Interval Intercept: -0.55 to 0.42 | ||
| ACE Axcel81 pairs | 0.7-15.0 mg/dL | Slope: 0.978Intercept: 0.33Correlation: 0.9911Std. Error Est: 0.23Confidence Interval Slope: 0.949 to 1.007Confidence Interval Intercept: 0.06 to 0.60 |
In-House Matrix Comparison: Serum vs. Plasma - ACE Inorganic Phosphorus Reagent
| System | Range | Results - Serum vs. Plasma |
|---|---|---|
| ACE100 pairs | 1.3-19.3 mg/dL | Slope: 1.042Intercept: -0.26Correlation: 0.9927Std. Error Est: 0.33Confidence Interval Slope: 1.017 to 1.067Confidence Interval Intercept: -0.38 to -0.14 |
| ACE Alera102 pairs | 1.3-19.3 mg/dL | Slope: 1.049Intercept: -0.28Correlation: 0.9928Std. Error Est: 0.33Confidence Interval Slope: 1.024 to 1.074Confidence Interval Intercept: -0.40 to -0.16 |
| ACE Axcel56 pairs | 0.5-19.8 mg/dL | Slope: 0.999Intercept: 0.04Correlation: 0.9950Std. Error Est: 0.34Confidence Interval Slope: 0.972 to 1.027Confidence 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-HouseMatrixComparison –Serum vs.Plasma | AlbuminLab | Sample | Mean | ACE Resultg/dL SD, %CV | Mean | ACE Alera Resultg/dL SD, %CV | ||
| Within-Run | Total | Within-Run | Total | |||||
| In-House | 1 | 3.5 | 0.051.4% | 0.072.0% | 3.5 | 0.020.6% | 0.041.1% | |
| POL 1 | 1 | 3.5 | 0.041.3% | 0.041.3% | 3.5 | 0.051.4% | 0.061.7% | |
| POL 2 | 1 | 3.5 | 0.061.7% | 0.072.0% | 3.6 | 0.051.4% | 0.051.5% | |
| POL 3 | 1 | 3.5 | 0.082.3% | 0.082.4% | 3.5 | 0.051.6% | 0.051.6% | |
| In-House | 2 | 5.0 | 0.061.2% | 0.061.2% | 5.0 | 0.051.0% | 0.051.1% | |
| POL 1 | 2 | 4.9 | 0.061.2% | 0.071.4% | 5.0 | 0.081.7% | 0.091.9% | |
| POL 2 | 2 | 4.9 | 0.030.6% | 0.061.2% | 5.0 | 0.061.2% | 0.081.6% | |
| POL 3 | 2 | 4.9 | 0.061.2% | 0.091.9% | 4.9 | 0.030.6% | 0.030.7% | |
| In-House | 3 | 6.2 | 0.111.9% | 0.132.1% | 6.2 | 0.061.0% | 0.071.1% | |
| POL 1 | 3 | 6.1 | 0.071.1% | 0.071.2% | 6.2 | 0.071.1% | 0.101.6% | |
| POL 2 | 3 | 6.1 | 0.101.6% | 0.121.9% | 6.2 | 0.061.0% | 0.071.1% | |
| POL 3 | 3 | 6.1 | 0.101.7% | 0.111.8% | 6.1 | 0.081.3% | 0.081.4% |
{10}------------------------------------------------
| ACE Result | ACE Alera Result | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| PerformanceData:In-HouseMatrixComparison -Serum vs.Plasma | TotalProtein | 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 SD1.7 | 0.17 SD2.4 | 6.9 | 0.08 SD1.2% | 0.15 SD2.1% | |
| POL 1 | 1 | 7.0 | 0.14 SD2.0% | 0.15 SD2.1% | 6.9 | 0.07 SD1.0% | 0.19 SD2.7% | |
| POL 2 | 1 | 7.0 | 0.16 SD2.3% | 0.17 SD2.4% | 7.0 | 0.19 SD2.7% | 0.19 SD2.7% | |
| POL 3 | 1 | 7.0 | 0.16 SD2.3% | 0.17 SD2.4% | 7.0 | 0.14 SD1.9% | 0.14 SD1.9% | |
| In-House | 2 | 10.7 | 0.21 SD2.0% | 0.21 SD2.0% | 10.5 | 0.05 SD0.5% | 0.06 SD0.6% | |
| POL 1 | 2 | 10.6 | 0.06 SD0.6% | 0.06 SD0.6% | 10.5 | 0.09 SD0.9% | 0.33 SD3.2% | |
| POL 2 | 2 | 10.5 | 0.12 SD1.2% | 0.15 SD1.5% | 10.6 | 0.21 SD1.9% | 0.22 SD2.1% | |
| POL 3 | 2 | 10.5 | 0.10 SD1.0% | 0.11 SD1.0% | 10.6 | 0.16 SD1.5% | 0.16 SD1.5% | |
| In-House | 3 | 13.6 | 0.11 SD0.8% | 0.26 SD1.9% | 13.5 | 0.17 SD1.3% | 0.20 SD1.5% | |
| POL 1 | 3 | 13.6 | 0.14 SD1.1% | 0.20 SD1.5% | 13.4 | 0.14 SD1.1% | 0.34 SD2.5% | |
| POL 2 | 3 | 13.5 | 0.32 SD2.3% | 0.37 SD2.7% | 13.6 | 0.21 SD1.5% | 0.23 SD1.7% | |
| POL 3 | 3 | 13.6 | 0.16 SD1.2% | 0.17 SD1.2% | 13.6 | 0.14 SD1.0% | 0.18 SD1.3% |
・
:
{12}------------------------------------------------
| Performance Data:Precision - POL | POL - Precision for ACE and ACE Alera Clinical Chemistry Systems | ||||||
|---|---|---|---|---|---|---|---|
| InorganicPhosphorusU.V. | ACE Result | ACE Alera Result | |||||
| Lab | Sample | Mean | mg/dL SD, %CVWithin-Run | mg/dL SD, %CVTotal | Mean | mg/dL SD, %CVWithin-Run | mg/dL SD, %CVTotal |
| In-House | 1 | 2.7 | 0.08 SD3.0% | 0.08 SD3.0% | 2.8 | 0.06 SD2.1% | 0.06 SD2.1% |
| POL 1 | 1 | 2.7 | 0.03 SD1.2% | 0.05 SD1.9% | 2.7 | 0.04 SD1.4% | 0.10 SD3.8% |
| POL 2 | 1 | 2.6 | 0.06 SD2.3% | 0.09 SD3.6% | 2.5 | 0.02 SD0.9% | 0.11 SD4.4% |
| POL 3 | 1 | 2.8 | 0.06 SD2.1% | 0.10 SD3.5% | 2.9 | 0.05 SD1.9% | 0.07 SD2.4% |
| In-House | 2 | 7.0 | 0.07 SD1.0% | 0.09 SD1.3% | 7.1 | 0.07 SD0.9% | 0.09 SD1.3% |
| POL 1 | 2 | 7.0 | 0.04 SD0.6% | 0.07 SD1.1% | 7.1 | 0.07 SD0.9% | 0.18 SD2.5% |
| POL 2 | 2 | 6.7 | 0.08 SD1.2% | 0.14 SD2.1% | 6.7 | 0.07 SD1.1% | 0.22 SD3.2% |
| POL 3 | 2 | 7.2 | 0.04 SD0.6% | 0.07 SD1.0% | 7.4 | 0.10 SD1.4% | 0.13 SD1.7% |
| In-House | 3 | 11.1 | 0.14 SD1.2% | 0.18 SD1.6% | 11.3 | 0.09 SD0.8% | 0.11 SD0.9% |
| POL 1 | 3 | 11.1 | 0.13 SD1.2% | 0.14 SD1.3% | 11.3 | 0.16 SD1.4% | 0.27 SD2.4% |
| POL 2 | 3 | 10.9 | 0.12 SD1.1% | 0.21 SD1.9% | 10.6 | 0.15 SD1.4% | 0.21 SD1.9% |
| POL 3 | 3 | 11.4 | 0.13 SD1.1% | 0.18 SD1.6% | 11.7 | 0.11 SD0.9% | 0.14 SD1.2% |
.
.
{13}------------------------------------------------
| PerformanceData:Precision -POL | POL – Method Comparison for ACE Clinical Chemistry System | ||||
|---|---|---|---|---|---|
| Reagent | Statistic | ACE In-House (x) vs.ACEPOL 1 (y) | ACE In-House (x) vs.ACEPOL 2 (y) | ACE In-House (x) vs.ACEPOL 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 | ||
| InorganicPhosphorusU.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}------------------------------------------------
| PerformanceData: | 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 | ||
| InorganicPhosphorusU.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
| ACEReagents | Low LevelTested | Upper LevelTested | Linear to: | Linear RegressionEquation |
|---|---|---|---|---|
| ALB | 0.1 g/dL | 7.6 g/dL | 7.6 g/dL | y = 0.980x + 0.01r2 = 0.9982 |
| TP | 0.2 g/dL | 15.1 g/dL | 15.1 g/dL | y=0.991x + 0.04r2 = 0.9979 |
| CA | 0.3 g/dL | 16.5 mg/dL | 16.5 mg/dL | y=0.992x +0.27r2 = 0.9990 |
| PHOS | 0.2 mg/dL | 21 mg/dL | 21 mg/dL | y=1.001x +0.03r2 = 0.9995 |
{16}------------------------------------------------
Performance Data:
ACE Alera
Interferences - ACE Alera Clinical Chemistry System
| Interferentson 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 | ||
| ALBg/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% | |
| Serum High | 4.3 | 0.03, 0.7% | 0.10, 2.3% | |
| CAmg/dL | Serum Low | 6.5 | 0.08, 1.3% | 0.13, 2.1% |
| Serum Mid | 9.8 | 0.12, 1.2% | 0.22, 2.3% | |
| Serum High | 12.6 | 0.23, 1.8% | 0.29, 2.3% | |
| TPg/dL | Serum Low | 4.2 | 0.10, 2.3% | 0.11, 2.6% |
| Serum Mid | 6.8 | 0.09, 1.3% | 0.14, 2.1% | |
| Serum High | 10.1 | 0.23, 2.3% | 0.32, 3.1% | |
| PHOSmg/dL | Serum Low | 2.0 | 0.04, 2.3% | 0.11, 5.7% |
| Serum Mid | 3.8 | 0.12, 3.2% | 0.16, 4.2% | |
| Serum High | 6.5 | 0.17, 2.5% | 0.24, 3.6% |
{17}------------------------------------------------
| PerformanceData:ACE Alera | Method Comparison - ACE Alera Clinical Chemistry SystemIn-House ACE (x) versus In-House ACE Alera (y) | ||||
|---|---|---|---|---|---|
| ALB | TP | CA | PHOS | ||
| n | 50 | 56 | 55 | 55 | |
| Range | 1.0 - 6.4 g/dL | 0.2 - 13.6 g/dL | 0.2 - 13.7 mg/dL | 0.2 -18.4 mg/dL | |
| Slope | 1.005 | 1.009 | 0.991 | 1.006 | |
| Intercept | -0.03 | -0.01 | -0.02 | -0.01 | |
| CorrelationCoefficient | 0.9961 | 0.9988 | 0.9990 | 0.9994 | |
| Std. Error | 0.08 | 0.12 | 0.13 | 0.10 | |
| CI Slope | 0.979 to 1.030 | 0.995 to 1.022 | 0.979 to 1.003 | 0.997 to 1.016 | |
| CI Intercept | -0.13 to 0.08 | -0.10 to 0.08 | -0.13 to 0.08 | -0.06 to 0.03 | |
| Conclusions: | Based on the foregoing data, the device is safe and effective for use in clinical laboratoriesand physician office laboratories. This data indicates substantial equivalence for lithiumheparin plasma sample collection tubes to the predicate device's use of serum samplecollection tubes. This data also indicates that the ACE Alera Clinical Chemistry System issubstantially equivalent to the predicate device ACE Clinical Chemistry System. |
{18}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/18/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of a human figure embracing a globe, signifying the department's mission of protecting the health of all Americans and providing essential human services.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 19, 2013
Alfa Wassermann Diagnostic Technologies, LLC C/O Hyman Katz, Ph.D. 4 Henderson Drive WEST CALDWELL NJ 07006
Re: K131488
Trade/Device Name: ACE Albumin Reagent ACE Total Protein Reagent ACE Calcium-Arsenazo Reagent ACE Inorganic Phosphorus U.V. Reagent Regulation Number: 21 CFR 862.1035 Regulation Name: Albumin test system Regulatory Class: II
Product Code: CIX, CEK, CJY, CEO Dated: July 17, 2013 Received: July 18, 2013
Dear Dr. Katz:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2-Dr. Katz
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm 115800.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Salcty/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Carol C. Benson -S
for
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K131488
Device Name: ACE Albumin Reagent
-
ACE Albumin Reagent is intended for the quantitative determination of Indications for Use: 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.
Device Name: ACE Total Protein Reagent -
Indications for Use: 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.
Prescription Use X (21 CFR Part 801 Subpart D)
Over-The-Counter Use. (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE: CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of in Vitro Devices or Radiological Health (OIR)
Ruth A. Chesler -S
Division Sign-Off Office of In Vitro Devices or Radiological Health 510(k) K131488 .
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Indications for Use
510(k) Number (if known): K131488
Device Name: ACE Calcium-Arsenazo Reagent
-
ACE Calcium-Arsenazo Reagent is intended for the quantitative Indications for Use: 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.
Device Name: ACE Inorganic Phosphorus U.V. Reagent -
Indications for Use: 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.
Prescription Use X (21 CFR Part 801 Subpart D)
Over-The-Counter Use. (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of In Vitro Devices or Radiological Health (OIR)
Ruth A. Chesler -S
Division Sign-Off Office of In Vitro Devices or Radiological Health 510(k) K131488
§ 862.1035 Albumin test system.
(a)
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.(b)
Classification. Class II.