(97 days)
The ACE Alkaline Phosphatase Reagent is intended for the quantitative determination of alkaline phosphatase activity in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Measurements of alkaline phosphatase are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases. This test is intended for use in clinical laboratories and physician office laboratories. For in vitro diagnostic use only.
The ACE Amylase Reagent is intended for the quantitative determination of α-amylase activity in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas). This test is intended for use in clinical laboratories and physician office laboratories. For in vitro diagnostic use only.
The ACE ALT Reagent is intended for the quantitative determination of alanine aminotransferase activity in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Alanine aminotransferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases. This test is intended for use in clinical laboratories and physician office laboratories. For in vitro diagnostic use only.
The ACE AST Reagent is intended for the quantitative determination of aspartate aminotransferase activity in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Measurements of aspartate aminotransferase are used in the diagnosis and treatment of certain types of liver and heart disease. This test is intended for use in clinical laboratories and physician office laboratories. For in vitro diagnostic use only.
In the ACE Alkaline Phosphatase Reagent assay, alkaline phosphatase catalyzes the hydrolysis of colorless p-nitrophenyl phosphate to p-nitrophenol and inorganic phosphate. In an alkaline solution (pH 10.5), p-nitrophenol is in the phenoxide form and has a strong absorbance at 408 nm. The rate of increase in absorbance, monitored bichromatically at 408 nm/486 nm, is directly proportional to the alkaline phosphatase activity in the sample.
In the ACE Amylase Reagent assay, α-amylase hydrolyzes the 2-chloro-p-nitrophenyl-α-D-maltotrioside substrate to release 2-chloro-p-nitrophenol and form 2-chloro-p-nitrophenyl-α-D-maltoside, maltotriose and glucose. The rate of increase in absorbance, monitored bichromatically at 408 nm/ 647 nm, is directly proportional to the α-amylase activity in the sample.
In the ACE ALT Reagent assay, alanine aminotransferase converts the L-alanine and α-ketoglutarate substrates in the reagent to L-glutamate and pyruvate, respectively. Lactate dehydrogenase (LDH) catalyzes the oxidation of the reduced cofactor to the cofactor. The rate of conversion of the reduced cofactor to the cofactor can be determined by monitoring the decrease in absorbance bichromatically at 340 nm/647 nm. This rate of conversion from the reduced cofactor to the cofactor is a function of the activity of ALT in the sample.
In the ACE AST Reagent assay, aspartate aminotransferase converts the L-aspartate and α-ketoglutarate in the reagent to oxaloacetate and L-glutamate, respectively. The oxaloacetate undergoes reduction, with concurrent oxidation of NADH to NAD+ in the malate dehydrogenase-catalyzed indicator reaction. NADH absorbs strongly at 340 nm, whereas NAD+ does not. Therefore, the rate of conversion of NADH to NAD+ can be determined by monitoring the decrease in absorbance bichromatically at 340 nm/647 nm. This rate of conversion from NADH to NAD+ is a function of the activity of AST in the sample. Lactate dehydrogenase is added to prevent interference from endogenous pyruvate, which is normally present in blood.
Here's an analysis of the provided information regarding the acceptance criteria and study for the ACE reagents:
Summary of Acceptance Criteria and Reported Device Performance
The acceptance criteria for these in vitro diagnostic reagents (ALP, Amylase, ALT, AST) appear to be primarily demonstrated through comparisons with predicate devices and comprehensive performance characteristics like precision, linearity, and interference. The documentation focuses on demonstrating that the new devices perform equivalently to the existing predicate devices and meet established performance expectations for clinical chemistry assays.
1. Table of Acceptance Criteria and Reported Device Performance
Since this document describes multiple reagents and doesn't explicitly state pass/fail acceptance values for each performance metric, I will summarize the demonstrated performance and what can be inferred as the "acceptance criteria" (i.e., that the results are comparable to established predicate device performance and within acceptable clinical ranges).
| Performance Metric | Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Precision | Low total CV% (generally < 5-10% for clinical assays, often lower for high-precision analytes). Consistent across different instruments (ACE, Alera, Axcel) and sample types (serum, plasma). | ALP (Serum): Low: 1.9-2.3% Total CV; Mid: 1.0-1.3% Total CV; High: 0.7-1.7% Total CV.ALP (Plasma): Low: 3.7-5.1% Total CV; Mid: 3.3-4.0% Total CV; High: 2.9-3.1% Total CV.Amylase (Serum): Low: 2.1-3.4% Total CV; Mid: 1.2-1.4% Total CV; High: 1.2-1.9% Total CV.Amylase (Plasma): Low: 3.2-6.0% Total CV; Mid: 1.5-1.6% Total CV; High: 1.6-2.1% Total CV.ALT (Serum): Low: 3.3-4.0% Total CV; Mid: 1.6-2.0% Total CV; High: 1.5-1.9% Total CV.ALT (Plasma): Low: 4.0-4.7% Total CV; Mid: 1.0-1.4% Total CV; High: 0.7-1.4% Total CV.AST (Serum): Low: 3.3-5.7% Total CV; Mid: 1.5-1.8% Total CV; High: 1.3-1.6% Total CV.AST (Plasma): Low: 3.7-5.4% Total CV; Mid: 1.1-1.4% Total CV; High: 1.3-1.5% Total CV.POL Precision (ACE & Alera): Total CVs generally within similar ranges, demonstrating acceptable performance in Point of Care settings. Example: ALP Low on ACE ranges from 2.5-4.1% Total CV across POL sites. |
| Matrix Comparison (Serum vs. Plasma) | Slopes close to 1.0, intercepts close to 0, and correlation coefficients (R) close to 1.0 (e.g., >0.98 or 0.99) with narrow confidence intervals, indicating interchangeability of sample types. | ALP: Slopes 0.983-1.017, Intercepts -6.5 to -8.3, Correlations 0.9952-0.9982.Amylase: Slopes 0.977-0.994, Intercepts -1.76 to 1.7, Correlations 0.9994-0.9996.ALT: Slopes 0.985-1.003, Intercepts -3.35 to -3.6, Correlations 0.9986-0.9994.AST: Slopes 0.998-1.006, Intercepts 0.3 to 1.5, Correlations 0.9993-0.9998. All indicate a strong agreement between serum and plasma samples. |
| Method Comparison (vs. In-House ACE and POL sites) | Slopes close to 1.0, intercepts close to 0, and correlation coefficients (R) close to 1.0 (e.g., >0.98 or 0.99) with narrow confidence intervals, indicating consistency across different instruments and sites. | In-House ACE vs. POL ACE: • ALP: Slopes 0.977-0.989, Intercepts -9.5 to -2.8, Correlations 0.9987-0.9997.• AMY: Slopes 0.970-0.974, Intercepts 1.5-3.9, Correlations 0.9995-0.9998.• ALT: Slopes 0.982-1.021, Intercepts -4.7 to -2.3, Correlations 0.9978-0.9993.• AST: Slopes 0.992-1.019, Intercepts -0.6 to 2.4, Correlations 0.9989-0.9994.In-House ACE vs. POL Alera: • ALP: Slopes 0.997-1.029, Intercepts -6.6 to -4.1, Correlations 0.9986-0.9992.• AMY: Slopes 0.960-1.010, Intercepts 3.0-5.8, Correlations 0.9991-0.9995.• ALT: Slopes 0.970-1.019, Intercepts -3.5 to 2.4, Correlations 0.9977-0.9986.• AST: Slopes 1.004-1.040, Intercepts 0.5-1.8, Correlations 0.9992-0.9995.All indicate strong agreement between different sites and initial in-house testing, demonstrating substantial equivalence. |
| Detection Limits (LoB, LoD, LoQ) | Values below the clinical reference ranges and suitable for detecting low levels of analytes. | ACE Alera (Approximate):ALP: LoB 2.8, LoD 0.9, LoQ 4.8Amylase: LoB 0.2, LoD 3.3, LoQ 5.6ALT: LoB 1.6, LoD 4.8, LoQ 4.1AST: LoB 2.2, LoD 3.1, LoQ 3.3 |
| Linearity | Correlation coefficient (R^2) close to 1.0 (e.g., >0.99) over the specified measuring range, with slopes near 1 and intercepts near 0 for the regression equation. | ACE Alera: ALP: Linear to 1400 U/L, R^2 = 0.9993Amylase: Linear to 1900 U/L, R^2 = 0.9974ALT: Linear to 480 U/L, R^2 = 0.9992AST: Linear to 450 U/L, R^2 = 0.9992 |
| Interferences | No significant interference at stated concentrations of common interferents (Icterus, Hemolysis, Lipemia, Ascorbic Acid). | The document lists the tested concentrations of interferents (e.g., Icterus up to 70.6 mg/dL for ALP, Hemolysis up to 500 mg/dL for ALT, Lipemia up to 1000 mg/dL for ALP/Amylase, Ascorbic Acid 6 mg/dL for all). The implication, by inclusion in the performance data without negative remarks, is that these levels did not cause unacceptable interference. |
2. Sample Size Used for the Test Set and Data Provenance
- Precision (Serum vs. Plasma):
- In-House: Each dataset (low, mid, high for serum and plasma) involved "n=20" (number of replicates, likely over multiple days, contributing to within-run and total precision calculations).
- POL Precision (ACE & Alera): For each analyte (ALP, AMY, ALT, AST) and each POL site (POL 1, POL 2, POL 3), there were 2 to 3 sample levels (Low, Mid, High), with a reported "n" for each (e.g., n=24 for ALT/AST in initial in-house, but the POL tables don't explicitly state the 'n' for each specific mean/SD/CV, implying a standard number of replicates as per precision studies).
- Matrix Comparison (Serum vs. Plasma):
- ALP: ACE (108 pairs), ACE Alera (108 pairs), ACE Axcel (62 pairs).
- Amylase: ACE (104 pairs), ACE Alera (101 pairs), ACE Axcel (52 pairs).
- ALT: ACE (54 pairs), ACE Alera (52 pairs), ACE Axcel (56 pairs).
- AST: The number of pairs for AST in the serum vs. plasma matrix comparison is not explicitly stated in the provided snippet. However, based on the pattern of other analytes, it would likely be similar (e.g., 50+ pairs).
- Method Comparison (In-House vs. POL Sites):
- ALP: 49-50 samples per site.
- Amylase: 51 samples per site.
- ALT: 44-49 samples per site.
- AST: 50 samples per site.
- Linearity: Not explicitly stated as an "n" for samples, but rather as "low level tested," "upper level tested," and "linear to" values, which typically involve preparing a dilution series from a high concentration sample.
- Data Provenance: The studies are labeled "In-House" and "POL" (Point of Care). This suggests:
- Country of Origin: Likely the USA, given the FDA 510(k) submission.
- Retrospective or Prospective: These types of performance studies for IVDs are typically prospective, with samples analyzed specifically for the study. The method comparison data often uses a mix of native patient samples and spiked samples to cover the measuring range.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
This document describes the performance of IVD reagents on clinical chemistry systems. The "ground truth" here is not subjective, human interpretation (like in imaging AI), but rather the quantitative measurement of analytes.
- Number of Experts: Not applicable in the context of IVD reagent performance. The "ground truth" is established by the analytical method itself, or by comparison to a recognized reference method or a legally marketed predicate device.
- Qualifications of Experts: Not applicable. The "experts" would be qualified laboratory professionals operating the instruments and performing the biochemical assays according to established protocols.
4. Adjudication Method for the Test Set
Not applicable. As described above, the "truth" for these quantitative measurements is derived directly from the biochemical reactions and instrument readings, not subjective human judgment requiring adjudication. The predicate device's established performance serves as a comparative benchmark.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This is a submission for in vitro diagnostic reagents, not an AI-assisted diagnostic device that involves human readers interpreting images or complex data. Therefore, an MRMC study is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in essence, the performance data presented is "standalone" in the context of the device's function. The ACE reagents, when used on the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems, operate as an automated system to quantify the target analytes. The performance metrics (precision, linearity, method comparison, interferences) reflect the intrinsic analytical performance of the regent-analyzer combination without human intervention influencing the measurement itself. Human operators are involved in sample loading, quality control, and result review, but not in directly influencing the quantitative output in a way that would require a human-in-the-loop comparison for algorithm performance.
7. The Type of Ground Truth Used
The "ground truth" in this context is established by:
- Comparison to Predicate Devices: The primary method is demonstrating substantial equivalence to previously cleared devices (K113253, K931786, K930104, K113436, K113382). This means the new reagents provide results that are analytically comparable to those already accepted by the FDA.
- Expected Analytical Performance: Meeting industry-standard requirements for precision (low CV%), accuracy (linearity, inter-instrument/site agreement via regression analysis), and specificity (minimal interference).
- Expected Values/Ranges: The devices are expected to produce results that align with established "expected values" for healthy individuals.
8. The Sample Size for the Training Set
Not applicable. These are chemical reagents for quantitative diagnostic tests, not machine learning algorithms that require a "training set" in the conventional sense. The "training" for such systems involves analytical validation experiments to define reagent stability, reaction kinetics, and instrument parameters.
9. How the Ground Truth for the Training Set Was Established
Not applicable for the same reason as point 8. The "ground truth" for developing and validating these reagents is based on fundamental principles of analytical chemistry, biochemical reactions, and extensive internal testing to ensure the reagents perform as intended within the specified analytical parameters.
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131351
510(k) SUMMARY
| 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 5 2013 |
| Date SummaryPrepared: | July 3, 2013 | |
| Device: | Trade Name: | ACE Alkaline Phosphatase Reagent |
| Classification: | Class 2 | |
| Common/Classification Name: | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes(21 C. F.R. § 862.1050)Product Code CJE | |
| Trade Name: | ACE Amylase Reagent | |
| Classification: | Class 2 | |
| Common/Classification Name: | Saccharogenic, Amylase(21 C. F.R. § 862.1070)Product Code CIJ | |
| Trade Name: | ACE ALT Reagent | |
| Classification: | Class 1 | |
| Common/Classification Name: | NADH Oxidation/NAD Reduction, ALT/SGPT(21 C.F.R. § 862.1030)Product Code CKA | |
| Trade Name: | ACE AST Reagent | |
| Classification: | Class 2 | |
| Common/Classification Name: | NADH Oxidation/NAD Reduction, AST/SGOT(21 C.F.R. § 862.1100)Product Code CIT | |
| PredicateDevices: | Manufacturer for reagent system predicates:Alfa Wassermann ACE and ACE Axcel Clinical Chemistry Systems and ACEReagents (K113253, K931786, K930104, K113436, K113382) | |
| Device Descriptions: | In the ACE Alkaline Phosphatase Reagent assay, alkaline phosphatase catalyzes thehydrolysis of colorless p-nitrophenyl phosphate to p-nitrophenol and inorganicphosphate. In an alkaline solution (pH 10.5), p-nitrophenol is in the phenoxide formand has a strong absorbance at 408 nm. The rate of increase in absorbance, monitoredbichromatically at 408 nm/486 nm, is directly proportional to the alkaline phosphataseactivity in the sample.In the ACE Amylase Reagent assay, α-amylase hydrolyzes the 2-chloro-p-nitrophenyl-α-D-maltotrioside substrate to release 2-chloro-p-nitrophenol and form 2-chloro-p-nitrophenyl-α-D-maltoside, maltotriose and glucose. The rate of increase inabsorbance, monitored bichromatically at 408 nm/ 647 nm, is directly proportional tothe α-amylase activity in the sample.In the ACE ALT Reagent assay, alanine aminotransferase converts the L-alanine and α-ketoglutarate substrates in the reagent to L-glutamate and pyruvate, respectively.Lactate dehydrogenase (LDH) catalyzes the oxidation of the reduced cofactor to thecofactor. The rate of conversion of the reduced cofactor to the cofactor can bedetermined by monitoring the decrease in absorbance bichromatically at 340 nm/647nm. This rate of conversion from the reduced cofactor to the cofactor is a function ofthe activity of ALT in the sample.In the ACE AST Reagent assay, aspartate aminotransferase converts the L-aspartateand α-ketoglutarate in the reagent to oxaloacetate and L-glutamate, respectively. Theoxaloacetate undergoes reduction, with concurrent oxidation of NADH to NAD+ in the malate dehydrogenase-catalyzed indicator reaction. NADH absorbs strongly at 340 nm,whereas NAD+ does not. Therefore, the rate of conversion of NADH to NAD+ can bedetermined by monitoring the decrease in absorbance bichromatically at 340 nm/647nm. This rate of conversion from NADH to NAD+ is a function of the activity of ASTin the sample. Lactate dehydrogenase is added to prevent interference from endogenouspyruvate, which is normally present in blood. | |
| Intended Use: | Indications for Use:The ACE Alkaline Phosphatase Reagent is intended for the quantitative determinationof alkaline phosphatase activity in serum and lithium heparin plasma using the ACE,ACE Alera, and ACE Axcel Clinical Chemistry Systems. Measurements of alkalinephosphatase are used in the diagnosis and treatment of liver, bone, parathyroid, andintestinal diseases. This test is intended for use in clinical laboratories and physicianoffice laboratories. For in vitro diagnostic use only.The ACE Amylase Reagent is intended for the quantitative determination of α-amylaseactivity in serum and lithium heparin plasma using the ACE, ACE Alera, and ACEAxcel Clinical Chemistry Systems. Amylase measurements are used primarily for thediagnosis and treatment of pancreatitis (inflammation of the pancreas). This test isintended for use in clinical laboratories and physician office laboratories. For in vitrodiagnostic use only. | |
| Intended Use: | The ACE ALT Reagent is intended for the quantitative determination of alanineaminotransferase activity in serum and lithium heparin plasma using the ACE, ACEAlera, and ACE Axcel Clinical Chemistry Systems. Alanine aminotransferasemeasurements are used in the diagnosis and treatment of certain liver diseases (e.g.,viral hepatitis and cirrhosis) and heart diseases. This test is intended for use in clinicallaboratories and physician office laboratories. For in vitro diagnostic use only. | |
| The ACE AST Reagent is intended for the quantitative determination of aspartateaminotransferase activity in serum and lithium heparin plasma using the ACE, ACEAlera, and ACE Axcel Clinical Chemistry Systems. Measurements of aspartateaminotransferase are used in the diagnosis and treatment of certain types of liver andheart disease. This test is intended for use in clinical laboratories and physician officelaboratories. For in vitro diagnostic use only. | ||
| TechnologicalCharacteristics: | The ACE Alkaline Phosphatase Reagent is composed of two reagent bottles (Bufferand Substrate Reagent). The reagents contain AMP Buffer (pH 10.45), magnesiumacetate, and p-nitrophenyl phosphate. | |
| The ACE Amylase Reagent is composed of a single reagent bottle. The reagentscontain 2-chloro-p-nitrophenyl-a-D-maltotrioside, sodium chloride, calcium acetate,potassium thiocyanate, and MES buffer (pH 6.0). | ||
| The ACE ALT Reagent consists of two reagent bottles (Substrate and Coenzyme). Thereagents contain L-alanine, α-ketoglutarate, nicotinamide adenine dinucleotide-reduced(NADH), lactate dehydrogenase, and Tris buffer. | ||
| The ACE AST Reagent consists of two reagent bottles (Substrate and Coenzyme). Thereagents contain L-aspartate, α-ketoglutarate, nicotinamide adenine dinucleotide-reduced (NADH), malate dehydrogenase, lactate dehydrogenase, and Tris buffer. |
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| Comparison of similarities and differences with predicate device | ||
|---|---|---|
| Device Comparison with Predicate | ACE Alkaline Phosphatase Reagent | |
| ALP | Candidate Device | Predicate Device K931786 (ACE ALP) |
| Intended Use/ Indications for Use | The ACE Alkaline Phosphatase Reagent is intended for the quantitative determination of alkaline phosphatase activity. | Same |
| Platforms | ACE, ACE Alera®, and ACE Axcel Clinical Chemistry Systems | ACE Clinical Chemistry System |
| Method | Photometric | Same |
| Calibration Stability | Not a calibrated test | Same |
| On-Board Stability | SA2002: 20 DaysRX2002: 7 Days | Same |
| Sample Type | Serum and lithium heparin plasma | Serum |
| Sample Volume | 4 µL | Same |
| Reaction Volume | 169 µL | Same |
| Expected Values | 44 - 147 U/L | Same |
| Measuring Range | 9 - 1400 U/L | Same |
| Sample Stability | Serum ALP is stable for 7 days at 4-8°C and for 2 months at -20°C | Same |
| ACE Amylase Reagent | ||
| AMYLASE | Candidate Device | Predicate Device K931786 (ACE Amylase) |
| Intended Use/ Indications for Use | The ACE Amylase Reagent is intended for the quantitative determination of α-amylase activity. | Same |
| Platforms | ACE, ACE Alera®, and ACE Axcel Clinical Chemistry Systems | ACE Clinical Chemistry System |
| Method | Photometric | Same |
| Calibration Stability | Not a calibrated test | Same |
| On-Board Stability | 30 Days | Same |
| Sample Type | Serum and lithium heparin plasma | Serum |
| Sample Volume | 3 µL | Same |
| Reaction Volume | 168 µL | Same |
| Expected Values | 20 - 104 U/L | Same |
| Measuring Range | 9 - 1900 U/L | Same |
| ACE ALT Reagent | ||
| ALT | Candidate Device | Predicate DeviceK930104(ACE ALT) |
| Intended Use/Indications for Use | The ACE ALT Reagent is intended for thequantitative determination of alanineaminotransferase activity concentration. | Same |
| Platforms | ACE, ACE Alera®, and ACE Axcel ClinicalChemistry Systems | ACE ClinicalChemistry System |
| Method | Photometric | Same |
| Calibration Stability | Not a calibrated test | Same |
| On-Board Stability | 30 Days | Same |
| Sample Type | Serum and lithium heparin plasma | Serum |
| Sample Volume | 13 µL | Same |
| Reaction Volume | 185 µL | Same |
| Expected Values | 5 - 30 U/L | Same |
| Measuring Range | 4 - 480 U/L | Same |
| Sample Stability | Specimen is stable for 7 days at 4-8°C and -20°C. | Same |
| ACE AST Reagent | ||
| AST | Candidate Device | Predicate DeviceK930104(ACE AST) |
| Intended Use/Indications for Use | The ACE AST Reagent is intended for thequantitative determination of aspartateaminotransferase activity. | Same |
| Platforms | ACE, ACE Alera®, and ACE Axcel ClinicalChemistry Systems | ACE ClinicalChemistry System |
| Method | Photometric | Same |
| Calibration Stability | Not a calibrated test | Same |
| On-Board Stability | 30 Days | Same |
| Sample Type | Serum and lithium heparin plasma | Serum |
| Sample Volume | 13 µL | Same |
| Reaction Volume | 185 µL | Same |
| Expected Values | 7 - 31 U/L | Same |
| Measuring Range | 4 - 450 U/L | Same |
and the comments of the comments of the comments of the comments of
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Performance Data: In-House
Precision -Serum vs. Plasma
Performance data for the Alfa Wassermann ACE Reagents run on the Alfa Wassermann ACE, ACE Alera and ACE Axcel Clinical Chemistry Systems
In-House Precision: Serum vs. Plasma – ACE Alkaline Phosphatase Reagent
| Precision (SD, %CV) | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| ALP(n=20) | ACE | Alera | Axcel | ||||||
| Mean(U/L) | Within-Run | Total | Mean(U/L) | Within-Run | Total | Mean(U/L) | Within-Run | Total | |
| SerumLow | 92 | 1.2,1.3% | 1.9,2.0% | 91 | 0.8,0.9% | 2.0,2.2% | 90 | 1.2,1.3% | 2.1,2.3% |
| SerumMid | 649 | 6.3,1.0% | 8.6,1.3% | 642 | 6.4,1.0% | 6.4,1.0% | 645 | 6.8,1.0% | 6.9,1.1% |
| SerumHigh | 1198 | 20.2,1.7% | 20.8,1.7% | 1190 | 5.6,0.5% | 8.7,0.7% | 1194 | 6.1,0.5% | 7.9,0.7% |
| PlasmaLow | 76 | 1.9,2.5% | 2.8,3.7% | 75 | 0.8,1.1% | 3.4,4.6% | 74 | 1.1,1.5% | 3.7,5.1% |
| PlasmaMid | 614 | 5.8,0.9% | 24.4,4.0% | 609 | 5.1,0.8% | 20.2,3.3% | 613 | 3.4,0.6% | 20.5,3.3% |
| PlasmaHigh | 1163 | 6.8,0.6% | 33.5,2.9% | 1149 | 5.9,0.5% | 32.9,2.9% | 1155 | 7.6,0.7% | 35.7,3.1% |
In-House Precision: Serum vs. Plasma – ACE Amylase Reagent
| Precision (SD, %CV) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| AMY(n=20) | Mean(U/L) | Within-Run | Total | Mean(U/L) | Within-Run | Total | Mean(U/L) | Within-Run | Total | ||
| ACE | Alera | Axcel | |||||||||
| SerumLow | 46 | 0.7,1.5% | 0.9,2.1% | 46 | 1.0,2.1% | 1.5,3.3% | 46 | 1.2,2.6% | 1.6,3.4% | ||
| SerumMid | 830 | 9.2,1.1% | 11.5,1.4% | 825 | 5.1,0.6% | 11.9,1.4% | 826 | 9.2,1.1% | 11.9,1.4% | ||
| SerumHigh | 1597 | 15.0,0.9% | 19.8,1.2% | 1577 | 9.9,0.6% | 29.4,1.9% | 1586 | 8.5,0.5% | 18.6,1.2% | ||
| PlasmaLow | 41 | 0.7,1.8% | 1.3,3.2% | 42 | 0.5,1.3% | 1.5,3.5% | 41 | 1.0,2.5% | 2.5,6.0% | ||
| PlasmaMid | 806 | 8.1,1.0% | 12.5,1.5% | 801 | 4.4,0.5% | 13.1,1.6% | 805 | 5.3,0.7% | 12.2,1.5% | ||
| PlasmaHigh | 1604 | 15.4,1.0% | 29.3,1.8% | 1596 | 18.8,1.2% | 33.8,2.1% | 1604 | 21.6,1.3% | 25.0,1.6% |
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| Performance Data:In-HousePrecision –Serum vs.Plasma | In-House Precision: Serum vs. Plasma – ACE ALT Reagent | Precision (SD, %CV) | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| ALT(n=24) | Mean(U/L) | ACEWithin-Run | Total | Mean(U/L) | AleraWithin-Run | Total | Mean(U/L) | AxcelWithin-Run | Total | |
| Serum Low | 36 | 0.9,2.6% | 1.4,4.0% | 36 | 0.6,1.7% | 1.2,3.3% | 37 | 1.1,3.1% | 1.4,3.7% | |
| Serum Mid | 114 | 1.3,1.2% | 1.8,1.6% | 114 | 1.3,1.1% | 2.2,2.0% | 115 | 1.4,1.2% | 2.3,2.0% | |
| Serum High | 216 | 2.9,1.4% | 4.0,1.9% | 216 | 1.8,0.8% | 3.5,1.6% | 218 | 1.4,0.6% | 3.2,1.5% | |
| Plasma Low | 32 | 0.9,2.7% | 1.3,4.0% | 32 | 0.8,2.6% | 1.5,4.7% | 34 | 1.0,2.9% | 1.4,4.1% | |
| Plasma Mid | 112 | 1.1,1.0% | 1.5,1.4% | 112 | 0.9,0.8% | 1.1,1.0% | 113 | 1.0,0.9% | 1.5,1.4% | |
| Plasma High | 219 | 1.1,0.5% | 1.6,0.7% | 219 | 2.1,0.9% | 3.0,1.4% | 222 | 1.7,0.7% | 2.7,1.2% |
In-House Precision: Serum vs. Plasma – ACE AST Reagent
| Precision (SD, %CV) | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| AST(n=24) | Mean(U/L) | ACEWithin-Run | Total | Mean(U/L) | AleraWithin-Run | Total | Mean(U/L) | AxcelWithin-Run | Total |
| SerumLow | 26 | 0.7,2.6% | 1.2,4.5% | 25 | 0.7,2.7% | 0.8,3.3% | 25 | 1.1,4.3% | 1.4,5.7% |
| SerumMid | 155 | 1.3,0.8% | 2.7,1.8% | 155 | 1.0,0.7% | 2.8,1.8% | 155 | 0.7,0.5% | 2.3,1.5% |
| SerumHigh | 301 | 3.5,1.2% | 4.8,1.6% | 302 | 2.2,0.7% | 4.0,1.3% | 304 | 2.7,0.9% | 4.1,1.4% |
| PlasmaLow | 26 | 0.8,3.2% | 1.4,5.4% | 26 | 0.6,2.5% | 1.0,3.7% | 26 | 0.9,3.5% | 1.0,4.0% |
| PlasmaMid | 157 | 1.6,1.0% | 2.3,1.4% | 157 | 1.5,0.9% | 1.7,1.1% | 158 | 1.4,0.9% | 2.0,1.3% |
| PlasmaHigh | 304 | 3.5,1.2% | 4.5,1.5% | 303 | 2.6,0.9% | 3.9,1.3% | 305 | 3.2,1.1% | 4.3,1.4% |
{7}------------------------------------------------
| Performance Data:In-House MatrixComparison –Serum vs.Plasma | Performance data for the Alfa Wassermann ACE Reagents run on the Alfa Wassermann ACE, ACE Alera and ACE Axcel Clinical Chemistry SystemIn-House Matrix Comparison: Serum vs. Plasma – ACE ALP Reagent | |||
|---|---|---|---|---|
| System | Range | Results – Serum vs. Plasma | ||
| ACE108 pairs | 9 - 1274 U/L | Slope:Intercept:Correlation:Std. Error Est:Confidence Interval Slope:Confidence Interval Intercept: | 0.998-8.30.998013.50.986 to 1.010-11.5 to -5.1 | |
| ACE Alera108 pairs | 9 - 1202 U/L | Slope:Intercept:Correlation:Std. Error Est:Confidence Interval Slope:Confidence Interval Intercept: | 0.983-6.40.995220.20.965 to 1.002-11.2 to -1.6 | |
| ACE Axcel62 pairs | 11 - 1222 U/L | Slope:Intercept:Correlation:Std. Error Est:Confidence Interval Slope:Confidence Interval Intercept: | 1.017-6.50.998214.51.001 to 1.033-11.1 to -1.8 | |
| In-House Matrix Comparison: Serum vs. Plasma – ACE Amylase Reagent | ||||
| System | Range | Results – Serum vs. Plasma | ||
| ACE104 pairs | 11 - 1766 U/L | Slope:Intercept:Correlation:Std. Error Est:Confidence Interval Slope:Confidence Interval Intercept: | 0.9771.70.99958.80.970 to 0.983-0.2 to 3.6 | |
| ACE Alera101 pairs | 11 - 1703 U/L | Slope:Intercept:Correlation:Std. Error Est:Confidence Interval Slope:Confidence Interval Intercept: | 0.9790.90.99949.00.972 to 0.986-1.0 to 2.9 | |
| ACE Axcel52 pairs | 10 - 1890 U/L | Slope:Intercept:Correlation:Std. Error Est:Confidence Interval Slope:Confidence Interval Intercept: | 0.994-1.760.999611.540.986 to 1.0025.33 to 1.80 |
{8}------------------------------------------------
| In-House Matrix Comparison: Serum vs. Plasma – ACE ALT Reagent | |||
|---|---|---|---|
| Performance Data: | System | Range | Results - Serum vs. Plasma |
| In-House Matrix Comparison – Serum vs. Plasma | ACE54 pairs | 4 - 460 U/L | Slope: 1.003Intercept: -3.6Correlation: 0.9994Std. Error Est: 2.8Confidence Interval Slope: 0.994 to 1.013Confidence Interval Intercept: -4.5 to -2.8 |
| ACE Alera52 pairs | 5 - 463 U/L | Slope: 1.000Intercept: -3.6Correlation: 0.9986Std. Error Est: 4.3Confidence Interval Slope: 0.985 to 1.015Confidence Interval Intercept: -4.9 to -2.2 | |
| ACE Axcel56 pairs | 6 - 469 U/L | Slope: 0.985Intercept: -3.35Correlation: 0.9993Std. Error Est: 2.94Confidence Interval Slope: 0.976 to 0.995Confidence Interval Intercept: -4.24 to -2.47 |
{9}------------------------------------------------
| Performance Data:Precision - POL | POL - Precision for ACE and ACE Alera Clinical Chemistry Systems(Note: Please refer to previously cleared submissions K113436 (ALP and Amylase) andK113382 (ALT and AST) for ACE Axcel POL data) | PerformanceData at POL:Precision -POL | POL - Precision for ACE and ACE Alera Clinical Chemistry Systems | ALT | ACE ResultsU/L SD, %CV | ACE Alera ResultsU/L SD, %CV | AST | ACE ResultsU/L SD, %CV | ACE Alera ResultsU/L SD, %CV | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ACE Results | ACE Alera Results | ACE ResultsU/L SD, %CV | ACE Alera ResultsU/L SD, %CV | Lab | Sample | Mean | Within-Run | Total | Mean | Within-Run | Total | Lab | Sample | Mean | Within-Run | Total | Mean | Within-Run | Total | ||||||||||||||||
| ALP | U/L SD, %CV | Mean | U/L SD, %CV | AMY | Mean | Within-Run | Total | Mean | Within-Run | Total | In-House | 1 | 33 | 0.92.7% | 1.33.9% | 32 | 1.13.5% | 1.23.9% | In-House | 1 | 28 | 1.45.1% | 2.17.4% | 28 | 1.24.5% | 1.76.0% | |||||||||
| Lab | Sample | Mean | Within-Run | Total | Within-Run | Total | In-House | 1 | 39 | 1.02.7% | 1.33.2% | 39 | 0.82.1% | 1.43.5% | POL 1 | 1 | 26 | 0.51.9% | 1.76.4% | 28 | 1.45.1% | 2.48.4% | POL 1 | 1 | 23 | 0.93.7% | 1.46.0% | 26 | 1.03.8% | 1.35.1% | |||||
| In-House | 1 | 59 | 1.22.0% | 1.42.5% | 60 | 1.11.8% | 1.32.1% | POL 1 | 1 | 37 | 0.51.5% | 1.23.2% | 38 | 0.92.4% | 1.74.4% | POL 2 | 1 | 27 | 0.93.2% | 1.86.7% | 26 | 0.93.6% | 2.18.2% | POL 2 | 1 | 28 | 1.55.6% | 1.76.0% | 27 | 2.07.5% | 2.48.9% | ||||
| POL 1 | 1 | 55 | 0.71.4% | 2.34.1% | 56 | 0.81.4% | 1.73.0% | POL 2 | 1 | 39 | 0.71.9% | 0.92.4% | 40 | 1.33.2% | 1.33.2% | POL 3 | 1 | 30 | 1.03.4% | 1.75.7% | 29 | 2.17.5% | 2.48.4% | POL 3 | 1 | 26 | 0.72.7% | 2.07.7% | 29 | 2.99.9% | 2.99.9% | ||||
| POL 2 | 1 | 54 | 0.91.6% | 1.62.9% | 59 | 1.22.0% | 2.13.5% | POL 3 | 1 | 39 | 0.61.6% | 1.12.7% | 39 | 1.02.5% | 1.12.8% | In-House | 2 | 191 | 4.82.5% | 4.82.5% | 190 | 4.02.1% | 4.12.1% | In-House | 2 | 223 | 6.42.9% | 6.63.0% | 222 | 4.82.2% | 7.13.2% | ||||
| POL 3 | 1 | 57 | 1.01.8% | 1.52.6% | 56 | 1.42.5% | 3.05.4% | In-House | 2 | 741 | 7.11.0% | 8.61.2% | 747 | 4.40.6% | 7.31.0% | POL 1 | 2 | 189 | 1.20.6% | 1.60.8% | 193 | 1.70.9% | 2.01.0% | POL 1 | 2 | 220 | 2.21.0% | 4.01.8% | 220 | 2.00.9% | 3.21.5% | ||||
| In-House | 2 | 648 | 5.50.8% | 6.71.0% | 653 | 4.50.7% | 7.01.1% | POL 1 | 2 | 725 | 4.60.6% | 11.51.6% | 723 | 4.70.6% | 7.01.0% | POL 2 | 2 | 192 | 2.31.2% | 5.93.1% | 194 | 2.21.1% | 2.51.3% | POL 2 | 2 | 227 | 2.00.9% | 4.82.1% | 233 | 3.81.6% | 5.02.1% | ||||
| POL 1 | 2 | 632 | 6.91.1% | 13.42.1% | 626 | 7.41.2% | 16.72.7% | POL 2 | 2 | 727 | 7.41.0% | 8.21.1% | 770 | 4.30.6% | 6.10.8% | POL 3 | 2 | 188 | 2.91.5% | 3.92.1% | 195 | 3.51.8% | 5.02.6% | POL 3 | 2 | 223 | 2.61.2% | 4.72.1% | 229 | 5.32.3% | 7.23.2% | ||||
| POL 2 | 2 | 631 | 6.21.0% | 11.91.9% | 659 | 4.20.6% | 18.02.7% | POL 3 | 2 | 737 | 9.61.3% | 11.31.5% | 747 | 5.80.8% | 7.41.0% | In-House | 3 | 309 | 2.20.7% | 3.71.2% | 307 | 4.01.3% | 4.11.3% | In-House | 3 | 410 | 6.31.5% | 6.81.7% | 406 | 2.90.7% | 6.81.7% | ||||
| POL 3 | 2 | 642 | 3.70.6% | 8.61.3% | 640 | 5.90.9% | 21.93.4% | In-House | 3 | 1429 | 7.50.5% | 13.10.9% | 1437 | 11.60.8% | 12.80.9% | POL 1 | 3 | 304 | 4.01.3% | 4.41.4% | 309 | 3.11.0% | 3.61.2% | POL I | 3 | 416 | 5.01.2% | 5.51.3% | 416 | 7.81.9% | 9.22.2% | ||||
| In-House | 3 | 1191 | 7.00.6% | 10.70.9% | 1192 | 9.40.8% | 13.41.1% | POL 1 | 3 | 1389 | 18.11.3% | 27.82.0% | 1388 | 19.51.4% | 21.61.6% | POL 2 | 3 | 311 | 2.90.9% | 10.23.3% | 314 | 2.30.7% | 2.60.8% | POL 2 | 3 | 420 | 9.02.2% | 10.22.4% | 428 | 5.11.2% | 5.61.3% | ||||
| POL 1 | 3 | 1145 | 10.30.9% | 23.02.0% | 1135 | 19.01.7% | 25.02.2% | POL 2 | 3 | 1401 | 22.41.6% | 23.81.7% | 1500 | 10.30.7% | 11.70.8% | POL 3 | 3 | 303 | 3.41.1% | 5.01.6% | 310 | 8.52.8% | 9.13.0% | POL 3 | 3 | 407 | 3.90.9% | 7.31.8% | 417 | 8.22.0% | 12.12.9% | ||||
| POL 2 | 3 | 1159 | 12.81.1% | 17.21.5% | 1209 | 9.60.8% | 29.32.4% | POL 3 | 3 | 1410 | 12.90.9% | 15.71.1% | 1435 | 8.40.6% | 14.41.0% | ||||||||||||||||||||
| POL 3 | 3 | 1185 | 6.20.5% | 7.30.6% | 1165 | 6.60.6% | 37.23.2% |
{10}------------------------------------------------
{11}------------------------------------------------
{12}------------------------------------------------
{13}------------------------------------------------
| Performance Data:MethodComparison -POL on ACE | Reagent | Statistic | In-House ACE (x)vs.POL 1 ACE (y) | In-House ACE (x)vs.POL 2 ACE (y) | In-House ACE(x)vs.POL 3 ACE (y) |
|---|---|---|---|---|---|
| ALP | n | 49 | 50 | 50 | |
| Range | 58 to 1199 | 58 to 1199 | 58 to 1199 | ||
| Regression | $y = 0.989x - 9.5$ | $y = 0.977x - 7.9$ | $y = 0.982x - 2.8$ | ||
| Correlation | 0.9987 | 0.9997 | 0.9995 | ||
| Std. Error Est. | 12.4 | 5.9 | 7.4 | ||
| CI Slope | 0.975 to 1.004 | 0.970 to 0.984 | 0.973 to 0.990 | ||
| CI Intercept | -13.8 to -5.1 | -9.9 to -5.8 | -5.4 to -0.2 | ||
| AMY | n | 51 | 51 | 51 | |
| Range | 28 to 1732 | 28 to 1732 | 28 to 1732 | ||
| Regression | $y = 0.970x + 1.5$ | $y = 0.973x + 3.6$ | $y = 0.974x + 3.9$ | ||
| Correlation | 0.9995 | 0.9998 | 0.9998 | ||
| Std. Error Est. | 11.1 | 7.5 | 7.4 | ||
| CI Slope | 0.962 to 0.979 | 0.967 to 0.978 | 0.968 to 0.980 | ||
| CI Intercept | -2.1 to 5.2 | 1.1 to 6.0 | 1.5 to 6.3 | ||
| ALT | n | 44 | 47 | 49 | |
| Range | 6 to 442 | 6 to 442 | 6 to 442 | ||
| Regression | $y = 1.006x - 4.7$ | $y = 1.021x - 4.0$ | $y = 0.982x - 2.3$ | ||
| Correlation | 0.9978 | 0.9993 | 0.9981 | ||
| Std. Error Est. | 6.5 | 3.7 | 5.7 | ||
| CI Slope | 0.985 to 1.026 | 1.010 to 1.033 | 0.964 to 0.999 | ||
| CI Intercept | -6.9 to -2.4 | -5.2 to -2.8 | -4.1 to -0.4 | ||
| AST | n | 50 | 50 | 50 | |
| Range | 6 to 413 | 6 to 413 | 6 to 413 | ||
| Regression | $y = 0.999x - 0.6$ | $y = 1.019x + 2.4$ | $y = 0.992x + 0.6$ | ||
| Correlation | 0.9993 | 0.9989 | 0.9994 | ||
| Std. Error Est. | 3.9 | 4.9 | 3.6 | ||
| CI Slope | 0.988 to 1.010 | 1.005 to 1.033 | 0.982 to 1.003 | ||
| CI Intercept | -1.9 to 0.6 | 0.9 to 4.0 | -0.6 to 1.7 |
{14}------------------------------------------------
| PerformanceData at POL: | POL - Method Comparison for ACE Alera Clinical Chemistry System | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| MethodComparison - | In-House ACE (x) | In-House ACE (x) | In-House ACE (x) | ||||||
| POL on ACEAlera | Reagent | Statistic | vs.POL 1 Alera (y) | vs.POL 2 Alera (y) | vs.POL 3 Alera (y) | ||||
| રા | રેી | રેપ | |||||||
| nRange | 58 to 1199 | 58 to 1199 | 58 to 1199 | ||||||
| Regression | y = 0.997x - 4.6 | y = 1.029x - 4.1 | y = 1.010x - 6.6 | ||||||
| Correlation | 0.9992 | 0.9991 | 0.9986 | ||||||
| ALP | 10.1 | 10.8 | 13.0 | ||||||
| Std. Error Est. | 0.995 to 1.025 | ||||||||
| CI Slope | 0.985 to 1.008 | 1.016 to 1.041 | -11.2 to -2.1 | ||||||
| CI Intercept | -8.1 to -1.1રે I | -7.9 to -0.4રે । | ર I | ||||||
| n | 28 to 1732 | 28 to 1732 | 28 to 1732 | ||||||
| Range | y = 1.010x + 5.8 | y = 0.990x + 3.7 | |||||||
| RegressionCorrelation | y = 0.960x + 3.00.9991 | 0.9995 | 0.9995 | ||||||
| AMY | Std. Error Est. | 15.1 | 11.7 | 11.3 | |||||
| CI Slope | 0.948 to 0.971 | 1.001 to 1.018 | 0.981 to 0.999 | ||||||
| CI Intercept | -1.9 to 7.9 | 2.0 to 9.6 | 0.0 to 7.4 | ||||||
| n | રે રેપ | 48 | રે0 | ||||||
| Range | 6 to 442 | 6 to 442 | 6 to 442 | ||||||
| Regression | y = 1.019x - 0.5 | y = 1.012x - 3.5 | y = 0.970x + 2.4 | ||||||
| ALT | Correlation | 0.9986 | 0.9985 | 0.9977 | |||||
| Std. Error Est. | રું I | 5.3 | 6.1 | ||||||
| CI Slope | 1.003 to 1.035 | 0.995 to 1.028 | 0.951 to 0.990 | ||||||
| Cl Intercept | -2.1 to 1.1 | -5.3 to -1.8 | 0.5 to 4.4 | ||||||
| n | રેપ | ર૦ | રે) | ||||||
| Range | 6 to 413 | 6 to 413 | 6 to 413 | ||||||
| Regression | y = 1.028x + 1.4 | y = 1.040x + 0.5 | y = 1.004x + 1.8 | ||||||
| AST | Correlation | 0.9995 | 0.9992 | 0.9995 | |||||
| Std. Error Est. | 3.5 | 4.3 | 3.3 | ||||||
| CI Slope | 1.018 to 1.037 | 1.027 to 1.052 | 0.994 to 1.013 | ||||||
| CI Intercept | 0.3 to 2.5 | -0.8 to 1.9 | 0.8 to 2.9 | ||||||
{15}------------------------------------------------
Performance Data: Performance data for the Alfa Wassermann ACE Reagents run on the ACE Alera Alfa Wassermann ACE Alera Clinical Chemistry Systems Detection Limits - ACE Alera Clinical Chemistry System ACE Alera ALP Amylase ALT AST LoB (U/L) 2.8 0.2 1.6 2.2 : LoD (U/L) 0.9 3.3 4.8 3.1
4.8
LoQ (U/L)
Linearity - ACE Alera Clinical Chemistry System
5.6
4.1
3.3
| ACEReagents | Lowleveltested | Upperleveltested | Linear to: | LinearRegressionEquation | R^2 |
|---|---|---|---|---|---|
| ALP | 4.0U/L | 1401 U/L | 1400 U/L | $y = 0.998x - 0.5$ | 0.9993 |
| Amylase | 4.0U/L | 2012 U/L | 1900 U/L | $y = 1.013x + 0.2$ | 0.9974 |
| ALT | 3.1U/L | 504 U/L | 480 U/L | $y = 1.007x - 0.17$ | 0.9992 |
| AST | 3.0U/L | 491 U/L | 450 U/L | $y = 1.013x + 0.24$ | 0.9992 |
{16}------------------------------------------------
| Performance Data:ACE Alera | Interferences - ACE Alera Clinical Chemistry System | ||||
|---|---|---|---|---|---|
| Interferents onACE Alera | ALP | Amylase | ALT | AST | |
| Icterus | 70.6 mg/dL | 30.0 mg/dL | 50 mg/dL | 50 mg/dL | |
| Hemolysis | 62.5 mg/dL | 62.5 mg/dL | 500 mg/dL | 62.5 mg/dL | |
| Lipemia | 1000 mg/dL | 1000 mg/dL | 419 mg/dL | 439 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 | Mean | Precision (SD, %CV) | |||
| Within-Run | Total | ||||
| ALPU/L | Low | 43 | 0.9, 2.2% | 1.9, 4.5% | |
| Mid | 164 | 2.8, 1.7% | 5.5, 3.4% | ||
| High | 339 | 5.3, 1.6% | 8.9, 2.6% | ||
| AMYLASEU/L | Low | 45 | 0.9, 2.1% | 1.5, 3.3% | |
| Mid | 139 | 1.7, 1.2% | 3.9, 2.8% | ||
| High | 311 | 5.0, 1.6% | 7.7, 2.5% | ||
| ALTU/L | Low | 37 | 1.2, 3.3% | 1.8, 4.9% | |
| Mid | 181 | 2.2, 1.2% | 3.2, 1.8% | ||
| High | 320 | 5.2, 1.6% | 5.2, 1.6% | ||
| ASTU/L | Low | 34 | 1.1, 3.3% | 1.5, 4.4% | |
| Mid | 175 | 3.5, 2.0% | 3.6, 2.1% | ||
| High | 347 | 6.3, 1.8% | 6.4, 1.9% |
:
{17}------------------------------------------------
| PerformanceData:ACE Alera | Method Comparison - ACE Alera Clinical Chemistry SystemIn-House ACE (x) vs. In-House ACE Alera (y) | |||
|---|---|---|---|---|
| ALP | Amylase | ALT | AST | |
| n | 60 | 57 | 50 | 50 |
| Range (U/L) | 9 to 1199 | 10 to 1732 | 6 to 442 | 6 to 413 |
| Slope | 0.991 | 0.995 | 0.988 | 1.006 |
| Intercept | 0.5 | 2.9 | 1.3 | 1.5 |
| CorrelationCoefficient | 0.9999 | 0.9998 | 0.9999 | 0.9998 |
| Std. Error | 3.5 | 6.6 | 1.6 | 1.9 |
| CI Slope | 0.987 to 0.995 | 0.990 to 1.000 | 0.983 to 0.992 | 1.001 to 1.012 |
| CI Intercept | -0.5 to 1.6 | 0.9 to 4.9 | 0.8 to 1.8 | 0.9 to 2.2 |
| Conclusions: | Based on the foregoing data, the device is safe and effective for use in clinicallaboratories and physician office laboratories. These data indicate substantial equivalencefor lithium heparin plasma sample collection tubes to the predicate device's use of serumsample collection tubes. |
{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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an eagle or bird-like figure with three wing-like shapes.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 15, 2013
Alfa Wassermann Diagnostic Technologies, LLC C/O Hyman Katz, Ph.D. 4 Henderson Drive WEST CALDWELL NJ 07006
Re: K131351 Trade/Device Name: ACE Alkaline Phosphatase Reagent ACE Amylase Reagent ACE ALT Reagent ACE AST Reagent Regulation Number: 21 CFR 862.1050 Regulation Name: Alkaline phosphatase or isoenzymes test system Regulatory Class: II Product Code: CJE, CJE, CKA, CIT Dated: July 8, 2013 Received: July 9, 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, Drig 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, ilstig 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 mastering.
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 nequirements 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 madical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (7) CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 100-1050.
{19}------------------------------------------------
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fila.gov/AboutFDA/Conters/CDRH001 (21 CPR Par 801), please
the Center for Devices and AboutFDA/Centers/CDRHOITices/ucm I 15809.html for the Center for Devices and Radiological Health's (CDRHCHICENCESTLEMILLING Tor
note the required antitled With Li note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding of reference to premation (21CFR Party of CFR Party (21 CFR Part 803), please go to
http://www.fdagov/MedicalDevices/Safety/ReportalProblem/default.hum 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 tolli the (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
{20}------------------------------------------------
Indications for Use
510(k) Number (if known): k131351_________________________________________________________________________________________________________________________________________
Device Name: ACE Alkaline Phosphatase Reagent The ACE Alkaline Phosphatase Reagent is intended for the Indications for Use: quantitative determination of alkaline phosphatase activity in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Measurements of alkaline phosphatase are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases. This test is intended for, von in, clinical laboratories and physician office laboratories. For in vitro diagnostic use only.
Device Name: ACE Amylase Reagent
Indications for Use: The ACE Amylase Reagent is intended for the quantitative determination of a-amylase activity in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas). This test is intended for use in clinical laboratories and physician office laboratories. For in vitro diagnostic use only.
Prescription Use X AND/OR Over-The-Counter Use. (21 CFR Part 801 Subpart D) (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
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) K131351
Page 1 of 2
{21}------------------------------------------------
Indications for Use
510(k) Number (if known): ___k131351
Device Name: ACE ALT Reagent
The ACE ALT Reagent is intended for the quantitative Indications for Use: determination of alanine aminotransferase activity in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Alanine aminotransferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases. This test is intended for use in clinical laboratories and physician office laboratories. For in vitro diagnostic use only.
Device Name: ACE AST Reagent
Indications for Use: The ACE AST Reagent is intended for the quantitative determination of aspartate aminotransferase activity in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Measurements of aspartate aminotransferase are used in the diagnosis and treatment of certain types of liver and heart disease. This test is intended for use in clinical laboratories and 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)
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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) ======================================================================================================================================================================= K131351
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§ 862.1050 Alkaline phosphatase or isoenzymes test system.
(a)
Identification. An alkaline phosphatase or isoenzymes test system is a device intended to measure alkaline phosphatase or its isoenzymes (a group of enzymes with similar biological activity) in serum or plasma. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.(b)
Classification. Class II.