(132 days)
The ACE Carbon Dioxide (CO2-LC) Reagent is intended for the quantitative determination of carbon dioxide concentration in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
The ACE Direct Bilirubin Reagent is intended for the quantitative determination of direct bilirubin concentration in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic, hematological and metabolic disorders, including hepatitis and gall bladder block. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
The ACE Total Bilirubin Reagent is intended for the quantitative determination of total bilirubin concentration in serum and lithium heparin plasma using the ACE, ACE Alera and ACE Axcel Clinical Chemistry System. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic, hematological and metabolic disorders, including hepatitis and gall bladder block. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
The ACE Magnesium Reagent is intended for the quantitative determination of magnesium in serum and lithium heparin plasma using the ACE, ACE Alera and ACE Axcel Clinical Chemistry Systems. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium). This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
In the ACE Carbon Dioxide (CO2-LC) Reagent assay, serum carbon dioxide (in the form of bicarbonate) reacts with phosphoenolpyruvate in the presence of phosphoenolpyruvate carboxylase and magnesium to yield oxaloacetic acid and phosphate. In the presence of malate dehydrogenase, the reduced cofactor is oxidized by oxaloacetic acid. The reduced cofactor absorbs strongly at 408 nm whereas its oxidized form does not. The rate of decrease in absorbance, monitored bichromatically at 408 nm/692 nm, is proportional to the carbon dioxide content of the sample.
In the ACE Direct Bilirubin Reagent assay, sodium nitrite added to sulfanilic acid forms diazotized sulfanilic acid. Bilirubin glucuronide in serum reacts with diazotized sulfanilic acid to form azobilirubin, which absorbs strongly at 554 nm. The increase in absorbance, measured bichromatically at 554 nm/692 nm, one minute after sample addition, is directly proportional to the direct bilirubin concentration.
In the ACE Total Bilirubin Reagent assay, sodium nitrite, when added to sulfanilic acid, forms diazotized sulfanilic acid. Bilirubin in serum reacts with diazotized sulfanilic acid to form azobilirubin, which absorbs strongly at 554 nm. The inclusion of dimethyl sulfoxide (DMSO) in the reagent as an accelerator causes both direct and indirect bilirubin to react rapidly. The increase in absorbance, measured bichromatically at 554 nm/692 nm, is directly proportional to the total bilirubin concentration in the sample.
Magnesium ions in serum react with Xylidyl blue-1 in an alkaline medium to produce a red complex which is measured bichromatically at 525 nm/692 nm. The intensity of color produced is directly proportional to the magnesium concentration in the sample. EGTA prevents calcium interference by preferential chelation of calcium present in the sample. A surfactant system is included to remove protein interference.
The provided text describes several in vitro diagnostic reagents (ACE Carbon Dioxide (CO2-LC) Reagent, ACE Direct Bilirubin Reagent, ACE Total Bilirubin Reagent, and ACE Magnesium Reagent) and their associated performance data. There isn't information about an AI-powered device or software. Therefore, questions related to AI aspects like multi-reader multi-case studies, effect size of AI assistance, or standalone algorithm performance are not applicable.
The acceptance criteria are not explicitly stated as clear thresholds in the provided document; rather, the document presents detailed performance data (precision, linearity, interference, and method comparison) that demonstrates the device's capability to perform as intended and to be substantially equivalent to its predicate devices. The "reported device performance" is presented directly through tables and statistical analyses for each reagent.
Here's an attempt to structure the available information based on the request, interpreting "acceptance criteria" as the performance demonstrated to support substantial equivalence:
1. Table of Acceptance Criteria and Reported Device Performance
Since explicit "acceptance criteria" (i.e., predefined thresholds for performance metrics) are not provided in the document, the "Reported Device Performance" below represents the data presented that presumably met the internal criteria for demonstrating substantial equivalence. The document primarily focuses on precision, linearity, interference, and method comparison with predicate devices and between different systems (ACE, ACE Alera, ACE Axcel).
ACE Carbon Dioxide (CO2-LC) Reagent
| Metric | Acceptance Criteria (Inferred from study design and historical data, not explicitly stated values) | Reported Device Performance (Summary of results across systems/sites) |
|---|---|---|
| Precision (In-House) | (Implied to be comparable to or better than predicate and acceptable for clinical use) | Serum: Low: ~1.1-2.5% CV (Within-Run), ~5.6-7.5% CV (Total)Mid: ~1.2-1.5% CV (Within-Run), ~3.3-3.7% CV (Total)High: ~0.6-2.8% CV (Within-Run), ~2.6-3.2% CV (Total)Plasma:Low: ~1.3-3.0% CV (Within-Run), ~3.8-6.1% CV (Total)Mid: ~0.7-1.2% CV (Within-Run), ~5.0-5.5% CV (Total)High: ~1.0% CV (Within-Run), ~2.3-2.5% CV (Total) |
| Precision (POL sites) | (Implied to be comparable to in-house and acceptable for clinical use) | ACE: Low (Sample 1): ~1.6-3.3% CV (Within-Run), ~3.0-4.3% CV (Total)Mid (Sample 2): ~1.7-3.1% CV (Within-Run), ~2.7-7.4% CV (Total)High (Sample 3): ~1.8-2.4% CV (Within-Run), ~2.4-6.4% CV (Total)ACE Alera: Low (Sample 1): ~1.3-2.0% CV (Within-Run), ~3.0-6.7% CV (Total)Mid (Sample 2): ~0.9-1.7% CV (Within-Run), ~2.4-3.9% CV (Total)High (Sample 3): ~1.0-1.6% CV (Within-Run), ~3.1-5.8% CV (Total) |
| Method Comparison (Serum vs. Plasma) | (Slope near 1, intercept near 0, high correlation) | ACE: Slope: 1.031, Intercept: -1.03, Correlation: 0.9922ACE Alera: Slope: 1.000, Intercept: -0.09, Correlation: 0.9955ACE Axcel: Slope: 0.988, Intercept: -0.35, Correlation: 0.9889 |
| Method Comparison (POL vs. In-House) | (Slope near 1, intercept near 0, high correlation) | ACE (POL 1-3 vs. In-House ACE): Slopes: 0.963-0.984, Intercepts: -0.71-1.29, Correlations: 0.9530-0.9908 ACE Alera (POL 1-3 vs. In-House ACE): Slopes: 0.972-0.987, Intercepts: 0.10-0.57, Correlations: 0.9767-0.9903 |
| Detection Limits (ACE Alera) | (Appropriate for clinical use) | LoB: 1.27 mEq/L, LoD: 1.97 mEq/L, LoQ: 3.03 mEq/L |
| Linearity (ACE Alera) | (Linearity up to/beyond desired measuring range) | Linear to: 50 mEq/L (Equation: y=1.006x + 0.01) |
| Interferences (ACE Alera) | (No significant interference from common interferents) | No significant interference at or below Icterus 58.8 mg/dL, Hemolysis 250 mg/dL, Lipemia 2388 mg/dL, Ascorbic Acid 6 mg/dL |
ACE Direct Bilirubin Reagent
| Metric | Acceptance Criteria (Inferred from study design and historical data, not explicitly stated values) | Reported Device Performance (Summary of results across systems/sites) |
|---|---|---|
| Precision (In-House) | (Implied to be comparable to or better than predicate and acceptable for clinical use) | Serum: Low: ~12.5-24.5% CV (Within-Run), ~14.0-30.0% CV (Total)Mid: ~0.9-1.6% CV (Within-Run), ~1.2-2.2% CV (Total)High: ~0.6-1.5% CV (Within-Run), ~1.1-1.7% CV (Total)Plasma:Low: ~16.6-26.6% CV (Within-Run), ~19.7-35.4% CV (Total)Mid: ~0.8-2.4% CV (Within-Run), ~1.1-2.8% CV (Total)High: ~0.7-1.9% CV (Within-Run), ~1.1-2.3% CV (Total) |
| Precision (POL sites) | (Implied to be comparable to in-house and acceptable for clinical use) | ACE: Low (Sample 1): ~2.9-4.2% CV (Within-Run), ~2.9-4.9% CV (Total)Mid (Sample 2): ~1.0-1.8% CV (Within-Run), ~1.3-2.1% CV (Total)High (Sample 3): ~1.3-2.3% CV (Within-Run), ~2.0-2.3% CV (Total)ACE Alera: Low (Sample 1): ~2.5-5.1% CV (Within-Run), ~2.5-5.4% CV (Total)Mid (Sample 2): ~1.0-1.5% CV (Within-Run), ~1.0-1.9% CV (Total)High (Sample 3): ~0.6-2.6% CV (Within-Run), ~1.3-2.6% CV (Total) |
| Method Comparison (Serum vs. Plasma) | (Slope near 1, intercept near 0, high correlation) | ACE: Slope: 1.021, Intercept: 0.00, Correlation: 0.9982ACE Alera: Slope: 1.005, Intercept: 0.01, Correlation: 0.9978ACE Axcel: Slope: 1.004, Intercept: 0.00, Correlation: 0.9983 |
| Method Comparison (POL vs. In-House) | (Slope near 1, intercept near 0, high correlation) | ACE (POL 1-3 vs. In-House ACE): Slopes: 1.003-1.022, Intercepts: 0.04-0.11, Correlations: 0.9984-0.9986 ACE Alera (POL 1-3 vs. In-House ACE): Slopes: 0.969-0.995, Intercepts: 0.09-0.11, Correlations: 0.9984-0.9991 |
| Detection Limits (ACE Alera) | (Appropriate for clinical use) | LoB: 0.06 mg/dL, LoD: 0.08 mg/dL, LoQ: 0.12 mg/dL |
| Linearity (ACE Alera) | (Linearity up to/beyond desired measuring range) | Linear to: 14.0 mg/dL (Equation: y=1.015x + 0.16) |
| Interferences (ACE Alera) | (No significant interference from common interferents) | Not Applicable (Icterus), No significant interference at or below Hemolysis 62.5 mg/dL, Lipemia 782 mg/dL, Ascorbic Acid 6 mg/dL |
ACE Total Bilirubin Reagent
| Metric | Acceptance Criteria (Inferred from study design and historical data, not explicitly stated values) | Reported Device Performance (Summary of results across systems/sites) |
|---|---|---|
| Precision (In-House) | (Implied to be comparable to or better than predicate and acceptable for clinical use) | Serum: Low: ~11.0-21.3% CV (Within-Run), ~13.9-21.3% CV (Total)Mid: ~1.0-1.1% CV (Within-Run), ~1.0-1.1% CV (Total)High: ~0.4-0.7% CV (Within-Run), ~0.5-0.8% CV (Total)Plasma:Low: ~20.3-23.7% CV (Within-Run), ~21.3-29.4% CV (Total)Mid: ~0.5-1.0% CV (Within-Run), ~0.5-1.1% CV (Total)High: ~0.5-0.6% CV (Within-Run), ~0.5-0.7% CV (Total) |
| Precision (POL sites) | (Implied to be comparable to in-house and acceptable for clinical use) | ACE: Low (Sample 1): ~3.4-5.5% CV (Within-Run), ~3.7-5.8% CV (Total)Mid (Sample 2): ~0.5-1.7% CV (Within-Run), ~1.3-3.7% CV (Total)High (Sample 3): ~1.0-1.2% CV (Within-Run), ~1.2-2.1% CV (Total)ACE Alera: Low (Sample 1): ~4.2-4.9% CV (Within-Run), ~4.5-5.2% CV (Total)Mid (Sample 2): ~0.7-2.0% CV (Within-Run), ~0.8-2.1% CV (Total)High (Sample 3): ~0.5-1.4% CV (Within-Run), ~0.6-1.7% CV (Total) |
| Method Comparison (Serum vs. Plasma) | (Slope near 1, intercept near 0, high correlation) | ACE: Slope: 1.017, Intercept: 0.01, Correlation: 0.9996ACE Alera: Slope: 1.020, Intercept: 0.00, Correlation: 0.9993ACE Axcel: Slope: 1.008, Intercept: 0.00, Correlation: 0.9995 |
| Method Comparison (POL vs. In-House) | (Slope near 1, intercept near 0, high correlation) | ACE (POL 1-3 vs. In-House ACE): Slopes: 0.979-1.000, Intercepts: 0.00-0.04, Correlations: 0.9995-0.9998 ACE Alera (POL 1-3 vs. In-House ACE): Slopes: 0.957-1.020, Intercepts: 0.01-0.07, Correlations: 0.9991-0.9998 |
| Detection Limits (ACE Alera) | (Appropriate for clinical use) | LoB: 0.11 mg/dL, LoD: 0.14 mg/dL, LoQ: 0.14 mg/dL |
| Linearity (ACE Alera) | (Linearity up to/beyond desired measuring range) | Linear to: 40.0 mg/dL (Equation: y=1.004x + 0.03) |
| Interferences (ACE Alera) | (No significant interference from common interferents) | Not Applicable (Icterus), No significant interference at or below Hemolysis 62.5 mg/dL, Lipemia 951 mg/dL, Ascorbic Acid 6 mg/dL |
ACE Magnesium Reagent
| Metric | Acceptance Criteria (Inferred from study design and historical data, not explicitly stated values) | Reported Device Performance (Summary of results across systems/sites) |
|---|---|---|
| Precision (In-House) | (Implied to be comparable to or better than predicate and acceptable for clinical use) | Serum: Low: ~3.1-5.1% CV (Within-Run), ~4.3-5.9% CV (Total)Mid: ~1.7-2.6% CV (Within-Run), ~1.8-3.0% CV (Total)High: ~1.0-1.4% CV (Within-Run), ~1.6-1.7% CV (Total)Plasma:Low: ~2.4-4.7% CV (Within-Run), ~4.1-6.8% CV (Total)Mid: ~2.4-2.8% CV (Within-Run), ~2.6-3.7% CV (Total)High: ~0.9-1.6% CV (Within-Run), ~1.8-1.9% CV (Total) |
| Precision (POL sites) | (Implied to be comparable to in-house and acceptable for clinical use) | ACE: Low (Sample 1): ~3.3-4.6% CV (Within-Run), ~5.0-6.3% CV (Total)Mid (Sample 2): ~1.3-2.5% CV (Within-Run), ~2.8-3.5% CV (Total)High (Sample 3): ~1.1-1.8% CV (Within-Run), ~1.4-3.1% CV (Total)ACE Alera: Low (Sample 1): ~3.0-6.0% CV (Within-Run), ~4.5-8.4% CV (Total)Mid (Sample 2): ~2.0-2.9% CV (Within-Run), ~2.5-5.2% CV (Total)High (Sample 3): ~0.9-1.9% CV (Within-Run), ~1.6-4.8% CV (Total) |
| Method Comparison (Serum vs. Plasma) | (Slope near 1, intercept near 0, high correlation) | ACE: Slope: 0.957, Intercept: 0.04, Correlation: 0.9765ACE Alera: Slope: 0.986, Intercept: 0.05, Correlation: 0.9817ACE Axcel: Slope: 0.986, Intercept: 0.025, Correlation: 0.9892 |
| Method Comparison (POL vs. In-House) | (Slope near 1, intercept near 0, high correlation) | ACE (POL 1-3 vs. In-House ACE): Slopes: 0.970-1.026, Intercepts: -0.04-0.16, Correlations: 0.9902-0.9927 ACE Alera (POL 1-3 vs. In-House ACE): Slopes: 0.990-1.010, Intercepts: -0.11-0.00, Correlations: 0.9870-0.9930 |
| Detection Limits (ACE Alera) | (Appropriate for clinical use) | LoB: 0.26 mg/dL, LoD: 0.37 mg/dL, LoQ: 0.37 mg/dL |
| Linearity (ACE Alera) | (Linearity up to/beyond desired measuring range) | Linear to: 6.1 mg/dL (Equation: y=0.959x + 0.27) |
| Interferences (ACE Alera) | (No significant interference from common interferents) | No significant interference at or below Icterus 50 mg/dL, Hemolysis 500 mg/dL, Lipemia 620 mg/dL, Ascorbic Acid 6 mg/dL |
2. Sample Size Used for the Test Set and the Data Provenance
The document describes several types of studies:
-
In-House Precision:
- CO2-LC: Low, Mid, High serum and plasma samples were tested (number of replicates per sample and runs is implicitly part of SD/CV calculation, but not explicitly stated).
- Direct Bilirubin: Low, Mid, High serum and plasma samples.
- Total Bilirubin: Low, Mid, High serum and plasma samples.
- Magnesium: Low, Mid, High serum and plasma samples.
- Data Provenance: In-house (Alfa Wassermann Diagnostic Technologies, LLC, West Caldwell, NJ), prospective testing.
-
POL (Physician Office Laboratory) Precision: Studies conducted at 3 POL sites.
- CO2-LC: 3 samples at each of 3 POL sites and in-house.
- Direct Bilirubin: 3 samples at each of 3 POL sites and in-house.
- Total Bilirubin: 3 samples at each of 3 POL sites and in-house.
- Magnesium: 3 samples at each of 3 POL sites and in-house.
- Data Provenance: Not explicitly stated but inferred to be from POLs in the USA (prospective testing under typical POL conditions).
-
In-House Matrix Comparison (Serum vs. Plasma):
- CO2-LC: 53-54 pairs (serum/plasma) on ACE and ACE Alera; 51 pairs on ACE Axcel.
- Direct Bilirubin: 102 pairs on ACE; 101 pairs on ACE Alera; 56 pairs on ACE Axcel.
- Total Bilirubin: 102 pairs on ACE and ACE Alera; 56 pairs on ACE Axcel.
- Magnesium: 101 pairs on ACE and ACE Alera; 55 pairs on ACE Axcel.
- Data Provenance: In-house, retrospective (presumably collected for a range of values).
-
POL Method Comparison (In-House ACE vs. POL ACE/Alera):
- CO2-LC: 45-46 samples per POL site comparison.
- Direct Bilirubin: 49-51 samples per POL site comparison.
- Total Bilirubin: 48-50 samples per POL site comparison.
- Magnesium: 50-52 samples per POL site comparison.
- Data Provenance: Not explicitly stated but inferred to be from POLs in the USA (prospective testing under typical POL conditions) compared against in-house data.
-
Detection Limits (LoB, LoD, LoQ), Linearity, Interferences (ACE Alera):
- Sample sizes for detection limits and linearity: Not explicitly stated, typically involves multiple replicates at various concentrations.
- Sample sizes for interferences: Not explicitly stated, typically involves samples spiked with various concentrations of interferents.
- Data Provenance: In-house.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the document. For in vitro diagnostic assays, the "ground truth" is typically the reference method or established clinical laboratory results obtained from a highly accurate and calibrated instrument or laboratory using validated methods, rather than human expert consensus for image or clinical interpretation. The document compares performance against other (presumably established) methods and predicate devices.
4. Adjudication Method for the Test Set
This concept (e.g., 2+1, 3+1 for resolving discrepancies) is not applicable to these types of in vitro diagnostic device studies. Performance is measured numerically and objectively.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This is an in vitro diagnostic assay, not an AI-powered diagnostic imaging device.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm. The performance data presented are for the reagent and instrument system.
7. The Type of Ground Truth Used
For precision studies, the "ground truth" is the true concentration of the analyte in the control material or patient sample, which is established by reference methods or manufacturing specifications of the control materials. For method comparison studies, the predicate device's results or an established in-house method are used as the comparative reference. The document states the intended use is for "quantitative determination" of analytes, implying comparison to a quantitative gold standard.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning device and therefore does not have a "training set" in that context. The development of reagents and the establishment of their performance characteristics do not involve machine learning training sets.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no "training set" for these reagents in the context of AI/ML.
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. K123953
510(k) SUMMARY
·
·
MAY 2 2013
| 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 | ||
| Date Summary Prepared: | April 25, 2013 | ||
| Device: | Trade Name: | ACE Carbon Dioxide (CO2-LC) Reagent | |
| Classification: | Class 2 | ||
| Common/Classification Name: | Enzymatic, Carbon-Dioxide(21 C. F.R. § 862.1160)Product Code KHS | ||
| Trade Name: | ACE Direct Bilirubin Reagent | ||
| Classification: | Class 2 | ||
| Common/Classification Name: | Diazo Colorimetry, Bilirubin(21 C. F.R. § 862.1110)Product Code CIG | ||
| Trade Name: | ACE Total Bilirubin Reagent | ||
| Classification: | Class 2 | ||
| Common/Classification Name: | Diazo Colorimetry, Bilirubin(21 C. F.R. § 862.1110)Product Code CIG | ||
| Trade Name: | ACE Magnesium Reagent | ||
| Classification: | Class 1, reserved | ||
| Common/Classification Name: | Photometric Method, Magnesium(21 C. F.R. § 862.1495)Product Code JGJ |
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| PredicateDevices: | Alfa Wassermann ACE Carbon Dioxide (CO2-LC) Reagent, ACE Direct BilirubinReagent, ACE Total Bilirubin Reagent, and ACE Magnesium Reagent(K931786) | Intended Use: | Indications for Use: |
|---|---|---|---|
| DeviceDescriptions: | In the ACE Carbon Dioxide (CO2-LC) Reagent assay, serum carbon dioxide (in theform of bicarbonate) reacts with phosphoenolpyruvate in the presence ofphosphoenolpyruvate carboxylase and magnesium to yield oxaloacetic acid andphosphate. In the presence of malate dehydrogenase, the reduced cofactor is oxidized byoxaloacetic acid. The reduced cofactor absorbs strongly at 408 nm whereas its oxidizedform does not. The rate of decrease in absorbance, monitored bichromatically at 408nm/692 nm, is proportional to the carbon dioxide content of the sample.In the ACE Direct Bilirubin Reagent assay, sodium nitrite added to sulfanilic acid formsdiazotized sulfanilic acid. Bilirubin glucuronide in serum reacts with diazotizedsulfanilic acid to form azobilirubin, which absorbs strongly at 554 nm. The increase inabsorbance, measured bichromatically at 554 nm/692 nm, one minute after sample addi-tion, is directly proportional to the direct bilirubin concentration.In the ACE Total Bilirubin Reagent assay, sodium nitrite, when added to sulfanilic acid,forms diazotized sulfanilic acid. Bilirubin in serum reacts with diazotized sulfanilic acidto form azobilirubin, which absorbs strongly at 554 nm. The inclusion of dimethylsulfoxide (DMSO) in the reagent as an accelerator causes both direct and indirectbilirubin to react rapidly. The increase in absorbance, measured bichromatically at 554 nm/692 nm, is directly proportional to the total bilirubin concentration in the sample.Magnesium ions in serum react with Xylidyl blue-1 in an alkaline medium to produce ared complex which is measured bichromatically at 525 nm/692 nm. The intensity ofcolor produced is directly proportional to the magnesium concentration in the sample.EGTA prevents calcium interference by preferential chelation of calcium present in thesample. A surfactant system is included to remove protein interference. | The ACE Carbon Dioxide (CO2-LC) Reagent is intended for the quantitativedetermination of carbon dioxide concentration in serum and lithium heparin plasmausing the ACE, ACE Alera®, and ACE Axcel Clinical Chemistry Systems.Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment ofnumerous potentially serious disorders associated with changes in body acid-basebalance. This test is intended for use in clinical laboratories and physician officelaboratories. For in vitro diagnostic use only. | |
| The ACE Direct Bilirubin Reagent is intended for the quantitative determination ofdirect bilirubin concentration in serum and lithium heparin plasma using the ACE,ACE Alera, and ACE Axcel Clinical Chemistry Systems. Measurements of the levels ofbilirubin, an organic compound formed during the normal and abnormal destruction ofred blood cells, is used in the diagnosis and treatment of liver, hemolytic, hematologicaland metabolic disorders, including hepatitis and gall bladder block. This test is intendedfor use in clinical laboratories and physician office laboratories. For in vitro diagnosticuse only | |||
| The ACE Total Bilirubin Reagent is intended for the quantitative determination of totalbilirubin concentration in serum and lithium heparin plasma using the ACE, ACEAlera and ACE Axcel Clinical Chemistry System. Measurements of the levels ofbilirubin, an organic compound formed during the normal and abnormal destruction ofred blood cells is used in the diagnosis and treatment of liver, hemolytic, hematologicaland metabolic disorders, including hepatitis and gall bladder block. This test is intendedfor use in clinical laboratories and physician office laboratories. For in vitro diagnosticuse only. | |||
| The ACE Magnesium Reagent is intended for the quantitative determination ofmagnesium in serum and lithium heparin plasma using the ACE, ACE Alera andACE Axcel Clinical Chemistry Systems. Magnesium measurements are used in thediagnosis and treatment of hypomagnesemia (abnormally low plasma levels ofmagnesium) and hypermagnesemia (abnormally high plasma levels of magnesium).This test is intended for use in clinical laboratories and physician office laboratories. Forin vitro diagnostic use only. |
100 - 100 -
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| TechnologicalCharacteristics: | The ACE Carbon Dioxide (CO2-LC) Reagent consists of a single reagent bottle. Thereagent contains Phosphoenolpyruvate, nicotinamide adenine dinucleotide, analog,reduced, phosphoenol pyruvate carboxylase and malate dehydrogenase. |
|---|---|
| The ACE Direct Bilirubin Reagent is composed of two reagent bottles (Direct BilirubinReagent and Sodium Nitrite Reagent). The reagents contain Sulfanilic Acid,hydrochloric acid, and sodium nitrite. | |
| The ACE Total Bilirubin Reagent is composed of two reagent bottles (Total BilirubinReagent and Sodium Nitrite Reagent). The reagents contain sulfanilic acid, hydrochloricAcid, DMSO and sodium Nitrite. | |
| The ACE Magnesium Reagent is composed of a single reagent bottle. The reagentcontains Xylidyl blue-1 and EGTA. |
. . .
| DeviceComparisonwith Predicate | Comparison of similarities and differences with predicatedeviceACE Carbon Dioxide (CO2-LC) Reagent | ||
|---|---|---|---|
| CO2-LC | Candidate Device | PredicateK9317(ACE CO2 | |
| Intended Use | The ACE Carbon Dioxide (CO2-LC) Reagent isintended for the quantitative determination of carbondioxide concentration. | Same | |
| Platforms | ACE, ACE Alera®, and ACE Axcel Clinical ChemistrySystems | ACE ClinicalChemistry System | |
| Method | Photometric | Same | |
| Calibration Stability | 7 days | Same | |
| On-Board Stability | 14 days | Same | |
| Sample Type | Serum and lithium heparin plasma | Serum | |
| Sample Volume | 6 µL | Same | |
| Reaction Volume | 156 µL | Same | |
| Expected Values | 23 - 29 mEq/L | Same | |
| Measuring Range | 4 - 50 mEq/L | Same | |
| Sample Stability | Separated from cells, carbon dioxide is stable for 7 | Same |
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| DeviceComparisonwith Predicate | ACE Direct Bilirubin Reagent | ||
|---|---|---|---|
| Direct Bilirubin | Candidate Device | Predicate DeviceK931786(ACE DirectBilirubin) | |
| Intended Use/Indications for Use | The ACE Direct Bilirubin Reagent is intended for thequantitative determination of direct bilirubinconcentration. | Same | |
| Platforms | ACE, ACE Alera®, and ACE Axcel ClinicalChemistry Systems | ACE ClinicalChemistry 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 | 20 µL | Same | |
| Reaction Volume | 355 µL | Same | |
| Expected Values | <0.2 mg/dL | Same | |
| Measuring Range | 0.1 - 14.0 mg/dL | Same | |
| Sample Stability | Samples must be stored away from sunlight orfluorescent lights because bilirubin is subject tophotodegradation. Specimens may be stored at 4-8°Cfor 7 months or 6 months at -20°C. | Same | |
| Total Bilirubin | ACE Total Bilirubin ReagentCandidate Device | Predicate Device .K931786(ACE TotalBilirubin) | |
| Intended Use/Indications for Use | The ACE Total Bilirubin Reagent is intended for thequantitative determination of total bilirubinconcentration. | Same | |
| Platforms | ACE, ACE Alera®, and ACE Axcel ClinicalChemistry Systems | ACE ClinicalChemistry 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 | 20 µL | Same | |
| Reaction Volume | 380 µL | Same | |
| Expected Values | 0.3 - 1.2 mg/dL | Same | |
| Measuring Range | 0.2 - 40.0 mg/dL | Same | |
| Sample Stability | Samples must be stored away from sunlight or | Same |
·
:
.
:
:
,
.
{5}------------------------------------------------
| DeviceComparisonwith Predicate | Magnesium | Candidate Device | Predicate DeviceK931786(ACE Magnesium) |
|---|---|---|---|
| Intended Use/Indications for Use | ACE Magnesium Reagent is intended for thequantitative determination of magnesium. | Same | |
| Platforms | ACE, ACE Alera®, and ACE Axcel ClinicalChemistry Systems | ACE ClinicalChemistry System | |
| Method | Photometric | Same | |
| Calibration Stability | 30 Day | Same | |
| On-Board Stability | 30 Days | Same | |
| Sample Type | Serum and lithium heparin plasma | Serum | |
| Sample Volume | 3 µL | Same | |
| Reaction Volume | 488 µL | Same | |
| Expected Values | 1.6 - 2.6 mg/dL | Same | |
| Measuring Range | 0.4 - 6.1 mg/dL | Same | |
| Sample Stability | Serum magnesium is stable for 7 days at 4-8°C and1 year at -20 °C if the serum is separated from theerythrocytes. | Same |
the state of the state of the states of the states
·
and the control control control control controllers and
{6}------------------------------------------------
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 CO2-LC Reagent
| Precision (SD, %CV) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| CO2-LCmEq/L | ACEMean | Within-Run | Total | AleraMean | Within-Run | Total | AxcelMean | Within-Run | Total | ||
| SerumLow | 24.0 | 0.27,1.1% | 1.34,5.6% | 24.6 | 0.61,2.5% | 1.85,7.5% | 23.9 | 0.48,2.0% | 1.56,6.5% | ||
| SerumMid | 34.1 | 0.72,1.2% | 1.22,3.6% | 35.7 | 0.41,1.2% | 1.17,3.3% | 34.3 | 0.52,1.5% | 1.26,3.7% | ||
| SerumHigh | 45.6 | 0.57,2.8% | 2.7,3.2% | 47.0 | 0.55,1.2% | 2.7,3.2% | 45.4 | 0.25,0.6% | 1.19,2.6% | ||
| PlasmaLow | 22.9 | 0.29,1.3% | 0.86,3.8% | 23.3 | 0.71,3.0% | 1.43,6.1% | 23.1 | 0.29,1.3% | 0.86,3.8% | ||
| PlasmaMid | 33.7 | 0.41,1.2% | 1.85,5.5% | 34.8 | 0.34,1.0% | 1.77,5.1% | 33.8 | 0.24,0.7% | 1.69,5.0% | ||
| PlasmaHigh | 45.6 | 0.46,1.0% | 1.14,2.5% | 46.9 | 0.46,1.0% | 1.10,2.4% | 45.3 | 0.47,1.0% | 1.05,2.3% |
In-House Precision: Serum vs. Plasma – ACE Direct Bilirubin Reagent
| DirectBilirubinmg/dL | ACE | Alera | Axcel | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Mean | Within-Run | Total | Mean | Within-Run | Total | Mean | Within-Run | Total | |
| SerumLow | 0.2 | 0.04,24.5% | 0.05,30.0% | 0.2 | 0.03,16.0% | 0.04,20.1% | 0.1 | 0.02,12.5% | 0.02,14.0% |
| SerumMid | 4.7 | 0.04,0.9% | 0.06,1.2% | 4.7 | 0.06,1.4% | 0.10,2.2% | 4.7 | 0.08,1.6% | 0.08,1.6% |
| SerumHigh | 8.4 | 0.05,0.6% | 0.09,1.1% | 8.3 | 0.06,0.8% | 0.09,1.1% | 8.3 | 0.13,1.5% | 0.14,1.7% |
| PlasmaLow | 0.1 | 0.03,26.6% | 0.03,26.6% | 0.1 | 0.03,23.4% | 0.05,35.4% | 0.1 | 0.02, 16.6% | 0.02,19.7% |
| PlasmaMid | 4.8 | 0.04,0.8% | 0.05,1.1% | 4.8 | 0.08,1.7% | 0.13,2.8% | 4.8 | 0.11,2.4% | 0.11,2.4% |
| PlasmaHigh | 8.5 | 0.09,1.1% | 0.14,1.6% | 8.5 | 0.06,0.7% | 0.10,1.1% | 8.5 | 0.16,1.9% | 0.20,2.3% |
{7}------------------------------------------------
In-House Precision: Serum vs. Plasma – ACE Total Bilirubin Reagent
Performance Data:
In-House Precision -Serum vs. Plasma
.
| TotalBilirubinmg/dL | ACEMean | Within-Run | Total | AleraMean | Within-Run | Total | AxcelMean | Within-Run | Total | ||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Precision (SD, %CV) | |||||||||||
| SerumLow | 0.3 | 0.07,21.3% | 0.07,21.3% | 0.3 | 0.04,11.0% | 0.05,15.7% | 0.3 | 0.04,13.4% | 0.04,13.9% | ||
| SerumMid | 13.3 | 0.13,1.0% | 0.13,1.0% | 13.0 | 0.14,1.1% | 0.14,1.1% | 13.3 | 0.13,1.0% | 0.13,1.0% | ||
| SerumHigh | 26.1 | 0.18,0.7% | 0.21,0.8% | 25.5 | 0.12,0.5% | 0.12,0.5% | 26.1 | 0.11,0.4% | 0.17,0.7% | ||
| PlasmaLow | 0.2 | 0.04,20.3% | 0.05,21.3% | 0.2 | 0.06,23.7% | 0.07,29.4% | 0.2 | 0.04,20.6% | 0.05,23.9% | ||
| PlasmaMid | 13.2 | 0.11,0.8% | 0.12,0.9% | 13.0 | 0.13,1.0% | 0.14,1.1% | 13.2 | 0.06,0.5% | 0.07,0.5% | ||
| PlasmaHigh | 26.2 | 0.15,0.6% | 0.17,0.6% | 25.6 | 0.12,0.5% | 0.18,0.7% | 26.1 | 0.13,0.5% | 0.14,0.5% |
In-House Precision: Serum vs. Plasma -- ACE Magnesium Reagent
| Precision (SD, %CV) | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Magnesiummg/dL | ACEMean | Within-Run | Total | AleraMean | Within-Run | Total | AxcelMean | Within-Run | Total |
| SerumLow | 2.0 | 0.10,5.1% | 0.12,5.9% | 2.1 | 0.06,3.1% | 0.09,4.3% | 1.9 | 0.07,3.6% | 0.08,4.3% |
| SerumMid | 3.7 | 0.09,2.5% | 0.11,3.0% | 3.8 | 0.06,1.7% | 0.07,1.8% | 3.7 | 0.09,2.6% | 0.09,2.6% |
| SerumHigh | 5.6 | 0.05,1.0% | 0.10,1.7% | 5.6 | 0.08,1.4% | 0.09,1.6% | 5.5 | 0.08,1.4% | 0.09,1.7% |
| PlasmaLow | 1.7 | 0.08,4.7% | 0.11,6.2% | 1.7 | 0.06,3.5% | 0.07,4.1% | 1.7 | 0.04,2.4% | 0.11,6.8% |
| PlasmaMid | 3.5 | 0.09,2.7% | 0.10,2.8% | 3.5 | 0.09,2.4% | 0.09,2.6% | 3.4 | 0.09,2.8% | 0.13,3.7% |
| PlasmaHigh | 5.3 | 0.04,0.9% | 0.10,1.9% | 5.4 | 0.09,1.6% | 0.10,1.8% | 5.3 | 0.05,1.0% | 0.09,1.8% |
{8}------------------------------------------------
| PerformanceData: | Performance data for the Alfa Wassermann ACE Reagents run on the | ||
|---|---|---|---|
| In-House | Alfa Wassermann ACE, ACE Alera and ACE Axcel Clinical Chemistry | ||
| Matrix | Systems | ||
| Comparison -Serum vs.Plasma | In-House Matrix Comparison: Serum vs. Plasma – ACE CO2-LC Reagent | ||
| System | Range | Results - Serum vs. Plasma | |
| ACE53 pairs | 4.9-47.9 mEq/L | Slope: 1.031Intercept: -1.03Correlation: 0.9922Std. Error Est: 1.13Confidence Interval Slope: 0.995 to 1.067Confidence Interval Intercept: -2.11 to 0.04 | |
| ACE Alera54 pairs | 4.7-48.2 mEq/L | Slope: 1.000Intercept: -0.09Correlation: 0.9955Std. Error Est: 0.86Confidence Interval Slope: 0.974 to 1.027Confidence Interval Intercept: -0.81 to 0.64 | |
| ACE Axcel51 pairs | 5.5-47.9 mEq/L | Slope: 0.988Intercept: -0.35Correlation: 0.9889Std. Error Est: 1.12Confidence Interval Slope: 0.946 to 1.031Confidence Interval Intercept: -1.29 to 0.60 | |
| In-House Matrix Comparison: Serum vs. Plasma – ACE Direct Bilirubin Reagent | |||
| System | Range | Results - Serum vs. Plasma | |
| ACE102 pairs | 0.1-10.8 mg/dL | Slope: 1.021Intercept: 0.00Correlation: 0.9982Std. Error Est: 0.10Confidence Interval Slope: 1.009 to 1.033Confidence Interval Intercept: -0.02 to 0.03 | |
| ACE Alera101 pairs | 0.1-11.0 mg/dL | Slope: 1.005Intercept: 0.01Correlation: 0.9978Std. Error Est: 0.11Confidence Interval Slope: 0.992 to 1.018Confidence Interval Intercept: -0.02 to 0.03 | |
| ACE Axcel56 pairs | 0.1-13.1 mg/dL | Slope: 1.004Intercept: 0.00Correlation: 0.9983Std. Error Est: 0.16Confidence Interval Slope: 0.988 to 1.020Confidence Interval Intercept: -0.04 to 0.05 | |
| System | Range | Results - Serum vs. Plasma | |
| ACE102 pairs | 0.1-37.2 mg/dL | Slope: 1.017Intercept: 0.01Correlation: 0.9996Std. Error Est: 0.15Confidence Interval Slope: 1.011 to 1.022Confidence Interval Intercept: -0.03 to 0.04 | |
| ACE Alera102 pairs | 0.2-36.7 mg/dL | Slope: 1.020Intercept: 0.00Correlation: 0.9993Std. Error Est: 0.20Confidence Interval Slope: 1.012 to 1.028Confidence Interval Intercept: -0.05 to 0.04 | |
| ACE Axcel56 pairs | 0.2-35.5 mg/dL | Slope: 1.008Intercept: 0.00Correlation: 0.9995Std. Error Est: 0.22Confidence Interval Slope: 1.000 to 1.017Confidence Interval Intercept: -0.06 to 0.07 |
{9}------------------------------------------------
.
:
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and the comments of the comments of the comments of
| ACE101 pairs | 1.2-5.8 mg/dL | Correlation: 0.9765Std. Error Est: 0.19Confidence Interval Slope: 0.902 to 0.994Confidence Interval Intercept: -0.02 to 0.18 |
|---|---|---|
| ACE Alera101 pairs | 1.0-5.9 mg/dL | Slope: 0.986Intercept: 0.05Correlation: 0.9817Std. Error Est: 0.15Confidence Interval Slope: 0.948 to 1.024Confidence Interval Intercept: -0.06 to 0.10 |
| ACE Axcel55 pairs | 1.2-5.8 mg/dL | Slope: 0.986Intercept: 0.025Correlation: 0.9892Std. Error Est: 0.125Confidence Interval Slope: 0.947 to 1.026Confidence Interval Intercept: -0.61 to 0.111 |
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{10}------------------------------------------------
| Performance Data:Precision - POL | POL - Precision studies at 3 POC sites for ACE Alera Clinical Chemistry System(ACE system was also tested concurrently and comparable precision was obtained | DBILI | ACE Resultmg/dL SD, %CV | ACE Alera Resultmg/dL SD, %CV | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| CO2_LC | ACE Result | ACE Alera Result | Lab | Sample | Mean | Within-Run | Total | Mean | Within-Run | Total | ||||||||
| Lab | Sample | Mean | mEq/L SD, %CV | Mean | mEq/L SD, %CV | In-House | 1 | 1.0 | 0.03 SD2.90% | 0.03 SD2.90% | 1.0 | 0.05 SD5.10% | 0.05 SD5.40% | |||||
| Within-Run | Total | Within-Run | Total | POL 1 | 1 | 0.9 | 0.04 SD4.20% | 0.05 SD4.90% | 0.9 | 0.04 SD4.80% | 0.05 SD5.40% | |||||||
| In-House | 1 | 21.2 | 0.33 SD1.60% | 0.63 SD3.00% | 21.1 | 0.43 SD2.00% | 0.81 SD3.90% | POL 2 | 1 | 0.9 | 0.03 SD3.30% | 0.05 SD5.20% | 0.9 | 0.02 SD2.50% | 0.02 SD2.50% | |||
| POL 1 | 1 | 20.3 | 0.68 SD3.30% | 0.88 SD4.30% | 22.3 | 0.28 SD1.30% | 0.67 SD3.00% | POL 3 | 1 | 0.9 | 0.03 SD3.50% | 0.03 SD3.50% | 0.9 | 0.00 SD0.00% | 0.00 SD0.00% | |||
| POL 2 | 1 | 23 | 0.55 SD2.40% | 1.54 SD6.70% | 22.4 | 0.59 SD2.60% | 0.84 SD3.80% | In-House | 2 | 5.0 | 0.05 SD1.00% | 0.07 SD1.30% | 4.9 | 0.07 SD1.50% | 0.09 SD1.90% | |||
| POL 3 | 1 | 22.3 | 0.42 SD1.90% | 1.10 SD4.90% | 24.3 | 0.37 SD1.50% | 1.53 SD6.30% | POL 1 | 2 | 4.9 | 0.09 SD1.80% | 0.10 SD2.10% | 4.8 | 0.05 SD1.00% | 0.05 SD1.00% | |||
| In-House | 2 | 24.2 | 0.46 SD1.90% | 0.66 SD2.70% | 24.2 | 0.42 SD1.70% | 0.77 SD3.20% | POL 2 | 2 | 4.8 | 0.07 SD1.50% | 0.12 SD2.50% | 4.8 | 0.07 SD1.50% | 0.08 SD1.70% | |||
| POL 1 | 2 | 24.9 | 0.77 SD3.10% | 1.38 SD5.60% | 25.6 | 0.32 SD1.30% | 0.63 SD2.40% | POL 3 | 2 | 4.7 | 0.10 SD2.10% | 0.11 SD2.40% | 4.9 | 0.10 SD2.00% | 0.10 SD2.00% | |||
| POL 2 | 2 | 26.2 | 0.43 SD1.70% | 1.92 SD7.40% | 26 | 0.24 SD0.90% | 1.00 SD3.90% | In-House | 3 | 8.0 | 0.18 SD2.30% | 0.18 SD2.30% | 7.8 | 0.20 SD2.60% | 0.20 SD2.60% | |||
| POL 3 | 2 | 25.9 | 0.34 SD1.30% | 1.08 SD4.20% | 27.8 | 0.29 SD1.10% | 1.60 SD5.80% | POL 1 | 3 | 7.9 | 0.16 SD2.00% | 0.17 SD2.20% | 7.9 | 0.06 SD0.80% | 0.07 SD0.90% | |||
| In-House | 3 | 27.3 | 0.49 SD1.80% | 0.65 SD2.40% | 27 | 0.43 SD1.60% | 0.83 SD3.10% | POL 2 | 3 | 7.7 | 0.10 SD1.30% | 0.16 SD2.00% | 7.8 | 0.04 SD0.60% | 0.10 SD1.30% | |||
| POL 1 | 3 | 30.4 | 0.73 SD2.40% | 1.75 SD5.80% | 28.4 | 0.39 SD1.40% | 0.94 SD3.30% | POL 3 | 3 | 7.7 | 0.09 SD1.20% | 0.12 SD1.50% | 8.0 | 0.08 SD1.00% | 0.08 SD1.10% | |||
| POL 2 | 3 | 29.6 | 0.62 SD2.10% | 1.88 SD6.40% | 29.3 | 0.48 SD1.60% | 0.94 SD3.20% | |||||||||||
| POL 3 | 3 | 29.5 | 0.26 SD0.90% | 1.08 SD3.60% | 30.7 | 0.29 SD1.00% | 1.60 SD5.20% |
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{11}------------------------------------------------
Performance Data at POL:
Precision -
POL
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. .
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{12}------------------------------------------------
| TBILI | ACE Resultmg/dL SD, %CV | ACE Alera Resultmg/dL SD, %CV | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| PerformanceData at POL:Precision - POL | Lab | Sample | Mean | Within-Run | Total | Mean | Within-Run | Total | ||
| In-House | 1 | 1.2 | 0.04 SD3.40% | 0.04 SD3.70% | 1.2 | 0.05 SD4.20% | 0.05 SD4.50% | |||
| POL 1 | 1 | 1.2 | 0.07 SD5.50% | 0.07 SD5.80% | 1.2 | 0.04 SD3.20% | 0.04 SD3.70% | |||
| POL 2 | 1 | 1.1 | 0.05 SD4.00% | 0.07 SD6.40% | 1.2 | 0.06 SD4.90% | 0.06 SD5.00% | |||
| POL 3 | 1 | 1.1 | 0.04 SD3.40% | 0.05 SD4.40% | 1.1 | 0.05 SD4.80% | 0.06 SD5.20% | |||
| In-House | 2 | 11.5 | 0.20 SD1.70% | 0.20 SD1.80% | 11.3 | 0.23 SD2.00% | 0.24 SD2.10% | |||
| POL 1 | 2 | 11.2 | 0.05 SD0.50% | 0.42 SD3.70% | 11.4 | 0.07 SD0.70% | 0.09 SD0.80% | |||
| POL 2 | 2 | 11.3 | 0.05 SD0.50% | 0.15 SD1.30% | 11.3 | 0.17 SD1.50% | 0.17 SD1.50% | |||
| POL 3 | 2 | 10.9 | 0.09 SD0.80% | 0.11 SD1.00% | 11.2 | 0.09 SD0.80% | 0.09 SD0.80% | |||
| In-House | 3 | 20.9 | 0.24 SD1.10% | 0.27 SD1.30% | 20.6 | 0.27 SD1.30% | 0.35 SD1.70% | |||
| POL 1 | 3 | 20.0 | 0.24 SD1.20% | 0.24 SD1.20% | 20.7 | 0.11 SD0.50% | 0.12 SD0.60% | |||
| POL 2 | 3 | 20.3 | 0.21 SD1.00% | 0.42 SD2.10% | 20.5 | 0.11 SD0.50% | 0.15 SD0.70% | |||
| POL 3 | 3 | 19.9 | 0.24 SD1.20% | 0.26 SD1.30% | 20.3 | 0.28 SD1.40% | 0.28 SD1.40% | |||
| MG | ACE Resultmg/dL SD, %CV | ACE Alera Resultmg/dL SD, %CV | ||||||||
| Lab | Sample | Mean | Within-Run | Total | Mean | Within-Run | Total | |||
| In-House | 1 | 1.7 | 0.05 SD3.30% | 0.09 SD5.70% | 1.7 | 0.05 SD3.00% | 0.07 SD4.50% | |||
| POL 1 | 1 | 1.7 | 0.05 SD3.30% | 0.11 SD6.30% | 1.7 | 0.07 SD4.20% | 0.10 SD5.90% | |||
| POL 2 | 1 | 1.8 | 0.08 SD4.60% | 0.09 SD5.00% | 1.5 | 0.09 SD6.00% | 0.13 SD8.40% |
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{13}------------------------------------------------
| PerformanceData at POL:Precision -POL | ||||||||
|---|---|---|---|---|---|---|---|---|
| In-House | 2 | 3.7 | 0.09 SD2.50% | 0.12 SD3.30% | 3.6 | 0.07 SD2.00% | 0.09 SD2.50% | |
| POL 1 | 2 | 3.7 | 0.05 SD1.30% | 0.11 SD3.00% | 3.8 | 0.11 SD2.80% | 0.13 SD3.60% | |
| POL 2 | 2 | 3.7 | 0.07 SD1.90% | 0.13 SD3.50% | 3.5 | 0.10 SD2.90% | 0.18 SD5.20% | |
| POL 3 | 2 | 3.6 | 0.09 SD2.50% | 0.10 SD2.80% | 3.7 | 0.08 SD2.10% | 0.13 SD3.60% | |
| In-House | 3 | 5.6 | 0.10 SD1.80% | 0.14 SD2.60% | 5.5 | 0.05 SD1.00% | 0.10 SD1.80% | |
| POL 1 | 3 | 5.7 | 0.09 SD1.60% | 0.11 SD1.90% | 5.8 | 0.08 SD1.40% | 0.12 SD2.10% | |
| POL 2 | 3 | 5.6 | 0.09 SD1.60% | 0.17 SD3.10% | 5.4 | 0.10 SD1.90% | 0.26 SD4.80% | |
| POL 3 | 3 | 5.5 | 0.06 SD1.10% | 0.08 SD1.40% | 5.5 | 0.05 SD0.90% | 0.09 SD1.60% |
·
.
{14}------------------------------------------------
Performance Data: Method
POL – Method Comparison for ACE Clinical Chemistry System
Comparison -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) |
|---|---|---|---|---|
| CO2-LC | n | 46 | 45 | 45 |
| Range | 3.6 to 42.5 | 3.6 to 46.2 | 3.6 to 46.2 | |
| Regression | $y = 0.963x - 0.71$ | $y = 0.976x + 1.29$ | $y = 0.984x + 0.42$ | |
| Correlation | 0.9710 | 0.9530 | 0.9908 | |
| Std. Error Est. | 1.38 | 2.10 | 0.94 | |
| CI Slope | 0.893 to 1.034 | 0.884 to 1.069 | 0.943 to 1.025 | |
| CI Intercept | -2.34 to 0.92 | -0.91 to 3.49 | -0.56 to 1.40 | |
| DirectBilirubin | n | 49 | 49 | 49 |
| Range | 0.1 to 12.4 | 0.1 to 12.4 | 0.1 to 12.4 | |
| Regression | $y = 1.022x + 0.04$ | $y = 1.003x + 0.11$ | $y = 1.012x + 0.06$ | |
| Correlation | 0.9986 | 0.9985 | 0.9984 | |
| Std. Error Est. | 0.14 | 0.14 | 0.14 | |
| CI Slope | 1.006 to 1.038 | 0.987 to 1.019 | 0.995 to 1.029 | |
| CI Intercept | 0.00 to 0.08 | 0.07 to 0.15 | 0.02 to 0.11 | |
| TotalBilirubin | n | 48 | 50 | 49 |
| Range | 0.2 to 39.3 | 0.2 to 39.3 | 0.2 to 39.3 | |
| Regression | $y = 0.979x + 0.00$ | $y = 1.000x + 0.04$ | $y = 1.000x + 0.01$ | |
| Correlation | 0.9995 | 0.9998 | 0.9998 | |
| Std. Error Est. | 0.27 | 0.18 | 0.17 | |
| CI Slope | 0.970 to 0.989 | 0.994 to 1.006 | 0.994 to 1.006 | |
| CI Intercept | -0.08 to 0.08 | -0.01 to 0.09 | -0.05 to 0.06 | |
| Magnesium | n | 51 | 52 | 51 |
| Range | 0.6 to 6.1 | 0.6 to 6.1 | 0.6 to 6.1 | |
| Regression | $y = 0.970x + 0.12$ | $y = 0.975x + 0.16$ | $y = 1.026x - 0.04$ | |
| Correlation | 0.9902 | 0.9927 | 0.9925 | |
| Std. Error Est. | 0.13 | 0.11 | 0.12 | |
| CI Slope | 0.931 to 1.009 | 0.941 to 1.008 | 0.989 to 1.062 | |
| CI Intercept | 0.03 to 0.21 | 0.08 to 0.23 | -0.13 to 0.04 |
{15}------------------------------------------------
| POL – Method Comparison (performed at POC sites) for ACE Alera ClinicalChemistry System against the predicate device tested in-house | ||||
|---|---|---|---|---|
| Reagent | Statistic | In-House ACE (x) vs.POL 1 Alera (y) | In-House ACE (x) vs.POL 2 Alera (y) | In-House ACE (x) vs.POL 3 Alera (y) |
| CO2-LC | n | 45 | 45 | 46 |
| Range | 2.0 to 46.0 | 2.0 to 46.0 | 2.0 to 46.0 | |
| Regression | $y = 0.984x + 0.15$ | $y = 0.972x + 0.57$ | $y = 0.987x + 0.10$ | |
| Correlation | 0.9903 | 0.9767 | 0.9790 | |
| Std. Error Est. | 0.95 | 1.45 | 1.38 | |
| CI Slope | 0.941 to 1.026 | 0.908 to 1.037 | 0.926 to 1.049 | |
| CI Intercept | -0.81 to 1.12 | -0.90 to 2.05 | -1.30 to 1.50 | |
| DirectBilirubin | n | 51 | 51 | 51 |
| Range | 0.1 to 12.4 | 0.1 to 12.4 | 0.1 to 12.4 | |
| Regression | $y = 0.995x + 0.09$ | $y = 0.969x + 0.11$ | $y = 0.991x + 0.10$ | |
| Correlation | 0.9991 | 0.9984 | 0.9990 | |
| Std. Error Est. | 0.10 | 0.14 | 0.11 | |
| CI Slope | 0.983 to 1.007 | 0.953 to 0.985 | 0.979 to 1.004 | |
| CI Intercept | 0.05 to 0.12 | 0.07 to 0.15 | 0.06 to 0.13 | |
| Total Bilirubin | n | 50 | 50 | 50 |
| Range | 0.2 to 39.4 | 0.2 to 39.4 | 0.2 to 39.4 | |
| Regression | $y = 1.020x + 0.02$ | $y = 0.957x + 0.07$ | $y = 0.981x + 0.01$ | |
| Correlation | 0.9998 | 0.9991 | 0.9998 | |
| Std. Error Est. | 0.18 | 0.34 | 0.16 | |
| CI Slope | 1.013 to 1.026 | 0.945 to 0.968 | 0.976 to 0.987 | |
| CI Intercept | -0.03 to 0.08 | -0.03 to 0.17 | -0.04 to 0.06 | |
| Magnesium | n | 50 | 50 | 50 |
| Range | 0.7 to 5.9 | 0.7 to 5.9 | 0.7 to 5.9 | |
| Regression | $y = 1.010x + 0.00$ | $y = 1.004x - 0.11$ | $y = 0.990x - 0.07$ | |
| Correlation | 0.9870 | 0.9886 | 0.9930 | |
| Std. Error Est. | 0.12 | 0.11 | 0.09 | |
| CI Slope | 0.963 to 1.057 | 0.960 to 1.048 | 0.956 to 1.024 | |
| CI Intercept | -0.10 to 0.10 | -0.20 to -0.02 | -0.14 to 0.00 |
・
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and the same of the same
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Performance Data:
ACE Alera
Performance data for the Alfa Wassermann ACE Reagents run on the Alfa Wassermann ACE Alera Clinical Chemistry Systems
Detection Limits - ÀCE Alera Clinical Chemistry System
| ACE Alera | CO2(mEq/L) | DBILI(mg/dL) | TBILI(mg/dL) | MG(mg/dL) |
|---|---|---|---|---|
| LoB | 1.27 | 0.06 | 0.11 | 0.26 |
| LoD | 1.97 | 0.08 | 0.14 | 0.37 |
| LoQ | 3.03 | 0.12 | 0.14 | 0.37 |
Linearity - ACE Alera Clinical Chemistry System
| ACEReagents | Low leveltested | Upper leveltested | Linear to: | Linear RegressionEquation |
|---|---|---|---|---|
| CO2(mEq/L) | 0.1 | 53.0 | 50 | y=1.006x + 0.01 |
| DBILI(mg/dL) | 0.1 | 16.0 | 14.0 | y=1.015x + 0.16 |
| TBILI(mg/dL) | 0.1 | 41.6 | 40.0 | y=1.004x + 0.03 |
| MG(mg/dL) | 0.4 | 6.4 | 6.1 | y=0.959x + 0.27 |
{17}------------------------------------------------
Performance
Data:
ACE Alera
Interferences - ACE Alera Clinical Chemistry System
| ACEAlera | Icterus | Hemolysis | Lipemia(Intralipid)/Triglycerides | Ascorbic Aci |
|---|---|---|---|---|
| C02 | No significantinterferenceat or below58.8 mg/dL | No significantinterferenceat or below250 mg/dL | No significantinterferenceat or below2388 mg/dLTriglyccrides | No significantinterferenceat or below6 mg/dL |
| DBili | Not Applicable | No significantinterferenceat or below62.5 mg/dL | No significantinterferenceat or below782 mg/dLTriglycerides | No significantinterferenceat or below6 mg/dL |
| TBili | Not Applicable | No significantinterferenceat or below62.5 mg/dL | No significantinterferenceat or below951 mg/dLTriglycerides | No significantinterferenceat or below6 mg/dL |
| MG | No significantinterferenceat or below50 mg/dL | No significantinterferenceat or below500 mg/dL | No significantinterference at orbelow620 mg/dLTriglycerides | No significantinterferenceat or below6 mg/dL |
{18}------------------------------------------------
Precision - ACE Alera Clinical Chemistry System
Performance Data:
ACE Alera
| on ACE Alera | Precision (SD, %CV) | PerformanceData: | Method Comparison - ACE Alera Clinical Chemistry System | |||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Mean | Within-Run | Total | ACE Alera | In-House ACE (x) vs. In-House ACE Alera (y) | ||||||
| CO2mEq/L | Low | 12.8 | 0.55, 4.3% | 1.20, 9.4% | CO2(mEq/L) | DBILI (mg/dL) | TBILI(mg/dL) | MG(mg/dL) ' | ||
| Mid | 15.2 | 0.48, 3.2% | 1.49, 9.8% | n | 46 | 49 | 49 | 50 | ||
| High | 21.7 | 0.82, 3.8% | 2.58, 11.9% | Range | 3.6 to 46.2 | 0.1 to 12.4 | 0.2 to 39.3 | 0.6 to 6.1 | ||
| DBILImg/dL | Low | 0.3 | 0.02, 5.3% | 0.02, 6.5% | Slope | 0.981 | 0.998 | 1.001 | 0.960 | |
| Mid | 1.7 | 0.04, 2.6% | 0.11, 6.6% | Intercept | -0.6 | 0.00 | 0.00 | 0.12 | ||
| High | 3.2 | 0.08, 2.7% | 0.18, 5.6% | CorrelationCoefficient | 0.9974 | 0.99999 | 1.000 | 0.9906 | ||
| TBILImg/dL | Low | 0.5 | 0.03, 5.7% | 0.04, 8.5% | Std. Error | 1.45 | 0.04 | 0.06 | (). 1() | |
| Mid | 3.1 | 0.04, 1.2% | 0.13, 4.1% | CI Slope | 0.918 to 1.045 | 0.993 to 1.003 | 0.999 to 1.003 | 0.922 to 0.998 | ||
| High | 7.7 | 0.08, 1.1% | 0.28, 3.7% | CI Intercept | -2.12 to 0.91 | -0.01 to 0.01 | -0.02 to 0.02 | 0.04 to 0.21 | ||
| MGmg/dL | Low | 1.6 | 0.07, 4.3% | 0.08, 5.1% | ||||||
| Mid | 2.5 | 0.07, 2.6% | 0.09, 3.7% | |||||||
| High | 3.6 | 0.10, 2.7% | 0.12, 3.3% |
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{20}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/20/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 2, 2013
LLC
Alfa Wasserman Diagnostic Technologies, LLC C/O Hyman Katz, Ph.D. 4 Henderson Drive WEST CALDWELL NJ 07006
Re: K123953
Trade/Device Name: ACE Carbon Dioxide (CO2-LC) Reagent ACE Direct Bilirubin Reagent ACE Total Bilirubin Reagent ACE Magnesium Reagent Regulation Number: 21 CFR 862.1160
Regulation Name: Bicarbonate/carbon dioxide test system Regulatory Class: II Product Code: KHS, CIG, JGJ Dated: March 22, 2013 Received: March 25, 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, listing 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
{21}------------------------------------------------
Page 2-Dr. Katz
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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/ucm115809.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/Safety/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/Resourcesfor You/Industry/default.htm.
Sincerely yours, Carol C. Benson -S
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
for
Enclosure
{22}------------------------------------------------
Indications for Use
510(k) Number (if known): K123953
| Device Name: | ACE Carbon Dioxide (CO2-LC) Reagent |
|---|---|
| Indications for Use: | The ACE Carbon Dioxide (CO2-LC) Reagent is intended for the quantitative determination of carbon dioxide concentration in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. |
| Device Name: | ACE Direct Bilirubin Reagent |
| Indications for Use: | The ACE Direct Bilirubin Reagent is intended for the quantitative determination of direct bilirubin concentration in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Measurements of the levels of bilirubin, an organic |
compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic, hematological and metabolic disorders, including hepatitis and gall bladder block. 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) AND/OR
Over-The-Counter Use. (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)
YungW.Chan -S
Division Sign-Off Office of In Vitro Devices or Radiological Health 510(k) K123953
Page 1 of 2
{23}------------------------------------------------
Indications for Use
510(k) Number (if known): K123953
Device Name: ACE Total Bilirubin Reagent
Indications for Use: The ACE Total Bilirubin Reagent is intended for the quantitative determination of total bilirubin concentration in serum and lithium heparin plasma using the ACE, ACE Alera and ACE Axcel Clinical Chemistry System. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic, hematological and metabolic disorders, including hepatitis and gall bladder block. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
Device Name: ACE Magnesium Reagent
Indications for Use: The ACE Magnesium Reagent is intended for the quantitative determination of magnesium in serum and lithium heparin plasma using the ACE, ACE Alera and ACE Axcel Clinical Chemistry Systems. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium). 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) AND/OR
Over-The-Counter Use. (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)
YungW.Chan -S
Division Sign-Off Office of In Vitro Devices or Radiological Health 510(k) = K123953
Page 2 of 2
§ 862.1160 Bicarbonate/carbon dioxide test system.
(a)
Identification. A bicarbonate/carbon dioxide test system is a device intended to measure bicarbonate/carbon dioxide in plasma, serum, and whole blood. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.(b)
Classification. Class II.