ACE ALKALINE PHOSPHATASE REAGENT, AMYLASE REAGENT, ALT REAGENT, AST REAGENT

K131351 · Alfa Wassermann Diagnostic Technologies, LLC · CJE · Aug 15, 2013 · Clinical Chemistry

Device Facts

• Record ID: K131351
• Device Name: ACE ALKALINE PHOSPHATASE REAGENT, AMYLASE REAGENT, ALT REAGENT, AST REAGENT
• Applicant: Alfa Wassermann Diagnostic Technologies, LLC
• Product Code: CJE · Clinical Chemistry
• Decision Date: Aug 15, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1050
• Device Class: Class 2

Intended Use

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.

Device Story

Reagents for quantitative photometric/colorimetric analysis of ALP, Amylase, ALT, and AST; used on ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Input: serum or lithium heparin plasma samples. Operation: automated photometric measurement of reaction rates (e.g., NADH oxidation for ALT/AST; p-nitrophenol formation for ALP). Output: enzyme activity levels (U/L). Used in clinical/physician office labs by trained personnel. Results assist clinicians in diagnosing liver, bone, parathyroid, intestinal, pancreatic, and heart conditions.

Clinical Evidence

Bench testing only. Precision studies (n=20-24) and matrix comparison studies (serum vs. plasma) performed across three platforms (ACE, ACE Alera, ACE Axcel). Matrix comparison showed high correlation (r > 0.99) and slopes near 1.0. Linearity, LoB, LoD, and LoQ established for ACE Alera system.

Technological Characteristics

Photometric/colorimetric assay reagents. ALP: p-nitrophenyl phosphate substrate. Amylase: 2-chloro-p-nitrophenyl-α-D-maltotrioside. ALT/AST: NADH-based kinetic assays. Automated analysis on ACE/ACE Alera/ACE Axcel systems. No calibration required. Traceable to IFCC or ERM-AD454/457 standards.

Indications for Use

Indicated for quantitative determination of ALP, amylase, ALT, and AST activity in serum and lithium heparin plasma for diagnosis/treatment of liver, bone, parathyroid, intestinal, pancreatic, and heart diseases. Intended for clinical and physician office laboratories.

Regulatory Classification

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.

Predicate Devices

• ACE Alkaline Phosphatase Reagent (K931786)
• ACE Amylase Reagent (K931786)
• ACE ALT Reagent (K930104)
• ACE AST Reagent (K930104)

Submission Summary (Full Text)

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131351

# 510(k) SUMMARY

| 510(k) Owner: | Alfa Wassermann Diagnostic Technologies, LLC<br>4 Henderson Drive<br>West Caldwell, NJ 07006 | |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| Contact: | [e-mail]<br>Hyman Katz, Ph.D.<br>Phone: [phone]<br>Fax: [phone] | AUG 1 5 2013 |
| Date Summary<br>Prepared: | July 3, 2013 | |
| Device: | Trade Name: | ACE Alkaline Phosphatase Reagent |
| | Classification: | Class 2 |
| | Common/Classification Name: | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes<br>(21 C. F.R. § 862.1050)<br>Product Code CJE |
| | Trade Name: | ACE Amylase Reagent |
| | Classification: | Class 2 |
| | Common/Classification Name: | Saccharogenic, Amylase<br>(21 C. F.R. § 862.1070)<br>Product Code CIJ |
| | Trade Name: | ACE ALT Reagent |
| | Classification: | Class 1 |
| | Common/Classification Name: | NADH Oxidation/NAD Reduction, ALT/SGPT<br>(21 C.F.R. § 862.1030)<br>Product Code CKA |
| | Trade Name: | ACE AST Reagent |
| | Classification: | Class 2 |
| | Common/Classification Name: | NADH Oxidation/NAD Reduction, AST/SGOT<br>(21 C.F.R. § 862.1100)<br>Product Code CIT |
| Predicate<br>Devices: | Manufacturer for reagent system predicates:<br>Alfa Wassermann ACE and ACE Axcel Clinical Chemistry Systems and ACE<br>Reagents (K113253, K931786, K930104, K113436, K113382) | |
| Device Descriptions: | In the ACE Alkaline Phosphatase Reagent assay, alkaline phosphatase catalyzes the<br>hydrolysis of colorless p-nitrophenyl phosphate to p-nitrophenol and inorganic<br>phosphate. In an alkaline solution (pH 10.5), p-nitrophenol is in the phenoxide form<br>and has a strong absorbance at 408 nm. The rate of increase in absorbance, monitored<br>bichromatically at 408 nm/486 nm, is directly proportional to the alkaline phosphatase<br>activity in the sample.<br><br>In the ACE Amylase Reagent assay, α-amylase hydrolyzes the 2-chloro-p-nitrophenyl-<br>α-D-maltotrioside substrate to release 2-chloro-p-nitrophenol and form 2-chloro-p-<br>nitrophenyl-α-D-maltoside, maltotriose and glucose. The rate of increase in<br>absorbance, monitored bichromatically at 408 nm/ 647 nm, is directly proportional to<br>the α-amylase activity in the sample.<br><br>In the ACE ALT Reagent assay, alanine aminotransferase converts the L-alanine and α-<br>ketoglutarate substrates in the reagent to L-glutamate and pyruvate, respectively.<br>Lactate dehydrogenase (LDH) catalyzes the oxidation of the reduced cofactor to the<br>cofactor. The rate of conversion of the reduced cofactor to the cofactor can be<br>determined by monitoring the decrease in absorbance bichromatically at 340 nm/647<br>nm. This rate of conversion from the reduced cofactor to the cofactor is a function of<br>the activity of ALT in the sample.<br><br>In the ACE AST Reagent assay, aspartate aminotransferase converts the L-aspartate<br>and α-ketoglutarate in the reagent to oxaloacetate and L-glutamate, respectively. The<br>oxaloacetate undergoes reduction, with concurrent oxidation of NADH to NAD+ in the malate dehydrogenase-catalyzed indicator reaction. NADH absorbs strongly at 340 nm,<br>whereas NAD+ does not. Therefore, the rate of conversion of NADH to NAD+ can be<br>determined by monitoring the decrease in absorbance bichromatically at 340 nm/647<br>nm. This rate of conversion from NADH to NAD+ is a function of the activity of AST<br>in the sample. Lactate dehydrogenase is added to prevent interference from endogenous<br>pyruvate, which is normally present in blood. | |
| Intended Use: | Indications for Use:<br>The ACE Alkaline Phosphatase Reagent is intended for the quantitative determination<br>of alkaline phosphatase activity in serum and lithium heparin plasma using the ACE,<br>ACE Alera, and ACE Axcel Clinical Chemistry Systems. Measurements of alkaline<br>phosphatase are used in the diagnosis and treatment of liver, bone, parathyroid, and<br>intestinal diseases. This test is intended for use in clinical laboratories and physician<br>office laboratories. For <i>in vitro</i> diagnostic use only.<br><br>The ACE Amylase Reagent is intended for the quantitative determination of α-amylase<br>activity in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE<br>Axcel Clinical Chemistry Systems. Amylase measurements are used primarily for the<br>diagnosis and treatment of pancreatitis (inflammation of the pancreas). This test is<br>intended for use in clinical laboratories and physician office laboratories. For <i>in vitro</i><br>diagnostic use only. | |
| | | |
| Intended Use: | The ACE ALT Reagent is intended for the quantitative determination of alanine<br>aminotransferase activity in serum and lithium heparin plasma using the ACE, ACE<br>Alera, and ACE Axcel Clinical Chemistry Systems. Alanine aminotransferase<br>measurements are used in the diagnosis and treatment of certain liver diseases (e.g.,<br>viral hepatitis and cirrhosis) and heart diseases. This test is intended for use in clinical<br>laboratories and physician office laboratories. For in vitro diagnostic use only. | |
| | The ACE AST Reagent is intended for the quantitative determination of aspartate<br>aminotransferase activity in serum and lithium heparin plasma using the ACE, ACE<br>Alera, and ACE Axcel Clinical Chemistry Systems. Measurements of aspartate<br>aminotransferase are used in the diagnosis and treatment of certain types of liver and<br>heart disease. This test is intended for use in clinical laboratories and physician office<br>laboratories. For in vitro diagnostic use only. | |
| Technological<br>Characteristics: | The ACE Alkaline Phosphatase Reagent is composed of two reagent bottles (Buffer<br>and Substrate Reagent). The reagents contain AMP Buffer (pH 10.45), magnesium<br>acetate, and p-nitrophenyl phosphate. | |
| | The ACE Amylase Reagent is composed of a single reagent bottle. The reagents<br>contain 2-chloro-p-nitrophenyl-a-D-maltotrioside, sodium chloride, calcium acetate,<br>potassium thiocyanate, and MES buffer (pH 6.0). | |
| | The ACE ALT Reagent consists of two reagent bottles (Substrate and Coenzyme). The<br>reagents contain L-alanine, α-ketoglutarate, nicotinamide adenine dinucleotide-reduced<br>(NADH), lactate dehydrogenase, and Tris buffer. | |
| | The ACE AST Reagent consists of two reagent bottles (Substrate and Coenzyme). The<br>reagents contain L-aspartate, α-ketoglutarate, nicotinamide adenine dinucleotide-<br>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 Days<br>RX2002: 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 Device<br>K930104<br>(ACE ALT) |
| Intended Use/<br>Indications for Use | The ACE ALT Reagent is intended for the<br>quantitative determination of alanine<br>aminotransferase activity concentration. | Same |
| Platforms | ACE, ACE Alera®, and ACE Axcel Clinical<br>Chemistry Systems | ACE Clinical<br>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 | 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 Device<br>K930104<br>(ACE AST) |
| Intended Use/<br>Indications for Use | The ACE AST Reagent is intended for the<br>quantitative determination of aspartate<br>aminotransferase activity. | Same |
| Platforms | ACE, ACE Alera®, and ACE Axcel Clinical<br>Chemistry Systems | ACE Clinical<br>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 | 13 µL | Same |
| Reaction Volume | 185 µL | Same |
| Expected Values | 7 - 31 U/L | Same |
| Measuring Range | 4 - 450 U/L | Same |

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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<br>(n=20) | ACE | | | Alera | | | Axcel | | |
| | Mean<br>(U/L) | Within-<br>Run | Total | Mean<br>(U/L) | Within-<br>Run | Total | Mean<br>(U/L) | Within-<br>Run | Total |
| Serum<br>Low | 92 | 1.2,<br>1.3% | 1.9,<br>2.0% | 91 | 0.8,<br>0.9% | 2.0,<br>2.2% | 90 | 1.2,<br>1.3% | 2.1,<br>2.3% |
| Serum<br>Mid | 649 | 6.3,<br>1.0% | 8.6,<br>1.3% | 642 | 6.4,<br>1.0% | 6.4,<br>1.0% | 645 | 6.8,<br>1.0% | 6.9,<br>1.1% |
| Serum<br>High | 1198 | 20.2,<br>1.7% | 20.8,<br>1.7% | 1190 | 5.6,<br>0.5% | 8.7,<br>0.7% | 1194 | 6.1,<br>0.5% | 7.9,<br>0.7% |
| Plasma<br>Low | 76 | 1.9,<br>2.5% | 2.8,<br>3.7% | 75 | 0.8,<br>1.1% | 3.4,<br>4.6% | 74 | 1.1,<br>1.5% | 3.7,<br>5.1% |
| Plasma<br>Mid | 614 | 5.8,<br>0.9% | 24.4,<br>4.0% | 609 | 5.1,<br>0.8% | 20.2,<br>3.3% | 613 | 3.4,<br>0.6% | 20.5,<br>3.3% |
| Plasma<br>High | 1163 | 6.8,<br>0.6% | 33.5,<br>2.9% | 1149 | 5.9,<br>0.5% | 32.9,<br>2.9% | 1155 | 7.6,<br>0.7% | 35.7,<br>3.1% |

## In-House Precision: Serum vs. Plasma – ACE Amylase Reagent

| | | | Precision (SD, %CV) | | | | | | | | |
|----------------|---------------|---------------|---------------------|---------------|---------------|---------------|---------------|---------------|---------------|--|--|
| AMY<br>(n=20) | Mean<br>(U/L) | Within-Run | Total | Mean<br>(U/L) | Within-Run | Total | Mean<br>(U/L) | Within-Run | Total | | |
| | ACE | | | | Alera | | | | Axcel | | |
| Serum<br>Low | 46 | 0.7,<br>1.5% | 0.9,<br>2.1% | 46 | 1.0,<br>2.1% | 1.5,<br>3.3% | 46 | 1.2,<br>2.6% | 1.6,<br>3.4% | | |
| Serum<br>Mid | 830 | 9.2,<br>1.1% | 11.5,<br>1.4% | 825 | 5.1,<br>0.6% | 11.9,<br>1.4% | 826 | 9.2,<br>1.1% | 11.9,<br>1.4% | | |
| Serum<br>High | 1597 | 15.0,<br>0.9% | 19.8,<br>1.2% | 1577 | 9.9,<br>0.6% | 29.4,<br>1.9% | 1586 | 8.5,<br>0.5% | 18.6,<br>1.2% | | |
| Plasma<br>Low | 41 | 0.7,<br>1.8% | 1.3,<br>3.2% | 42 | 0.5,<br>1.3% | 1.5,<br>3.5% | 41 | 1.0,<br>2.5% | 2.5,<br>6.0% | | |
| Plasma<br>Mid | 806 | 8.1,<br>1.0% | 12.5,<br>1.5% | 801 | 4.4,<br>0.5% | 13.1,<br>1.6% | 805 | 5.3,<br>0.7% | 12.2,<br>1.5% | | |
| Plasma<br>High | 1604 | 15.4,<br>1.0% | 29.3,<br>1.8% | 1596 | 18.8,<br>1.2% | 33.8,<br>2.1% | 1604 | 21.6,<br>1.3% | 25.0,<br>1.6% | | |

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| Performance Data:<br>In-House<br>Precision –<br>Serum vs.<br>Plasma | In-House Precision: Serum vs. Plasma – ACE ALT Reagent | Precision (SD, %CV) | | | | | | | | |
|---------------------------------------------------------------------|--------------------------------------------------------|---------------------|-------------------|--------------|---------------|---------------------|--------------|---------------|---------------------|--------------|
| | ALT<br>(n=24) | Mean<br>(U/L) | ACE<br>Within-Run | Total | Mean<br>(U/L) | Alera<br>Within-Run | Total | Mean<br>(U/L) | Axcel<br>Within-Run | Total |
| | Serum Low | 36 | 0.9,<br>2.6% | 1.4,<br>4.0% | 36 | 0.6,<br>1.7% | 1.2,<br>3.3% | 37 | 1.1,<br>3.1% | 1.4,<br>3.7% |
| | Serum Mid | 114 | 1.3,<br>1.2% | 1.8,<br>1.6% | 114 | 1.3,<br>1.1% | 2.2,<br>2.0% | 115 | 1.4,<br>1.2% | 2.3,<br>2.0% |
| | Serum High | 216 | 2.9,<br>1.4% | 4.0,<br>1.9% | 216 | 1.8,<br>0.8% | 3.5,<br>1.6% | 218 | 1.4,<br>0.6% | 3.2,<br>1.5% |
| | Plasma Low | 32 | 0.9,<br>2.7% | 1.3,<br>4.0% | 32 | 0.8,<br>2.6% | 1.5,<br>4.7% | 34 | 1.0,<br>2.9% | 1.4,<br>4.1% |
| | Plasma Mid | 112 | 1.1,<br>1.0% | 1.5,<br>1.4% | 112 | 0.9,<br>0.8% | 1.1,<br>1.0% | 113 | 1.0,<br>0.9% | 1.5,<br>1.4% |
| | Plasma High | 219 | 1.1,<br>0.5% | 1.6,<br>0.7% | 219 | 2.1,<br>0.9% | 3.0,<br>1.4% | 222 | 1.7,<br>0.7% | 2.7,<br>1.2% |

## In-House Precision: Serum vs. Plasma – ACE AST Reagent

| Precision (SD, %CV) | | | | | | | | | |
|---------------------|---------------|-------------------|--------------|---------------|---------------------|--------------|---------------|---------------------|--------------|
| AST<br>(n=24) | Mean<br>(U/L) | ACE<br>Within-Run | Total | Mean<br>(U/L) | Alera<br>Within-Run | Total | Mean<br>(U/L) | Axcel<br>Within-Run | Total |
| Serum<br>Low | 26 | 0.7,<br>2.6% | 1.2,<br>4.5% | 25 | 0.7,<br>2.7% | 0.8,<br>3.3% | 25 | 1.1,<br>4.3% | 1.4,<br>5.7% |
| Serum<br>Mid | 155 | 1.3,<br>0.8% | 2.7,<br>1.8% | 155 | 1.0,<br>0.7% | 2.8,<br>1.8% | 155 | 0.7,<br>0.5% | 2.3,<br>1.5% |
| Serum<br>High | 301 | 3.5,<br>1.2% | 4.8,<br>1.6% | 302 | 2.2,<br>0.7% | 4.0,<br>1.3% | 304 | 2.7,<br>0.9% | 4.1,<br>1.4% |
| Plasma<br>Low | 26 | 0.8,<br>3.2% | 1.4,<br>5.4% | 26 | 0.6,<br>2.5% | 1.0,<br>3.7% | 26 | 0.9,<br>3.5% | 1.0,<br>4.0% |
| Plasma<br>Mid | 157 | 1.6,<br>1.0% | 2.3,<br>1.4% | 157 | 1.5,<br>0.9% | 1.7,<br>1.1% | 158 | 1.4,<br>0.9% | 2.0,<br>1.3% |
| Plasma<br>High | 304 | 3.5,<br>1.2% | 4.5,<br>1.5% | 303 | 2.6,<br>0.9% | 3.9,<br>1.3% | 305 | 3.2,<br>1.1% | 4.3,<br>1.4% |

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| Performance Data:<br>In-House Matrix<br>Comparison –<br>Serum vs.<br>Plasma | Performance data for the Alfa Wassermann ACE Reagents run on the Alfa Wassermann ACE, ACE Alera and ACE Axcel Clinical Chemistry System<br>In-House Matrix Comparison: Serum vs. Plasma – ACE ALP Reagent | | | |
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