ABX PENTRA 400, CALCIUM CP, CREATININE CP, PHOSPHORUS CP, AMYLASE CP, URINE CONTROL L/H

K070249 · Horiba Abx · CIC · Apr 26, 2007 · Clinical Chemistry

Device Facts

• Record ID: K070249
• Device Name: ABX PENTRA 400, CALCIUM CP, CREATININE CP, PHOSPHORUS CP, AMYLASE CP, URINE CONTROL L/H
• Applicant: Horiba Abx
• Product Code: CIC · Clinical Chemistry
• Decision Date: Apr 26, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1145
• Device Class: Class 2

Indications for Use

ABX PENTRA Calcium CP reagent with associated calibrators and controls are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer for quantitative in vitro diagnostic determination of calcium in human serum, plasma and urine based on a photometric test using orthocresolphtalein complexone. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). ABX PENTRA Creatinine CP reagent with associated calibrators and controls are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer for quantitative in vitro diagnostic determination of creatinine in human serum, plasma and urine based on a kinetic method using alkaline picrate (Jaffé method). Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes. ABX PENTRA Phosphorus CP reagent with associated calibrators and controls are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer for quantitative in vitro diagnostic determination of phosphorus in human serum, plasma and urine based on a UV method using phosphomolybdate. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance. ABX PENTRA Amylase CP reagent with associated calibrators and controls are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer for quantitative in vitro diagnostic determination of the activity of the enzyme amylase in human serum, plasma and urine based on an enzymatic photometric assay. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas). The ABX PENTRA Urine Control L/H is for use in quality control by monitoring accuracy and precision.

Device Story

Reagents for ABX PENTRA 400 Clinical Chemistry Analyzer; perform quantitative in vitro diagnostic determination of amylase, calcium, creatinine, and phosphorus in human serum, plasma, and urine. Amylase uses enzymatic photometric assay; Calcium uses photometric test with orthocresolphtalein complexone; Creatinine uses kinetic alkaline picrate (Jaffe) method; Phosphorus uses UV phosphomolybdate method. Device includes liquid urine controls (low/high) for accuracy/precision monitoring. Operated by laboratory personnel in clinical settings. Output provides analyte concentration/activity levels to assist clinicians in diagnosing/monitoring pancreatitis, renal disease, parathyroid disorders, and bone conditions.

Clinical Evidence

Bench testing only. Precision evaluated per CLSI EP5-A2; linearity per CLSI EP6-A; method comparison per CLSI EP9-A2 using 110-124 human urine specimens per analyte. Results showed high correlation (r > 0.99) and acceptable bias (range -1.1% to 9.1%) against predicate methods. No clinical studies performed.

Technological Characteristics

Photometric clinical chemistry reagents; bi-reagent or mono-reagent cassettes. Methods: orthocresolphtalein complexone (Calcium), alkaline picrate/Jaffé (Creatinine), phosphomolybdate UV (Phosphorus), enzymatic photometric (Amylase). Liquid-based urine controls. Designed for use on ABX PENTRA 400 discrete photometric benchtop analyzer.

Indications for Use

Indicated for quantitative in vitro diagnostic determination of calcium, creatinine, phosphorus, and amylase in human serum, plasma, and urine to aid in the diagnosis and treatment of parathyroid, bone, renal, and pancreatic diseases. Intended for prescription use on the ABX PENTRA 400 analyzer.

Regulatory Classification

Identification

A calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

Predicate Devices

• K896224
• K941837
• K883962
• K972297
• K020817

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE

A. 510(k) Number:
k070249

B. Purpose for Submission:
To expand the indications for use with urine and to add urine control materials

C. Measurand:
Amylase, calcium, creatinine, and phosphorus

D. Type of Test:
Quantitative

E. Applicant:
HORIBA ABX

F. Proprietary and Established Names:
ABX PENTRA Amylase CP, ABX PENTRA Calcium CP, ABX PENTRA Creatinine CP, ABX PENTRA Phosphorus CP, and ABX PENTRA Urine Control L/H

G. Regulatory Information:

1. Regulation section:
21 CFR 862.1070: Amylase Test System, 862.1145: Calcium Test System, 862.1225: Creatinine Test System, 862.1580: Phosphorus (inorganic) Test System, and 862.1660: Quality Control Material (assayed and unassayed)

2. Classification:
Class II: Amylase, Calcium, and Creatinine
Class I, reserved: QC Material
Class I: Phosphorus

3. Product codes:

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JFJ – Catalytic Methods, Amylase; CIC – Cresolphthalein Complexone, Calcium; CGX – Alkaline Picrate, Colorimetry, Creatinine; CEO – Phosphomolybdate (colorimetric), Inorganic Phosphorus; and JJY – Multi-Analyte Controls, All Kinds (Assayed and Unassayed)

4. Panel:
Chemistry (75)

H. Intended Use:

1. Intended uses:
See Indications for use below.

2. Indications for use:

ABX PENTRA Amylase CP reagent with associated calibrators and controls are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer for quantitative in vitro diagnostic determination of the activity of the enzyme amylase in human serum, plasma and urine based on an enzymatic photometric assay. Amylase measurements are used in the diagnosis and treatment of pancreatitis (inflammation of the pancreas).

ABX PENTRA Calcium CP reagent with associated calibrators and controls are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer for quantitative in vitro diagnostic determination of calcium in human serum, plasma and urine based on a photometric test using orthocresolphtalein complexone. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

ABX PENTRA Creatinine CP reagent with associated calibrators and controls are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer for quantitative in vitro diagnostic determination of creatinine in human serum, plasma and urine based on a kinetic method using alkaline picrate (Jaffe® method). Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

ABX PENTRA Phosphorus CP reagent with associated calibrators and controls are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer for quantitative in vitro diagnostic determination of creatinine in human serum, plasma and urine based on a UV method using phosphomolybdate. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.

ABX PENTRA Urine Control L/H is for use in quality control by monitoring accuracy and precision.

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3. Special conditions for use statement(s):

The device is for prescription use.

4. Special instrument requirements:

ABX PENTRA 400 Clinical Chemistry Analyzer

I. Device Description:

The ABX PENTRA Amylase CP is composed of a bi-reagent cassette with 26 mL and 6.5 mL compartments. Reagent 1 consists of Good's buffer, NaCl, MgCl₂, α-Glucosidase, and sodium azide. Reagent 2 consists of Good's buffer, EPS-G7, and sodium azide.

The ABX PENTRA Calcium CP is composed of a bi-reagent cassette with 66 mL and 16.5 mL compartments. Reagent 1 consists of ethanolamine and detergents. Reagent 2 consists of o-Cresolphthalein complexone, 8-Hydroxyquinoline, and hydrochloric acid.

The ABX PENTRA Creatinine CP is composed of a bi-reagent cassette with two 28 mL compartments. Reagent 1 consists of picric acid, and Reagent 2 consists of sodium hydroxide and disodium phosphate.

The ABX PENTRA Phosphorus CP is composed of a mono-reagent cassette with a 29.5 mL compartment. The reagent consists of sulfuric acid and ammonium molybdate.

The ABX PENTRA Urine Control L/H is a liquid prepared from human urine with added constituents of human and animal origin, chemicals, preservatives, and stabilizers. The set is composed of 2 vials: 1 vial of low control (10 mL) and 1 vial of high control (10 mL).

All reagents are supplied ready-to-use.

J. Substantial Equivalence Information:

1. Predicate device name(s):

Infinity™ Amylase Liquid Stable Reagent, Roche Calcium, Roche Creatinine, Roche Inorganic Phosphorus, and Liquichek™ Urine Chemistry Control

2. Predicate 510(k) number(s):

k972297, k896224, k941837, k883962, and k020817

3. Comparison with predicate:

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| Amylase | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | Quantitative determination of α-amylase in serum, plasma and urine | Quantitative determination of α-amylase in human serum or urine |
| Methodology | Enzymatic photometric assay | Same |
| Measuring Range | 4.92 to 2000 U/L | 10 to 2000 U/L |
| Calcium | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | Quantitative determination of calcium in serum, plasma and urine | Quantitative measurement of calcium in serum, heparinized plasma, or urine |
| Methodology | Photometric test using orthocresolphthalein complexone | Same |
| Measuring Range | 0.12 to 24.06 mg/dL | 0.08 to 15.0 mg/dL |
| Creatinine | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | Quantitative determination of creatinine in serum, plasma and urine | Quantitative determination of creatinine in serum, plasma, and urine |
| Methodology | Kinetic method using alkaline picrate (modification of the Jaffe’ reaction) | Same |
| Measuring Range | 1.3 to 316.4 mg/dL | Up to 200 mg/dL |
| Phosphorus | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | Quantitative determination of phosphorus in serum, plasma and urine | Quantitative determination of inorganic phosphorus in serum and urine |
| Methodology | UV method using phosphomolybdate | Same |

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| Phosphorus | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Measuring Range | 1.28 to 198.4 mg/dL | Up to 150 mg/dL |
| Urine Control | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | Monitoring accuracy and precision for the methods below | Monitoring the precision of laboratory testing procedures for the analytes below |
| Matrix | Human urine with added constituents of human and animal origin, chemicals, preservatives and stabilizers | Same |
| Analytes | Amylase, calcium, creatinine, and phosphorus | Amylase, calcium, chloride, cortisol, creatinine, glucose, human chorionic gonadotropin, magnesium, microalbumin (albumin), osmolality, pH, phosphorus, potassium, sodium, specific gravity, urea, urea nitrogen, and uric acid |
| Format | Liquid | Same |
| Levels | Two levels | Same |

# K. Standard/Guidance Document Referenced (if applicable):

EP5-A2 - Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline-Second Edition
EP6-A - Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline
EP9-A2 - Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline-Second Edition
EP21-A - Evaluation of Total Analytical Error for Clinical Laboratory Methods; Approved Guideline
- Guidance for Industry and FDA Staff: "Format for Traditional & Abbreviated 510(k)s": August 12, 2005
- "Guidance for Industry and FDA Staff Bundling Multiple Devices or Multiple Indications in a Single Submission, November 2003"

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- "Guidance for Industry – In vitro diagnostics Creatinine Test System July 1998"
- "In vitro diagnostic devices: Guidance for the preparation of 510(k) submissions Jan 1997"

## L. Test Principle:

The amylase assay is based on an enzymatic photometric test. The calcium assay is based on a photometric test using orthocresolphthalein complexone. The creatinine assay is based on a kinetic method using alkaline picrate (Jaffe' method). The phosphorus assay is based on a UV method using phosphomolybdate.

## M. Performance Characteristics (if/when applicable):

### 1. Analytical performance:

#### a. Precision/Reproducibility:

**Amylase:**

To evaluate within run precision, ABX Pentra Urine Control L/H (level 1 & 2) and three human urine specimens were tested 20 times in a single run for each sample, per the Valtec guideline (Vassault et al., Ann. Biol. Clin., 1986 (44), 686-745). The results found were as follows:

| U/L | Control L | Control H | Sample 1 | Sample 2 | Sample 3 |
| --- | --- | --- | --- | --- | --- |
| Mean | 44.7 | 169.4 | 86.4 | 157.7 | 286.8 |
| %CV | 3.16 | 1.14 | 1.65 | 0.63 | 0.63 |

To evaluate between run and total precision, ABX Pentra Urine Control L/H (level 1 & 2) and three human urine specimens were tested in duplicate for 20 days, two series per day, per the CLSI document, EP5-A. The results found were as follows:

| U/L | Control L | Control H | Sample 1 | Sample 2 | Sample 3 |
| --- | --- | --- | --- | --- | --- |
| Mean | 53.98 | 163.45 | 46.79 | 135.54 | 394.54 |
| %CV | | | | | |
| Total | 4.29 | 1.51 | 6.03 | 3.96 | 3.19 |
| Between Day | 2.01 | 1.04 | 5.19 | 3.56 | 3.02 |
| Between Run | 2.67 | 0.68 | 1.78 | 1.34 | 0.94 |

## Calcium:

To evaluate within run precision, ABX Pentra Urine Control L/H (level 1 & 2) and three human urine specimens were tested 20 times in a single run for each sample, per

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the Valtec guideline (Vassault et al., Ann. Biol. Clin., 1986 (44), 686-745). The results found were as follows:

| | Control L | Control H | Sample 1 | Sample 2 | Sample 3 |
| --- | --- | --- | --- | --- | --- |
| Mean (mmol/L) | 2.39 | 3.56 | 1.11 | 2.51 | 4.10 |
| Mean (mg/dL) | 9.57 | 14.29 | 4.44 | 10.05 | 16.43 |
| %CV | 1.83 | 0.54 | 1.00 | 0.84 | 0.96 |

To evaluate between run and total precision, ABX Pentra Urine Control L/H (level 1 & 2) and three human urine specimens were tested in duplicate for 20 days, two series per day, per the CLSI document, EP5-A. The results found were as follows:

| | Control L | Control H | Sample 1 | Sample 2 | Sample 3 |
| --- | --- | --- | --- | --- | --- |
| Mean (mmol/L) | 1.98 | 3.00 | 0.93 | 2.56 | 4.24 |
| Mean (mg/dL) | 7.93 | 12.05 | 3.73 | 10.25 | 16.98 |
| %CV | | | | | |
| Total | 2.40 | 2.33 | 3.61 | 2.83 | 2.37 |
| Between Day | 1.61 | 1.86 | 2.57 | 2.26 | 1.99 |
| Between Run | 0.93 | 0.72 | 1.15 | 1.43 | 1.17 |

# Creatinine:

To evaluate within run precision, ABX Pentra Urine Control L/H (level 1 & 2) and four human urine specimens were tested 20 times in a single run for each sample, per the Valtec guideline (Vassault et al., Ann. Biol. Clin., 1986 (44), 686-745). The results found were as follows:

| | Control | | Sample | | | |
| --- | --- | --- | --- | --- | --- | --- |
| | Low | High | 1 | 2 | 3 | 4 |
| Mean (μmol/L) | 4302 | 9249 | 984 | 8062 | 19767 | 25073 |
| Mean (mg/dL) | 48.6 | 104.5 | 11.1 | 91.1 | 223.4 | 283.3 |
| %CV | 2.09 | 1.34 | 4.44 | 1.73 | 1.51 | 1.88 |

To evaluate between run and total precision, ABX Pentra Urine Control L/H (level 1 & 2) and three human urine specimens were tested in 6 runs (one run per day, one calibration per run). The results found were as follows:

| | Control L | Control H | Sample 1 | Sample 2 | Sample 3 |
| --- | --- | --- | --- | --- | --- |
| Mean (μmol/L) | 5489.25 | 12211.58 | 999.15 | 8390.83 | 18757.37 |
| Mean (mg/dL) | 62.03 | 137.99 | 11.29 | 94.82 | 211.96 |
| %CV | | | | | |

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| Total | 1.23 | 4.04 | 4.60 | 2.30 | 3.25 |
| --- | --- | --- | --- | --- | --- |
| Day to Day | 0.33 | 3.90 | 2.20 | 1.29 | 3.08 |
| Within Run | 1.18 | 1.06 | 4.04 | 1.90 | 1.04 |

# Phosphorus:

To evaluate within run precision, ABX Pentra Urine Control L/H (level 1 & 2) and five human urine specimens were tested 20 times in a single run for each sample, per the Valtec guideline (Vassault et al., Ann. Biol. Clin., 1986 (44), 686-745). The results found were as follows:

| | Control | | Sample | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | Low | High | 1 | 2 | 3 | 4 | 5 |
| Mean (mmol/L) | 6.1 | 14.3 | 2.1 | 12.8 | 19.6 | 47.0 | 53.4 |
| Mean (mg/dL) | 19.0 | 44.2 | 6.6 | 39.8 | 60.9 | 145.6 | 165.4 |
| %CV | 1.67 | 0.80 | 3.87 | 1.21 | 0.94 | 1.78 | 0.79 |

To evaluate between run and total precision, ABX Pentra Urine Control L/H (level 1 & 2) and two human urine specimens were tested in duplicate for 20 days, two series per day, per the CLSI document, EP5-A. The results found were as follows:

| | Control L | Control H | Sample 1 | Sample 2 |
| --- | --- | --- | --- | --- |
| Mean (mmol/L) | 6.3 | 14.8 | 2.3 | 29.8 |
| Mean (mg/dL) | 19.5 | 45.9 | 7.1 | 92.4 |
| | | %CV | | |
| Total | 2.82 | 2.06 | 5.95 | 1.97 |
| Between Day | 1.53 | 1.76 | 3.74 | 1.62 |
| Between Run | 1.89 | 0.75 | 1.44 | 0.95 |

# b. Linearity/assay reportable range:

# Amylase:

To evaluate linearity, different levels of amylase (from saliva) solutions were tested without post-dilution, in accordance with CLSI document, EP6-A. The acceptable bias with the linearity is $\pm 8\%$ . Two studies were conducted, and the method was demonstrated to be linear from 105 to $2184~\mathrm{U / L}$ and from 7.2 to $149.9~\mathrm{U / L}$ . Combining the ranges, the data supports the linearity claim of 7.2 to $2000~\mathrm{U / L}$ .

A study was performed to compare manual dilution with the automatic dilution performed by the Pentra 400. Human urines spiked with amylase solutions at different activities higher than the linearity were used, and the mean of manual and automatic results were calculated. The acceptable bias with the linearity is $\pm 8\%$ . The samples ranged from 2166.4 to $5909.0~\mathrm{U / L}$ and yielded acceptable bias,

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substantiating the post-dilution claim of up to 6000 U/L.

## Calcium:

To evaluate linearity, different concentrations of aqueous calcium solutions were tested without post-dilution, in accordance with CLSI document, EP6-A. The acceptable bias with the linearity is ± 10%. The method was demonstrated to be linear from 0.55 to 6.91 mmol/L (2.21 to 27.70 mg/dL), supporting the linearity claim of up to 6 mmol/L (24.06 mg/dL).

A study was performed to compare manual dilution with the automatic dilution performed by the Pentra 400. Human urines spiked with calcium solutions at different activities higher than the linearity were used, and the mean of manual and automatic results were calculated. The acceptable bias with the linearity is ± 10%. The samples ranged from 24.29 to 47.68 mg/dL and yielded acceptable bias, substantiating the post-dilution claim of up to 48.12 mg/dL.

## Creatinine:

To evaluate linearity, different concentrations of aqueous creatinine solutions were tested without post-dilution, in accordance with CLSI document, EP6-A. The acceptable bias with the linearity is ± 8%. The method was demonstrated to be linear from 138 to 29070 μmol/L (1.56 to 328.49 mg/dL), supporting the linearity claim of up to 28000 μmol/L (316.4 mg/dL).

A study was performed to compare manual dilution with the automatic dilution performed by the Pentra 400. Human urines spiked with creatinine solutions at different activities higher than the linearity were used, and the mean of manual and automatic results were calculated. The acceptable bias with the linearity is ± 8%. The samples ranged from 29604 to 81372 μmol/L and yielded acceptable bias, substantiating the post-dilution claim of up to 84000 μmol/L (949.2 mg/dL).

## Phosphorus:

To evaluate linearity, different concentrations of aqueous phosphate solutions were tested without post-dilution, in accordance with CLSI document, EP6-A. The acceptable bias with the linearity is ± 8%. The method was demonstrated to be linear from 1.72 to 67.69 mmol/L (5.33 to 209.84 mg/dL), supporting the linearity claim of up to 64 mmol/L (198.4 mg/dL).

A study was performed to compare manual dilution with the automatic dilution performed by the Pentra 400. Human urines spiked with phosphate solutions at different activities higher than the linearity were used, and the mean of manual and automatic results were calculated. The acceptable bias with the linearity is ± 8%. The samples ranged from 66.21 to 125.7 mmol/L and yielded acceptable bias, substantiating the post-dilution claim of up to 128 mmol/L (396.8 mg/dL).

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c. Traceability, Stability, Expected values (controls, calibrators, or methods):

The controls are biological source material. The serum from each donor contributing urine for this product was tested by FDA accepted methods and found non-reactive for Hepatitis B Surface Antigen (HBsAg), antibody to Hepatitis C (HCV) and antibody to HIV-1/HIV-2.

The values of the controls are assigned from the ABX PENTRA master calibrator, reagents and analyzers and are lot-specific. The target values are the median of multiple determinations. The values are verified by performing additional measurements and comparing the means to the values and conference ranges assigned.

The shelf-life stability of the controls was evaluated using two lots and was determined to be 2 years in unopened vials stored at 2-8°C. The stability after opening was evaluated by testing recovery of results between time of opening and time at expiration point. The stability was determined to be 30 days at 2-8°C, with vial tightly closed when not in-use.

d. Detection limit:

The minimum detection limit (MDL), based on the Valtec guideline (Vassault et al., Ann. Biol. Clin., 1986 (44), 686-745), is calculated from 30 measurements of physiological water (NaCl 0.9 g/L). The MDL is equal to the mean of the measurements + 4.65 SD.

Amylase: The MDL is 4.92 U/L.

Calcium: The MDL is 0.03 mmol/L or 0.12 mg/dL.

Creatinine: The MDL is 110.83 μmol/L or 1.3 mg/dL.

Phosphorus: The MDL is 0.41 mmol/L or 1.28 mg/dL.

e. Analytical specificity:

Interfering substances in solution were added to pooled human urine with two different analyte concentrations (normal and high), for each of the four analytes below. The interference study was performed following the Valtec guideline (Vassault et al., Ann. Biol. Clin., 1986 (44), 686-745).

Amylase: Hemoglobin up to 290 μmol/L (500 mg/dL) and conjugated bilirubin up to 650 μmol/L (38 mg/dL) do not interfere with amylase determination by this test.

Calcium: Hemoglobin up to 278 μmol/L (479 mg/dL) and conjugated bilirubin up to 350 μmol/L (20.5 mg/dL) do not interfere with calcium determination by this test.

Creatinine: Hemoglobin up to 290 μmol/L (500 mg/dL) and conjugated bilirubin up to 650 μmol/L (38 mg/dL) do not interfere with creatinine determination by this test.

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Phosphorus: Hemoglobin up to 213 μmol/L (367 mg/dL) and conjugated bilirubin up to 650 μmol/L (38 mg/dL) do not interfere with phosphorus determination by this test.

f. Assay cut-off:

Not applicable

2. Comparison studies:

a. Method comparison with predicate device:

Comparison studies were performed using recommendations in CLSI EP9-A2.

Amylase:

One hundred and twenty-one (121) human urine specimens were analyzed on the subject device and a commercially available assay. The samples ranged from 13.3 to 1955.6 U/L. The linear regression equation was as follows: y = 1.133x + 42.179, r = 0.9945. Using Passing-Bablock regression procedure, y = 1.17x + 21.90, r = 0.9891. Based on CLSI EP21-A and the comparison study, the average bias is 9.1%.

Calcium:

One hundred and twenty-four (124) human urine specimens were analyzed on the subject device and a commercially available assay. The samples ranged from 0.26 to 23.68 mg/dL (0.06 to 5.90 mmol/L). The linear regression equation was as follows: y = 1.152x - 0.830, r = 0.9952. Using Passing-Bablock regression procedure, y = 1.13x - 0.50, r = 0.99. Based on the CLSI document EP21-A and the comparison study, the average bias is 1.0%.

Creatinine:

One hundred and ten (110) human urine specimens were analyzed on the subject device and a commercially available assay. The samples ranged from 2.8 to 311.5 mg/dL (248 to 27566 μmol/L). The linear regression equation was as follows: y = 0.977x + 1.152, r = 0.9976. Using Passing-Bablock regression procedure, y = 0.99x - 0.98, r = 0.9953. Based on the CLSI document EP21-A and the comparison study, the average bias is -1.1%.

Phosphorus:

One hundred and nineteen (119) human urine specimens were analyzed on the subject device and a commercially available assay. The samples ranged from 2.2 to 196.8 mg/dL (0.7 to 63.5 mmol/L). The linear regression equation was as follows: y = 1.091x - 2.555, r = 0.9946. Using Passing-Bablock regression procedure, y = 1.07x -

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1.10, r = 0.9892. Based on the CLSI document EP21-A and the comparison study, the average bias is 2.4%.

b. Matrix comparison:
Not applicable

3. Clinical studies:
a. Clinical Sensitivity:
Not applicable
b. Clinical specificity:
Not applicable
c. Other clinical supportive data (when a. and b. are not applicable):
Not applicable

4. Clinical cut-off:
Not applicable

5. Expected values/Reference range:
The expected values are provided in the package insert with the citation for the literature source.

N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

O. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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