Yumizen C1200 ALP, Yumizen C1200 Albumin
Device Facts
| Record ID | K191245 |
|---|---|
| Device Name | Yumizen C1200 ALP, Yumizen C1200 Albumin |
| Applicant | HORIBA ABX SAS |
| Product Code | CJE · Clinical Chemistry |
| Decision Date | Aug 30, 2019 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1050 |
| Device Class | Class 2 |
Indications for Use
Yumizen C1200 ALP reagent is intended for the quantitative in vitro diagnostic determination of alkaline phosphatase in human serum and plasma based on a kinetic photometric test using p-nitrophenylphosphate. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases. Yumizen C1200 Albumin reagent is intended for the quantitative in vitro diagnostic determination of albumin in human serum and plasma by colorimetry. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.
Device Story
Yumizen C1200 ALP and Albumin reagents are liquid, in vitro diagnostic assays for use on the Yumizen C1200 analyzer. ALP assay uses kinetic photometric method with p-nitrophenylphosphate to measure catalytic activity; Albumin assay uses colorimetric bromocresol green dye-binding procedure. Analyzers process human serum or lithium heparin plasma samples. Output is quantitative concentration of ALP (U/L) or Albumin (g/dL). Healthcare providers use results to diagnose and monitor liver, bone, parathyroid, and kidney conditions. Device is intended for clinical laboratory use by trained personnel.
Clinical Evidence
Bench testing only. Performance validated via CLSI guidelines (EP05-A3, EP17-A2, EP09-A3, EP06-A, EP25-A). Precision studies (within-run/total) showed CVs within limits. Method comparison against predicates (Passing-Bablok regression) showed high correlation (r²=0.993 for ALP; r²=0.990 for Albumin). Interference testing confirmed no significant bias (>10%) for common substances. Linearity and LoD/LoQ established for claimed measuring ranges.
Technological Characteristics
Liquid reagents. ALP: 2-amino-2-methyl-1-propanol, magnesium acetate, zinc sulphate, HEDTA, p-nitrophenylphosphate. Albumin: citrate buffer, bromocresol green. Measurement: kinetic photometry (ALP) and colorimetry (Albumin). Instrument: Yumizen C1200. Traceability: IFCC reference procedure (ALP), ERM-DA470 (Albumin).
Indications for Use
Indicated for quantitative in vitro diagnostic determination of alkaline phosphatase and albumin in human serum and plasma for diagnosis and treatment of liver, bone, parathyroid, intestinal, and kidney diseases. Prescription use only; not for point-of-care use.
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
Related Devices
- K991762 — ALKALINE PHOPHATASE (ALP), PRODUCT NO'S 118-01, 118-02 · A.P. Total Care, Inc. · Sep 2, 1999
- K101090 — EASYRA ALKALINE PHOSPHATASE, ASPARTATE AMINOTRANSFERASE AND AMYLASE REAGENTS · Medica Corp. · May 20, 2011
Submission Summary (Full Text)
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Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov
# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY
ASSAY ONLY
## I Background Information:
A 510(k) Number
K191245
B Applicant
Horiba Abx Sas
C Proprietary and Established Names
Yumizen C1200 ALP, Yumizen C1200 Albumin
D Regulatory Information
| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| CJE | Class II | 21 CFR 862.1050 - Alkaline Phosphatase Or Isoenzymes Test System | CH - Clinical Chemistry |
| CIX | Class II | 21 CFR 862.1035 - Albumin test system | CH - Clinical Chemistry |
## II Submission/Device Overview:
A Purpose for Submission:
New devices
B Measurand:
Alkaline phosphatase (ALP)
Albumin
C Type of Test:
ALP - Quantitative; kinetic photometric
Albumin - Quantitative; colorimetry
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# III Intended Use/Indications for Use:
## A Intended Use(s):
See Indications for Use below.
## B Indication(s) for Use:
Yumizen C1200 ALP reagent is intended for the quantitative in vitro diagnostic determination of alkaline phosphatase in human serum and plasma based on a kinetic photometric test using p-nitrophenylphosphate. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.
Yumizen C1200 Albumin reagent is intended for the quantitative in vitro diagnostic determination of albumin in human serum and plasma by colorimetry. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.
## C Special Conditions for Use Statement(s):
Rx - For Prescription Use Only
Not for point-of-care use
## D Special Instrument Requirements:
Yumizen C1200
# IV Device/System Characteristics:
## A Device Description:
The Yumizen C1200 ALP assay consists of the following reagents:
Reagent 1: 1.1 mol/L 2-amino-2-methyl-1-propanol (pH 10.4), 2 mmol/L magnesium acetate, 0.5 mmol/L zinc sulphate, and 2.5 mmol/L HEDTA
Reagent 2: 80 mmol/L p-Nitrophenylphosphate
The Yumizen C1200 Albumin assay consists the following reagents: 30 mmol/L citrate buffer (pH 4.2) and 0.26 mmol/L bromocresol green.
## B Principle of Operation:
ALP- Quantitative measurement of the catalytic activity of alkaline phosphatase in human serum and plasma in accordance with a standardized method. In the presence of magnesium and zinc ions, p-nitrophenyl phosphate is cleaved by alkaline phosphatases in the sample into phosphate and p-nitrophenol. The p-nitrophenol released is directly proportional to the catalytic ALP activity. It is determined by measuring the increase in absorbance.
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Albumin- Colorimetric test for the quantitative determination of albumin in serum and plasma using Bromocresol Green dye binding procedure. At pH 4.20, in succinate buffer and with a nonionic surfactant, the bromocresol green (BCG) fixes itself selectively to the albumin present in the sample, producing a blue color which is measured at 628 nm. The intensity of the coloring is directly proportional to the albumin concentration.
V Substantial Equivalence Information:
A Predicate Device Name(s):
ALP IFCC Gen.2
ABX PENTRA Albumin CP
B Predicate 510(k) Number(s):
k171080
k060434
C Comparison with Predicate(s):
ALP
| Device & Predicate Device(s): | K191245 | K171080 |
| --- | --- | --- |
| Device Trade Name | Yumizen C1200 ALP | ALP IFCC Gen.2 |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | For quantitative in vitro determination of Alkaline Phosphatase (ALP) in serum or plasma. | Same |
| Matrix | Serum, plasma in lithium heparin | Same |
| Reagent format | Liquid | Same |
| Measurement | Quantitative | Same |
| Reference range | 40-129 U/L (Men) 35-104 U/L (Women) | Same |
| General Device Characteristic Differences | | |
| Instrument | Yumizen C1200 | Cobas Integra systems |
| Reagent On-board Stability | 1 week after opening | 4 weeks on-board at 10-15°C |
| Measuring Range | 6.0-1200 U/L | 3.0-1200 U/L |
| Automatic post-dilution: | Can measure ALP concentrations up to 4800 U/L with the automatic postdilution. | Results from samples diluted using the re-run function are automatically multiplied by a factor of 5. |
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ALBUMIN
| Device & Predicate Device(s): | K191245 | K060434 |
| --- | --- | --- |
| Device Trade Name | Yumizen C1200 Albumin | ABX Pentra Albumin CP |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | For the quantitative in vitro diagnostic determination of albumin in human serum and plasma by colorimetry. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys. | Same |
| Matrix | Serum, plasma in lithium heparin | Same |
| Reagent format | Liquid | Same |
| Measurement | Quantitative | Same |
| Method | Colorimetry | Same |
| Measuring Range | 0.46-5.60 g/dL | Same |
| Automatic post-dilution: | Up to 11.20 g/dL | Same |
| General Device Characteristic Differences | | |
| Instrument | Yumizen C1200 | ABX Pentra 400 Clinical Chemistry Analyzer |
| Sample Volume | 1μL/test | 2μL |
| Reagent On board Stability | Stable for 6 weeks. | Stable for 83 days (11 weeks) |
| Calibration Stability | 6 weeks | 14 days |
VI Standards/Guidance Documents Referenced:
CLSI Guidelines:
- CLSI EP05-A3: Evaluation of Precision of Quantitative Measurement Procedures–Third Edition – October 2014
- CLSI EP17-A2: Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures – Second Edition – June 2012
- CLSI EP06-A: Evaluation of the Linearity of Quantitative measurement Procedures A Statistical Approach – First Edition – April 2003
- CLSI C28-A3: Defining, Establishing, and Verifying Reference Intervals in the Clinical laboratory- Third Edition – November 2008
- CLSI EP25-A: Evaluation of Stability of In Vitro Diagnostic reagents
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VII Performance Characteristics (if/when applicable):
A Analytical Performance:
1. Precision/Reproducibility:
Repeatability studies were conducted by testing 2 control materials (Yumizen C1200 N Multi Control and Yumizen C1200 P Multi Control) and low, mid, and high serum samples (5 specimens for ALP and 3 specimens for albumin). For each sample, 20 replicates were measured. For the repeatability study, samples were analyzed in a single run on a single instrument using a single lot of reagent for each assay.
The results of the repeatability study are shown in the table below:
| Test | Samples | N | Mean | Within-run | |
| --- | --- | --- | --- | --- | --- |
| | | | | SD | %CV |
| ALP (U/L) | Control 1 | 20 | 80.60 | 0.43 | 0.54 |
| | Control 2 | 20 | 198.20 | 1.61 | 0.81 |
| | Sample 1 | 20 | 10.64 | 0.37 | 3.49 |
| | Sample 2 | 20 | 19.34 | 0.21 | 1.07 |
| | Sample 3 | 20 | 52.11 | 0.47 | 0.91 |
| | Sample 4 | 20 | 386.68 | 1.27 | 0.33 |
| | Sample 5 | 20 | 1155.16 | 5.92 | 0.51 |
| Albumin (g/L) | Control 1 | 20 | 39.26 | 0.15 | 0.37 |
| | Control 2 | 20 | 49.23 | 0.32 | 0.64 |
| | Low Sample | 20 | 20.11 | 0.12 | 0.60 |
| | Mid Sample | 20 | 39.89 | 0.26 | 0.64 |
| | High Sample | 20 | 55.82 | 0.28 | 0.51 |
Precision studies to evaluate lot-to-lot reagent variability were conducted following CLSI EP05-A3 guideline. Pooled samples of sera with concentration spanning the analytical measuring range (5 specimens for ALP and 3 specimens for albumin) and 2 controls (Yumizen C1200 N Multi Control and Yumizen C1200 P Multi Control) were tested in triplicate with 2 runs per day over 5 days, using three lots of reagents and one instrument.
The results of the lot-to-lot precision study for are shown in the table below:
| Test | Samples | N | Mean | Within Lot | | Between Lot | | Total Precision | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | | SD | %CV | SD | %CV | SD | %CV |
| ALP (U/L) | Control 1 | 90 | 74.44 | 2.10 | 2.8 | 0.00 | 0.0 | 2.10 | 2.8 |
| | Control 2 | 90 | 165.83 | 4.86 | 2.9 | 0.00 | 0.0 | 4.86 | 2.9 |
| | Sample 1 | 90 | 10.24 | 0.36 | 3.5 | 0.17 | 1.6 | 0.40 | 3.9 |
| | Sample 2 | 90 | 21.76 | 0.77 | 3.5 | 0.00 | 0.0 | 0.77 | 3.5 |
| | Sample 3 | 90 | 46.50 | 1.16 | 2.5 | 0.00 | 0.0 | 1.16 | 2.5 |
| | Sample 4 | 90 | 438.24 | 13.98 | 3.2 | 0.00 | 0.0 | 13.98 | 3.2 |
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| Test | Samples | N | Mean | Within Lot | | Between Lot | | Total Precision | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | | SD | %CV | SD | %CV | SD | %CV |
| Albumin (g/L) | Control 1 | 90 | 37.67 | 0.41 | 1.1 | 0.00 | 0.0 | 0.41 | 1.1 |
| | Control 2 | 90 | 53.24 | 0.55 | 1.0 | 0.00 | 0.0 | 0.55 | 1.0 |
| | Low Sample | 90 | 22.07 | 0.74 | 3.4 | 0.00 | 0.0 | 0.74 | 3.4 |
| | Mid Sample | 90 | 43.41 | 0.74 | 1.7 | 0.22 | 0.5 | 0.77 | 1.8 |
| | High Sample | 90 | 53.52 | 0.41 | 0.8 | 0.11 | 0.2 | 0.43 | 0.8 |
CLSI EP05-A3 was used to evaluate reproducibility of the assay. Using a single lot of reagents and 3 instruments, pooled samples of sera with concentration spanning the analytical measuring range (5 specimens for ALP and 3 specimens for albumin) and 2 controls (Yumizen C1200 N Multi Control and Yumizen C1200 P Multi Control) were tested in duplicate with 2 runs per day over 20 days.
The results of the reproducibility study for are shown in the tables below:
| Test | Samples | N | Mean | Repeatability | | Between Run | | Between Day | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | | SD | %CV | SD | %CV | SD | %CV |
| ALP (U/L) | Control 1 | 240 | 81.98 | 0.65 | 0.8 | 2.18 | 2.7 | 2.58 | 3.2 |
| | Control 2 | 240 | 201.77 | 1.03 | 0.5 | 4.75 | 2.4 | 6.29 | 3.1 |
| | Sample 1 | 240 | 11.71 | 0.39 | 3.3 | 0.36 | 3.1 | 0.40 | 3.4 |
| | Sample 2 | 240 | 21.58 | 0.39 | 1.8 | 0.52 | 2.4 | 0.71 | 3.3 |
| | Sample 3 | 240 | 56.27 | 0.56 | 1.0 | 2.11 | 3.7 | 2.17 | 3.9 |
| | Sample 4 | 240 | 428.89 | 2.56 | 0.6 | 10.79 | 2.5 | 15.23 | 3.6 |
| | Sample 5 | 240 | 1,042.42 | 5.32 | 0.5 | 11.10 | 1.1 | 13.04 | 1.3 |
| Albumin (g/L) | Control 1 | 240 | 37.8 | 0.17 | 0.4 | 0.90 | 2.4 | 0.68 | 1.8 |
| | Control 2 | 240 | 47.1 | 0.15 | 0.3 | 0.38 | 0.8 | 0.84 | 1.8 |
| | Low Sample | 240 | 20.1 | 0.14 | 0.7 | 0.63 | 3.2 | 0.17 | 0.8 |
| | Mid Sample | 240 | 39.3 | 0.15 | 0.4 | 0.55 | 1.4 | 0.69 | 1.8 |
| | High Sample | 240 | 54.2 | 0.21 | 0.4 | 0.71 | 1.3 | 0.89 | 1.6 |
| Test | Samples | N | Mean | Within Lab | | Between Lab | | Total Precision | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | | SD | %CV | SD | %CV | SD | %CV |
| ALP (U/L) | Control 1 | 240 | 81.98 | 3.44 | 4.2 | 3.03 | 3.7 | 4.59 | 5.6 |
| | Control 2 | 240 | 201.77 | 7.95 | 3.9 | 6.97 | 3.5 | 10.58 | 5.2 |
| | Sample 1 | 240 | 11.71 | 0.66 | 5.7 | 0.52 | 4.4 | 0.84 | 7.2 |
| | Sample 2 | 240 | 21.58 | 0.96 | 4.4 | 0.85 | 4.0 | 1.29 | 6.0 |
| | Sample 3 | 240 | 56.27 | 3.08 | 5.5 | 2.32 | 4.1 | 3.85 | 6.8 |
| | Sample 4 | 240 | 428.89 | 18.84 | 4.4 | 6.92 | 1.6 | 20.07 | 4.7 |
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| Test | Samples | N | Mean | Within Lab | | Between Lab | | Total Precision | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | | SD | %CV | SD | %CV | SD | %CV |
| | Sample 5 | 240 | 1,042.42 | 17.93 | 1.7 | 18.21 | 1.7 | 25.56 | 2.5 |
| Albumin (g/L) | Control 1 | 240 | 37.8 | 1.14 | 3.0 | 0.10 | 0.3 | 1.14 | 3.0 |
| | Control 2 | 240 | 47.1 | 0.94 | 2.0 | 0.00 | 0.0 | 0.94 | 2.0 |
| | Low Sample | 240 | 20.1 | 0.67 | 3.3 | 0.00 | 0.0 | 0.67 | 3.3 |
| | Mid Sample | 240 | 39.3 | 0.90 | 2.3 | 0.12 | 0.3 | 0.91 | 2.3 |
| | High Sample | 240 | 54.2 | 1.16 | 2.1 | 0.00 | 0.0 | 1.16 | 2.1 |
2. Linearity:
Linearity studies were performed according to CLSI EP06-A guideline. Ten levels of dilutions were prepared by mixing different proportions of serum samples with high and low concentrations of the analytes. Each sample was tested 4 times on a single instrument using a single reagent lot per assay. The summary of the linear regression analysis of the data is presented below:
| Test | Slope | Intercept | r² | Range tested | Claimed Range |
| --- | --- | --- | --- | --- | --- |
| ALP | 0.9402 | 3.907 | 0.993 | 0-1,620 U/L | 6 - 1,200 U/L |
| Albumin | 0.9632 | 0.4211 | 0.990 | 0-60.2 g/L | 4.6 - 56 g/L |
The linearity studies support the sponsor's claimed measuring ranges as described in the table above.
3. Analytical Specificity/Interference:
An interference study was performed based on CLSI EP07-A2 guideline. For both assays (ALP and Albumin) pooled human sera with two different analyte concentrations were spiked with increasing concentrations of the potential interferent and analyzed in quadruplicates. The sponsor states that interference is considered to be non-significant if the difference between the samples with and without interferent are within 10%.
The results of the highest concentration tested without significant interference are summarized in the table below.
| Analyte | Interferent | Highest concentration tested that did not show significant interference (mg/dL) |
| --- | --- | --- |
| ALP | Hemoglobin | 500 |
| | Triglycerides | 504.88 |
| | Total bilirubin | 28.84 |
| | Direct bilirubin | 26.36 |
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| Analyte | Interferent | Highest concentration tested that did not show significant interference (mg/dL) |
| --- | --- | --- |
| | Acetylsalicylic Acid | 65.16 |
| | Ascorbic acid | 5.98 |
| | Ibuprofen | 50.1 |
| | Acetaminophen | 20 |
| Albumin | Hemoglobin | 375 |
| | Triglycerides | 463.75 |
| | Total bilirubin | 31.39 |
| | Direct bilirubin | 26.27 |
| | Ascorbic acid | 5.98 |
| | Ibuprofen | 50.10 |
| | Acetaminophen | 20 |
| | Acetylsalicylic Acid | 65.16 |
The sponsor includes the following limitation in the labeling of the Yumizen C1200 ALP reagent:
“Measurements in patients treated with asfotase alfa”(Strensiq) are expected to be elevated due to the presence of this drug.”
4. Assay Reportable Range:
The claimed measuring ranges are described in the table below.
| Analyte | Reportable Range |
| --- | --- |
| ALP | 6-1,200 U/L |
| Albumin | 4.6 to 56 g/L |
5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):
The information on the traceability of the assays is provided below:
| Analyte | Traceability |
| --- | --- |
| ALP | IFCC reference measurement procedure |
| Albumin | ERM-DA470 |
6. Detection Limit:
Detection capabilities for each analyte were evaluated following the CLSI EP17-A2 guideline.
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Limit of blank (LoB) study was performed by testing 1 blank sample of ALP and 4 blank samples of using 2 reagent lots over 4 days on 3 different instruments. Each day, for each reagent lot, 5 replicate measurements were recorded (60 results per reagent lot for ALP and 64 results per reagent lot of albumin). The LoB was calculated non-parametrically at the 95th percentile for each lot. The higher LoB for both reagent lots was chosen as the assay's LoB.
Limit of detection (LoD) study was performed by testing 4 low level samples using 2 reagent lots over 4 days on a single instrument. Each day, for each reagent lot, 4 replicate measurements were recorded (64 results per reagent lot). LoD was calculated non-parametrically. The higher LoD of the two lots was the assay's LoD.
Limit of quantitation (LoQ) study was performed using 4 low level human sera samples measured over 4 days on a single instrument using 2 reagent lots. Each day, for each reagent lot, 4 replicate measurements were recorded (128 results total). The sponsor defines LoQ as the lowest concentration for which the total error (TE) is less than 40%; calculated as |bias| + 2*standard deviation.
| Endpoint | ALP (U/L) | Albumin (g/L) |
| --- | --- | --- |
| LoB | 0.71 | 0.41 |
| LoD | 1.40 | 0.57 |
| LoQ | 5.85 | 3.34 |
| Assay Claimed Range | 6 - 1,200 | 4.6 - 56 |
7. Assay Cut-Off:
Not applicable.
B Comparison Studies:
1. Method Comparison with Predicate Device:
Method comparison studies were conducted by testing native human serum samples with ALP and albumin analyte concentrations within the claimed analytical ranges of each assay. ALP was measured using the Yumizen C1200 ALP reagent on the Yumizen C1200 analyzer (candidate device) and results were compared to those obtained from the Roche's ALP IFCC Gen.2 assay on the cobas c502 module analyzer (predicate device). Albumin was measured using the Yumizen C1200 Albumin assay on the Yumizen C1200 analyzer and results were compared to those obtained from the ABX PENTRA Albumin CP reagent on the ABX Pentra C400 analyzer (predicate device). Samples were assayed in duplicate over 5 days. Only the first replicate was used for data analysis. The correlation between the predicate device and the candidate are summarized below.
Serum:
| Analyte | N | Slope | Intercept | R² | Test Range | Claimed Measuring Range |
| --- | --- | --- | --- | --- | --- | --- |
| ALP | 165 | 0.9402 | 3.907 | 0.993 | 17.8-920.29 U/L | 6-1,200 U/L |
| Albumin | 111 | 0.9632 | 0.4211 | 0.990 | 7.2-54.8 g/L | 4.6-56 g/L |
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Method comparison data supports that serum is an acceptable sample for the ALP and albumin assays.
In addition, the sponsor conducted method comparison studies to demonstrate that the candidate devices can measure ALP and Albumin in lithium heparin plasma samples. Lithium heparin plasma samples were evaluated using the Yumizen C1200 ALP and Yumizen C1200 Albumin reagents on the Yumizen C1200 analyzer and results were compared to those obtained from the predicate devices. Each sample was derived from a single donor in a lithium-heparin collection tube. Each sample was measured by the candidate device in duplicate, but only the first replicate was used for analysis. Results are summarized below:
| Analyte | N | Slope | Intercept | R² | Test Range |
| --- | --- | --- | --- | --- | --- |
| ALP | 40 | 1.013 | 0.3709 | 0.993 | 20.39-1,167.67 U/L |
| Albumin | 70 | 1.009 | 0.7690 | 0.988 | 14.21-55.53 g/L |
The results indicate lithium heparin plasma specimens are suitable for use with the candidate devices.
2. Matrix Comparison:
The performance of the device with serum and lithium heparin plasma samples was evaluated in the method comparison section above.
C Clinical Studies:
1. Clinical Sensitivity:
Not applicable.
2. Clinical Specificity:
Not applicable.
3. Other Clinical Supportive Data (When 1. and 2. Are Not Applicable):
Not applicable.
D Clinical Cut-Off:
Not applicable.
E Expected Values/Reference Range:
Reference range studies for the ALP and albumin assays were conducted according to CLSI EP28-A3c to verify values cited from the literature. Serum samples were collected at a blood bank from healthy, normal adults (n=44/sex for ALP and 125 total for albumin).
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Each sample was assayed in duplicate. Results of the assays confirm the normal range for adults identified in the literature as referenced below:
ALP
Adults (37°C)¹
Men: 40-129 U/L
Women: 35-104 U/L
Consensus values (37°C)²
Men: 40-130 U/L
Women: 35-105 U/L
Children (37°C)³
Boys
0 – 14 days: 83-248 U/L
15 days – < 1 year: 122-469 U/L
1 – < 10 years: 142-335 U/L
10 – < 13 years: 129-417 U/L
13 – < 15 years: 116-468 U/L
15 – < 17 years: 82-331 U/L
17 – < 19 years: 55-149 U/L
Girls
0 – 14 days: 83-248 U/L
15 days – < 1 year: 122-469 U/L
1 – < 10 years: 142-335 U/L
10 – < 13 years: 129-417 U/L
13 – < 15 years: 57-254 U/L
15 – < 17 years: 50-117 U/L
17 – < 19 years: 45-87 U/L
Albumin⁴
4 days – 14 years: 38 - 54 g/L
14 - 18 years: 32 - 45 g/L
20 - 60 years: 35 - 52 g/L
60 - 90 years: 32 - 46 g/L
> 90 years: 29 - 45 g/L
References:
¹ Abicht K, El-Samalouti V, Junge W, et al. Multicenter evaluation of new GGT and ALP reagents with new reference standardization and determination of 37 °C reference intervals. Clin Chem Lab Med 2001;39:Special Supplement pp S 346.
² Thomas L, Müller M, Schumann G, et al. Consensus of DGKL and VDGH for interim reference intervals on enzymes in serum. J Lab Med 2005;29:301-308.
³ Estey MP, Cohen AH, Colantonio DA, et al. CLSI-based transference of the CALIPER database of pediatric reference intervals from Abbott to Beckman, Ortho, Roche and Siemens Clinical Chemistry Assays: Direct validation using reference samples from the CALIPER cohort. Clin Biochem 2013;46:1197-1219.
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$^{4}$ Roberts WL, McMillin GA, Burtis CA, Bruns DE. Reference Information for the Clinical Laboratory. Tietz Textbook of Clinical Chemistry and Molecular Diagnostics, 4th Ed., Burtis CA, Ashwood ER, Bruns DE. (Elsevier Saunders eds. St Louis USA) (2006): 2254.
## VIII Proposed Labeling:
The labeling supports the finding of substantial equivalence for this device.
## IX Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
