Amylase2
Device Facts
| Record ID | K210633 |
|---|---|
| Device Name | Amylase2 |
| Applicant | Abbott Ireland Diagnostics Division |
| Product Code | JFJ · Clinical Chemistry |
| Decision Date | May 26, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1070 |
| Device Class | Class 2 |
Indications for Use
The Amylase2 assay is used for the quantitation of amylase in human serum, plasma, or urine on the ARCHITECT c System. The Amylase2 assay is to be used primarily as an aid in the diagnosis and treatment of pancreatitis (inflammation of the pancreas).
Device Story
Amylase2 is an automated clinical chemistry assay for the ARCHITECT c System; measures amylase concentration in human serum, plasma, or urine. Principle: two-part enzymatic/colorimetric reaction; Ethylidene-4-NP-G7 (EPS) hydrolyzed by α-amylase; α-glucosidase then hydrolyzes the product into glucose and 4-nitrophenol. Change in absorbance at 404 nm is proportional to α-amylase concentration. Used in clinical laboratories by trained personnel. Output provides quantitative amylase levels to assist physicians in diagnosing and monitoring pancreatitis. Benefits include standardized, automated, and precise measurement of amylase activity.
Clinical Evidence
Bench testing only. Performance validated via precision (within-lab and reproducibility), accuracy (bias vs IRMM/IFCC-456), linearity, and interference studies per CLSI guidelines (EP05-A3, EP06-A, EP07, EP09-A3, EP17-A2). Method comparison against predicate showed correlation coefficient of 1.00 for both serum and urine. No clinical data presented.
Technological Characteristics
Enzymatic/colorimetric assay. Reagents: α-glucosidase (16.000 KU/L) and Ethylidene-4-NP-G7 (6.501 g/L) with sodium azide preservative. Operates on ARCHITECT c8000 analyzer. Measures absorbance at 404 nm. Traceable to IRMM/IFCC-456. Supports automated and manual dilution for extended measuring intervals.
Indications for Use
Indicated for the quantitation of amylase in human serum, plasma, or urine to aid in the diagnosis and treatment of pancreatitis.
Regulatory Classification
Identification
An amylase test system is a device intended to measure the activity of the enzyme amylase in serum and urine. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).
Predicate Devices
- Amy (K981653)
Related Devices
- K191454 — Atellica CH Amylase_2 (AMY_2) · Siemens Healthcare Diagnostics, Inc. · Jul 30, 2019
- K981653 — AMY · Abbott Laboratories · Aug 28, 1998
Submission Summary (Full Text)
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FDA
U.S. FOOD & DRUG
ADMINISTRATION
# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY
ASSAY ONLY
## I Background Information:
A 510(k) Number
K210633
B Applicant
Abbott Ireland Diagnostics Division
C Proprietary and Established Names
Amylase2
D Regulatory Information
| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| JFJ | Class II | 21 CFR 862.1070 - Amylase Test System | CH - Clinical Chemistry |
## II Submission/Device Overview:
A Purpose for Submission:
New device
B Measurand:
Amylase
C Type of Test:
Quantitative Enzymatic/Colorimetric
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov
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K210633 - Page 2 of 12
## III Intended Use/Indications for Use:
### A Intended Use(s):
See Indications for Use below.
### B Indication(s) for Use:
The Amylase2 assay is used for the quantitation of amylase in human serum, plasma, or urine on the ARCHITECT c System.
The Amylase2 assay is to be used primarily as an aid in the diagnosis and treatment of pancreatitis (inflammation of the pancreas).
### C Special Conditions for Use Statement(s):
Rx - For Prescription Use Only
### D Special Instrument Requirements:
ARCHITECT c8000 clinical chemistry analyzer
## IV Device/System Characteristics:
### A Device Description:
The Amylase2 assay is comprised of a reagent kit that is run on the ARCHITECT c System. Each kit has two reagents: R1 and R2. R1 contains α-glucosidase 16.000 KU/L. R2 contains Ethylidene-4-NP-G7 (EPS) 6.501 g/L, both R1 and R2 have sodium azide as preservative. The Amylase2 assay is calibrated by the user using one of two methods:
- Calibration method, using the Consolidated Chemistry Calibrator.
- Calibration Factor method, using a fixed calibration factor value (4412) to calculate result
There are separate assay parameter files that the user must upload for use with each of the calibration methods. The Instructions for Use (IFU) provides information on calibration set up for the two methods.
### B Principle of Operation:
The Amylase2 assay is a two-part reaction. Ethylidene-4-NP-G7 (EPS) is hydrolyzed by α-amylase to form 4,6- ethylidene-α-(1,4)-D-glucopyranosyl-Gx and 4-nitrophenyl-α-(1,4)-glucopyranosyl-G(7-x). The 4-nitrophenyl-α-(1,4)-glucopyranosyl-G(7-x) is then hydrolyzed into glucose monomers and the assay chromophore (4-nitrophenol) by α-glucosidase. The resulting change in absorbance at 404 nm is proportional to the α-amylase concentration in the sample.
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V Substantial Equivalence Information:
A Predicate Device Name(s):
Amy
B Predicate 510(k) Number(s):
K981653
C Comparison with Predicate(s):
| Device & Predicate Device(s): | K210633 | K981653 |
| --- | --- | --- |
| Device Trade Name | Amylase2 | Amy |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | The assay is used for the quantitation of amylase. | Same |
| Measurand | Amylase | Same |
| Method | Enzymatic | Same |
| Specimen type | Serum, Plasma, Urine | Same |
| General Device Characteristic Differences | | |
| Traceability | IRMM/IFCC-456 | Molar extinction coefficient of CNP (non-IFCC method) |
| Calibration Method | Calibrator or Calibration factor method | Calibration factor Method |
| Assay range | Serum/Plasma: Analytical measuring interval: 3–3010 U/L Extended measuring interval: 3010- 5959 U/L Urine: Analytical measuring interval: 3–3010 U/L Extended measuring interval: 3010-8600 U/L | Serum/Plasma/Urine: Analytical measuring interval: 3–3010 U/L Flex Rate Linearity: 6554 U/L |
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VI Standards/Guidance Documents Referenced:
CLSI EP05-A3 Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline—Third Edition.
CLSI EP07-A3 Interference Testing in Clinical Chemistry; Approved Guideline —Third Edition.
CLSI EP17-A2 Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline—Second Edition.
VII Performance Characteristics (if/when applicable):
A Analytical Performance:
1. Precision/Reproducibility:
Precision studies were performed according to CLSI EP05-A3.
Serum precision was assessed by testing two levels of controls and three contrived serum panels (target concentrations of 4 U/L, 170 U/L, and 2800 U/L) samples in duplicates, two times per day, for 20 days, three lots of reagent, three instruments for a total of 80 replicates per sample for each lot. The results of the precision studies are summarized below for one representative lot. The within-laboratory SD and %CV were estimated using the within-run, between-run, and between-day variance components.
Serum, Calibration method :
| Sample Type | n | Mean U/L | Repeatability | | Within-Lab Precision | |
| --- | --- | --- | --- | --- | --- | --- |
| | | | SD U/L | CV (%) | SD U/L | CV (%) |
| Serum QC 1 | 80 | 77 | 0.5 | 0.6 | 1.5 | 2.0 |
| Serum QC 2 | 80 | 413 | 3.3 | 0.8 | 6.7 | 1.6 |
| Panel A | 80 | 4 | 0.3 | 7.4 | 0.5 | 11.0 |
| Panel B | 80 | 162 | 0.8 | 0.5 | 3.3 | 2.1 |
| Panel C | 80 | 2629 | 14.8 | 0.6 | 51.6 | 2.0 |
Serum, Calibration Factor method :
| Sample Type | n | Mean U/L | Repeatability | | Within-Lab Precision | |
| --- | --- | --- | --- | --- | --- | --- |
| | | | SD U/L | CV (%) | SD U/L | CV (%) |
| Serum QC 1 | 80 | 76 | 0.5 | 0.6 | 1.5 | 2.0 |
| Serum QC 2 | 80 | 411 | 3.3 | 0.8 | 6.7 | 1.6 |
| Panel A | 80 | 4 | 0.3 | 6.5 | 0.4 | 9.7 |
| Panel B | 80 | 161 | 0.8 | 0.5 | 3.4 | 2.1 |
| Panel C | 80 | 2615 | 14.7 | 0.6 | 51.2 | 2.0 |
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Urine Precision was assessed by testing two levels of controls and five contrived human urine panels (target concentrations of 5 U/L, 16 U/L, 500 U/L, 2000 U/L, and 2800 U/L) in duplicates, two times per day, for 20 days, 3 lots of reagent, 3 instruments for a total of 80 replicates per sample for each lot. The within-laboratory SD and %CV were estimated using the within-run, between-run, and between-day variance components. The results of the urine precision studies are summarized below for one representative lot.
Urine, Calibration method:
| Sample Type | n | Mean U/L | Repeatability | | Within-Lab Precision | |
| --- | --- | --- | --- | --- | --- | --- |
| | | | SD U/L | CV (%) | SD U/L | CV (%) |
| Urine QC 1 | 80 | 55 | 0.4 | 0.8 | 0.5 | 1.0 |
| Urine QC 2 | 80 | 180 | 0.8 | 0.4 | 1.3 | 0.7 |
| Panel A | 80 | 6 | 0.3 | 5.4 | 0.5 | 7.9 |
| Panel B | 80 | 18 | 0.4 | 2.1 | 0.4 | 2.4 |
| Panel C | 80 | 538 | 2.7 | 0.5 | 5.3 | 1.0 |
| Panel D | 80 | 1891 | 10.2 | 0.5 | 20.4 | 1.1 |
| Panel E | 80 | 2625 | 12.2 | 0.5 | 20.3 | 0.8 |
Urine, Calibration Factor method:
| Sample Type | n | Mean U/L | Repeatability | | Within-Lab Precision | |
| --- | --- | --- | --- | --- | --- | --- |
| | | | SD U/L | CV (%) | SD U/L | CV (%) |
| Urine QC 1 | 80 | 55 | 0.4 | 0.7 | 0.6 | 1.0 |
| Urine QC 2 | 80 | 179 | 0.8 | 0.4 | 1.3 | 0.7 |
| Panel A | 80 | 6 | 0.4 | 6.5 | 0.5 | 8.4 |
| Panel B | 80 | 18 | 0.4 | 2.1 | 0.5 | 2.6 |
| Panel C | 80 | 535 | 2.7 | 0.5 | 5.3 | 1.0 |
| Panel D | 80 | 1881 | 10.1 | 0.5 | 20.2 | 1.1 |
| Panel E | 80 | 2611 | 12.2 | 0.5 | 20.1 | 0.8 |
Reproducibility:
Reproducibility studies were performed according to the CLSI EP05-A3 guideline.
Serum:
Testing was conducted using five control samples, one lot of reagent, one lot of calibrator, one lot of controls, and three instruments. Each instrument was operated by a different technician. Samples were tested in three replicates, two times per day for five days, for a total of 90 replicates. The results of the precision studies are summarized below for one representative lot. The within-laboratory SD and %CV were estimated using the within-run, between-run, and between-day variance components.
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| Sample Type | n | Mean U/L | Repeatability | | Within-Lab Precision | | Reproducibility | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | SD U/L | CV (%) | SD U/L | CV (%) | SD U/L | CV (%) |
| QC 1 | 90 | 74 | 0.4 | 0.6 | 0.6 | 0.8 | 0.6 | 0.9 |
| QC 2 | 90 | 416 | 2.5 | 0.6 | 3.0 | 0.7 | 3.1 | 0.7 |
| QC 3 | 90 | 37 | 0.4 | 1.0 | 0.5 | 1.3 | 0.6 | 1.6 |
| QC 4 | 90 | 113 | 0.8 | 0.7 | 0.8 | 0.7 | 0.9 | 0.8 |
| QC 5 | 90 | 351 | 1.2 | 0.4 | 1.3 | 0.4 | 1.6 | 0.4 |
Urine:
Testing was conducted using four controls, one lot of reagent, one lot of calibrator, one lot of controls, and three instruments. Each instrument was operated by a different technician. Samples were tested in three replicates, two times per day for five days, for a total of 90 replicates. The results of the precision studies are summarized below for one representative lot. The within-laboratory SD and $\% \mathrm{CV}$ were estimated using the summation of the within-run, between-run, and between-day variance components.
| Sample Type | n | Mean U/L | Repeatability | | Within-Lab Precision | | Reproducibility | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | SD U/L | CV (%) | SD U/L | CV (%) | SD U/L | CV (%) |
| QC 1 | 90 | 54 | 0.5 | 1.0 | 0.5 | 1.0 | 0.6 | 1.1 |
| QC 2 | 90 | 171 | 1.2 | 0.7 | 1.2 | 0.7 | 1.6 | 0.9 |
| QC 3 | 90 | 66 | 0.4 | 0.7 | 0.5 | 0.8 | 0.9 | 1.3 |
| QC 4 | 90 | 232 | 1.6 | 0.7 | 2.2 | 1.0 | 2.4 | 1.0 |
2. Linearity:
In this study, one contrived low level amylase sample with a concentration at or below the limit f quantitation (LoQ) was mixed with one high level contrived amylase sample with a concentration at or above the upper limit of the analytical measuring interval to create 14 samples/pools for serum and urine. Samples were tested in duplicate using one reagent lot and one instrument. The mean results were plotted against the expected results, below is the linear regression analysis.
Serum:
- Calibration method: $y = 0 + 1.0102x$
- Calibration factor method: $y = 0 + 1.0095x$
Urine:
- Calibration method: $y = 0 + 0.9886x$
- Calibration factor method: $y = 0 + 0.9898x$
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Auto Dilution study:
The sponsor conducted a study to validate the auto-dilute feature available for both serum and urine extended range. Five human serum samples were prepared by spiking α-amylase stock solution into a serum pool to obtain the target concentration values of 3800, 4500, 5200, 5900, and 6600 U/L. Five urine samples were prepared by spiking α-amylase stock solution into a urine pool to obtain the target concentration values of 3800, 4500, 5200, 5900, and 6600 U/L. Three runs were performed, each sample was tested in replicates of five on two instruments for a total of 30 replicates. The percent dilution recovery (% Dilution Recovery) relative to the assigned sample concentration was calculated for the automated dilution with calibration method and calibration factor method. Results of this study supported the sponsor's claim that samples with amylase concentrations above 3010 U/L can be auto diluted 1:2 (i.e. 1:1.98) to obtain results up to 5959 U/L for serum and auto diluted 1:3 (i.e. 1:2.86) to obtain results up to 8600 U/L for urine.
Manual Dilution study:
The sponsor conducted a study to validate the manual-dilution available for both serum and urine extended range. For serum, three sets of manually diluted samples (1:2 dilution with saline) were prepared for each sample by two technicians. Each sample was tested in replicates of five on one instrument for a total of 30 replicates. The percent dilution recovery (% Dilution Recovery) relative to the assigned sample concentration was calculated for the manual dilution with calibration method and calibration factor method. Results of this study supported the sponsor's claim that samples with amylase concentrations above 3010 U/L can be diluted manually 1:2 to obtain results up to 5959 U/L for serum and diluted manually 1:3 to obtain results up to 8600 U/L for urine.
3. Analytical Specificity/Interference:
Interference studies were performed in accordance with the CLSI EP07-A3 guideline.
Serum:
Studies were conducted using two samples with amylase concentration of 50 U/L and 200 U/L. Each sample had one aliquot for test sample and one for reference sample. Samples were run in 10 replicates on one reagent lot, one instrument. The difference between the mean concentration of the test and reference samples was calculated and the % difference was calculated. The sponsor defined Amylase2 interference if the two-sided 95% confidence interval (CI) values around the % difference was within or equal to ± 10%. The results for the Calibration Factor method were generated using the absorbance data from the Calibrator method, two-sided 95% CI around the % difference for amylase samples targeted at 50 U/L and 200 U/L. The results for Calibration factor method ranged from -10% to 5% and calibration method from -10% to 6%. The following table lists the concentrations of each substance at which no significant interference was found:
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| Interferent | Highest concentration tested that did not show significant interference |
| --- | --- |
| Conjugated Bilirubin | 60 mg/dL |
| Unconjugated Bilirubin | 60 mg/dL |
| Hemoglobin | 1000 mg/dL |
| Total Protein | 15 g/dL |
| Triglycerides | 1500 mg/dL |
| Acetaminophen | 160 mg/L |
| Acetylcysteine | 150 mg/L |
| Acetylsalicylic acid | 30 mg/L |
| Ampicillin-Na | 80 mg/L |
| Ascorbic acid | 60 mg/L |
| Biotin | 4250 ng/mL |
| Ca-dobesilate | 60 mg/L |
| Cefotaxime | 53 mg/dL |
| Cefoxitin | 6600 mg/L |
| Cyclosporine | 2 mg/L |
| Doxycycline | 20 mg/L |
| Ibuprofen | 220 mg/L |
| Icodextrin | 3.6 mg/dL |
| Levodopa | 8 mg/L |
| Methyldopa | 25 mg/L |
| Metronidazole | 130 mg/L |
| Pancreozymin | 314 pg/mL |
| Phenylbutazone | 330 mg/L |
| Rifampicin | 50 mg/L |
| Sodium heparin | 4 U/mL |
| Theophylline | 60 mg/L |
Urine:
The study was conducted using two urine samples with amylase concentration at 450 U/L and 1400 U/L. Each sample had two aliquots and tested for the test sample (spiked with potentially interfering substances) and for the reference sample. Samples were run in 10 replicates, 1 reagent lot, 1 instrument. The difference between the mean concentration of the test and reference samples and the % difference was calculated for calibration method and calibration factor method. The sponsor defined Amylase2 interference if the two-sided 95% Confidence Interval (CI) values around the % difference was within or equal to ± 10%, at the target amylase levels of 450 U/L and 1400 U/L. The results for the Calibration Factor method were generated using the absorbance data from the Calibrator method. Two-sided 95% CI around the % difference for amylase samples ranged from -1% to 1% for both calibration method and calibration factor method.
The following table lists the concentrations of each substance at which no significant interference was found:
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| Interferent | Highest concentration tested that did not show significant interference |
| --- | --- |
| Ascorbate | 150 mg/dL |
| Boric acid | 250 mg/dL |
| Glucose | 1000 mg/dL |
| Protein | 50 mg/dL |
| Acetaminophen | 16 mg/dL |
| Acetylcysteine | 15 mg/dL |
| Biotin | 4250 ng/mL |
| Ibuprofen | 22 mg/dL |
| Sodium Carbonate | 1.25 g/dL |
| Sodium Fluoride | 400 mg/dL |
| Sodium Oxalate | 60 mg/dL |
Acetic acid (8.5N), hydrochloric acid (6N) and nitric acid (6N) were found to interfere at amylase levels of 450 U/L and 1400 U/L.
The following limitation for acidified urine samples is included in the Amylase2 reagent package insert: “Amylase2 testing should not be performed on acidified urine samples due to enzyme instability.”
Icodextrin interference: Treatment with icodextrin can result in decreased amylase results at therapeutically relevant interferent concentrations and samples from patients with this treatment should not be tested.
Ascorbate interference: The following interference beyond +/-10% was observed at the 200 mg/dL level of Ascorbate and added to labeling:
| Interferent | Interferent Level | Analyte Level | % Interference (95% CI) |
| --- | --- | --- | --- |
| Ascorbate | 200 mg/dL | 450 U/L | -21% (-21%, -20%) |
| Ascorbate | 200 mg/dL | 1400 U/L | -18% (-19%, -17%) |
4. Assay Reportable Range:
The assay has an analytical measuring interval of 3-3010 U/L for serum, plasma, and urine specimens with an extended measuring interval of 3010-5959 U/L for serum and 3010-8600 U/L for urine.
5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):
The Amylase2 assay is traceable to IRMM/IFCC-456 reference material.
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6. Detection Limit:
Detection capability studies of the Amylase 2 assay on the ARCHITECT c8000 with serum and urine for limit of blank (LoB), limit of detection (LoD), and limit of quantitation (LoQ) was conducted following the recommendations in CLSI EP17-A2. Data analysis was conducted using both the calibration method and calibration factor method.
LoB
The 95th percentile of the zero-analyte sample concentrations based on n ≥ 60 replicates using each of three lots of reagent and two instruments was calculated and considered the estimated LoB.
LoD
The LoD was determined parametrically using the lowest concentration at which the analyte could be detected with 95% probability based on n ≥ 60 replicates of low-analyte level samples tested using each of three lots of reagent and two instruments.
LoQ
The LoQ was defined as the lowest concentration at which a maximum allowable precision of 20 %CV was met and was determined from n ≥ 60 replicates of low-analyte level samples using each of three lots of reagent and two instruments.
The results of the detection limit studies are presented in the table below:
| Matrix | LoB | LoD | LoQ | Analytical Measuring Interval |
| --- | --- | --- | --- | --- |
| Serum | 0 U/L | 1 U/L | 2 U/L | 3-3010 U/L |
| Urine | 0 U/L | 1 U/L | 3 U/L | 3-3010 U/L |
7. Assay Cut-Off:
Not applicable.
B Comparison Studies:
1. Method Comparison with Predicate Device:
A method comparison study was conducted by testing 124 serum samples and 103 urine samples. Two of 124 of serum samples and seven of 103 of urine samples were spiked with amylase stock solution. For the candidate device, samples were tested using three lots of reagents and one lot each of calibrator and controls on two ARCHITECT c8000 instruments. For the predicate device, samples were tested using one lot each of reagents, calibrator, and controls on two ARCHITECT c8000 instruments. Each sample was tested in duplicate using both methods and testing occurred over three days. A Passing-Bablok evaluation was performed by comparing the first replicate result from the candidate device versus the mean result from the predicate device. The results are summarized below:
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| Sample | n | Slope | Intercept | r | Test range (per predicate) |
| --- | --- | --- | --- | --- | --- |
| Serum, calibration method | 124 | 0.98 | -1.00 | 1.0 | 6-2788 |
| Serum, calibration factor method | 124 | 0.96 | -1.00 | 1.0 | 6-2788 |
| Urine, calibration method | 103 | 0.93 | -1.00 | 1.00 | 4-2916 |
| Urine, calibration factor method | 103 | 0.93 | -1.00 | 1.00 | 4-2916 |
2. Matrix Comparison:
A matrix comparison study was performed to evaluate the suitability of other blood specimen types for use with the Amylase2 assay. A total of 65 samples were tested using one lot of the Amylase2 reagent, one lot of the Consolidated Chemistry Calibrator, one lot of commercially available controls, and one instrument in triplicate. The first replica result of the test tube type was used for comparison to the mean of the replica for the control tube type (serum). The results are shown below:
Calibration method:
| Specimen Type | N | Min | Max | r | Intercept | Slope |
| --- | --- | --- | --- | --- | --- | --- |
| Lithium heparin (plasma) | 65 | 20 | 2638 | 1.00 | -0.82 | 1.01 |
| Sodium heparin (plasma) | 65 | 20 | 2526 | 1.00 | -0.89 | 1.01 |
| Lithium heparin (separator tube, plasma) | 65 | 20 | 2417 | 1.00 | -0.57 | 1.01 |
| Serum (separator tube) | 65 | 21 | 2565 | 1.00 | 0.33 | 1.00 |
Calibration factor method:
| Specimen Type | N | Min | Max | r | Intercept | Slope |
| --- | --- | --- | --- | --- | --- | --- |
| Lithium heparin (plasma) | 65 | 20 | 2602 | 1.00 | -0.67 | 1.00 |
| Sodium heparin (plasma) | 65 | 20 | 2492 | 1.00 | -0.75 | 1.00 |
| Lithium heparin (separator tube, plasma) | 65 | 20 | 2385 | 1.00 | -0.85 | 1.01 |
| Serum (separator tube) | 65 | 21 | 2531 | 1.00 | 0.33 | 1.00 |
The study results support the sponsor's claim that serum separator tube, lithium heparin, lithium heparin serum separator tube and sodium heparin tube are acceptable collection methods for serum and plasma samples to be used with this assay.
C Clinical Studies:
1. Clinical Sensitivity:
Not applicable
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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:
| Sample Type | Range U/L |
| --- | --- |
| Serum^{1} | 28-100 |
| Urine Random^{1} | |
| Male | 16-491 |
| Female | 21-447 |
| Timed Urine^{2} | 1-17 U/hour |
| Adult (24-hour urine)^{3} | 170-2000 |
1. Junge W, Wortmann W, Wilke B, et al. Development and evaluation of assays for the determination of total and pancreatic amylase at 37 degrees C according to the principle recommended by the IFCC. Clin Biochem 2001;34(8):607-615.
2. Burtis CA, Ashwood ER, editors. Tietz Textbook of Clinical Chemistry. 2nd ed. Philadelphia, PA: WB Saunders; 1994.
3. Wu AHB, editor. Tietz Clinical Guide to Laboratory Tests. 4th ed. St. Louis, MO: Saunders Elsevier; 2006:102.
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.
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