SENTINEL PANCREATIC AMYLASE
Device Facts
| Record ID | K051447 |
|---|---|
| Device Name | SENTINEL PANCREATIC AMYLASE |
| Applicant | Sentinel Ch. Srl |
| Product Code | JFJ · Clinical Chemistry |
| Decision Date | Jan 26, 2006 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1070 |
| Device Class | Class 2 |
Indications for Use
The Sentinel Pancreatic Amylase test is used for the quantitation of pancreatic amylase levels in human serum or plasma. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas). For In Vitro use only.
Device Story
Sentinel Pancreatic Amylase is an in vitro diagnostic reagent kit for quantitative analysis of pancreatic amylase in human serum or plasma. Used on Abbott Aeroset and Abbott Architect c8000 systems. Employs two-step enzymatic colorimetric assay; incubation step uses monoclonal antibodies to inhibit salivary alpha-amylase; reaction step uses defined oligosaccharides (4, 6-ethylidene-G7pNP) cleaved by pancreatic alpha-amylase; resulting fragments hydrolyzed to p-nitrophenol (pNP) and glucose by alpha-glucosidase. Increase in absorbance proportional to pancreatic alpha-amylase activity. Results provided to clinicians to assist in diagnosis and treatment of pancreatitis.
Clinical Evidence
Bench testing only. Precision studies (intra-assay and inter-assay) performed on Aeroset and c8000 systems with CV < 6%. Linearity established up to 2200 IU/L. Method comparison studies (n=72 for Aeroset vs predicate, r=0.9994; n=56 for c8000 vs Aeroset, r=0.9998) demonstrate high correlation. Analytical specificity tested against hemoglobin, bilirubin, and triglycerides with no interference at specified concentrations.
Technological Characteristics
In vitro diagnostic assay; two-reagent enzymatic colorimetric method. Uses monoclonal antibodies for salivary amylase inhibition and EPS substrate for pancreatic amylase detection. Analyzed via spectrophotometry (absorbance increase). Linear range up to 2200 U/L; sensitivity 1 U/L. Designed for use on automated clinical chemistry analyzers.
Indications for Use
Indicated for the quantitative measurement of pancreatic amylase in human serum or plasma 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
- Roche Pancreatic Amylase on the Hitachi 911 Analyzer (k895880)
Related Devices
- K210633 — Amylase2 · Abbott Ireland Diagnostics Division · May 26, 2022
- K981216 — AMY · Abbott Laboratories · Jun 8, 1998
Submission Summary (Full Text)
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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
ASSAY ONLY TEMPLATE
A. 510(k) Number:
k051447
B. Purpose for Submission:
New device
C. Measurand:
Pancreatic Amylase
D. Type of Test:
Quantitative, Enzymatic, Colorimetric
E. Applicant:
Sentinel CH. S.r.l.
F. Proprietary and Established Names:
Pancreatic Amylase
G. Regulatory Information:
1. Regulation section:
21CFR §862.1070
2. Classification:
Class II
3. Product code:
JFJ Catalytic Methods, Amylase
4. Panel:
75 Chemistry
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H. Intended Use:
1. Intended use(s):
See indications for use below.
2. Indication(s) for use:
The Sentinel Pancreatic Amylase test is used for the quantitation of pancreatic amylase levels in human serum or plasma. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas). For In Vitro use only.
3. Special conditions for use statement(s):
For Prescription use only
4. Special instrument requirements:
Abbott Aeroset and Abbott Architect c8000 Systems
I. Device Description:
The Sentinel Pancreatic Amylase reagent is used for the quantitative analysis of pancreatic amylase in serum and plasma on the Abbott Aeroset and Abbott Architect c8000 systems. Two ready-to-use, liquid reagents are supplied with the kit.
Reagent 1: 2X40 mL HEPES* buffer 52.5 mmol/L (pH 7.15), sodium chloride 87 mmol/L, magnesium chloride 12.6 mmol/L, α-glucosidase ≥ 4 kU/L, mouse antibodies to salivary α-amylase ≥30 mg/L, and sodium azide <0.1%
Reagent 2: 2X11 mL HEPES* buffer 52.5 mmol/L (pH 7.15), 4, 6-ethylidene-G7pNP ≥4 mmol/L, sodium azide <0.1%
*HEPES: 2-[4-(2-hydroxyethyl)-1-piperazinyl]-ethane sulfonic acid.
J. Substantial Equivalence Information:
1. Predicate device name(s):
Roche Pancreatic Amylase on the Hitachi 911 Analyzer
2. Predicate 510(k) number(s):
k895880
3. Comparison with the predicate:
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| Similarities | | |
| --- | --- | --- |
| Characteristic | Device | Predicate |
| Intended Use | Quantitative determination of alpha-amylase in serum and plasma | Quantitative determination of alpha-amylase in serum, plasma and urine |
| Measurement method | Colorimetric, enzyme-based | Same |
| Analytical Range | 1-2200 U/L | 3-1500 U/L |
| | | |
| Shelf Life Stability | 2-8 °C until expiration date on label | Same |
| On Board | 30 days on analyzer | 28 days on analyzer |
## K. Standard/Guidance Document Referenced (if applicable):
None referenced
## L. Test Principle:
This is an enzymatic, colorimetric two step assay. In the incubation step, the activity of the human salivary $\alpha$-amylase is inhibited by two different monoclonal antibodies without affecting the pancreatic $\alpha$-amylase. In the reaction step, defined oligosaccharides such as 4, 6-ethylidene (G7) p-nitrophenyl-pNP (G1) $\alpha$, D-maltonepatoside (ethylidine-$\mathrm{G}_7\mathrm{PNP}$) are cleaved under the catalytic action of $\alpha$-pancreatic amylases. The $\mathrm{G}_2\mathrm{PNP}$, $\mathrm{G}_3\mathrm{PNP}$ and $\mathrm{G}_4\mathrm{PNP}$ fragments that are formed are completely hydrolyzed to p-nitrophenol (pNP) and glucose by $\alpha$-glucosidase. The increase of absorbance due to pNP formation is proportional to the pancreatic $\alpha$-amylase activity in the sample.
## M. Performance Characteristics (if/when applicable):
### 1. Analytical performance:
#### a. Precision/Reproducibility:
Intra-assay precision on the Aeroset was assessed by assaying three control samples twenty times in one run. Intra-assay precision on the c8000 was assessed by assaying two control samples twenty times in one run. The sponsor states the acceptance criterion for the precision studies is: $\mathrm{CV} < 6\%$. The results are presented in the tables below.
Intra Assay Precision Aeroset
| Level 1 | | Level 2 | Level 3 |
| --- | --- | --- | --- |
| Mean (U/L) | 30.2 | 121.2 | 292.0 |
| SD | 0.67 | 0.67 | 0.79 |
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| %CV | 2.22 | 0.55 | 0.27 |
| --- | --- | --- | --- |
Intra Assay Precision c8000
| Level 1 | | Level 2 |
| --- | --- | --- |
| Mean (U/L) | 33.4 | 89.1 |
| SD | 0.49 | 0.45 |
| %CV | 1.47 | 0.50 |
Inter-Assay Precision was assessed on the Aeroset by assaying three levels of control in duplicate in 2 runs for 14 days.
Inter-Assay Precision was assessed on the c8000 by assaying two levels of control in duplicate, one run, for 15 days.
The results are presented in the table below.
Inter Assay Precision Aeroset
| Level | Mean | Within Run | | Run to Run | | Total | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | U/L | SD | CV% | SD | CV% | SD | CV% |
| 1 | 30.1 | 0.42 | 1.40 | 0.58 | 1.92 | 1.20 | 3.99 |
| 2 | 121.8 | 0.48 | 0.40 | 1.64 | 1.34 | 1.99 | 1.64 |
| 3 | 291.9 | 0.89 | 0.31 | 2.56 | 0.88 | 3.25 | 1.11 |
Inter Assay Precision c8000
| Level | Mean | Within Run | | Run to Run | | Total | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | U/L | SD | CV% | SD | CV% | SD | CV% |
| 1 | 33.6 | 0.32 | 0.90 | 0.40 | 1.20 | 0.51 | 1.50 |
| 2 | 89.4 | 0.32 | 0.40 | 0.40 | 0.40 | 0.50 | 0.60 |
b. Linearity/assay reportable range:
The linearity was assessed by testing serial dilutions. The High Standard was prepared by adding a commercially marketed pure enzyme to an albumin matrix. Eight amylase linearity solutions were prepared by quantitatively diluting this stabilized stock standard. Linearity was assessed from duplicate testing of these solutions on the Aeroset system. The sponsor's studies show that the assay is linear to 2200 IU/L.
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
The sponsor verifies the traceability of the assay using an internal standard.
The sponsor establishes the reagent shelf life by performing real-time performance studies that support the 18 months stability claim.
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The sponsor establishes reagent "on board" stability through real-time measurement of five control materials that are tested in triplicate at time 0 and 30 days. The studies support the 30 day stability claim of the reagent "on board" the analyzers.
d. Detection limit:
The sensitivity of the assay is 1 U/L. The sensitivity is determined on twenty replicates of normal saline and represents the lowest pancreatic $\alpha$ -amylase activity that can be distinguished from zero. It is calculated as 3 SD of the twenty replicates. The company also performed a precision study with a sample value of approximately 1 U/L. The sample was run ten times and has a $\% \mathrm{CV}$ of $16.1\%$ .
e. Analytical specificity:
Studies were performed to assess common or known substances that could interfere with the method. A summary is presented in the table below:
| Compound | Concentration-No Interference |
| --- | --- |
| Hemoglobin | 500 mg/dL |
| Bilirubin | 40 mg/dL |
| Triglycerides | 1500 mg/dL |
f. Assay cut-off:
Not applicable.
2. Comparison studies:
a. Method comparison with predicate device:
The Aeroset Pancreatic Amylase test (y) was compared with a commercially marketed method (x). A total of 72 serum samples ranging from 5-2428 U/L were tested. The results are as follows:
$$
n = 72, r = 0.9994, y = 0.965x + 3.843
$$
The c8000 Pancreatic Amylase test (y) was compared with the Aeroset method (x). A total of 56 serum samples ranging from 4-2290 U/L were tested.
The results are as follows:
$$
n = 56, r = 0.9998, y = 1.011x - 0.796
$$
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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):
4. Clinical cut-off:
Not applicable.
5. Expected values/Reference range:
The following literature reference values are provided:
Serum-plasma 8-53 U/L
Junge W, Waldenstrom J, Bouman, A et al. Evaluation of the Assays for Total and Pancreatic $\alpha$-Amylase based on 100% Cleavage of Et-G7-PNP at 6 European Clinical Centers (Poster Medlab 97) Basel, Switzerland: 12th IFCC European Congress of Clinical Chemistry, August 17-22, 1997.
The package insert recommends that each laboratory establish its own expected range.
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.
