The Sentinel Pancreatic Amylase 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 Description

The Sentinel Pancreatic Amylase is an in vitro diagnostic assay for the quantitative determination of pancreatic amylase in serum or plasma. The Sentinel Pancreatic Amylase is a two-reagent format that is carried out in two successive steps. In the first incubation step, the activity of the human salivary alpha-amylase is inhibited using two different monoclonal antibodies with no effect on the pancreatic alpha-amylase. In the second reaction step, the pancreatic alpha-amylase catalyses the hydrolysis of the EPS substrate (Ethylidene Protected Substrate) p-nitrophenyl-maltoheptaoside 4,6ethylidene-blocked (Ethylidene-G7PNP) forming 2 ethylidene-G4 + 2 G3PNP + ethylidene-G3 + G4PNP. The a-glycosidase hydrolyses all fragments of G2PNP. G3PNP, and G4PNP into p-nitro phenol (PNP) and glucose (G). The increase of absorbance, due to PNP formation, is proportional to the activity of pancreatic alphaamylase in the examined sample.

AI/ML Overview

The Sentinel Pancreatic Amylase is an in vitro diagnostic assay for the quantitative determination of pancreatic amylase in serum or plasma. The study conducted aimed to demonstrate substantial equivalence to the Roche Pancreatic Amylase assay (K895880) on the Roche analyzer.

Here's a breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Characteristic	Acceptance Criteria (Implied by Predicate Equivalence)	Reported Device Performance (Sentinel Pancreatic Amylase)
Method Comparison	Acceptable correlation with the Roche Pancreatic Amylase assay. (Specific quantitative criteria likely defined internally, but generally indicating a high correlation coefficient, slope near 1, and small Y-intercept)	AEROSET vs. Roche Pancreatic Amylase (Hitachi 911):- Correlation Coefficient: 0.9994- Slope: 0.965- Y-intercept: 3.843ARCHITECT c8000 vs. Sentinel Pancreatic Amylase (AEROSET):- Correlation Coefficient: 0.9998- Slope: 1.011- Y-intercept: -0.796
Precision	Acceptable within-run, between-run, and between-day variability. (Specific %CV targets likely defined internally, comparable to the predicate device)	AEROSET Analyzer:- Total %CV for Level 1: 3.99%- Total %CV for Level 2: 1.64%- Total %CV for Level 3: 1.11%ARCHITECT c8000 Analyzer:- Total %CV for Level 1: 1.50%- Total %CV for Level 2: 0.60%
Linearity	Linear range comparable to or exceeding the predicate device.	Up to 2200 U/L
Limit of Detection (Sensitivity)	Limit of detection comparable to or better than the predicate device.	1 U/L

2. Sample size used for the test set and the data provenance

Method Comparison (AEROSET vs. Roche): Samples ranged from 5 to 2428 U/L. The exact number of individual samples is not explicitly stated, but the range indicates a broad spectrum of pancreatic amylase levels were tested.
Method Comparison (ARCHITECT c8000 vs. AEROSET): Samples ranged from 4 to 2290 U/L. The exact number of individual samples is not explicitly stated.
Precision Studies: Three levels of control material for the AEROSET and two levels of control material for the ARCHITECT c8000. For each level, within-run, between-run, and between-day studies were performed, implying multiple replicates were run over several days. The exact number of replicates is not specified.
Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. Given it's an in vitro diagnostic assay, the samples would typically be human serum or plasma originating from patients, and the study would be conducted prospectively (collecting samples and running tests according to a defined protocol).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This section is not applicable to this type of in vitro diagnostic assay. For quantitive chemical assays like the Pancreatic Amylase test, "ground truth" is established by the highly accurate and precise measurements from a reference method (the predicate device in this case, and potentially higher-order reference methods for calibration), not by expert consensus or interpretation of images.

4. Adjudication method for the test set

This is not applicable for a quantitative chemical assay. Adjudication methods like "2+1" or "3+1" are typically used in clinical imaging or pathology studies where there's subjectivity in interpretation by multiple experts. For this device, the comparison is directly between numerical results from two different assays.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. An MRMC study is relevant for diagnostic imaging or pathology, specifically to assess the impact of a device (often AI-powered) on the performance of human readers. The Sentinel Pancreatic Amylase is a fully automated in vitro diagnostic assay that provides a quantitative numerical result; it does not involve human "readers" in the diagnostic interpretation process that an AI might assist.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Yes, the studies described are standalone performance studies (algorithm only). The Sentinel Pancreatic Amylase is an automated instrument-based assay, and its performance characteristics (precision, linearity, limit of detection, and method comparison) are evaluated based on the analytical measurements produced by the device itself, without human intervention in the diagnostic interpretation. The comparison is made against another standalone diagnostic assay (the predicate).

7. The type of ground truth used

The "ground truth" for the test set was essentially the measurements obtained from the legally marketed predicate device, the Roche Pancreatic Amylase assay (K895880) on the Roche analyzer (and Hitachi 911 Analyzer). For precision, linearity, and limit of detection, the ground truth is established by the inherent analytical capabilities of the assay and potentially by preparing reference materials with known concentrations. The goal of the study was to show substantial equivalence to this established method.

8. The sample size for the training set

This is not applicable in the context of this 510(k) summary for an in vitro diagnostic reagent kit. "Training set" refers to data used to develop and optimize a model or algorithm, typically for AI/machine learning applications. For a chemical assay like this, there isn't an "algorithm" in the same sense that requires a training set. The assay's performance is based on its chemical reactions and instrument calibration, which are developed through R&D and analytical validation, not by training on a data set.

9. How the ground truth for the training set was established

As noted above, the concept of a "training set" and its associated ground truth is not applicable to this type of device submission. The chemical and enzymatic reactions, as well as the measurement principles, are based on established scientific principles and analytical chemistry, not on machine learning from a training data set.

Summary

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JAN 2 6 2006

510(k) Summary

Submitter's Name/Address

Sentinel CH. Srl Via Principe Eugenio 5 20155 Milan - ITALY

Contact Person Mr. Davide Spada Application Specialist Telephone: +39 02 345514.1 Facsimile: +39 02 345514.64 E-Mail: spada(@sentinel.it

Date of Preparation of this Summary:	January 19, 2006
Device Trade or Proprietary Name:	Sentinel Pancreatic Amylase
Device Common/Usual Name or Classification Name:	Pancreatic Amylase
Classification Number/Class:	JFJ/Class II

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________

Test Description:

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absorbance, due to PNP formation, is proportional to the activity of pancreatic alphaamylase in the examined sample.

Substantial Equivalence:

The Sentinel Pancreatic Amylase is substantially equivalent to the Roche Pancreatic Amylase assay (K895880) on the Roche analyzer. These assays yield similar Performance Characteristics.

Similarities:

Both assays are in vitro clinical chemistry methods. .
. Both assays can be used for the quantitative determination of pancreatic amylase.
. Both assays yield similar clinical results.

Differences:

There is a difference between the assay ranges.

Intended Use:

The Sentinel Pancreatic Amylase is used for the quantitation of pancreatic amylase in serum or plasma.

Performance Characteristics:

Comparative performance studies were conducted using the AEROSET® and ARCHITECT® c8000® analyzers.

Method comparison studies of the Pancreatic Amylase on the AEROSET analyzer yielded acceptable correlation with the Roche Pancreatic Amylase assay on the Hitachi 911 Analyzer. The correlation coefficient = 0.9994, slope = 0.965, and Y-intercept = 3.843. Samples ranged from 5 to 2428 U/L.

Method comparison studies of the Sentinel Pancreatic Amylase on the ARCHITECT c8000 analyzer yielded acceptable correlation with the Sentinel Pancreatic Amylase on

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the AEROSET analyzer. The correlation coefficient = 0.9998, slope = 1.011, and Y-intercept = -0.796. Samples ranged from 4 to 2290 U/L.

Precision studies were conducted using the Sentinel Pancreatic Amylase. Within-run, between-run, and between-day studies were performed on the AEROSET analyzer using three levels of control material. The total %CV for Level 1 is 3.99%, Level 2 is 1.64%, and Level 3 is 1.11%. Within-run, between-run, and between-day studies were performed on the ARCHITECT c8000 analyzer using two levels of control material. The total %CV for Level 1 is 1.50% and Level 2 is 0.60%.

The Sentinel Pancreatic Amylase is linear up to 2200 U/L. The limit of detection (sensitivity) of the Sentinel Pancreatic Amylase is 1 U/L.

These data demonstrate that the performance of the Sentinel Pancreatic Amylase is substantially equivalent to the performance of the Roche Pancreatic Amylase assay on the Hitachi 911 analyzer.

Conclusion:

The Sentinel Pancreatic Amylase is substantially equivalent to the Roche Pancreatic Amylase assay on the Roche analyzer as demonstrated by results obtained in the studies.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 2 6 2006

Mr. Davide Spada Application Specialist Sentinel CH. S.r.l. Via Principe Eugenio, 5 20155 Milan- Italy

Re: K051447

Trade/Device Name: Sentinel Pancreatic Amylase Regulation Number: 21 CFR§862.1070 Regulation Name: Amylase test system Regulatory Class: Class II Product Code: JFJ Dated: January 3, 2006 Received: January 12, 2006

Dear: Mr. Spada

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 --

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97), You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Alberto G

Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): Kosly 47

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Cinn Chippeie
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്‍സ്‌റ്റ് In Vitro Diagnostic Device Svaluation and Safety

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KGS1447

Regulation Number and Section

§ 862.1070 Amylase test system.

(a)
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).(b)
Classification. Class II.