(238 days)
Not Found
No
The device description details a chemical assay based on enzymatic reactions and spectrophotometry. There is no mention of AI, ML, or any computational analysis beyond standard quantitative measurements. The performance studies focus on analytical performance metrics like correlation, precision, linearity, and limit of detection, which are typical for in vitro diagnostic assays and do not suggest the use of AI/ML.
No
This device is an in vitro diagnostic assay used for measuring pancreatic amylase levels to aid in the diagnosis and treatment of pancreatitis, not for directly treating a condition.
Yes
The intended use states that "Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis". The device quantifies pancreatic amylase levels, which is a diagnostic measurement.
No
The device description clearly outlines a chemical assay involving reagents and enzymatic reactions to measure pancreatic amylase levels. This is an in vitro diagnostic (IVD) test kit, which is a hardware-based medical device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states: "For In Vitro use only." It also describes the device's use for "quantitation of pancreatic amylase levels in human serum or plasma," which are biological samples taken from the body.
- Device Description: The description details a chemical assay performed on serum or plasma samples to measure the activity of pancreatic amylase. This process is conducted outside of the living body.
- Purpose: The measurements are used "primarily for the diagnosis and treatment of pancreatitis," indicating a medical purpose related to diagnosing a disease.
These characteristics align directly with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
N/A
Intended Use / Indications for Use
The Sentinel Pancreatic Amylase is used for the quantitation of pancreatic amylase in serum or plasma.
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.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
Product codes (comma separated list FDA assigned to the subject device)
JFJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Pancreas
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The limit of detection (sensitivity) of the Sentinel Pancreatic Amylase is 1 U/L.
For the AEROSET analyzer study: correlation coefficient = 0.9994, slope = 0.965, and Y-intercept = 3.843. Samples ranged from 5 to 2428 U/L.
For the ARCHITECT c8000 analyzer study: correlation coefficient = 0.9998, slope = 1.011, and Y-intercept = -0.796. Samples ranged from 4 to 2290 U/L.
Precision studies on AEROSET analyzer: total %CV for Level 1 is 3.99%, Level 2 is 1.64%, and Level 3 is 1.11%.
Precision studies on ARCHITECT c8000 analyzer: total %CV for Level 1 is 1.50% and Level 2 is 0.60%.
Linearity up to 2200 U/L.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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:
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
1
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
2
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.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the three branches of government. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
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).
4
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
5
510(k) Number (if known): Kosly 47
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
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.
Prescription Use X (Part 21 CFR 801 Subpart D)
i
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
Action Sign-Off
്സ്റ്റ് In Vitro Diagnostic Device Svaluation and Safety
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KGS1447