(66 days)
Not Found
No
The device description and performance studies focus on a chemical reaction and spectrophotometric measurement, with no mention of AI or ML algorithms for data analysis or interpretation.
No.
It is an in vitro diagnostic assay used for the quantitation of amylase in human serum, plasma, or urine, primarily for diagnosis and treatment of pancreatitis, not for directly treating a disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis". This directly indicates the device's diagnostic purpose. Additionally, the "Device Description" identifies it as an "in vitro diagnostic assay".
No
The device description clearly states it is an "in vitro diagnostic assay" and a "clinical chemistry assay" that involves chemical reactions and measurement of absorbance at 405 nm. This indicates it is a physical assay kit or system, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the assay is used for the "quantitation of amylase in human serum, plasma, or urine" and that these measurements are used for the "diagnosis and treatment of pancreatitis". This clearly indicates that the device is intended to be used in vitro (outside the body) to analyze biological samples for diagnostic purposes.
- Device Description: The "Device Description" further reinforces this by describing the assay as an "in vitro diagnostic assay for the quantitative determination of amylase in serum, plasma, or urine." It also details the chemical reaction that occurs in vitro to measure the amylase activity.
- Predicate Device: The mention of a "Predicate Device(s)" which is another IVD (Roche® Cobas Mira® Plus Automated Chemistry System Amylase assay) is also a strong indicator that this device falls under the same regulatory category.
The information provided aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The amylase assay is used for the quantitation of amylase in human serum, plasma, or urine.
The Amylase assay is is used for the quantitation of amylase in serum, plasma, or urine. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).
Product codes
75JFJ
Device Description
Amylase is an in vitro diagnostic assay for the quantitative determination of amylase in serum, plasma, or urine. The Amylase assay is a clinical chemistry assay. The amylase in the sample hydrolyzes the 2-chloro-4-nitrophenyl-a-D-maltotrioside (CNPG3) to release 2-chloro-4-nitrophenol (CPNP) and form 2-chloro-4-nitrophenylα-D-maltoside (CNPG2), maltotriose (G3), and glucose (G). The rate of formation of the 2-chloro-4-nitrophenol is measured as an increase in the absorbance at 405 nm and is directly proportional to the activity of amylase present in the sample.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Comparative performance studies were conducted using the ALCYON™ Analyzer. The Amylase assay method comparison vielded acceptable correlation with the Roche Cobas Mira Plus Automated Chemistry System Amylase assay for the serum and urine applications. For serum applications, the correlation coefficient = 0.9791. slope = 1.126, and Y-intercept = - 18.427 U/L. For urine applications, the correlation coefficient = 0.9702, slope = 0.977, and Y-intercept = 0.447 U/L. Precision studies were conducted using the Amylase assay. Within-run, between-run, and between-day studies were performed using two levels of control material. The total %CV for Level 1/Panel 111 is 3.3% and Level 2/Panel 112 is 3.7% for serum applications, and 10.6% for Level 1/Panel 131, and 4.4% for Level 2/Panel 132 for urine applications. The Amylase assay is linear up to 2,500 U/L. The limit of quantititation (sensitivity) of the Amylase assay is 4.268 U/L. These data demonstrate that the performance of the Amylase assay is substantially equivalent to the performance of the Roche Cobas Mira Plus Automated Chemistry System Amylase assay for the serum and urine applications.
Key Metrics
For serum applications, the correlation coefficient = 0.9791. slope = 1.126, and Y-intercept = - 18.427 U/L.
For urine applications, the correlation coefficient = 0.9702, slope = 0.977, and Y-intercept = 0.447 U/L.
The total %CV for Level 1/Panel 111 is 3.3% and Level 2/Panel 112 is 3.7% for serum applications.
The total %CV is 10.6% for Level 1/Panel 131, and 4.4% for Level 2/Panel 132 for urine applications.
The Amylase assay is linear up to 2,500 U/L.
The limit of quantititation (sensitivity) of the Amylase assay is 4.268 U/L.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
JUN - 8 1999
510(k) Summary
Submitter's Name/Address Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038
Contact Person Mark Littlefield Section Manager MS 1-8 ADD Regulatory Affairs (972) 518-7861 Fax (972) 753-3367
| Date of Preparation of this Summary: | April 2, 1998 |
|---|---|
| Device Trade or Proprietary Name: | Amy |
| Device Common/Usual Name or Classification Name: | Amylase |
| Classification Number/Class: | 75JFJ/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:
Amylase is an in vitro diagnostic assay for the quantitative determination of amylase in serum, plasma, or urine. The Amylase assay is a clinical chemistry assay. The amylase in the sample hydrolyzes the 2-chloro-4-nitrophenyl-a-D-maltotrioside (CNPG3) to release 2-chloro-4-nitrophenol (CPNP) and form 2-chloro-4-nitrophenylα-D-maltoside (CNPG2), maltotriose (G3), and glucose (G). The rate of formation of the 2-chloro-4-nitrophenol is measured as an increase in the absorbance at 405 nm and is directly proportional to the activity of amylase present in the sample.
Amylase 510(k) April 2, 1998 AmylaE2.lwp
Section II Page 1
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Substantial Equivalence:
The Amylase assay is substantially equivalent to the Roche® Cobas Mira® Plus Automated Chemistry System Amylase assay (K903309) for serum, plasma, or urine applications.
These assavs vield similar Performance Characteristics.
Similarities to Roche:
- Both assays are in vitro clinical chemistry methods. .
- Both assays can be used for the quantitative determination of amylase in serum . or urine.
- Both assays yield similar clinical results. .
Differences to Roche:
- The Roche Amylase assay on the Cobas Mira Plus Automated System is not . intended for use with heparinized plasma.
Intended Use:
The amylase assay is used for the quantitation of amylase in human serum, plasma, or urine.
Performance Characteristics:
Comparative performance studies were conducted using the ALCYON™ Analyzer. The Amylase assay method comparison vielded acceptable correlation with the Roche Cobas Mira Plus Automated Chemistry System Amylase assay for the serum and urine applications. For serum applications, the correlation coefficient = 0.9791. slope = 1.126, and Y-intercept = - 18.427 U/L. For urine applications, the correlation coefficient = 0.9702, slope = 0.977, and Y-intercept = 0.447 U/L. Precision studies were conducted using the Amylase assay. Within-run, between-run, and between-day studies were performed using two levels of control material. The total %CV for Level 1/Panel 111 is 3.3% and Level 2/Panel 112 is 3.7% for serum applications, and 10.6% for Level 1/Panel 131, and 4.4% for Level 2/Panel 132 for urine applications. The
Amylase 510(k) April 2, 1998 AmylaE2.lwp
Section II Page 2
2
Amylase assay is linear up to 2,500 U/L. The limit of quantititation (sensitivity) of the Amylase assay is 4.268 U/L. These data demonstrate that the performance of the Amylase assay is substantially equivalent to the performance of the Roche Cobas Mira Plus Automated Chemistry System Amylase assay for the serum and urine applications.
Conclusion:
The Amylase assay is substantially equivalent to the Roche Cobas Mira Plus Automated Chemistry System Amylase assay as demonstrated by results obtained in the studies.
Amylase 510(k) April 2, 1998 AmylaE2.lwp
Section II Page 3
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.
8 1000 JUN
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mark Littlefield Section Manager, Regulatory Affairs Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038
Re : K981216 Amylase Regulatory Class: II Product Code: JFJ Dated: April 2, 1998 Received: April 3, 1998
Dear Mr. Littlefield:
We have reviewed your Section 510 (k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual reqistration, 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Litman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known): Jrg K/2 16
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The Amylase assay is is used for the quantitation of amylase in serum, plasma, or urine. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).
00000000
| (Division Sign-Off) | |
|---|---|
| Division of Clinical Laboratory Devices | |
| 40(K) Number . | n981216 |
:
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concy rence of CDRH, Office of Device Evaluation (ODE) Prescription Use Over-The-Counter Use ----------OR (Per 21 CFR 801.109) (Optional Format 1-2-96)
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510(k) Number (if known): Jrg K/2 16
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The Amylase assay is is used for the quantitation of amylase in serum, plasma, or urine. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).
(Division Sign-Off)
Division of Clinical Laboratory Devices
| 510(k) Number | K981216 |
|---|---|
| --------------- | --------- |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Concurrence of CDRH, Office of Device Evaluation (ODE) Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ Prescription Use OR (Per 21 CFR 801.109)
(Optional Format 1-2-96)