The Amylase assay is used for the quantitation of amylase in human serum, plasma, or urine. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).

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.

AI/ML Overview

The Abbott Laboratories Amylase assay is an in vitro diagnostic assay for the quantitative determination of amylase in serum, plasma, or urine, used primarily for the diagnosis and treatment of pancreatitis. The assay measures the rate of formation of 2-chloro-4-nitrophenol, which is directly proportional to the amylase activity.

The device's performance was compared to the Roche Cobas Mira Plus Automated Chemistry System Amylase assay (K903309) for substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance:

Performance Characteristic	Acceptance Criteria (from predicate K903309)	Reported Device Performance (Amylase assay)
Correlation Coefficient (Serum)	Not explicitly stated, but "similar performance characteristics" is implied.	0.9791
Slope (Serum)	Not explicitly stated, but "similar performance characteristics" is implied.	1.126
Y-intercept (Serum)	Not explicitly stated, but "similar performance characteristics" is implied.	-18.427 U/L
Correlation Coefficient (Urine)	Not explicitly stated, but "similar performance characteristics" is implied.	0.9702
Slope (Urine)	Not explicitly stated, but "similar performance characteristics" is implied.	0.977
Y-intercept (Urine)	Not explicitly stated, but "similar performance characteristics" is implied.	0.447 U/L
Total %CV (Serum, Level 1)	Not explicitly stated, but "similar performance characteristics" is implied.	3.3%
Total %CV (Serum, Level 2)	Not explicitly stated, but "similar performance characteristics" is implied.	3.7%
Total %CV (Urine, Level 1)	Not explicitly stated, but "similar performance characteristics" is implied.	10.6%
Total %CV (Urine, Level 2)	Not explicitly stated, but "similar performance characteristics" is implied.	4.4%
Linearity (Upper Limit)	Not explicitly stated, but "similar performance characteristics" is implied.	2,500 U/L
Limit of Quantitation (Sensitivity)	Not explicitly stated, but "similar performance characteristics" is implied.	4.268 U/L

Study Proving Acceptance Criteria:

Comparative performance studies were conducted using the ALCYON™ Analyzer to demonstrate substantial equivalence to the predicate device.

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

Sample Size: The document does not explicitly state the number of samples used for the comparative performance studies (method comparison and precision studies).
Data Provenance: The document does not specify the country of origin of the data. It is a retrospective study, comparing the performance of the new Amylase assay with an existing, legally marketed device using collected data.

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

This is an in vitro diagnostic device for quantitative chemical analysis. The "ground truth" is established through the measured values of the predicate device (Roche Cobas Mira Plus Automated Chemistry System Amylase assay) against which the new device's performance is compared, and through control materials for precision studies. No human experts are involved in establishing the ground truth for this type of quantitative assay performance study.

4. Adjudication method for the test set:

Not applicable. As described above, this is a quantitative chemical assay, and the "ground truth" is derived from the predicate device and control materials, not expert adjudication.

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:

Not applicable. This is an in vitro diagnostic assay, not an AI-assisted diagnostic imaging or human-read interpretation device. Therefore, MRMC studies and the concept of human reader improvement with AI assistance are not relevant.

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

Yes, the performance characteristics presented are for the Amylase assay in a standalone algorithm-only manner, running on the ALCYON™ Analyzer. The comparison is between two automated assay systems.

7. The type of ground truth used:

The ground truth for the comparison study is the quantitative results obtained from the predicate device (Roche Cobas Mira Plus Automated Chemistry System Amylase assay). For precision studies, the ground truth is the expected values of the control materials.

8. The sample size for the training set:

Not applicable. This is not a machine learning or AI-driven device that requires a "training set" in the conventional sense. The device's calibration and method development are based on established chemical principles and manufacturer-specific optimization processes, not on training data sets.

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

Not applicable, as explained in point 8.

Summary

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JUN - 8 1999

K981216

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 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

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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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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

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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).

00000000

(Division Sign-Off)
Division of Clinical Laboratory Devices40(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:

(Division Sign-Off)

Division of Clinical Laboratory Devices

510(k) Number	K981216
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(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)

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.