Pancreatic Amylase (PAM) Reagent is intended for the quantitative determination of pancreas-specific amylase activity in human serum, plasma or urine on SYNCHRON Systems. Measurement of pancreatic amylase is useful in the diagnosis and treatment of pancreatitis.

Device Description

Beckman Coulter's Pancreatic Amylase (PAM) Reagent is a liquid stable, ready-to-use reagent designed for optimal performance on the SYNCHRON CX and LX Systems. The assay is intended for use in the quantitative determination of pancreas-specific amylase activity in human serum, plasma, or urine. The reagent kit contains two 60-test cartridges.

AI/ML Overview

The provided document describes the safety and effectiveness of the SYNCHRON® Systems Pancreatic Amylase Reagent through a comparison to a predicate device. The information focuses on equivalency to the predicate device and does not involve AI or human reader performance. Therefore, many of the requested categories related to AI performance, expert adjudication, or MRMC studies are not applicable.

Here's the available information relevant to your request, with "Not Applicable" for categories that do not fit this type of device submission:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for substantial equivalence are demonstrated through method comparison and precision experiments against a legally marketed predicate device. While explicit numerical acceptance criteria for the method comparison are not stated, the conclusion is that the data supports "substantial equivalence."

Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance (SYNCHRON LX Systems PAM Imprecision)
Within-Run Imprecision	Not explicitly stated (Substantial Equivalence to Predicate)
Serum Control 1 Mean		64 U/L
Serum Control 1 S.D.		0.8 U/L
Serum Control 1 %C.V.		1.3 %
Serum Control 2 Mean		410 U/L
Serum Control 2 S.D.		3.3 U/L
Serum Control 2 %C.V.		0.8 %
Serum Control 3 (ORDAC) Mean		772 U/L
Serum Control 3 (ORDAC) S.D.		8.3 U/L
Serum Control 3 (ORDAC) %C.V.		1.1 %
Urine Control 1 Mean		148 U/L
Urine Control 1 S.D.		1.0 U/L
Urine Control 1 %C.V.		0.7 %
Total Imprecision	Not explicitly stated (Substantial Equivalence to Predicate)
Serum Control 1 Mean		64 U/L
Serum Control 1 S.D.		2.7 U/L
Serum Control 1 %C.V.		4.3 %
Serum Control 2 Mean		410 U/L
Serum Control 2 S.D.		4.5 U/L
Serum Control 2 %C.V.		1.1 %
Serum Control 3 (ORDAC) Mean		772 U/L
Serum Control 3 (ORDAC) S.D.		10.5 U/L
Serum Control 3 (ORDAC) %C.V.		1.4 %
Urine Control 1 Mean		148 U/L
Urine Control 1 S.D.		1.9 U/L
Urine Control 1 %C.V.		1.3 %

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

For the imprecision study, test samples included Serum Control 1, Serum Control 2, Serum Control 3 (ORDAC), and Urine Control 1. For each of these, N = 80 measurements were taken for both within-run and total imprecision. The document does not specify the country of origin of the data or whether it was retrospective or prospective, but this is typically prospective data collection during device development.

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

Not applicable. This is an in vitro diagnostic (IVD) device, and ground truth is established through laboratory measurement principles, not expert interpretation in the medical imaging or diagnostic sense. The "ground truth" for the imprecision study is the known concentration of the controls and the established reference method for comparison (the predicate device).

4. Adjudication method for the test set

Not applicable. This type of submission does not involve adjudication by experts.

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 device is an in vitro diagnostic reagent, not an AI-assisted diagnostic tool for human readers.

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

The device itself is a standalone reagent used on an automated analyzer (SYNCHRON LX Systems). The performance data presented (imprecision) is for the device's analytical performance on this system. There is no "algorithm" in the sense of AI, but rather a chemical assay.

7. The type of ground truth used

For the method comparison study, the ground truth is implicitly the results obtained from the predicate device (Beckman Coulter's SYNCHRON CX Pancreatic Amylase (PAMY) Reagent), as the goal is to demonstrate substantial equivalence. For the imprecision studies, the ground truth for the "mean (U/L)" values of the controls are established values for those control materials.

8. The sample size for the training set

Not applicable. This is an IVD reagent, not an AI system that requires a training set. The development of the reagent formulation is based on chemical principles and optimization, not machine learning training.

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

Not applicable, as there is no training set in the context of AI.

Summary

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JAN 1 5 2002

K013978 510(k) Summary SYNCHRON® Systems Pancreatic Amylase Reagent

1.0 Submitted By:

Mary Beth Tang Regulatory Affairs Specialist Beckman Coulter, Inc. 200 S. Kraemer Blvd., W-104 Brea, California 92822-8000 Telephone: (714) 961-3777 Fax: (714) 961-4123

2.0 Date Submitted:

November 30, 2001

3.0 Device Name(s):

3.1 Proprietary Names

SYNCHRON® Systems Pancreatic Amylase Reagent

3.2 Classification Name

Amylase test system (21 CFR § 862.1070)

4.0 Predicate Device(s):

Beckman Coulter	Predicate	Manufacturer	DocketNumber
SYNCHRON® SystemsPancreatic Amylase(PAM) Reagent	SYNCHRON CX® SystemsPancreatic Amylase(PAMY) Reagent	Beckman Coulter	K934293

5.0 Description:

6.0 Intended Use:

Pancreatic Amylase (PAM) Reagent is intended for the quantitative determination of pancreas-specific amylase activity in human serum, plasma or urine on SYNCHRON Systems.

Mailing Address: 200 S. Kraemer Boulevard P.O. Box 8000 Brea, CA 92822-8000

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Comparison to Predicate(s): 7.0

Assay	Aspect/Characteristic	Comments
SIMILARITIES
SYNCHRON®Systems PAMReagent	Intended use	Same as Beckman CoulterSYNCHRON CX® PAMY Reagent
	Methodology
	Antibody source (mouse)
	Storage (+2°C to +8°C)
	Shelf life
	Sample type (serum, plasma, urine)
	Sample size
	Analytic range
DIFFERENCES
	Reagent formulation	PAM: ready to use liquid reagentPAMY: lyophilized componentsrequiring preparation
	Reagent volume per test	PAM: 240 μl
		PAMY: 220 μl
	On-instrument stability	PAM: 30 days
		PAMY: 14 days
	Instrument platforms	PAM: CX and LX
		PAMY: CX only

Summary of Performance Data: 8.0

The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. Equivalence is demonstrated through method comparison and precision experiments that relate results obtained from the SYNCHRON Pancreatic Amylase (PAM) Assay to the Beckman Coulter's SYNCHRON CX Pancreatic Amylase (PAMY) Reagent.

Method Comparison Study Results*

			【【】【【】【】【【】【】【】【】【】【】【】【】【】【】【】【】【】【	છે ઊભ્તાસBA-66 -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
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*Data shown was collected using SYNCHRON LX Systems. Equivalency between SYNCHRON CX and LX Systems has been established by correlation analysis.

Estimated SYNCHRON LX Systems PAM Imprecision

Sample	Mean (U/L)	S.D. (U/L)	%C.V.	N
	Within-Run Imprecision
Serum Control 1	64	0.8	1.3	80
Serum Control 2	410	3.3	0.8	80
Serum Control 3 (ORDAC)	772	8.3	1.1	80
Urine Control 1	148	1.0	0.7	80
	Total Imprecision
Serum Control 1	64	2.7	4.3	80
Serum Control 2	410	4.5	1.1	80
Serum Control 3 (ORDAC)	772	10.5	1.4	80
Urine Control 1	148	1.9	1.3	80

The Summary of Safety and Effectiveness information for the SYNCHRON Systems Pancreatic Amylase Reagent is found in TAB 1 of this notice and is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and implementing regulation 21 CFR 807.92.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in capital letters.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 1 5 2002

Ms. Mary Beth Tang Regulatory Affairs Specialist Beckman Coulter, Inc. 200 S. Kraemer Blvd. M/S W-104 Box 8000 Brea, CA 92822-8000

Re: K013978

R015776
Trade/Device Name: SYNCHRON® Systems Pancreatic Amylase Reagent Regulation Number: 21 CFR 862.1070 Regulation Name: Amylase test system Regulatory Class: Class II Product Code: JFJ Dated: November 30, 2001 Received: December 3, 2001

Dear Ms. Tang:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becarent of the device is substantially equivalent (for the indications ferenced above and have actesinglegally marketed predicate devices marketed in interstate for use stated in the enclosed) to togals) to togals (1976) Device Amendments, or to comments from to may 20, 1978, are one and the provisions of the Federal Food, Drug, devices that have been receasines arquire approval of a premarket approval application (PMA). allu Cosmette Act (10t) market the device, subject to the general controls provisions of the Act. The I ou may, therefore, mainer of the Act include requirements for annual registration, listing of general connolis provisions of visitions and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it II your device is classified (600 wor of als. Existing major regulations affecting your device can may be subject to sach adderal Regulations, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oouv ocements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I loase oc actives that I Dr usean that your device complies with other requirements of the Act that I DA has made a color regulations administered by other Federal agencies. You must of any I coloral statutes and regirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of IT at 6077, adomig (21 (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality by ovisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your 510(k) premarket I mis lotter will and to your ding of substantial equivalence of your device to a legally marketed nouthoution. The I Dr 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 1 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, (201) 59 m 45 the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrb/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

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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page 1 of 1

510(k) Number (if known): K013978

SYNCHRON® Systems Pancreatic Amylase Reagent Device Name:

Indications for Use:

Pancreatic Amylase (PAM) Reagent is intended for the quantitative Pancreatic Anytase (1744) Treather activity in human serum, determination "Of "Paneloaan Coulter's SYNCHRON Systems by an immuno-Measurement of pancreatic amylase is useful in the inhibition method. diagnosis and treatment of pancreatitis.

Jean Cooper

(Division Sign-Off)
Division of Clinical Laboratory Levices
510(k) Number K013978

(Please Do Not WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(per 21 CFR 801.109)

Over-the-Counter Use 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.