The SYNCHRON Systems Lipase (LIPA) Reagent, in conjunction with SYNCHRON® Systems Lipase Calibrator, is intended for use in the quantitative determination of pancreatic lipase activity in serum or plasma samples. This assay is designed for use with clinical chemistry analyzers from Beckman Instruments, such as the SYNCHRON CX® and LX™ Clinical Systems.

Device Description

This assay is designed for use with clinical chemistry analyzers from Beckman Instruments, such as the SYNCHRON CX® AND LX™ Clinical Systems. The SYNCHRON Systems Lipase (LIPA) Reagent, when used in coniunction with SYCNRHON Systems Lipase Calibrator, is intended for use in the quantitative determination of pancreatic lipase activity in serum or plasma samples. Lipase measurements are used in diagnosis and treatment of diseases of the pancreas such as acute pancreatitis and obstruction of the pancreatic duct.

AI/ML Overview

The provided text describes the performance data for the SYNCHRON Systems Lipase (LIPA) Reagent. Here's a breakdown of the requested information:

1. Table of acceptance criteria and the reported device performance:

The document doesn't explicitly state "acceptance criteria" but presents performance data that would be used to demonstrate substantial equivalence. The predicate device is the SYNCHRON Systems Lipase Reagent on the CX System. The new device is the SYNCHRON Systems Lipase Reagent on the LX System.

Performance Metric	Acceptance Criteria (Implied by Predicate)	Reported Device Performance (SYNCHRON Systems Lipase Reagent on the LX System)
Method Comparison vs. Predicate		(Compared to SYNCHRON Systems Lipase Reagent on the CX System)
Slope	Close to 1.000	1.068
Intercept	Close to 0 U/L	-0.42 U/L
Correlation Coefficient (r)	Close to 1.000	0.997
Measuring Range (Linearity)
Default Measuring Range	Linear - 5-600 U/L	Linear - 5-600 U/L
ORDAC Measuring Range	Linear - 480-1200 U/L	Linear - 480-1200 U/L
Imprecision (Within-Run)
Level 1 %C.V.	Low variability	1.38%
Level 2 %C.V.	Low variability	1.54%
Level 3 %C.V.	Low variability	7.18%
Imprecision (Total)
Level 1 %C.V.	Low variability	2.28%
Level 2 %C.V.	Low variability	2.24%
Level 3 %C.V.	Low variability	9.77%

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

Sample Size for Method Comparison: 91 samples (n=91) were used for the method comparison study between the SYNCHRON Systems Lipase Reagent on the LX System and the predicate system (SYNCHRON Systems Lipase Reagent on the CX System).
Sample Size for Imprecision: 80 samples (n=80) were used for each of the three levels of imprecision testing (within-run and total imprecision).
Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It is implied to be internal testing conducted by Beckman Instruments, Inc.

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

This information is not applicable as this is an in vitro diagnostic (IVD) device for quantitative biochemical measurement, not an AI or imaging device requiring expert interpretation for ground truth. The "ground truth" for this device is the actual lipase activity in the samples, determined by the predicate device or a reference method.

4. Adjudication method for the test set:

This information is not applicable for the same reasons as point 3. Adjudication usually pertains to discrepancies in human interpretation, which is not relevant here.

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

This information is not applicable. This is an IVD device for automated quantitative analysis, not an AI-assisted diagnostic tool that involves human readers.

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

The performance reported is inherently "standalone" in the context of an automated IVD chemistry analyzer. The SYNCHRON Systems Lipase Reagent on the LX System performs the quantitative determination of pancreatic lipase activity without human involvement in the measurement process itself, beyond loading samples and calibrators. The reported slope, intercept, correlation, and imprecision are characteristics of the reagent and analyzer system.

7. The type of ground truth used:

The ground truth for the method comparison study was established by the predicate method, specifically the "SYNCHRON Systems Lipase Reagent on the CX System." For linearity and imprecision studies, the "ground truth" would be established by the known concentrations/activities of quality control materials or reference methods.

8. The sample size for the training set:

This information is not applicable. This IVD device is a chemical reagent and an analyzer system, not a machine learning or AI model that requires a "training set" in the computational sense. The performance characteristics are derived from chemical reactions and instrument calibration.

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

This information is not applicable for the same reasons as point 8.

Summary

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Beckman Instruments, Section 510(k) Notification SYNCHRON Systems Lipase Reagent Summary of Safety and Effectiveness

K970905

1. Submitted by:
  Sheri Hall Product Submissions Manager Beckman Instruments, Inc. 200 S. Kraemer Blvd., W-337 Brea, California 92822-8000 Telephone: (714) 993-8916, FAX (714) 961-4457

JUN - 4 1997

1. Date Submitted:
  3 March 1997
1. Device Name(s):
  SYNCHRON® Systems Lipase (LIPA) Reagent Lipase test system (21 CFR 862.1465)

4. Predicate Device(s):

	Predicate	Predicate Company	Docket Number
SYNCHRON CXSystems Lipase(LIPA) Reagent	Genzyme LipaseReagent	Toyo Jozo Co., Ltd(Japan)	K952180
SYNCHRON LXClinical System	SYNCHRON CXClinical System	BeckmanInstruments, Inc.	K965240

5. Description:

6. Intended Use:

ﻤ ﻌﻠﻢ ﻭ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﻘﺎﺑﻠﺔ ﺍﻟﻤﻘﺎﺑ

The SYNCHRON Systems Lipase (LIPA) Reagent, in conjunction with SYCNHRON Systems Lipase Calibrator, is intended for use in the quantitative determination of pancreatic lipase activity in serum or plasma samples. This assay is designed for use with clinical chemistry analyzers from Beckman Instruments, such as the SYCNRHON CX and LX Clinical Systems.

7. Comparison to the Predicate:

The SYNCHRON Systems Lipase (LIPA) Reagent is similar to the predicate in the intended use, chemical reaction, reagent components and packaging, measurement method, default measuring range, and calibration method. They differ in the SYCNHRON Systems Lipase Reagent uses the system ORDAC (over range detection and correction) feature to expand the measuring range to 1200 U/L.

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Beckman Instruments, Section 510(k) Notification SYNCHRON Systems Lipase Reagent Summary of Safety and Effectiveness

8. Summary of Performance Data:

ーーーーーーーーーーーーー

The data in the Premarket Notification supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. A summary of the data follows:

Reagent	Slope	Intercept (U/L)	r	n	Predicate Method
SYNCHRON SystemsLipase Reagent on theLX System	1.068	-0.42	0.997	91	SYNCHRON SystemsLipase Reagent on theCX System

Sample Type	Measuring Option	Measuring Range	Assessment
serum	default	5 - 600 U/L	linear
	ORDAC	480 - 1200 U/L	linear

Imprecision
Sample	Mean(U/L)	S.D.(U/L)	%C.V.	n
Within-Run Imprecision
Level 1	109.53	1.51	1.38	80
Level 2	269.80	4.15	1.54	80
Level 3	16.33	1.17	7.18	80
Total Imprecision
Level 1	109.53	2.50	2.28	80
Level 2	269.80	6.03	2.24	80
Level 3	16.33	1.59	9.77	80

This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92.

Method Comparison

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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 is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle, with its wings outstretched.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN - 4 1997

Sheri Hall Manager, Premarket Regulatory Beckman Instruments, Inc. 200 S. Kraemer Boulevard, M/S W-337 P.O. Box 8000 92822-8000 Brea, California

K970905 Re: SYNCHRON® Systems Lipase (LIPA) Reagent Requlatory Class: II Product Code: CHI, JIT Dated: April 28, 1997 Received: May 2, 1997

Dear Ms. Hall:

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, Druq, 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 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ಗ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addicion, FDA may publish further announcements 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 beqin 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic 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 requlation 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 Gutman

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):

SYNCHRON® Systems Device Name: Lipase (LIPA) Reagent

Indications for Use:

21 CFR § 862.1465 Lipase Test System

(a) Identification. A lipase test system is a device intended to measure the activity of the enzyme lipase in serum. Lipase measurements are used in diagnosis and treatment of diseases of the pancreas such as acute pancreatitis and obstruction of the pancreatic duct. (b) Classification. Class I .

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K970805

Prescription Use (per 21 CFR 801.109)

Over-the-Counter Use Optional Format 1-2-96

Regulation Number and Section

§ 862.1465 Lipase test system.

(a)
Identification. A lipase test system is a device intended to measure the activity of the enzymes lipase in serum. Lipase measurements are used in diagnosis and treatment of diseases of the pancreas such as acute pancreatitis and obstruction of the pancreatic duct.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.