The SYNCHRON Enzyme Validator Set, in conjunction with specified enzyme assays on Beckman SYNCHRON® Systems, is intended to provide points of reference in the measurement of selected human enzymes. Use of this product will result in assay values which are compatible with those from methods recommended by the International Federation of Clinical Chemistry (IFCC) and the German Society for Clinical Chemistry (Deutsche Gesellschaft fur Klinische Chemie (DGKCh). Lipase values are specific for the LIP chemistry on SYNCHRON Systems.

Device Description

The SYNCHRON Systems Enzyme Validator Set is designed for optimal performance on the SYNCHRON CX (CX4/CX4CE/CX4A/CX4PRO, CX5/CX5CE/CX5A/CX5PRO. CX7/CX7RTS/CX7Δ/CX7PRO, CX9ALX /CX9PRO) and LX (LX20/LXPRO/LXi) Systems. Each kit of SYNCHRON Enzyme Validator consists of 3 X 5 mL each of Levels 1 and 2 of SYNCHRON Enzyme Validator, two (2) calibration diskettes, one (1) instruction insert, and one (1) Assigned Values sheet.

AI/ML Overview

The provided text describes a submission for a medical device called the "SYNCHRON® Systems Enzyme Validator Set Levels 1 and 2". This device is a calibrator for selected human enzymes on SYNCHRON® Systems.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission states: "Performance data from validation testing supports equivalency." However, it does not provide a specific table of acceptance criteria or quantitative performance metrics for the revised device (SYNCHRON® Systems Enzyme Validator Set Levels 1 and 2). It only mentions that the device has been value assigned for ALT, AMY, AST, CK, GGT and LD using the new 2002 IFCC reference method, and that Amylase (AMY) has been added to the list of analytes traceable to the IFCC reference method. The core claim is substantial equivalence to a legally marketed predicate device (SYNCHRON® Systems Validator Set, K984014).

Therefore, a detailed table cannot be created from the given information. The implicit acceptance criterion is that the new validator set provides "assay values which are compatible with those from methods recommended by the International Federation of Clinical Chemistry (IFCC) and the German Society for Clinical Chemistry (Deutsche Gesellschaft fur Klinische Chemie (DGKCh)."

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample size used for validation testing of the SYNCHRON Enzyme Validator Set. It also does not mention the data provenance (e.g., country of origin, retrospective or prospective nature of the study).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not provide details on the number of experts or their qualifications used to establish ground truth for the test set. It mentions that the device was "value assigned ... using the new 2002 IFCC reference method," implying that the ground truth directly stems from these established reference methods rather than expert clinical review of specific test cases.

4. Adjudication Method for the Test Set

No information is provided regarding an adjudication method for a test set. The validation process appears to rely on concordance with established reference methods rather than human review of cases.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No MRMC study is mentioned. This device is a calibrator, not a diagnostic imaging or screening tool that would typically involve human readers. Therefore, an MRMC study and effect size for human reader improvement with AI assistance are not applicable to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device itself is a calibrator, which inherently functions as a "standalone" product in the sense that it provides reference points for automated assays. The performance data would be generated directly by the SYNCHRON® Systems using the calibrator, comparing the results to the IFCC reference methods. Therefore, in a sense, the performance evaluation is of the calibrator's ability to enable the SYNCHRON® Systems to produce accurate readings, which is an algorithm-only (instrument-only) performance. However, the document doesn't explicitly frame it as an "algorithm-only" study in the modern sense of AI device evaluation.

7. The Type of Ground Truth Used

The ground truth used for value assignment is based on International Federation of Clinical Chemistry (IFCC) reference methods and methods recommended by the German Society for Clinical Chemistry (Deutsche Gesellschaft fur Klinische Chemie (DGKCh)).

8. The Sample Size for the Training Set

The document does not mention a training set sample size. This is not a machine learning device in the typical sense; it's a calibrator designed to work with existing analytical systems. Building a "training set" for an algorithm, as understood in AI, is not part of this device's development or validation described here.

9. How the Ground Truth for the Training Set Was Established

Given that there's no mention of a traditional "training set" for an AI algorithm, this question is not applicable. The device's "ground truth" (its assigned values) is established by its manufacturing process and verified against IFCC and DGKCh reference methods.

Summary

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AUG 1 8 2003

510(k) SUMMARY

1.0 Submitted By:

K032287

Kim Walker Senior Regulatory Affairs Specialist Beckman Coulter, Inc. 200 S. Kraemer Blvd. W-104 Brea, CA 92822-8000 Telephone: (714) 961-4912 FAX: (714) 961-4123

2.0 Date Submitted

July 23, 2003

3.0 Device Name(s):

3.1 Proprietary Names SYNCHRON® Systems Enzyme Validator Set Levels 1 and 2
3.2 Classification Names Calibrator. [862.1150]

4.0 Legally Marketed Device

The SYNCHRON® Systems Enzyme Validator Set claims substantial equivalence to the SYNCHRON® Systems Validator Set currently in commercial distribution. (FDA 510(k) Number K984014)

5.0 Device Description

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Intended Use 6.0

7.0 Comparison to the Predicate (Description of the Modification to the Legally Marketed Device)

The SYNCHRON Enzyme Validator Set has been value assigned for ALT, AMY, AST, CK, GGT and LD using the new 2002 IFCC reference method. Additionally, Amylase (AMY) has been added to the list of analytes traceable to the IFCC reference method. There has been no change to the calibrator's formula. AMY was present in the predicate calibrator but was never value assigned.

8.0 Summary of Performance Data

Performance data from validation testing supports equivalency.

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Section 1: ADMINISTRATIVE INFORMATION

1.0 Submitted By:

Beckman Coulter. Inc. 200 S. Kraemer Blvd. W-104 Brea, CA 92822-8000

Primary Contact: Kim Walker, Senior Regulatory Affairs Specialist Telephone: (714) 961-4912 FAX: (714) 961-4123 E-mail: kawalker@beckman.com

Secondary Contact: Annette Hellie, Staff Regulatory Specialist Telephone: (714) 993-8767 FAX: (714) 961-4123 E-mail: athellie@beckman.com

2.0 Sponsor Address/FDA Registration Number

Beckman Coulter, Inc. 200 S. Kraemer Blvd. W-104 Brea, CA 92822-8000 Establishment Registration No. 2050012

3.0 Product Name/Classification Name and Number

Proprietary Names

SYNCHRON® Systems Enzyme Validator Set Levels 1 and 2

Classification Names

Calibrator [862.1150]

4.0 Device Classification

FDA has classified clinical chemistry test systems of this type into Class II.

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5.0 Section 514 Compliance

This Special 510(k): Device Modification submission is prepared pursuant to the FDA publication: The New 510(k) Paradigm: Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications -Issue Date: March 20, 1998

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/4/Picture/2 description: The image shows a black and white drawing of a logo or symbol. The symbol consists of a circle made of small dots, with three curved lines extending from the right side of the circle. The lines are thick and black, and they appear to be stylized representations of something like waves or motion. The overall design is simple and abstract.

AUG 1 8 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Kim Walker Senior Regulatory Affairs Specialist Beckman Coulter, Inc. 200 S. Kraemer Blvd, M/S - W-104 Box 8000 Brea, CA 92822-8000

K032287 Re:

Trade/Device Name: SYNCHRON® Systems Enzyme Validator Set Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX Dated: July 23, 2003 Received: July 24, 2003

Dear Ms. Walker:

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).

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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 (301) 594-3084. 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/dsma/dsmamain.html.

Sincerely yours,

Steven Putman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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page 1 of 1

510(k) Number (if known): K 032287

SYNCHRON® Systems Enzyme Validator Set Device Name:

Indications for Use:

(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

Sean Cooper
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K032287

Regulation Number and Section

§ 862.1150 Calibrator.

(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.