The SYNCHRON® Systems 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 for specific for the LIP chemistry on SYNCHRON Systems.

Device Description

The SYNCHRON® Systems Enzyme Validator Set Levels 1 and 2 are used for calibration of various enzymes in the clinical laboratory. This consists of 3 X 5 mL bottles each of Levels 1 and 2. The storage temperature for this product is -15℃ to -20°C.

AI/ML Overview

The provided text does not contain detailed acceptance criteria or a study that extensively proves the device meets specific performance metrics in the way a typical medical device study would describe.

However, based on the information provided, here's a summary tailored to the request, extracting what is available and noting what is not.

Explanation of Device Acceptance and Study:

The "SYNCHRON® Systems Enzyme Validator Set" is a calibrator intended for use with Beckman SYNCHRON Systems to establish reference points for measuring selected human enzymes. The regulatory submission (510(k)) focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than detailed performance against specific acceptance criteria in a quantitative study.

The primary "study" mentioned is "Stress stability studies," which supports the product's 18-month stability claim. The core of the acceptance for this device is its intended use to provide assay values compatible with methods recommended by the IFCC and DGKCh, and for lipase values specific to the LIP chemistry on SYNCHRON Systems.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from Intended Use & Regulatory Equivalence)	Reported Device Performance
Primary Claim: Provide points of reference in the measurement of selected human enzymes.	Not explicitly stated as a numerical performance metric. The "Summary of Performance Data" (Section 8.0) states: "The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to calibrators already in commercial distribution."
Compatibility: Result in assay values compatible with IFCC and DGKCh recommended methods.	Not explicitly stated as a numerical performance metric. Implied to be met through substantial equivalence to the predicate, which presumably already demonstrated this compatibility.
Lipase Specificity: Lipase values specific for LIP chemistry on SYNCHRON Systems.	Not explicitly stated as a numerical performance metric. Implied to be met through substantial equivalence and the addition of assigned lipase analyte values which were identical to the predicate.
Shelf-Life Stability: Maintain performance over an 18-month shelf-life.	"Stress stability studies of the Enzyme Validator support the Beckman stability claim of 18 months."

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

The document does not detail a "test set" in the context of human samples or clinical data. The studies performed were "Stress stability studies" on the calibrator itself. No sample size for a "test set" of human specimens is mentioned, nor is there information on data provenance (country of origin, retrospective/prospective) for such a test set.

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

This information is not provided. The nature of the device (a calibrator) and the regulatory pathway (510(k) substantial equivalence) typically do not involve expert consensus on clinical "ground truth" for a test set in the way an imaging or diagnostic algorithm might. The "ground truth" for a calibrator relates to its assigned values, which are typically established through metrological traceability and standard reference materials.

4. Adjudication Method for the Test Set

Not applicable/Not mentioned, as there is no described test set requiring expert adjudication for ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This type of study is not relevant to a calibrator device and is not mentioned in the provided text.

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

This concept is not relevant to this device. The device is a calibrator, which provides reference points for an instrument (SYNCHRON Systems), but it is not an algorithm or an AI system.

7. The Type of Ground Truth Used

For the calibrator itself, the "ground truth" is its assigned analyte values, which are made "compatible with those from methods recommended by the International Federation of Clinical Chemistry (IFCC) and the German Society for Clinical Chemistry (DGKCh)." The document also notes that "Lipase values for specific for the LIP chemistry on SYNCHRON Systems" were assigned. This implies the use of internationally recognized reference methods and established analytical protocols to define the target values for the calibrator.

8. The Sample Size for the Training Set

The document does not describe a "training set" as this device is not an AI/ML algorithm.

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

Not applicable, as there is no training set for an AI/ML algorithm. The "ground truth" for the calibrator's values would be established through metrological procedures and reference methods, as mentioned in point 7.

Summary

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BEC 2 3 1998

Image /page/0/Picture/1 description: The image shows the logo for Beckman Coulter. The logo consists of a stylized, abstract symbol on the left, resembling an oval shape with a curved line running through it. To the right of the symbol, the words "BECKMAN" are stacked on top of "COULTER" in a bold, sans-serif font. The overall design is simple and professional, conveying a sense of innovation and reliability.

Summary of Safety & Effectiveness SYNCHRON® Systems Enzyme Validator Set

1.0 Submitted By:

Lucinda Stockert Staff Regulatory Specialist, Product Submissions 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 4, 1998

3.0 Device Name(s):

3.1 Proprietary Names

SYNCHRON® Systems Enzyme Validator Set

3.2 Classification Name

Calibrator (21 CFR §862.1150)

4.0 Predicate Device(s):

SYNCHRON SystemsReagent	Predicate	Manufacturer	DocketNumber
SYNCHRON® SystemsEnzyme Validator Set	SYNCHRON® SystemsEnzyme Validator Set	Beckman Coulter,Inc.	K971333 K951964

5.0 Description:

Telephone: (714) 993-5321 Facsimile: (714) 961-4165 Internet: www.beckmancoulter.com

2 NOV 93
10 06

01300/нисэ/

4984014

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Beckman Coulter, Inc., Section 510(k) Notification SYNCHRON® Systems Enzyme Validator Set Summary of Safety & Effectiveness

5.0 Intended Use:

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 for specific for the LIP chemistry on SYNCHRON Systems.

7.0 Comparison to Predicate(s):

Identical to predicate product with values assigned to the lipase analyte.

8.0 Summary of Performance Data:

The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to calibrators already in commercial distribution. Stress stability studies of the Enzyme Validator support the Beckman stability claim of 18 months.

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.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and head. The eagle is positioned to the right of a circular seal. The seal contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference of the circle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 23 1998

Lucinda Stockert Staff Regulatory Specialist, Product Submissions BECKMAN COULTER, INC. 200 S. Kraemer Blvd., W-104 Brea, CA 92822-8000

Re: K984014

Trade Name: SYNCHRON® Systems Enzyme Validator Set Regulatory Class: II Product Code: JIX Dated: November 4, 1998 November 11, 1998 Received:

Dear Ms. Stockert:

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 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). 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, qood 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 Regulation (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 requlatory action. In addition, 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 regulations.

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Page 2

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/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

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

510(k) Number (if known): Not-yet-assign

Device Name: SYNCHRON® Systems Enzyme Validator Set Levels 1 and 2

Indications for Use:

21 CFR 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.
(b) Classification. Class II.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

K. L. Lappala

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K984014

Prescription Use // (per 21 CFR 801.109)

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

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.