K Number
K984014
Device Name
SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2
Date Cleared
1998-12-23

(42 days)

Product Code
Regulation Number
862.1150
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
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.
More Information

No
The document describes a calibration set for enzyme assays, which is a chemical reagent product, not a software or hardware device that would typically incorporate AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".

No
The device is described as an "Enzyme Validator Set" used for calibration in clinical laboratories to measure human enzymes, not for treating or diagnosing patients directly.

No
Explanation: The device is described as a "Validator Set" used for "calibration of various enzymes in the clinical laboratory" and provides "points of reference in the measurement of selected human enzymes." It is not described as being used to diagnose conditions or diseases.

No

The device description explicitly states it consists of "3 X 5 mL bottles each of Levels 1 and 2," indicating a physical, reagent-based product, not software.

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use explicitly states that the device is used "in conjunction with specified enzyme assays on Beckman SYNCHRON Systems" and is "intended to provide points of reference in the measurement of selected human enzymes." This clearly indicates it's used to analyze human samples (enzymes) outside of the body (in vitro).
  • Device Description: The description states it's used for "calibration of various enzymes in the clinical laboratory." Calibration is a key function of IVD devices used to ensure the accuracy of diagnostic tests.
  • Care Setting: The intended user/care setting is a "clinical laboratory," which is where IVD testing is performed.
  • Predicate Devices: The presence of predicate devices with K numbers (K971333 and K951964) further confirms its classification as a medical device, and given its function, specifically an IVD.

The information provided strongly aligns with the definition and characteristics of an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

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.

Product codes

JIX

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K971333, K951964

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)

Not Found

§ 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.

0

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 Systems
Reagent | Predicate | Manufacturer | Docket
Number |
|-------------------------------------------|-------------------------------------------|--------------------------|--------------------|
| SYNCHRON® Systems
Enzyme Validator Set | SYNCHRON® Systems
Enzyme Validator Set | Beckman Coulter,
Inc. | K971333
K951964 |

5.0 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.

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

2 NOV 93
10 06

01300/нисэ/

4984014

1

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.

2

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.

3

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

4

page

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

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

Indications for Use:

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.

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)

OR

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