The SYNCHRON® Systems CAL 5 Plus, when used in conjunction with SYNCHRON® Systems and reagents, is intended for use in the calibration of Antistreptolysin-O (ASO-) on the SYNCHRON CX® Systems and for Antistreptolysin-O (ASO-), C-reactive protein (CRP), and Rheumatoid factor (RF) chemistries on the SYNCHRON LX™ Systems.

Device Description

This SYNCHRON Systems CAL 5 Plus is designed for use with clinical chemistry analyzers from Beckman Instruments, such as the SYNCHRON CX® and LX™ Clinical Systems. The SYNCHRON Systems CAL 5 Plus is for use in the calibration of SYNCHRON Systems Antistreptolysin-O (ASO-), C-reactive protein (CRP), and Rheumatoid factor (RF) chemistries. The SYNCHRON Systems CAL 5 Plus is a frozen liquid human serum matrix identical to the Beckman CAL 5 Plus product.

AI/ML Overview

Here's an analysis of the provided 510(k) summary for the SYNCHRON® Systems CAL 5 Plus, focusing on acceptance criteria and study details.

This document describes a calibrator device, which is different from a diagnostic device that processes images or patient data. As such, many of the typical acceptance criteria and study characteristics for AI-powered diagnostic devices (e.g., sample size, expert ground truth, MRMC studies, standalone performance) are not applicable or described in this type of submission. The focus for a calibrator is on its stability and ability to provide accurate reference points.

Acceptance Criteria and Reported Device Performance

For this calibrator, the primary performance characteristic evaluated is its stability. The acceptance criterion is that the device maintains stability for a claimed duration of 24 months.

Acceptance Criterion	Reported Device Performance
Stability of CAL 5 Plus for ASO, CRP, and RF	Predicted stability of 32-33 months (exceeding Beckman's 24-month stability claim)

Study Details (as applicable to a calibrator)

Since this is a calibrator and not a diagnostic device, many of the requested categories are not directly applicable. I will address the relevant sections and note when information is not provided or applicable for this type of submission.

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a "test set" in the traditional sense. The stability study involved incubating the calibrator at different stress temperatures (32°C, 37°C, 41°C) for specific durations (40 days, 24 days, 15.5 days, respectively). The number of individual calibrator units or replicates tested is not provided.
- Data Provenance: Not specified other than "Beckman Instruments, Inc." (the manufacturer). There is no indication of country of origin of data or whether it was retrospective or prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. For a calibrator, "ground truth" is established by correlating its value assignment process to a "known standard via the anchor method." This is a metrological process, not an expert-driven diagnostic ground truth.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. See point 2.
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 a calibrator, not an AI-powered diagnostic device, and does not involve human readers interpreting data.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a chemical calibrator for in-vitro diagnostic assays, not an algorithm. Its "standalone" performance relates to its physical and chemical stability. The study described in the summary is a standalone performance evaluation of the calibrator itself.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Metrological Standard: The ground truth for value assignment is described as correlation to a "known standard via the anchor method." This refers to established chemical or biological reference materials and methodologies for calibrating laboratory assays.
The sample size for the training set:
- Not applicable. This device does not use machine learning, so there is no concept of a "training set."
How the ground truth for the training set was established:
- Not applicable. See point 7.

Summary

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K971283

Summary of Safety & Effectiveness SYNCHRON ® Systems CAL 5 Plus

JUN - 3 1997

1.0 Submitted By:

Sheri Hall Product Submissions Manager Beckman Instruments, Inc. 200 S. Kraemer Blvd., W-337 Brea, California 92822-8000 Telephone: (714) 993-8961 FAX: (714) 961-4457

Date Submitted: 2.0

28 March 1997

3.0 Device Name(s):

3.1 Proprietary Names

SYNCHRON® Systems CAL 5 Plus

3.2 Classification Name

(21 CFR § 862.1150) Calibrator

4.0 Predicate Device(s):

SYNCHRON SystemsCAL 5 Plus	Predicate	Predicate Company	DocketNumber
SYNCHRON SystemsCAL 5 Plus	Beckman CAL 5 Plus	BeckmanInstruments, Inc.	K926236/A

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Beckman Instruments, Inc., Section 510(k) Notification SYNCHRON® Systems CAL 5 Plus Summary of Safety & Effectiveness

5.0 Description:

6.0 Intended Use:

The SYNCHRON® Systems CAL 5 Plus, when used in conjunction with SYNCHRON® Systems and reagents, is intended for use in the callibration of Antistreptolysin-O (ASO-) on the SYNCHRON CX® Systems and for Antistreploysin-O (ASO-), C-reactive protein (CRP), and Rheumatoid factor (RF) chemistries on the SYNCHRON LX™ Systems.

7.0 Comparison to Predicate(s):

The SYNCHRON Systems CAL 5 Plus is a frozen liquid human serum matrix identical to the Beckman CAL 5 Plus product. The only difference between the Beckman CAL 5 Plus and the SYNCHRON Systems CAL 5 Plus is the instrument platform on which they are used. The Beckman Immunochemistry Systems are fully automated, specific protein analyzers, that measure by nephelometry; while the SYNCHRON Systems are fully automated, clinical chemistry analyzers that measure by spectrophotometry.

8.0 Summary of Performance Data:

The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence of the SYNCHRON Systems CAL 5 Plus to the Beckman CAL 5 Plus and is stable for ASO, CRP, and RF. The value assignment process for each analyte is correlated to a known standard via the anchor method. The SYNCHRON Systems CAL 5 Plus value assignment and verification processes yield acceptable calibrator assigned values for calibration on the SYNCHRON LX System and SYNCHRON CX Systems.

StressTemperature	Duration ofIncubation	PredictedStability	BeckmanStability Claim*
32°C	40 Days	32 Months	24 Months
37°C	24 Days	33 Months	24 Months
41°C	15.5 Days	32 Months	24 Months

SYNCHRON Systems CAL 5 Plus Stability Testing Summary
-------------------------------------------------------	--	--	--	--	--

Expiration dating placed on the package based on date of manufacture

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/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN - 3 1997

Ms. Sheri Hall Product Submissions Manager ..... Beckman Instruments, Inc. 200 S. Kraemer Boulevard, W-337 Brea, California 92822-8000

Re: K971283 Trade Name: SYNCHRON® Systems CAL 5 Plus Regulatory Class: II Product Code: JIX Dated: April 1, 1997 Received: April 7, 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. 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, 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. A 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 regulation may result in regulatory 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 53 i through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.

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.

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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 $09.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) ﺍ 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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/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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510(k) Number (if known):

SYNCHRON® Systems Device Name: CAL 5 Plus

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.

Retire E. Rogers
(Division Sign-Off)

Division of Clinical La 510(k) Number

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

V 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.