The SYNCHRON® CX Systems Prealbumin Calibrator, used in conjunction with SYNCHRON® Systems Prealbumin reagent, is intended for use on Beckman's SYNCHRON CX Systems for the calibration of prealbumin test systems.

Device Description

The SYNCHRON CX Systems Prealbumin Calibrator Set is a six level ready-to-use human serum-based liquid calibrator set manufactured by Beckman Coulter, Inc. Each kit contains 1 X 3 mL bottles of a specific level of calibrator (identified as Levels 1 to Level 6).

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the SYNCHRON® CX Systems Prealbumin Calibrator:

Acceptance Criteria and Device Performance

The provided document does not explicitly state specific numerical acceptance criteria for the SYNCHRON® CX Systems Prealbumin Calibrator. Instead, the primary basis for acceptance is a finding of "substantial equivalence" to a legally marketed predicate device.

The "Summary of Performance Data" states: "The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to products already in commercial distribution."

The comparison to the predicate device focuses on characteristics rather than quantitative performance metrics. While the document doesn't list specific performance criteria with numerical targets (e.g., accuracy within X%, precision with CV < Y%), the implication of "substantial equivalence" is that the new device performs comparably to the predicate for its intended use.

Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion (Implied by Substantial Equivalence)	Reported Device Performance
Intended Use: Calibration of Prealbumin (PAB) reagent on SYNCHRON CX Systems	Meets: Intended for this exact purpose, stated explicitly.
Source Material: Fresh frozen human plasma, defibrinated and processed	Meets: Same as Beckman Immunochemistry Systems CAL 3 predicate device.
Storage Temperature: +2°C to +8°C	Meets: Same as predicate device.
Form: Liquid, ready-to-use	Meets: Same as predicate device.
Stability: Sufficient for intended use	Meets: "Stress stability studies... support the Beckman stability claim of 24 months."
Value Assignment Methodology: Traceable to IFCC reference preparation (CRM 470)	Meets: Same as predicate device.
Safety and Effectiveness	Meets: Supports a finding of substantial equivalence.

Study Details

Sample Size Used for the Test Set and Data Provenance:
- The document does not specify a distinct "test set" sample size for evaluating the calibrator's performance in terms of clinical samples.
- The performance data primarily focuses on the calibrator's characteristics and stability.
- Data Provenance: Not explicitly stated regarding specific patient samples. The calibrator itself is human serum-based. The stress stability studies mentioned are likely internal lab studies, possibly using spiked samples or existing quality control materials.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This information is not provided in the document. Given that this is a calibrator for an in vitro diagnostic (IVD) device, "ground truth" for the calibrator's value assignment would typically be established through rigorous metrological traceability to international reference standards, rather than expert consensus on individual "test set" cases.
- The document states, "Traceable to the IFCC reference preparation for plasma proteins, lot CRM 470," which describes the method for establishing the ground truth (i.e., assigned values) for the calibrator levels.
Adjudication Method for the Test Set:
- Not applicable/Not mentioned. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which isn't the primary focus for the performance evaluation of a calibrator.
If a Multi-Reader, Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
- No, an MRMC comparative effectiveness study was not done. This type of study is for evaluating the impact of AI on human reader performance, which is not relevant for a calibrator device.
If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- This is an in vitro diagnostic calibrator, not an algorithm, so the concept of "standalone performance" in the context of AI algorithms doesn't directly apply. The calibrator's performance is intrinsically linked to the SYNCHRON CX Systems and the PAB reagent it calibrates. The "performance data" presented focuses on its characteristics and stability.
The Type of Ground Truth Used:
- For the calibrator's assigned values, the ground truth is established through metrological traceability to an international reference standard: "Traceable to the IFCC reference preparation for plasma proteins, lot CRM 470." This is a highly controlled and standardized method for assigning accurate values to calibrators.
The Sample Size for the Training Set:
- Not applicable/Not mentioned. This device is a calibrator, not an AI algorithm that requires a "training set" of data.
How the Ground Truth for the Training Set Was Established:
- Not applicable. As noted above, there is no "training set" in the context of this calibrator device. The "ground truth" for its assigned values (calibration levels) is established through traceability to the IFCC reference preparation.

Summary

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Summary of Safety & Effectiveness SYNCHRON® CX Systems Prealbumin Calibrator

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:

December 6, 1999

3.0 Device Name(s):

3.1 Proprietary Names

SYNCHRON® CX Systems Prealbumin Calibrator

3.2 Classification Name

Calibrator, (21 CFR §862.1150)

4.0 Predicate Device(s):

SYNCHRON SystemsReagent	Predicate	Manufacturer	DocketNumber
SYNCHRON® SystemsPAB Calibrator	BeckmanImmunochemistrySystems CAL 3	Beckman Coulter, Inc.	K854811

5.0 Description:

Mailing Address: 200 S. Kraemer Boulevard P.O. Box 8000 Brea, CA 92822-8000

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

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Beckman Coulter, Inc., Section 510(k) Notification SYNCHRON® CX Systems Prealbumin Calibrator Summary of Safety & Effectiveness

5.0 Intended Use:

The SYNCHRON® CX Systems Prealbumin Calibrator is intended for use with the SYNCHRON CX Systems for the calibration of Prealbumin (PAB) reagent.

7.0 Comparison to Predicate(s):

Reagent	Aspect/Characteristic	Comments
SYNCHRONSystems CX PABCalibrator	Source Material: Fresh frozen humanplasma that has been defibrinated andprocessed.	Same as BeckmanCAL 3
	Storage Temperature (+2°C to +8°C)
	Liquid, ready-to-use form
	Value Assignment Methodology
	Traceable to the IFCC referencepreparation for plasma proteins, lot CRM470.

Reagent	Aspect/Characteristic	Comments
SYNCHRONSystemsPABCalibrator	Intended Use:	SYNCHRON CX Systems PAB Calibrator isintended for use in calibration of SYNCHRONCX Systems Prealbumin Reagent.Beckman CAL 3 is intended for use incalibration of albumin and prealbumin onARRAY®, ARRAY® 360, and IMMAGE™Immunochemistry systems
	Levels of Analyte	SYNCHRON Systems PAB Calibrator: 6levelsBeckman CAL 3: 1 level

8.0 Summary of Performance Data:

The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to products already in commercial distribution. Stress stability studies of the Prealbumin calibrator support the Beckman stability claim of 24 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/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

3 2000 FEB

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Lucinda Stockert Staff Regulatory Specialist Beckman Coulter, Inc. 200 S. Kraemer Boulevard M/S W-104 Box 8000 Brea, California 92822-8000

Re: K994169

Trade Name: SYNCHRON® CX Systems Prealbumin Calibrator Regulatory Class: II Product Code: JIS Dated: December 6, 1999 Received: December 10, 1999

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, 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 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 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 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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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" (21CFR 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 Butman

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): Y 44 4 / 69

510(k) Number (If Known): n777169
Device Name: SYNCHRON® CX Systems

Prealbumin Calibrator

Indications for Use:

Clinical Significance:

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.

Jean Cooper

(Division Sign-Off)
Division of Clinical Laboratory Devices

Division of Clinical tory Devices 510(k) Number

(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

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.