MA Calibrator, when used in conjunction with SYNCHRON Systems MA Reagent (P/N 475100), is intended for use on the SYNCHRON CX Systems for the calibration of Microalbumin.

Device Description

The SYNCHRON CX® Systems Microalbumin Calibrator , when used in conjunction with SYNCHRON Systems Microalbumin Systems Reagent (P/N 475100), is intended for use on the SYNCHRON CX Systems for the calibration of Microalbumin. This product contains a 3.0 mL bottle each of Levels 1 to 6 of Microalbumin Calibrator.

AI/ML Overview

This document is a 510(k) Summary of Safety and Effectiveness for the SYNCHRON CX® Systems Microalbumin Calibrator. It outlines the device's intended use, comparison to a predicate device, and a summary of performance data.

Here's an analysis of the requested information based on the provided text:

1. Table of acceptance criteria and reported device performance

The document does not explicitly state acceptance criteria in a quantitative format, nor does it provide detailed device performance metrics beyond a stability claim. It focuses on demonstrating substantial equivalence to a predicate device.

Acceptance Criterion	Reported Device Performance
Stability	24 months (stress stability studies support this claim)

2. Sample size used for the test set and the data provenance

The document makes no mention of a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective). The "Summary of Performance Data" section is very brief and refers to "data in the Premarket Notification" without elaboration.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

There is no mention of experts, ground truth establishment methodologies, or their qualifications. The evaluation appears to be based on laboratory testing for stability and comparison to a predicate device, not on expert interpretations of results.

4. Adjudication method for the test set

No adjudication method is mentioned, as there is no described test set involving human interpretation requiring adjudication.

5. 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

This document describes a medical device calibrator, not an AI-based diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.

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

This calibrator is a physical product used to set reference points for a diagnostic system. It does not involve an algorithm or standalone performance in the sense of an AI model. Its performance is intrinsic to its chemical properties and stability.

7. The type of ground truth used

The concept of "ground truth" as typically applied to diagnostic accuracy studies (e.g., pathology, clinical outcomes) is not directly applicable here. For a calibrator, the "truth" likely refers to the assigned concentration values of the calibrator levels, which are traceable back to a reference standard. The document states:

Traceable to the IFCC reference preparation for plasma proteins, lot CRM 470.
This indicates that the "ground truth" for the calibrator's values is established by its traceability to an internationally recognized reference material.

8. The sample size for the training set

This device is not an algorithm or AI model that requires a "training set." Therefore, no training set or sample size is applicable or mentioned.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this device.

Summary

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Summary of Safety and Effectiveness SYNCHRON CX® Systems Microalbumin Calibrator

1.0 Submitted By:

Gail Lefebre Associate Requlatory Specialist, Product Submissions Beckman Coulter, Inc. 200 S. Kraemer Blvd., W-104 Brea, California 92822-8000 Telephone: (714) 993-8503 FAX: (714) 961-4123

2.0 Date Submitted:

December 17, 1999

3.0 Device Name(s):

3.1 Proprietary Names

SYNCHRON CX® Systems Microalbumin Calibrator

3.2 Classification Name

Calibrator, Primary (21 CFR § 862.1150)

4.0 Predicate Device(s):

SYNCHRON SystemsReagent	Predicate	Manufacturer	DocketNumber
SYNCHRON CX®Systems MicroalbuminCalibrator	BeckmanImmunochemistrySystems Urine ProteinCalibrator (UCAL)	Beckman Coulter, Inc.	K973928

5.0 Description:

6.0 Intended Use:

The SYNCHRON CX Systems Microalbumin Calibrator is a six-level calibrator intended for use on the SYNCHRON CX Systems for the calibration of Microalbumin (MA) reagent.

Beckman Coulter, Inc. 200 S. Kraemer Boulevard Brea, CA 92821

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

994325

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7.0 Comparison to Predicate(s):

Beckman Product	Predicate	Predicate Company	Docket Number
SYNCHRON CX®Systems MicroalbuminCalibrator	BeckmanImmunochemistry SystemsUrine Protein Calibrator(UCAL)	Beckman Coulter, Inc.	K973928

Reagent	Aspect/Characteristic	Comments
SYNCHRON Systems CX MACalibrator	Intended for calibration of urineMicroalbumin reagents	Same as UCAL
	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
SYNCHRON CX SystemsMA Calibrator	Intended Use:	SYNCHRON CX Systems MA Calibrator isintended for use in calibration of SYNCHRON CXSystems Microalbumin Reagent.
		Beckman Immunochemistry Systems UCAL isintended for use in calibration of microalbumin,urine transferrin, alpha-1-microglobulin, and urineimmunoglobulin G on ARRAY®, ARRAY® 360,and IMMAGE™ Immunochemistry Systems.
	Levels ofAnalyte:	SYNCHRON Systems MA Calibrator: 6 levels
		Beckman UCAL: 4 levels
	SourceMaterial:	CX MA pH buffer to which human serum albuminhas been added
		UCAL is prepared from human urine to whichalbumin has been added

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 Microalbumin 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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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 1 2 2000

Ms. Gail Lefebvre Associate Regulatory Specialist Beckman Coulter, Inc. 200 S. Kraemer Blvd., M/S W-104 Brea, California 92822-8000

Re: K994325

Trade Name: SYNCHRON CX® Systems Microalbumin Calibrator Regulatory Class: II Product Code: JIS Dated: December 17, 1999 Received: December 22, 1999

Dear Ms. Lefebvre:

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 (OS) 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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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.

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 _ of _

510(k) Number (if known): $994325

Device Name: SYNCHRON CX® Systems Microalbumin Calibrator

Indications for Use:

MA Calibrator, when used in conjunction with SYNCHRON Systems MA Reagent (P/N 475100), is intended for use on the SYNCHRON CX Systems for the calibration of Microalbumin.

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.

Dean Cooper

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K994325

(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)

(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.