The SYNCHRON LX Systems Transferrin (TRFN) Reagent, when used in conjunction with SYNCHRON LX Calibrator 1, is intended for the quantitative determination of human transferrin in serum or plasma. This assav is designed for use with clinical chemistry analyzers from Beckman instruments, such as the SYNCHRON LX20 Clinical System.

The measurement of transferrin in serum or other body fluids aids in the diagnosis of malnutrition, acute inflammation, infection, assessment of renal function and red blood cell disorders, such as iron deficiency anemia.

Device Description

The SYNCHRON LX Systems Transferrin (TRFN) Reagent in conjunction with SYNCHRON LX Calibrator 1, is intended for use on Beckman's SYNCHRON LX™20 Clinical Systems.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the SYNCHRON LX™ Systems Transferrin (TRFN) Reagent, as derived from the provided text:

Acceptance Criteria and Device Performance

The provided document describes the predicate device as the basis for substantial equivalence. Therefore, the acceptance criteria are implicitly based on demonstrating performance comparable to the predicate device, the Beckman Transferrin (TRFN) Reagent (K780913) on the ARRAY® Systems.

1. Table of Acceptance Criteria and Reported Device Performance:

Performance Metric	Acceptance Criteria (Implied by Predicate Equivalence)	Reported SYNCHRON LX TRFN Reagent Performance
Method Comparison	Close agreement with predicate method (e.g., slope near 1, intercept near 0, high correlation)	Slope: 1.041 Intercept: -20.7 mg/dL r (Correlation Coefficient): 0.9844
Shelf-Life Stability	Indefinite (based on predicate) or demonstrated over a reasonable period	24 months
Calibration Stability	Indefinite (based on predicate) or demonstrated over a reasonable period	14 days
On-Board Stability	Indefinite (based on predicate) or demonstrated over a reasonable period	60 days
Within-Run Imprecision (Low Level)	Low Coefficient of Variation (CV%)	Mean: 135.7 mg/dL S.D.: 2.00 mg/dL %C.V.: 1.47
Within-Run Imprecision (Mid Level)	Low Coefficient of Variation (CV%)	Mean: 218.6 mg/dL S.D.: 2.95 mg/dL %C.V.: 1.35
Within-Run Imprecision (High Level)	Low Coefficient of Variation (CV%)	Mean: 303.5 mg/dL S.D.: 4.08 mg/dL %C.V.: 1.34

2. Sample Size and Data Provenance for Test Set:

Sample Size (n) for Method Comparison: 80 samples were used for the method comparison study.
Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It is implied to be clinical samples used for comparison.

3. Number of Experts and Qualifications for Ground Truth (Test Set):

Not Applicable. For a quantitative assay like this, the "ground truth" for the test set is established by the reference method (the predicate device, Beckman's TRFN Transferrin Reagent on the ARRAY® Systems) rather than expert consensus on interpretation. There is no mention of experts establishing a ground truth for individual samples.

4. Adjudication Method for Test Set:

Not Applicable. Since the ground truth for this type of quantitative assay is based on chemical measurement by a reference method, there is no expert adjudication process.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. This is a quantitative in vitro diagnostic (IVD) assay designed to measure the concentration of transferrin in serum or plasma. MRMC studies are typically performed for imaging or qualitative diagnostic devices where human reader interpretation is a critical component. There is no human-in-the-loop performance involved in this specific device's operation or evaluation.

6. Standalone (Algorithm Only) Performance Study:

Yes, implicitly. The method comparison, stability, and imprecision studies directly evaluate the performance of the SYNCHRON LX TRFN Reagent and the SYNCHRON LX™20 Clinical Systems without human interpretation influencing the measurement results. The results are quantitative values obtained directly from the automated system.

7. Type of Ground Truth Used (Test Set):

Comparative Measurement (Predicate Device): The ground truth for the method comparison study was established by the measurements obtained from the Beckman's TRFN Transferrin Reagent on the ARRAY® Systems (K780913), which served as the predicate method. For stability and imprecision, the ground truth would be the known concentration of control materials or the inherent stability/repeatability of the assay itself.

8. Sample Size for Training Set:

The document does not explicitly state a specific "training set" size. For IVD reagents, development often involves extensive internal testing and optimization (which can be considered analogous to training) using a variety of samples and conditions. However, the FDA submission focuses on the validation (test set) data.

9. How Ground Truth for Training Set was Established:

As above, the document does not provide details on how ground truth was established for any "training" or development phase. For such an assay, the "ground truth" during development would typically involve:
- Reference materials/standards: Samples with known, accurately determined concentrations of transferrin.
- Established analytical methods: Using highly accurate and precise analytical techniques (e.g., gravimetric, spectrophotometric, or other validated methods) to determine the true values in samples used for optimization.
- Internal validation against existing, validated methods: Comparing results during development to other established and reliable methods for transferrin determination.

Summary

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K971958

AUG 20 1997

Summary of Safety & Effectiveness SYNCHRON LX™ Systems Transferrin (TRFN) Reagent

1.0 Submitted By:

Lucinda Stockert Senior Regulatory Specialist Beckman Instruments, Inc. 200 S. Kraemer Blvd., W-337 Brea, California 92822-8000 Telephone: (714) 961-3777 FAX: (714) 961-4457

2.0 Date Submitted:

21 May 1997

3.0 Device Name(s):

3.1 Proprietary Names

SYNCHRON LX™ Systems Transferrin (TRFN) Reagent

3.2 Classification Names

Transferrin immunological test system (21 CFR 866.5880)

4.0 Predicate Device(s):

SYNCHRON LXReagents	Predicate	PredicateCompany	DocketNumber
Transferrin (TRFN)Reagent	BeckmanTransferrin(TRFN) Reagent	BeckmanInstruments, Inc.	K780913

5.0 Description:

The SYNCHRON LX Systems Transferrin (TRFN) Reagent in conjunction with SYNCHRON LX Calibrator 1, is intended for use on Beckman's SYNCHRON LX™20 Clinical Systems.

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Beckman Instruments, Inc., Section 510(K) Notification SYNCHRON LX™ Systems Transferrin (TRFN) Reagent Summary of Safety & Effectiveness

6.0 Intended Use:

The SYNCHRON LX Systems Transferrin (TRFN) Reagent, when used in conjunction with SYNCHRON LX Calibrator 1, is intended for the quantitative determination of human transferin in serum or plasma. This assay is designed for use with clinical chemistry analyzers from Beckman Instruments, such as the SYNCHRON LX™20 Clinical System.

7.0 Comparison to Predicate(s):

The following table shows similarities and differences between the predicates identified in Section 4.0 of this summary.

Reagent	Aspect/Characteristic	Comments
SIMILARITIES
SYNCHRON LX Systems(TRFN) Reagent	Intended use	Same as the ARRAY SystemTRFN reagent quantitativedetermination of human transferrin
	Chemical reaction	Same principle as the ARRAYSystem TRFN reagent; formationof antigen-antibody complexes
	Antibody	Same source, antibody,processing, and buffer as theARRAY System TRFN reagent
	Calibration	Same as the ARRAY SystemTRFN reagent; single point updateof manufacturer determinedcalibration curve

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Reagent	Aspect/Characteristic	Comments
DIFFERENCES
SYNCHRON LXSystems (TRFN)Reagent	Methodology	The SYNCHRON LX reads turbidimetrically and theARRAY System reads nephelometrically
	Measurement method	The SYNCHRON LX runs the reaction at 37°C andreads an endpoint at 340 nm, where the ARRAYSystem runs at 26.5°C and reads the rate of increasein light scatter at 670 nm
	Range expansion	The SYNCHRON LX TRFN reagent measurestransferrin concentrations at the initial range of 75 -800 mg/dL; while the ARRAY TRFN reagentmeasures transferrin concentrations at the initial rangeof 75-800 mg/dL and expanded range of 12.5 - 4,500mg/dL
	Type of specimen	The SYNCHRON LX TRFN reagent measurestransferrin concentrations in serum or plasmasamples; while the ARRAY Systems TRFN reagentmeasures transferrin concentrations in serum (plasmasamples are not recommended) or urine samples.
	Antigen excesschecking	The SYNCHRON LX TRFN reagent was designed sothat high antigen concentrations will not report inrange; the ARRAY System adds extra antibody toobserve for additional activity
	Packaging	The SYNCHRON LX TRFN reagent is packaged inpolystyrene cartridges; the ARRAY System TRFNreagent is packaged in glass bottles

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Beckman Instruments, Inc., Section 510(k) Notification SYNCHRON LX™ Systems Transferin (TRFN) Reagent Summary of Safety & Effectiveness

Summary of Performance Data: 8.0

The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. Equivalence is demonstrated through method comparison, stability, and imprecision experiments that relate results obtained from Beckman's Immunochemistry System TRFN Transferrin (on ARRAY) Reagent to the SYNCHRON LX Transferrin (TRFN) Reagent.

Method Comparison Study Results SYNCHRON LX Transferrin (TRFN) Reagent vs. Beckman TRFN Transferrin Reagent (on ARRAY)

Reagent(Analyte)	Slope	Intercept(mg/dL)	r	n	Predicate Method
The SYNCHRON LXTransferrin (TRFN)Reagent	1.041	-20.7	0.9844	80	Beckman's TRFNTransferrin Reagent on theARRAY® Systems

Stability Study Results

Reagent	Product Claim
SYNCHRON LX Transferrin (TRFN)Reagent	24 month shelf-life14 day calibration stability60 days on-board stability

Estimated Within-Run Imprecision

Sample	Mean(mg/dL)	S.D.(mg/dL)	%C.V.	N
SYNCHRON LX Transferrin (TRFN) Reagent
Level 1	135.7	2.00	1.47	80
Level 2	218.6	2.95	1.35	80
Level 3	303.5	4.08	1.34	80

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/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Lucinda Stockert Senior Requlatory Specialist Beckman Instruments, Inc. 200 S. Kraemer Boulevard, W-337 Brea, California 92822-8000

AUG 20 1997

K971958/S1 Re: Trade Name: SYNCHRON LX™ Systems Transferrin (TRFN) Reagent Regulatory Class: II Product Code: DDG Dated: July 31, 1997 Received: August 5, 1997

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 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, Druq, 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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 GMF regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Piease 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

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 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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page _________________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known):

SYNCHRON LX™ Systems Transferrin (TRFN) Reagent Device Name:

Indications for Use: .........................................................................................................................................................

21 CFR 866.5880 Transferrin immunological test system

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off
Division of Clinical Laboratory Devices
510(k) Number

Prescription Use(per 21 CFR 801.109)	OR	Over-the-Counter UseOptional Format 1-2-96
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Regulation Number and Section

§ 866.5880 Transferrin immunological test system.

(a)
Identification. A transferrin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the transferrin (an iron-binding and transporting serum protein) in serum, plasma, and other body fluids. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia.(b)
Classification. Class II (performance standards).