The IMMAGE® Immunochemistry System Ferritin (FER) Reagent, when used in conjunction with Beckman Coulter IMMAGE® Immunochemistry Systems and Beckman Coulter Ferritin Calibrator, is intended for the quantitative determination of ferritin in human serum by turbidimetric immunoassay.

Beckman Coulter Ferritin Calibrator, when used in conjunction with Ferritin reagent, is intended for use on IMMAGE® Immunochemistry Systems for the calibration of ferritin.

Device Description

The IMMAGE® Immunochemistry System Ferritin (FER) Reagent and Fentiin Calibrator are designed for optimal performance on the IMMAGE® Immunochemistry Systems. They are intended for the quantitative determination of Ferritin in serum.

AI/ML Overview

Here's an analysis of the acceptance criteria and study detailed in the provided text, formatted as requested:

Acceptance Criteria and Device Performance

The document describes the IMMAGE® Immunochemistry System Ferritin (FER) Reagent and Calibrator. The core of the study reported is a comparison to a predicate device and an evaluation of the device's imprecision. The acceptance criteria are implicitly defined by the reported performance and the finding of "substantial equivalence" to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance	Study Type
Method Comparison:
Slope close to 1	1.059	Comparison to Predicate (IMx Ferritin)
Intercept close to 0	-6.5 ng/mL	Comparison to Predicate (IMx Ferritin)
Correlation coefficient (r) ≥ 0.98	0.987	Comparison to Predicate (IMx Ferritin)
Imprecision (within-run):
Level 1: ≤ 4.4% C.V.	4.4% C.V. (S.D. 2.4 ng/mL at 53.5 ng/mL Mean)	Imprecision Study
Level 2: ≤ 3.0% C.V.	3.0% C.V. (S.D. 5.3 ng/mL at 172.0 ng/mL Mean)	Imprecision Study
Level 3: ≤ 2.6% C.V.	2.6% C.V. (S.D. 10.5 ng/mL at 397.0 ng/mL Mean)	Imprecision Study
Imprecision (total):
Level 1: ≤ 5.5% C.V.	5.5% C.V. (S.D. 2.9 ng/mL at 53.5 ng/mL Mean)	Imprecision Study
Level 2: ≤ 4.1% C.V.	4.1% C.V. (S.D. 7.1 ng/mL at 172.0 ng/mL Mean)	Imprecision Study
Level 3: ≤ 3.1% C.V.	3.1% C.V. (S.D. 12.4 ng/mL at 397.0 ng/mL Mean)	Imprecision Study

Note: The acceptance criteria are inferred from the reported "good" performance metrics that led to substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

Method Comparison Study:
- Sample Size (n): 116 serum samples
- Data Provenance: Not explicitly stated, but clinical samples (serum) would typically be from a patient population. It is not specified if they were retrospective or prospective, nor the country of origin.
Imprecision Study:
- Sample Size (N): 80 replicates for each of the three levels (240 total measurements).
- Data Provenance: Not explicitly stated, but these would be internal laboratory samples or controls.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of in-vitro diagnostic device does not typically rely on "experts" in the same way an imaging or pathology device would for establishing ground truth.

For the method comparison study, the "ground truth" for the test set was effectively the measurements obtained from the predicate device (Abbott IMx® Ferritin). Therefore, the "experts" were the established and validated methodology of the predicate device.
For the imprecision study, the "ground truth" refers to the true concentration of ferritin in the control samples used. This would be established through robust analytical methods, often by the control manufacturer, and not by individual human experts in a consensus manner.

4. Adjudication Method for the Test Set

Not applicable for this type of in-vitro diagnostic device study. The comparison is quantitative to an existing method or to established control values, not subject to human expert 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

Not applicable. This device is an automated immunoassay system for quantitative determination of ferritin, not an AI-assisted diagnostic tool that involves human interpretation of varied cases.

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

Yes, the studies reported (method comparison and imprecision) represent standalone performance of the IMMAGE® Immunochemistry System Ferritin Reagent. The system performs the quantitative determination of ferritin automatically without human interpretive input for each measurement. Human involvement is in operating the system, loading samples, and interpreting the final quantitative results output by the machine.

7. The Type of Ground Truth Used

For the method comparison study: The ground truth was the quantitative results obtained from the predicate device, the Abbott IMx® Ferritin system. This is a form of "reference method" ground truth.
For the imprecision study: The ground truth was the known or assigned concentration values of control materials at different ferritin levels.

8. The Sample Size for the Training Set

The document does not provide information about a "training set" in the context of machine learning or AI. This is a traditional immunoassay system, not an AI-based device that undergoes a training phase with a specific dataset. The closest analogue would be the calibration process, which uses the IMMAGE® Immunochemistry System Ferritin Calibrator according to its instructions.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" in the context of AI/machine learning for this device. For the calibrators, the "ground truth" (assigned values) would be established by the manufacturer through rigorous analytical methods, often traceable to an international reference standard (e.g., WHO Standard as mentioned for the IMMAGE System FER Calibrator).

Summary

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DEC | 4 1998

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Summary of Safety & Effectiveness Beckman Coulter IMMAGE® Immunochemistry System Ferritin Reagent

1.0 Submitted By:

Richard T. Ross Staff Regulatory Specialist, Product Submissions Beckman Coulter, Inc. 200 South Kraemer Blvd., W-104 Brea, California 92822-8000 Telephone: (714) 961-4912 FAX: (714) 961-4123

2.0 Date Submitted:

21 September 1998

3.0 Device Name(s):

3.1 Proprietary Names

IMMAGE® Immunochemistry System Femitin (FER) Reagent IMMAGE® Immunochemistry System Ferritin Calibrator

Classification Name 3.2

Ferritin Test System (21 CFR §862.3920) Catibrator (21 CFR 5882.1150)

4.0 Predicate Device(s):

IMMAGE System	Predicate	Manufacturer	Docket Number
IMMAGE System Ferritin(FER) Reagent	IMx®* Ferritin (FER)	Abbott**Laboratories, Inc	K881345
IMMAGE System FerritinCalibrator			(K882233)DIGOXAL

*Trademark of Abbott Laboratories

** Abbott Laboratories, Abbott Park, IL 60064

5.0 Description:

6.0 Intended Use:

The IMMAGE® Immunochemistry System Ferritin (FER) Reagent, when used in conjunction Beckman Coulter's IMMAGE® Immunochemistry Systems and IMMAGE® with Immunochemistry System Ferritin Calibrator, is intended for the quantitative determination of femitin in human serum by turbidimetric immunoassay.

Beckman Coulter Ferritin Calibrator, when used in conjunction with Ferritin reagent, is intended for use on IMMAGE Immunochemistry Systems for the calibration of ferritin.

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7.0 Comparison to Predicate(s):

The following tables show similarities and differences between the predicate identified in Section 4.0 of this summary.

IMMAGE System	Aspect/Characteristic	Comments
IMMAGE System FER	Intended use.
Reagent	Reaction temperature of 37° C	Same as Abbott
IMMAGE System FER	Human Spleen Origin	IMx Ferritin
Calibrator	Calibrator linked to a WHO Standard

SIMILARITIES to the PREDICATE

DIFFERENCES from the PREDICATE

IMMAGESystem	Aspect/Characteristic	Comments
IMMAGESystem FERReagent	IMMAGE FER uses Near InfraredParticle Immunoassay (NIPIA) rateimmunoassay methodology	Abbott IMx reagents utilizefluorescence polarizationimmunoassay
	Antibody source for IMMAGE FER israbbit (polyclonal)	Antiserum sources for IMxFerritin are rabbit and mouse
IMMAGESystem FERCalibrator	Calibration	IMMAGE FER uses a singlepoint calibration while IMx ismultipoint
IMMAGESystem FERSample	IMMAGE System FER requires asample volume of 7.5 µL	IMx ferritin requires a samplevolume of 150µL

8.0 Summary of Performance Data:

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 and imprecision experiments.

Analyte	Sample Type	Slope	Intercept (ng/mL)	r	n	Predicate Method
IMMAGEFER Reagent	serum	1.059	-6.5	0.987	116	IMx Ferritin

Method Comparison Study Results

Estimated IMMAGE System Ferritin (FER) Reagent Imprecision

Sample	Mean (ng/mL)	S.D. (ng/mL)	%C.V.	N
Within-Run Imprecision
Level 1	53.5	2.4	4.4	80
Level 2	172.0	5.3	3.0	80
Level 3	397.0	10.5	2.6	80
Total Imprecision
Level 1	53.5	2.9	5.5	80
Level 2	172.0	7.1	4.1	80
Level 3	397.0	12.4	3.1	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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DEPARTMENT OF HEALTH & HUMAN SERVICES

2098 Gaither Road

Rockville MD 20850

Food and Drug Administration

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 tail feathers, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

DEC | 4 1998 Mr. Richard T. Ross Staff Requlatory Specialist, Product Submissions Beckman Coulter, Inc. 200 South Kraemer Boulevard, W-104 Brea, California 92822-8000

Re : K983340

IMMAGE® Immunochemistry System Ferritin (FER) Trade Name: Reagent and IMMAGE® Immunochemistry System Ferritin Calibrator Requlatory Class: II Product Code: DBF Dated: September 21, 1998 September 23, 1998 Received:

Dear Mr. Ross:

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 requlations 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 Requlation (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 Failure to comply with the GMP regulation may result in assumptions. 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.

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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" (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 Radioloqical Health

Enclosure

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K983340

page 1 of $\overline{J}$

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

Device Name:

IMMAGE® Immunochemistry System Ferritin (FER) Reagent

Indications for Use:

Clinical Significance:

Ferritin is the main iron storage protein in the body. The concentration of ferritin is directly proportional to the iron stores in the body. Measurement of ferritin may aid in the diagnosis of anemia and hemochromatosis (Iron overload).

Ferritin (21 CFR §866.5340)

(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)

Signature

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number	K983348

Prescription Use(per 21 CFR 801.109)		OR	Over-the-Counter UseOptional Format 1-2-96
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page 2 of 2

K983340

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

Device Name:

IMMAGE® Immunochemistry Systems Ferritin Calibrator

Indications for Use:

Beckman Coulter Ferritin Calibrator, when used in conjunction with Ferritin reagent, is intended for use on IMMAGE® Immunochemistry Systems for the calibration of ferritin.

Clinical Significance:

Calibrator (21 CFR §862.1150)

(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)

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

Prescription Use
(per 21 CFR 801.109)
OR
Over-the-Counter Use
Optional Format 1-2-96

Regulation Number and Section

§ 866.5340 Ferritin immunological test system.

(a)
Identification. A ferritin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the ferritin (an iron-storing protein) in serum and other body fluids. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency amemia.(b)
Classification. Class II (performance standards).