The IMMAGE® Immunochemistry System Beta-2-Microglobulin (B2MX) Reagent, when used in conjunction with Beckman Coulter's IMMAGE® Immunochemistry Systems and Calibrator 2, is intended for the quantitative determination of human Beta-2-Microglobulin in serum or plasma by rate nephelometry.

Device Description

The IMMAGE® Immunochemistry System Beta-2-Microglobulin (B2MX) Reagent is designed for optimal performance on the IMMAGE® Immunochemistry Systems. It is intended for the quantitative determination of beta-2-microglobulin in serum or plasma.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the Beckman Coulter IMMAGE® Immunochemistry System Beta-2-Microglobulin Reagent, based on the provided text:

Acceptance Criteria and Device Performance

The provided document does not explicitly state "acceptance criteria" in a table format with pass/fail thresholds. Instead, it presents performance data for a method comparison study and an imprecision study to demonstrate substantial equivalence to a predicate device. The implied acceptance is that the device performs comparably to the predicate device and exhibits acceptable imprecision for its intended use.

Here's a table summarizing the reported device performance, with the understanding that these are the results that presumably met the underlying (unspecified) acceptance criteria for substantial equivalence:

Performance Metric	Reported Device Performance (IMMAGE B2MX Reagent)	Implied Acceptance Criteria (relative to Predicate)
Method Comparison (vs. Array 360 Beta-2-Microglobulin)		Linear regression should demonstrate high correlation and agreement.
Slope	0.979	Close to 1.0
Intercept (mg/dL)	-0.017	Close to 0.0
Correlation Coefficient (r)	0.996	Close to 1.0 (indicating strong correlation)
Imprecision (Within-Run)		CV should be within clinically acceptable limits, and comparable to industry standards/predicate performance.
Level 1 (0.10 mg/dL)	10.0 %C.V.	Acceptable for low concentrations
Level 2 (1.84 mg/dL)	2.3 %C.V.	Low %C.V.
Level 3 (3.19 mg/dL)	1.9 %C.V.	Low %C.V.
Imprecision (Total)		CV should be within clinically acceptable limits, and comparable to industry standards/predicate performance.
Level 1 (0.10 mg/dL)	10.0 %C.V.	Acceptable for low concentrations
Level 2 (1.84 mg/dL)	2.6 %C.V.	Low %C.V.
Level 3 (3.19 mg/dL)	2.2 %C.V.	Low %C.V.

Study Details

The provided document describes two main studies: a method comparison study and an imprecision study.

2. Sample Size and Data Provenance

Test Set Sample Size (Method Comparison): 111 samples (for serum analytes)
Data Provenance: Not explicitly stated, but clinical laboratory device studies for FDA submission typically use samples from a clinical population. The document does not specify country of origin or whether samples were retrospective or prospective.

3. Number of Experts and Qualifications for Ground Truth

Not Applicable. For this type of in vitro diagnostic device (IVD) studying an analyte's quantitative determination, ground truth is established by a reference method (the predicate device in this case) and traceable calibrators, not by expert interpretation.

4. Adjudication Method

Not Applicable. No human interpretation or adjudication process is mentioned, as the study is a quantitative comparison of analytical methods.

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

No. An MRMC study is not relevant for this type of IVD, which quantifies a biomarker. MRMC studies are typically used for imaging diagnostics or other modalities requiring human interpretation.

6. Standalone Performance (Algorithm Only)

Yes. The studies present the analytical performance of the IMMAGE® Immunochemistry System Beta-2-Microglobulin Reagent as a standalone system. The results (slope, intercept, correlation, imprecision) directly reflect the algorithm's (reagent and instrument's) ability to measure the analyte without human interpretation in the results generation process.

7. Type of Ground Truth Used (Test Set)

Reference Method / Predicate Device Output. The "ground truth" for the method comparison study was the results obtained from the predicate device, the Beckman Array® Beta-2-Microglobulin (B2M) on the Array 360 system.

8. Sample Size for Training Set

Not explicitly stated/Not applicable in the same way as AI/ML. For IVD assay development, there isn't a "training set" in the machine learning sense. Instead, development involves experiments to optimize reagent formulation, calibration curves, and instrument parameters, which effectively "train" the assay to measure accurately. The document does not provide details on the number of samples used during this development/optimization phase.

9. How Ground Truth for Training Set Was Established

Not applicable in the same way as AI/ML. For IVD assays, the "ground truth" during development is established through the use of characterized reference materials, calibrators with known concentrations, and comparison to established reference methods or primary standards, ensuring traceability and accuracy. The document does not detail this process but it is standard for IVD development.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows a sequence of handwritten digits and a letter. The sequence starts with the letter 'K', followed by the numbers '983895'. The numbers are written in a cursive style, with some connections between the digits.

Image /page/0/Picture/2 description: The image shows the logo for Beckman Coulter. The logo consists of a stylized black circle with two curved lines inside, followed by the words "BECKMAN" on the top line and "COULTER" on the bottom line, both in a bold, sans-serif font. To the left of the circle is a smaller, solid black circle.

Summary of Safety & Effectiveness

Beckman Coulter IMMAGE® Immunochemistry System Beta-2-Microglobulin 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:

02 November 1998

3.0 Device Name(s):

Proprietary Names 3.1

IMMAGE® Immunochemistry System Beta-2-Microglobulin Reagent

3.2 Classification Name

(21 CFR §866.5630) Beta-2-Microglobulin immunological test system

4.0 Predicate Device(s):

IMMAGE Reagent	Predicate	Manufacturer	DocketNumber
IMMAGE SystemBeta-2-Microglobulin(B2MX)	Beckman Array® Beta-2-Microglobulin (B2M)	BeckmanInstruments, Inc.	K940353

5.0 Description:

6.0 Intended Use:

The IMMAGE® Immunochemistry System Beta-2-Microglobulin (B2MX) Reagent, when used in conjunction with Beckman Coulter's IMMAGE® Immunochemistry Systems and Calibrator 2, is intended for the quantitative determination of human beta-2-microglobulin in serum or plasma by rate nephelometry.

{1}------------------------------------------------

7.0 Comparison to Predicate(s):

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

IMMAGESystem	Aspect/Characteristic	Comments
IMMAGESystem	Intended use	Same as Array Beta-2-Microglobulin
B2MXReagent	Reaction temperature of 37° C
	Detection methodology of rate nephelometry

SIMILARITIES to the PREDICATE

DIFFERENCES from the PREDICATE

IMMAGESystem	Aspect/Characteristic	Comments
IMMAGESystem	Sample dilution	IMMAGE has on line sample dilution.Array requires off line sample dilution.
B2MXReagent	Antibody source	IMMAGE is rabbit (polyclonal). Array isgoat (polyclonal).
Reagent	Antibody reagentcomposition	IMMAGE is latex particle bound antibody.Array is soluble antibody.

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 and imprecision experiments.

Method Comparison Study Results

IMMAGE® System Beta-2-Microglobulin (B2MX) Reagent

Analyte	SampleType	Slope	Intercept(mg/dL)	r	n	Predicate Method
IMMAGEB2MXReagent	serum	0.979	-0.017	0.996	111	Array 360Beta-2-Microglobulin

IMMAGE® System Beta-2-Microglobulin (B2MX) Imprecision

Sample	Mean (mg/dL)	S.D. (mg/dL)	%C.V.	N
		Within-Run Imprecision
Level 1	0.10	0.010	10.0	80
Level 2	1.84	0.042	2.3	80
Level 3	3.19	0.062	1.9	80
		Total Imprecision
Level 1	0.10	0.010	10.0	80
Level 2	1.84	0.048	2.6	80
Level 3	3.19	0.069	2.2	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.

Image /page/1/Picture/14 description: The image shows a black and white close-up of a circular object. The object is mostly black, with a small white highlight on the upper left side. The object appears to be smooth and featureless, with no visible texture or details.

{2}------------------------------------------------

Public Health Service

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird-like figure. The logo is black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re: K983895 IMMAGE® Immunochemistry System Beta-2 Microglobulin Trade Name: Reagent Regulatory Class: II Product Code: JZG November 2, 1998 Dated: Received: November 3, 1998

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 regulations 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 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 obliqation 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.

{3}------------------------------------------------

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 leqally 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic 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 Putman

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

{4}------------------------------------------------

page 1 of 1

K983895 510(k) Number (if known): Not vet assigned-

Device Name:

IMMAGE® Immunochemistry System Beta-2-Microglobulin (B2MX) Reagent

Indications for Use:

Clinical Significance:

An increase in the concentration of serum beta-2-microglobulin can result from an overproduction of the protein by nucleated cells and/or decreased clearance by the kidneys. Under normal conditions, beta-2-microglobulin passes readily through the glomerular membrane. Levels of beta-2microglobulin in serum, therefore, are inversely proportional to glomerular filtration rate (GFR). Measurement of Beta-2-Microglobulin in serum or plasma assists in the diagnosis and management of patients with active rheumatoid arthritis and renal disease.

(21 CFR §866.5630) Beta-2-Microglobulin immunological test system

(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	K983895
510(k) Number

Prescription Use (per 21 CFR 801.109)
---------------------------------------	-----------------------------------------------

Over-the-Counter Use
Optional Format 1-2-96

Regulation Number and Section

§ 866.5630

Beta -2-microglobulin immunological test system.(a)
Identification. Abeta -2-microglobulin immunological test system is a device that consists of the reagents used to measure by immunochemical techniquesbeta -2-microglobulin (a protein molecule) in serum, urine, and other body fluids. Measurement ofbeta -2-microglobulin aids in the diagnosis of active rheumatoid arthritis and kidney disease.(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 § 866.9.