The IMMAGE Immunochemistry System Beta-2-Microglobulin (B2M) Reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 2, is intended for the quantitative determination of human beta-2-microglobulin by rate nephelometry.

Device Description

The IMMAGE Immunochemistry System B2M Reagent in conjunction with Beckman Calibrator 2, is intended for use in the quantitative determination of beta-2-microglobulin concentrations in human serum samples on Beckman's IMMAGE Immunochemistry System.

AI/ML Overview

The Beckman IMMAGE™ Immunochemistry System Beta-2-Microglobulin (B2M) Reagent is intended for the quantitative determination of human beta-2-microglobulin in serum by rate nephelometry. The study provided focuses on demonstrating substantial equivalence to a predicate device through method comparison, stability, and imprecision experiments, rather than establishing acceptance criteria against a specific clinical performance threshold.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for each performance metric. Instead, it presents the results of studies and implies that these results demonstrate substantial equivalence to the predicate device.

Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance
Method Comparison	Demonstrate substantial equivalence to the predicate device	Data presented (though not fully legible in the provided snippet) suggests comparison to Array System Beta-2-Microglobulin reagent. The summary states "Equivalence is demonstrated through method comparison..."
Shelf-life Stability	Meet product claim	24 month shelf-life
Open Container Stability	Meet product claim	14 day open container stability
Calibration Stability	Meet product claim	14 day calibration stability
Within-Run Imprecision	Low variability at different concentration levels (typical for IVD)	Level 1: Mean 0.34 mg/dL, SD 0.029 mg/dL, %CV 8.5 (N=80)
		Level 2: Mean 1.65 mg/dL, SD 0.045 mg/dL, %CV 2.7 (N=80)
		Level 3: Mean 3.43 mg/dL, SD 0.099 mg/dL, %CV 2.9 (N=80)

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

Method Comparison Study: The snippet of the table for method comparison is largely unreadable. It's impossible to determine the sample size from the provided text.
Imprecision Study (Within-Run): A sample size of N=80 was used for each of the three levels tested.
Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Typically, such studies for device submission are prospective and conducted in clinical laboratory settings.

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

This information is not applicable to this type of device and study. The IMMAGE Immunochemistry System B2M Reagent is an in-vitro diagnostic (IVD) device that quantitatively measures a biomarker (Beta-2-Microglobulin). The "ground truth" for such devices is typically established by reference methods or validated comparative methods, not by expert consensus on visual interpretation.

4. Adjudication Method for the Test Set

This information is not applicable as it pertains to subjective interpretations or classifications, which is not the nature of this quantitative IVD device.

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

A MRMC comparative effectiveness study was not done. This type of study is relevant for imaging devices where human readers interpret medical images, often with and without AI assistance. The Beckman IMMAGE system is a laboratory instrument for quantitative biomarker measurement.

6. Standalone (Algorithm Only) Performance Study

The provided document describes the performance of the entire device system (reagent with the IMMAGE Immunochemistry System), not just an isolated algorithm. The "algorithm" in this context is the rate nephelometry methodology, which is an integral part of the measurement system. Therefore, a standalone algorithm-only performance study as understood in the context of AI tools is not applicable.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is established by quantitative measurements derived from comparison to a predicate device (Array System Beta-2-Microglobulin (B2M) reagent) and through internal analytical performance studies (stability, imprecision). For quantitative assays, "ground truth" often refers to the true concentration of the analyte, frequently determined by validated reference methods or the performance of a legally marketed predicate device.

8. Sample Size for the Training Set

This information is not explicitly stated and is likely not applicable in the context of traditional IVD device development for chemical reagents and equipment. The IMMAGE Immunochemistry System B2M Reagent uses a nephelometric methodology. This is a physics-based measurement technique, not a machine learning algorithm that requires a "training set" in the conventional sense. The "training" of such a system involves calibrating the instrument with known standards to establish a calibration curve. Sample preparation and testing involves real patient samples (test set), but not algorithm training.

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

As explained above, there isn't a "training set" with established ground truth in the machine learning sense for this traditional IVD device. The calibration of the system would involve using known calibrator materials (e.g., Beckman Calibrator 2, mentioned in the Intended Use) with assigned values, which act as the "ground truth" for the instrument's calibration curve.

Summary

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BECKMAN

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Summary of Safety & Effectiveness IMMAGE™ Immunochemistry System Beta-2-Microglobulin (B2M) Reagent

NOV 20 1997

Submitted By: 1.0

Annette Hellie Sr. Regulatory Specialist, Product Submissions Beckman Instruments, Inc. 200 S. Kraemer Blvd., W-337 Brea, California 92822-8000 Telephone: (714) 993-8767 FAX: (714) 961-4457

2.0 Date Submitted:

October 6, 1997

3.0 Device Name(s):

3.1 Proprietary Names

IMMAGE™ Immunochemistry System Beta-2-Microglobulin (B2M) Reagent

3.2 Classification Name

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

4.0 Predicate Device(s):

IMMAGE SystemReagent	Predicate	Manufacturer	DocketNumber
IMMAGE System Beta-2-Microglobulin (B2M)	Array Systems Beta-2-Microglobulin(B2M)	Beckman Instruments,Inc.	K940353

5.0 Description:

6.0 Intended Use:

Beckman Instruments, Inc.

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2017 11:22 PM IST 11:20 PM IST 1

Beckman Instruments, Inc., Section 510(k) Notification IMMAGE™ Immunochemistry System Beta-2-Microglobulin (B2M) Reagent Summary of Safety & Effectiveness

Comparison to Predicate(s): 7.0

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

Reagent	Aspect/Characteristic	Comments
SIMILARITIES
IMMAGE SystemB2M Reagent	Analytic Range	Same as Array System Beta-2-Microglobulin reagent
	Off-line sample dilution
	Nephelometric methodology
	Antibody source (goat)
DIFFERENCES
IMMAGE SystemB2M Reagent	Buffer/Reagent volumes	IMMAGE System uses half of thevolumes than are utilized by the ArraySystem for B2M.
	Coreagent concentration	IMMAGE B2M has a higher coreagentconcentration than the Array Beta-2-Microglobulin reagent

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 companson, stability, and imprecision experiments that relate results obtained from the Beckman Reagent on the Array® 360 System to the IMMAGE System Reagent.

Method Comparison Study Results

IMMAGE Beta-2-Microglobulin (B2M) Reagent

. I E E A S E R E R B R B E S B E B E B B B E B B B B B B B B B B B B B B B B B B B B B B B B B B B B B B B B B B B B B B B B B B B B B B B B B B B B B B B B B B B B B B B B		*********.	ANSEPER'	STANTAL PARKET THE COLLECTION CONTENTION THE COLLECTION COLLEGIAL COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION CONTENTION CONTENTIONAL CONTENTIONAL CONTENTIONA

Stability Study Results

Reagent	Product Claim
IMMAGE B2M	24 month shelf-life14 day open container stability14 day calibration stability

Estimated Imprecision

Sample	Mean (mg/dL)	S.D. (mg/dL)	%C.V.	N
Within-Run Imprecision
Level 1	0.34	0.029	8.5	80
Level 2	1.65	0.045	2.7	80
Level 3	3.43	0.099	2.9	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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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Annette Hellie Senior Regulatory Specialist, Product Submissions Beckman Instruments, Inc. 200 S. Kraemer Boulevard, W-337 Brea, California 92822-8000

NOV 20 1997

Re: K973813 IMMAGE™ Immunochemistry System Beta-2-Microglobulin Trade Name: (B2M) Reagent Regulatory Class: II Product Code: JZG Dated: October 6, 1997 Received: October 7, 1997

Dear Ms. Hellie:

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, 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, labelinq, 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 requirement, 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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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 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

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510(k) Number (if known): K973813

Device Name: IMMAGE™ Immunochemistry System Beta-2-Microglobulin (B2M) Reagent

Indications for Use:

The IMMAGE Immunochemistry System Beta-2-Microglobulin (B2M) Reagent, when THE IMMAGE Inimanoonemisay Oyenni MMAGE™ Immunochemistry Systems and Beckman Calibrator 2, is intended for the quantitative determination of human beta-2microglobulin in serum by rate nephelometry.

(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 Devices510(k) Number ____________________________

Prescription Use	✓	OR	Over-the-Counter Use _________
(per 21 CFR 801.109)			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.