The ß 2-microglobulin determination is based upon turbidimetric immunoinhibition (TINIA) using a serum or plasma blood sample. The sample containing B 2-microglobulin is transferred into a TRIS buffer solution (R1 reagent). In the second step, an aliquot of solution of polyclonal antirabbit ß 2-microglobulin antibodies (R2 reagent) is added to mixture of the first step. The antibody will bind to the ß 2-microglobulin in the sample to form "aggregates" such that the amount of aggregate formed is proportionate to the amount of B 2-microglobulin present in the sample. The resulting agglutination complex is measured turbidimetrically whereby increased turbidity is reflected through an increase in optical density. Therefore, the amount of ß 2-microglobulin in the sample is directly proportional to the amount of turbidity formed.

AI/ML Overview

Here's an analysis of the provided text regarding the Tina-quant® ß 2-microglobulin Assay, structured to address your specific questions.

1. Table of Acceptance Criteria and Reported Device Performance

The submission doesn't explicitly state "acceptance criteria" in the format of a predefined pass/fail threshold for each performance characteristic. Instead, it presents performance data for the Tina-quant® ß 2-microglobulin assay and compares it to a predicate device (Abbott IMx® ß 2-microglobulin assay) to demonstrate substantial equivalence. Therefore, the "acceptance criteria" are implied to be the comparable performance to the legally marketed predicate device.

Feature	Acceptance Criteria (Implied - Comparable to Predicate)	Tina-quant® ß 2-microglobulin Performance	Abbott IMx® ß 2-microglobulin Performance (Predicate)
Precision (Intra-Assay %CV)	Comparable to Predicate	Low: 4.4, Mid: 1.9, High: 1.0	Low: 6.0, Mid: 4.4, High: 4.9
Precision (Inter-Assay %CV)	Comparable to Predicate	Sample 1: 2.6, Sample 2: 2.7	Low: 9.2, Mid: 6.8, High: 7.3
Lower Detection Limit	Comparable to Predicate	0.05 mg/L	0.5 µg/L (0.0005 mg/L)
Linearity	Established, range defined	0.20 - 8.0 mg/L	--- (Not explicitly stated in table)
Method Comparison (r-value)	High correlation with Predicate	r = 0.983 (Deming & Least Squares)	--- (Comparison done against this device)
Interfering Substances	No significant interference	No interference at defined conc.	--- (Not explicitly stated in table)
Specificity	Specific for target analyte	Specific for ß 2-microglobulin	Specific for ß 2-microglobulin

Note on Lower Detection Limit: There appears to be a unit discrepancy (mg/L vs µg/L) between the Tina-quant® and Abbott IMx® in the table, but assuming the Tina-quant®'s 0.05 mg/L is a typo for 0.05 µg/L, this would suggest a comparable or better (lower) detection limit. If 0.05 mg/L is correct, then the predicate has a significantly lower detection limit. This is a point that would ideally need clarification for a full comparison. However, given the context of a 510(k) summary, the FDA found it substantially equivalent.

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

Precision Test Set (N values):
- Intra-Assay: 21 samples per level (Low, Mid, High) for Tina-quant®. 12 samples per level for Abbott IMx®.
- Inter-Assay: 21 samples per sample for Tina-quant® (Sample 1, Sample 2). 90 samples per level for Abbott IMx®.
Method Comparison Test Set (N value): 36 samples.
Data Provenance: Not explicitly stated (e.g., country of origin). The data presented is characteristic of laboratory studies performed with collected samples. It is not specified if the data is retrospective or prospective, but performance characteristic studies are typically prospective laboratory evaluations.

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

This information is not provided in the given text. For an in-vitro diagnostic device like this, ground truth is typically established by:

The concentration values of known controls or spiked samples in precision, linearity, and interference studies.
The reference method (in this case, the Abbott IMx® device) for method comparison studies.
Therefore, "experts" in the traditional sense of clinical adjudication are not directly relevant here for establishing ground truth.

4. Adjudication Method for the Test Set

This information is not applicable/provided for this type of in-vitro diagnostic device. Clinical adjudication by experts is not a standard method for evaluating the performance characteristics (precision, linearity, method comparison) of an immunoassay. The comparison is done against a predicate device or defined reference values.

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 in-vitro diagnostic assay (a lab test), not an imaging or AI-assisted diagnostic tool that would involve human "readers" interpreting cases. Therefore, MRMC studies and AI assistance metrics are not relevant.

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

The device is a laboratory assay. Its performance is inherently "standalone" in the sense that it provides a quantitative measurement based on chemical reactions, without direct human interpretation of complex images or data that an AI algorithm might produce. The "algorithm" is the immunoturbidimetric reaction principle itself. The performance data presented (precision, linearity, detection limit) directly represents the standalone performance of the assay.

7. The Type of Ground Truth Used

Precision, Linearity, Interfering Substances: Ground truth would be based on known concentrations of beta-2-microglobulin in control materials, spiked samples, or serially diluted samples.
Method Comparison: The ground truth for comparative purposes is derived from the results obtained from the predicate device (Abbott IMx® ß 2-microglobulin assay) on the same patient samples.

8. The Sample Size for the Training Set

Not applicable/provided. In-vitro diagnostic assays of this nature do not typically involve a "training set" in the machine learning sense. The assay's chemical reagents and methodology are developed and optimized through R&D, not by training on a dataset.

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

Not applicable. As explained in #8, there is no "training set" or "ground truth for a training set" in the context of this immunoturbidimetric assay's development. The "ground truth" for developing such an assay would be the established chemical and biological principles of antibody-antigen reactions and turbidimetry, leading to the formulation and optimization of the reagents.

Summary

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OCT 16 1998

510(k) Summary

K980724

Introduction According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.

1. Submitter name, address, contact	Boehringer Mannheim CorporationP.O. Box 9002Pleasanton, CA 94566-0900(510) 730-8240FAX (510) 225-0654Contact Person: Betsy Soares-MaddoxDate Prepared: February 11, 1998
2. Device name	Proprietary name: Tina-quant® ẞ 2-microglobulin AssayCommon name: Immunoturbidometric assay for the determination of ẞ 2-microglobulin.Classification name: ẞ 2-microglobulin immunological test system
3. Predicate device	The Boehringer Mannheim Tina-quant® ẞ 2-microglobulin is substantially equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed Abbott IMx® ẞ 2-microglobulin assay.

Continued on next page

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510(k) Summary, Continued

The ß 2-microglobulin determination is based upon turbidimetric 4. Device immunoinhibition (TINIA) using a serum or plasma blood sample. The Description sample containing B 2-microglobulin is transferred into a TRIS buffer solution (R1 reagent). In the second step, an aliquot of solution of polyclonal antirabbit ß 2-microglobulin antibodies (R2 reagent) is added to mixture of the first step. The antibody will bind to the ß 2-microglobulin in the sample to form "aggregates" such that the amount of aggregate formed is proportionate to the amount of B 2-microglobulin present in the sample. The resulting agglutination complex is measured turbidimetrically whereby increased turbidity is reflected through an increase in optical density. Therefore, the amount of ß 2-microglobulin in the sample is directly proportional to the amount of turbidity formed. Immunoturbidometric assay for the quantitative in-vitro determination of ß 2-ಳು Intended use microglobulin. The Boehringer Mannheim Tina-quant® ß 2-microglobulin is substantially 6. Comparison equivalent to other products in commercial distribution intended for similar to predicate use. Most notably it is substantially equivalent to the currently marketed device Abbott IMx® ß 2-microglobulin assay. Continued on next page

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510(k) Summary, Continued

Comparison to predicate device cont.

The following table compares the Tina-quant® ß 2-microglobulin with the predicate device, Abbott IMx ® ß 2-microglobulin assay. Specific data on the performance of the test have been incorporated into the draft labeling in attachment 5. Labeling for the predicate device in provided in attachment 6.

Similarities:

•Intended Use: Immunoassay for the in vitro quantitative determination of ß 2-microglobulin

Differences:

Feature	Tina-quant® ß 2-microglobulin	Abbott IMx® ß 2-microglobulin
Sample Type	Serum and Plasma	Serum, Plasma, and Urine
Reaction testprinciple	Immunoturbidimetric	Microparticle
Instrumentrequired	Hitachi	Abbott IMx

Performance Characteristics:

Feature		Tina-quant® β 2-microglobulin		Abbott IMx® β 2-microglobulin
Precision	Intra and InterAssay (mg/l):		Intra and InterAssay (mg/L):
	Level	Low	Mid	High	Low	Mid	High
	N	21	21	21	12	12	12
Intra-Assay	Mean	0.57	2.26	7.75	1.7	3.9	9.7
	%CV	4.4	1.9	1.0	6.0	4.4	4.9
	Level	Sample 1	Sample 2		Low	Mid	High
	N	21	21		90	90	90
Inter-Assay	Mean	1.16	4.70		1.7	3.9	9.7
	%CV	2.6	2.7		9.2	6.8	7.3
Lower DetectionLimit		0.05 mg/L			0.5 µg/L

Continued on next page

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510(k) Summary, Continued

Performance Characteristics:

Comparison to predicate device, (cont.)

Feature	Tina-quant® β 2-microglobulin	Abbott IMx® β 2-microglobulin
Linearity	0.20 - 8.0 mg/L	---
MethodComparison	Vs Abbott IMx® β 2-microglobulinDeming's$y=1.26 x - 0.15$r=0.983SEE =0.23N=36Least Squares:$y = 1.24x - 0.11$r = 0.983SEE = 0.32N = 36	---
Interferingsubstances	No interference at:(≤ 10% error)Bilirubin 20 mg/dLHemoglobin 500 mg/dLLipemia 1500 mg/dLRheumatoidFactor 200 IU/mL	---
Specificity	Specific for β 2-microglobulin	Specific for β 2-microglobulin

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized abstract design of an eagle or bird-like figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top and left side of the logo in a circular fashion.

OCT 16 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Betsy Soares-Maddox Manager, Regulatory Affairs and Quality Assurance Boehringer Mannheim Corporation 4300 Hacienda Drive P.O. Box 9002 Pleasanton, California 94566-0900

K980724/S1 Re: Trade Name: Tina-quant® ß 2-microglobulin Assay Requlatory Class: II Product Code: JZG Dated: August 31, 1998 Received: September 1, 1998

Dear Ms. Soares-Maddox:

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, listinq 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 requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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 requlations.

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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 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 requlation 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 Autman

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): N/A

K980724

Device Name: Tina-quant® ß 2-microglobulin Assay

Indications For Use:

Intended use

Immunological latex agglutination test for the in vitro quantitative determination of ß 2microglobulin in human serum and plasma.

Measurement of beta-2-microglobulin aids in the diagnosis of active rheumatoid arthritis and kidney disease.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	✓	OR Over-The-Counter Use
(Per 21 CFR 801.109)		(Optional Format 1-2-96)

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

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.