The Dade Behring Dimension® Microalbumin (MALB) Flex® reagent cartridge method is an in vitro diagnostic test intended to quantitatively measure albumin in human urine. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases. Measurement also aids in the diagnosis and treatment of heart diseases or thyroid disorders which are characterized by proteinuria or albuminuria.

The Dade Behring Dimension® Microalbumin Calibrator is an in vitro diagnostic device intended for use on Dade Behring Dimension® clinical chemistry systems for medical purposes to establish points of reference that are used in the determination of albumin in urine.

Device Description

Method

The Microalbumin (MALB) method (DF114) is based on a particle-enhanced turbidimetric inhibition immunoassay (PETINIA) adapted to the Dimension® clinical chemistry system which allows direct quantitation of albumin in urine samples. The MALB Flex® reagent cartridge contains a particle reagent (PR) consisting of latex particles with human albumin bound to the surface. Aggregates of these particles are formed when a monoclonal antibody (Ab) to human albumin is introduced. Albumin (ALB) present in the sample competes with the particles for the antibody, thereby decreasing the rate of aggregation. Hence, the rate of aggregation is inversely proportional to the concentration of albumin in the sample. The rate of aggregation is measured using bichromatic turbidimetric reading at 340 and 700 nm. The concentration is determined by means of a mathematical function.

PR + Ab + ALB (sample) → PR-Ab Complex + Ab-ALB (scatters at 340 nm)

Calibrator

The Dade Behring Dimension® Microabumin Calibrator (DC114) is a buffered aqueous product containing weighed-in quantities of human albumin. The calibrator is packaged as a 5-level kit at nominal albumin concentrations of 0, 12.5, 25, 50, and 110 mg/L.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study findings for the Dimension® Microalbumin (MALB) Flex® reagent cartridge and Calibrator, based on the provided document:

Acceptance Criteria and Device Performance

Acceptance Criteria Category	Specific Metric (Comparison to Predicate)	Acceptance Value/Range	Reported Device Performance (Dimension® MALB vs. BN II)
Method Comparison	Slope	Not explicitly stated as a numerical range, but "good agreement" is implied. The predicate's performance serves as the benchmark for "substantial equivalence."	0.97
	Intercept	Not explicitly stated as a numerical range, but "good agreement" is implied.	0.45 mg/L
	Correlation Coefficient	"Good agreement" (correlation) implied.	0.999
(Implied)	Intended Use	Same as predicate	Quantitatively measure albumin in human urine. Aids in diagnosis of kidney/intestinal disease, heart disease, thyroid disorders characterized by proteinuria/albuminuria.
(Implied)	Design	Similar to predicate	Particle-enhanced turbidimetric inhibition immunoassay (PETINIA) for method; buffered aqueous product with human albumin for calibrator.

Note: The document focuses primarily on demonstrating substantial equivalence to a predicate device rather than setting explicit numerical acceptance criteria for various performance metrics (like lower and upper bounds for slope, intercept, or correlation coefficient). The "acceptance" is based on the comparative performance showing "good agreement" and "correlation" which supports the claim of substantial equivalence.

Study Details

Sample size used for the test set and the data provenance:
- Sample Size: 50 samples were used for the comparative performance evaluation.
- Data Provenance: The study was conducted "at Dade Behring," implying it was internally generated clinical or analytical data. The document does not specify the country of origin of the samples or if they were retrospective or prospective, but given it's an in-house comparison, it's likely retrospective analysis of stored or newly collected samples.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The "ground truth" for comparison was the results from the predicate device (BN II nephelometric N Antiserum to Human Albumin assay). The document does not mention any expert review or consensus for the results from either device.
Adjudication method for the test set:
- None specified. The study directly compared the measurements between the new device and the predicate device, not against a manually adjudicated "gold standard" where consensus among experts would be needed.
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:
- No, an MRMC study was not done. This device is a diagnostic assay for measuring albumin, not an imaging or AI-assisted diagnostic tool. Therefore, the concept of "human readers" and "AI assistance" doesn't apply to this type of device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The study focuses on the standalone performance of the Dimension® Microalbumin method. It is a fully automated assay system, and its performance is evaluated directly by comparing its quantitative output to that of another automated assay system (the predicate). There is no "human-in-the-loop" aspect to the measurement itself, only to the interpretation of the results by a clinician.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" was the quantitative measurement obtained from a legally marketed predicate device (Dade Behring BN II nephelometric N Antiserum to Human Albumin assay). This is a common approach for demonstrating substantial equivalence for in vitro diagnostic devices. It's essentially comparing to a "reference standard" provided by an existing, approved method.
The sample size for the training set:
- Not applicable/Not provided. This document describes a K033525 510(k) submission for an in vitro diagnostic reagent and calibrator. It is not a machine learning or AI-based device, so there is no "training set" in the context of algorithm development. The development of the assay method itself would involve research and development, but the concept of a separate "training set" as understood in AI/ML is not relevant here.
How the ground truth for the training set was established:
- Not applicable. As stated above, there is no "training set" in the context of an AI/ML algorithm for this device.

Summary

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

JAN 1 2 2004

Summary of Safety and Effectiveness Information

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR§807.92.

Submitter's Name:	Richard M. VaughtDade Behring Inc.P.O. Box 6101Newark, DE 19714-6101
Date of Preparation:	November 6, 2003
Name of Product(s):	Dimension® Microalbumin (MALB) Flex® reagent cartridge (DF114)andDimension® Microalbumin Calibrator (DC114)
FDA Classification Name(s):	Albumin test system (21CFR§866.5040)Calibrator (21CFR§862.1150)
Predicate Device(s):	Method: Other commercially available urinary albumin assaysystems such as the Dade Behring nephelometric (BN II)N Antiserum to Human Albumin assay (K972929).
	Calibrator: Other commercially available calibrators such as the DadeBehring Urinary Albumin Calibrator (K936201).

Device Description(s):

Method

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

using bichromatic turbidimetric reading at 340 and 700 nm. The concentration is determined by means of a mathematical function.

PR + Ab + ALB (sample) → PR-Ab Complex + Ab-ALB (scatters at 340 nm)

Calibrator

Intended Use:

Method

The Dade Behring Dimension® Microalbumin (MALB) Flex® reagent cartridge method is an in vitro diagnostic test intended to quantitatively measure albumin in human urine.

Calibrator

The Dade Behring Dimension® Microalbumin Calibrator is an in vitro diagnostic product used to calibrate the Microalbumin (MALB) method on Dade Behring Dimension® clinical chemistry systems.

Comparison to Predicate:

Split-sample comparative performance was evaluated at Dade Behring between the Dimension® MALB Flex® reagent cartridge method assay system and the BN II nephelometric N Antiserum to Human Albumin assay. The results are summarized below:

ComparativeMethod	Slope	Intercept(mg/L)	CorrelationCoefficient	n
N Antiserum to Human Albumin(Dade Behring BN II)	0.97	0.45	0.999	50

Comments on Substantial Equivalence:

Both Dade Bchring albumin assay systems - the Dimension® Microalbumin (MALB) Flex® reagent cartridge method and the BN 11 nephelometric N Antiserum to Human Albumin are intended for determination of albumin in urine. Split-sample comparative data demonstrate

rev PAGE 000006 1/5/2004

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

good agreement (correlation) between the methods. Both products utilize light scattering detection techniques for the measurement of albumin.

Conclusion:

The Dade Behring Dimension® Microalbumin (MALB) Flex® reagent cartridge method (DF114) and the Dade Behring BN II nephelometric N Antiserum to Human Albumin assay are substantially equivalent based on their intended purpose, design and the comparison performance results as described carlier. Also, the Dade Behring Dimension® Microalbumin Calibrator (DC114) is substantially equivalent to other calibrators, such as the Dade Behring Urinary Albumin Calibrator based on its design and intended purpose.

Richard M. Vaught Regulatory Affairs and Compliance Manager November 6, 2003

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 1 2 2004

Mr. Richard M. Vaught Regulatory Affairs and Compliance Manager Dade Behring Inc. P.O. Box 6101 Newark, DE 19714

Re: K033525

KU33223
Trade/Device Name: Dimension® Microalbumin (MALB) Flex® reagent cartridge (DF114) Dimension® Microalbumin Calibrator (DC114) Regulation Number: 21 CFR 866.5040 Regulation Name: Albumin immunological test system Regulatory Class: Class II Product Code: DCF; JIT Dated: November 6, 2003 Received: November 7, 2003

Dear Mr. Vaught:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou mayy are so 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I toase of actived a determination that your device complies with other requirements of the Act that I Drideral statutes and regulations administered by other Federal agencies. You must or uny I vith all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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

Page 2 --

This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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 Butman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Indications For Use Statement

Device Name(s):

Dimension® Microalbumin (MALB) Flex® reagent cartridge (DF114)

Dimension® Microalbumin Calibrator (DC114)

Indications for Usc:

The Dade Behring Dimension® Microalbumin (MALB) Flex® reagent cartridge method is an in vitro diagnostic test intended to quantitatively measure albumin in human urine. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases. Measurement also aids in the diagnosis and treatment of heart discases or thyroid disorders which are characterized by proteinuria or albuminuria.

Richard M. Vaught Regulatory Affairs and Compliance Manager

January 5, 2004

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	_
(Per 21 CFR 801.109)

510(k)_

Over-the-counter Use

Division Sign-Off

(Optional format 1-2-96)

Office of In Vitro Diagnostic Device Evaluation and Safety

32515

rev PAGE 000004 1/5/2004

Regulation Number and Section

§ 866.5040 Albumin immunological test system.

(a)
Identification. An albumin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the albumin (a plasma protein) in serum and other body fluids. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases.(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 § 866.9.