The ADVIA IMS Unsaturated Iron Binding Capacity (UIBC) assay is an in vitro diagnostic device intended to measure iron binding capacity in human serum and dlagmostly are new inding capacity are used in the diagnosis and treatment of anemias.

Device Description

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AI/ML Overview

The provided document describes a 510(k) summary for a new in vitro diagnostic device, the ADVIA® IMS™ Unsaturated Iron Binding Capacity (UIBC) method. The summary focuses on demonstrating substantial equivalence to a predicate device, the Technicon CHEM 1. Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state formal "acceptance criteria" in terms of predefined success thresholds (e.g., "CV must be < X%"). Instead, it presents performance data for the new device and the predicate device, implying that equivalence (or superior performance) to the predicate serves as the de facto acceptance benchmark for substantial equivalence.

Performance Metric	Acceptance Criteria (Implied by Predicate)	Reported Device Performance (ADVIA IMS)	Reported Predicate Performance (CHEM 1)
Imprecision (Total CV%)	Comparable to or better than predicate across different UIBC levels.
Level 48.0 ug/dL	N/A (predicate measured higher levels)	10.6%	5.3% (at 141 ug/dL)
Level 157/141 ug/dL	Comparable to CHEM 1 at 141 ug/dL (5.3%)	3.4%	5.3%
Level 537/559 ug/dL	Comparable to CHEM 1 at 559 ug/dL (4.5%)	1.0%	4.5%
Correlation (vs. Predicate)	High correlation (R close to 1) and low Syx with the predicate device.	R = 0.997, Syx = 7.86 ug/dL	N/A (ADVIA IMS vs. CHEM 1)
Regression Equation	Slope close to 1, intercept close to 0 (indicating good agreement).	Y = 0.96X - 8.76	N/A
Correlation (Serum vs Plasma)	High correlation (R close to 1) and low Syx between serum and plasma samples.	R = 0.999, Syx = 3.04 ug/dL	N/A
Regression Equation	Slope close to 1, intercept close to 0.	Y = 0.99X - 1.70	N/A
Interfering Substances	Effect (% change) should be acceptable for clinical use (no specific threshold stated, but implies minimal clinically significant interference).		N/A (Predicate data not shown for this)
Bilirubin (unconjugated)	N/A	-10%
Bilirubin (conjugated)	N/A	-5%
Lipids (Triglycerides)	N/A	-69%
Analytical Range	Should cover the clinically relevant range for UIBC.	30 to 560 ug/dL	Not explicitly stated for predicate in summary

Summary of Reported Device Performance:

Imprecision: The ADVIA IMS showed lower Total CV% at higher UIBC levels (157 ug/dL and 537 ug/dL) compared to the CHEM 1 at comparable levels, indicating better precision. At the lower level, direct comparison is difficult due to different predicate concentration.
Correlation (vs. CHEM 1): Very high correlation (R=0.997) and a low standard error of the estimate (Syx = 7.86 ug/dL) suggest strong agreement between ADVIA IMS and CHEM 1.
Correlation (Plasma vs Serum): Excellent correlation (R=0.999) and low Syx (3.04 ug/dL) between plasma and serum samples on the ADVIA IMS, indicating that either sample type can be used.
Interfering Substances: Bilirubin had a relatively small effect (-5% to -10%), but lipids (Triglycerides) showed a significant negative effect (-69%), which would require a cautionary note in the labeling.
Analytical Range: 30 to 560 ug/dL is provided.

2. Sample sizes used for the test set and the data provenance

Correlation (vs. Predicate):
- Sample Size: 58 Serum samples
- Data Provenance: Not explicitly stated (e.g., country of origin). It is retrospective as it compares the new device with an existing predicate using collected samples.
Correlation (Serum vs Plasma):
- Sample Size: 50 samples (presumably collected concurrently to compare serum and plasma from the same individuals)
- Data Provenance: Not explicitly stated. Likely prospective for this specific comparison.
Imprecision: Not specified, but typically involves repeated measurements of control samples or patient pools over several days.
Interfering Substances: Not explicitly stated per substance, but involves specific concentrations of interferents added to samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This document describes the performance of an in vitro diagnostic (IVD) device that measures a specific analyte (UIBC) in a sample. The "ground truth" for such devices is established by reference methods or validated predicate devices, not by expert interpretation of images or other qualitative data. Therefore:

Number of experts: Not applicable.
Qualifications of those experts: Not applicable.

4. Adjudication method for the test set

Not applicable, as the "ground truth" is determined by quantitative measurements from validated methods/devices rather than human interpretation requiring 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 is an IVD device for laboratory measurement, not an AI-assisted diagnostic imaging or interpretation system involving human readers.

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

Yes, the studies presented (Imprecision, Correlation, Interfering Substances, Analytical Range) represent the standalone performance of the ADVIA IMS device. This device functions as a laboratory analyzer, providing quantitative results directly from the sample without human intervention in the measurement process itself. The user interprets the numerical output.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for this type of IVD device is based on recognized reference methods or the performance of a legally marketed predicate device.

For the correlation study, the Technicon CHEM 1 (the predicate device) served as the reference for comparison of UIBC values.
For imprecision, the "ground truth" is the true analytical variability inherent in the method when measuring known concentrations.
For interfering substances, the "ground truth" is the UIBC concentration of samples without the interferent added.

8. The sample size for the training set

Not applicable for this type of IVD device. This device is based on chemical reactions and optical detection, not machine learning or artificial intelligence that requires a "training set."

9. How the ground truth for the training set was established

Not applicable, as no "training set" is used for this type of IVD device.

Summary

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OCT - 1 2001

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Unsaturated Iron Binding Capacity (UIBC) method for ADVIA® IMS™

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

The assigned 510(k) number is: HQ10340

1. Intended Use

This in vitro diagnostic procedure is intended to measure iron-binding capacity in human Such measurement is used in the diagnosis and serum.on the Bayer ADVIA® IMS™. treatment of anemia.

2. Predicate Device

The Research As and Children Company of Children Comments of Children Comments ofProduct Name		agent Part # Calibrator Part #
Technicon CHEMt	T01-1869-53 T03-1291-62

3. Device / Method

Product Name	REF	Calibrator Part #
Bayer ADVIA IMS	06254177	T03-1291-62

A. Imprecision

ADVIA IMS		CHEM 1
Level(ug/dL)	TotalCV(%)	Level(ug/dL)	TotalCV(%)
48.0	10.6	141	5.3
157	3.4	306	6.3
537	1.0	559	4.5

Correlation (Y=ADVIA IMS, X=comparison system)

Specimen type	Comparison System (X)	N	Regression Equation	Syx (ug/dL)	R	Sample Range (ug/dL)
Serum	CHEM 1	58	$Y=0.96X-8.76$	7.86	0.997	41.5 - 538.0
Plasma(y), Serum(x)	ADVIA IMS	50	$Y=0.99X-1.70$	3.04	0.999	114.1 - 438.9

Interfering Substances

InterferingSubstance	Interfering Sub.Conc. (mg/dL)	UIBC Conc(ug/dL)	Effect(% change)
Bilirubin (unconjugated)	12.5	212.7	-10
Bilirubin (conjugated)	12.5	208.2	-5
Lipids (Triglycerides)	250	211.7	-69

Analytical Range

Serum/Plasma: 30 to 560 ug/dL

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Alexis

7/20/01

Freerick Clerie
Manager Regulatory Affairs Bayer Corporation
511 Benedict Avenue Tarrytown, New York 10591-5097

Date

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a human figure in profile, with three overlapping shapes representing the head, body, and legs.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT - 1 2001

Kenneth T. Edds, Ph.D. Manager Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, NY 10591-5097

Re: K012340

Trade/Device Name: ADVIA IMS® Unsaturated Iron binding Capacity (UIBC) Regulation Number: 21 CFR 862.1415 Regulation Name: Iron-binding capacity test system Regulatory Class: Class I Product Code: JMO Dated: July 19, 2001 Received: July 24, 2001

Dear Dr. Edds:

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 for association to May 28, 1976, the enactment date of the Medical Device Amendments, or to econimer to prox co ria) 2011-03-2014 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 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -

This letter will allow you to begin marketing your device as described in your 510(k) premarket I his letter will anow you to ocen marketing , o walence of your device to a legally marketed notification. The PDA inding of successification 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 (2) CFF Part 801 and 1 II you desire specific acrico roll "see are contact the Office of Compliance at additionally 809.10 for in vius diagliostions on the promotion and advertising of your device, (201) 594-4388. Additionally, for questions of (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general entitled, "Misoranding by reference to precise to precised from the Division of Small information on your responsionales and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers International and October "http://www.fda.gov/cdrb/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 Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if known): KO12340

Device Name: ADVIA IMS® Unsaturated Iron binding Capacity (UIBC)

Indication For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use	OR	Over-The-Counter Use ______
(Per 21 CFR 801.109)

(Division Sign-Off)

Kevin Alexander Johnston Optional Formal 1-2-96

Division of Clinical Laboratory Devices

510(k) Number	K012340
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Regulation Number and Section

§ 862.1415 Iron-binding capacity test system.

(a)
Identification. An iron-binding capacity test system is a device intended to measure iron-binding capacity in serum. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.