The Total Iron Binding Capacity (IBCT) Flex® reagent cartridge for the Dimension® clinical chemistry system is an in vitro diagnostic device intended to quantitatively measure total iron binding capacity in human serum and plasma. Measurements of total iron binding capacity are used in the diagnosis and treatment of iron deficiency anemia and chronic inflammatory disorders.

Device Description

The IBCT method for the Dimension® clinical chemistry system is a fully automated assay in which serum or plasma is mixed with a ferric iron solution, to saturate all available iron-binding sites of transferrin in the sample. Under non-acidic conditions (pH 8.6), only unbound, excess saturating iron is available to be reduced to ferrous iron by ascorbic acid and to form a blue complex with Ferene®. Subsequent addition of acid (final pH of 4.5) releases the iron bound to transferrin; this additional iron is reduced to ferrous iron by ascorbic acid and forms an increased amount of blue complex with Ferene®. The increase in absorbance upon shifting from pH 8.6 to pH 4.5, measured using a bicromatic (600,700 nm) endpoint technique, is proportional to the concentration of transferrin-bound iron, and thus to the iron binding capacity (total) of the serum or plasma sample.

AI/ML Overview

The provided document is a 510(k) summary for the "Total Iron Binding Capacity (IBCT) Flex® reagent cartridge". It describes a device that measures total iron binding capacity in human serum and plasma and compares its performance to a predicate device.

Here's an analysis based on the provided text to answer your questions:

Acceptance Criteria and Study Details

1. Table of Acceptance Criteria and the Reported Device Performance:

Acceptance Criteria (Implied)	Reported Device Performance
High Correlation Coefficient	Correlation Coefficient: 0.971
Appropriate Slope	Slope: 1.14
Acceptable Intercept	Intercept: -22.4 ug/dL
Measurement Range	Measurement Range: 59 to 469 ug/dL TIBC

Note: The document does not explicitly state pre-defined acceptance criteria values for the correlation coefficient, slope, or intercept. However, for a device to be considered "substantially equivalent" to a predicate, these values would implicitly need to fall within an acceptable range, with 0.971 for correlation generally indicating strong agreement.

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: 137 clinical patient samples.
Data Provenance: Not explicitly stated, but given it refers to "clinical patient samples," it is implied to be from patient populations. It does not mention country of origin or whether it's retrospective or prospective.

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

Not applicable for this type of device and study. The "ground truth" in this context is the quantitative measurement provided by the predicate device (Dimension® Total Iron Binding Capacity (TIBC) Flex® reagent cartridge). Expert consensus is not used to establish the reference values for these types of clinical chemistry assays.

4. Adjudication method for the test set:

Not applicable. This is a quantitative comparison study between two diagnostic devices, not a study involving 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:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This is a performance comparison of an in-vitro diagnostic device against a predicate device, not an AI-assisted human reader study.

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

Yes, this study represents a standalone performance comparison. The IBCT Flex® reagent cartridge, when used with the Dimension® clinical chemistry system, operates as an automated assay without human intervention in the measurement process itself, similar to the predicate device. The performance data presented (correlation, slope, intercept) indicates its direct measurement capabilities.

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

The "ground truth" was established by the predicate device, the Dimension® Total Iron Binding Capacity (TIBC) Flex® reagent cartridge (K864230). The study performed a split sample comparison, meaning both the investigational device and the predicate device measured the same clinical patient samples, and the predicate's results served as the reference for comparison.

8. The sample size for the training set:

Not applicable. This is a comparison study for an in-vitro diagnostic reagent cartridge, not a machine learning or AI algorithm that requires a "training set." The device is a chemical reagent-based assay.

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

Not applicable, as this device does not involve a training set.

Summary

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

Image /page/0/Picture/0 description: The image shows a handwritten string of alphanumeric characters. The string is "K994115". The characters are written in a simple, clear style, making them easily readable. The image appears to be a close-up of the string, possibly extracted from a larger document or label.

JAN 2 8 2000

DADE BEHRING

DADE BEHRING INC. P.O. Box 6101 Newark, DE 19714

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:	Robin O. Norris
	Dade Behring Inc.
	P.O. Box 6101
	Newark, DE 19714-6101
Date of Preparation:	December 2, 1999
Name of Product:	Total Iron Binding Capacity (IBCT) Flex® reagent cartridge
FDA Classification Name:	Iron Binding Capacity Test System
Predicate Device:	Dimension® Total Iron Binding Capacity (TIBC) Flex® reagent cartridge (K864230)

Device Description: The IBCT method for the Dimension® clinical chemistry system is a fully automated assay in which serum or plasma is mixed with a ferric iron solution, to saturate all available iron-binding sites of transferrin in the sample. Under non-acidic conditions (pH 8.6), only unbound, excess saturating iron is available to be reduced to ferrous iron by ascorbic acid and to form a blue complex with Ferene®. Subsequent addition of acid (final pH of 4.5) releases the iron bound to transferrin; this additional iron is reduced to ferrous iron by ascorbic acid and forms an increased amount of blue complex with Ferene®. The increase in absorbance upon shifting from pH 8.6 to pH 4.5, measured using a bicromatic (600,700 nm) endpoint technique, is proportional to the concentration of transferrin-bound iron, and thus to the iron binding capacity (total) of the serum or plasma sample.

Intended Use: The Total Iron Binding Capacity (1BCT) Flex® reagent cartridge is used in the Dimension® clinical chemistry system to quantitatively measure total iron binding capacity in human serum and plasma.

Comparison to Predicate Device:

Item	IBCT Flex® reagent cartridge	TIBC Flex® reagent cartridge
Sample Type	serum and plasma	serum
Methodology	Photometric measurement	Pretreatment step, followed byPhotometric measurement
Detection	Bichromatic endpoint(600 and 700 nm)	Bichromatic endpoint(600 and 700 nm)

Comments on Substantial Equivalence: Split sample comparison between the IBCT Flex® reagent cartridge and TIBC Flex® reagent cartridges on the Dimension® clinical chemistry system gave a correlation coefficient of 0.971, slope of 1.14, and an intercept of -22.4 ug/dL when tested with 137 clinical patient samples ranging from 59 to 469 ug/dL TIBC.

The IBCT Flex® reagent cartridge is substantially equivalent in principle and performance to the TIBC Conclusion: Flex® reagent cartridge based on the comparison discussed abo

Robin Orner

Robin O. Norris Manager, Quality Assurance and Compliance December 2, 1999

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

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 2 8 2000

Ms. Robin O. Norris Manager, Quality Assurance and Compliance Dade Behring, Inc. Building 500, Mailbox 514 P.O. Box 6101 Newark, Delaware 19714-6101

Re: K994115
Trade Name: Total Iron Binding Capacity Flex® Reagent Cartridge Regulatory Class: I reserved Product Code: JMO Dated: December 2, 1999 Received: December 6, 1999

Dear Ms. Norris:

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 Regulations, 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 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.

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

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 regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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

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

Indications For Use Statement

Device Name: Total Iron Binding Capacity Flex® reagent cartridge

Indications for Use:

Jean Cooger
(Division Sign-Off)

510(k) Number

Robin O'nomis

Robin O. Norris Manager, Quality Assurance and Compliance

December 2, 1999

(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)

Over-the-counter Use

(Optional format 1-2-96)

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.