For in vitro diagnostic use only. VITROS Chemistry Products TIBC Kit with VITROS Chemistry Products Fe Slides quantitatively measures total iron-binding capacity (TIBC) in serum. The iron binding capacity is useful in the differential diagnosis of anemia, iron deficiency anemia, thalassemia, sideroblastic anemia, and iron poisoning.

VITROS Chemistry Products Calibrator Kit 4 is used to calibrate VITROS Chemistry Systems for the quantitative measurement of ALB, BuBc, Fe, TBIL, TIBC, and TP.

Device Description

The VITROS TIBC assay is performed using the VITROS Chemistry Products TIBC Kit, VITROS Chemistry Products Fe Slides, and the VITROS Chemistry Products Calibrator Kit 4 on VITROS Chemistry Systems.

The VITROS TIBC Kit consists of VITROS TIBC Columns (containing alumina) and VITROS Iron Saturating Reagent.

Total iron-binding capacity is determined by pretreating a sample using the method of Starr. Excess iron citrate reagent is added to the sample to saturate all available apotransferrin sites. After an incubation period of five minutes, the treated sample is applied to an alumina column where iron that is not bound to transferrin is adsorbed.

The transferrin-bound iron contained in the eluate represents the total iron-binding capacity of the sample.

A drop of eluate is deposited on the VITROS Fe Slide and is evenly distributed by the spreading layer to the underlying layers. After the addition of the eluate, the slide is incubated at 37℃. Two reflection density measurements at 600 nm are made at approximately one and five minutes. The difference in reflection density is proportional to the iron concentration in the sample.

Once a calibration has been performed for each slide lot, total iron binding capacity in unknown samples can be determined using the softwareresident two-point rate math model and the change in reflectance calculated for each unknown test slide.

VITROS Calibrator Kit 4 contains four levels of lyophilized standards with corresponding diluents. The standards are prepared from processed bovine serum and bovine serum albumin to which organic analytes, inorganic salts, electrolytes, stabilizers, and preservatives have been added. The diluents are prepared from processed water. Once reconstituted, the standards are used to calibrate VITROS Chemistry Systems for the quantitative measurement of total iron binding capacity in serum. Calibration of the VITROS TIBC assay requires the use of three of the four levels (bottles 1, 3 and 4). For in vitro diagnostic use only.

AI/ML Overview

This prompt describes a 510(k) summary for an in vitro diagnostic device, specifically the VITROS Chemistry Products TIBC Kit and Calibrator Kit 4. The document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and study results in the typical format of an AI/ML device study.

Therefore, much of the requested information regarding acceptance criteria, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment cannot be directly extracted from the provided text. These concepts are primarily relevant to clinical validation studies for AI/ML-driven medical devices, which this document is not.

The provided document describes a chemistry assay, not an AI/ML device. Therefore, the questions related to AI/ML specific criteria (such as number of experts, adjudication method, MRMC studies, effect size with AI, standalone performance, training set data, etc.) are not applicable in this context.

However, I can extract information related to the device's performance characteristics and how its equivalence to a predicate device was demonstrated.

Here's the information that can be extracted and how it relates (or doesn't relate) to your request:

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

The document doesn't explicitly state "acceptance criteria" in a quantitative sense for this submission. Instead, it demonstrates "substantial equivalence" to a predicate device by comparing various device characteristics. The "reported device performance" is essentially the modified device's characteristics, assumed to be acceptable because they are substantially equivalent to a legally marketed device.

Characteristic	Acceptance Criteria (Predicate)	Reported Device Performance (Modified)
Intended Use	For in vitro diagnostic use only. VITROS Chemistry Products TIBC Kit with VITROS Chemistry Products Fe Slides quantitatively measures total iron-binding capacity (TIBC) in serum. VITROS Chemistry Products Calibrator Kit 4 is used in the calibration of VITROS Chemistry Systems for the quantitative measurement of ALB, BuBc, Fe, TBIL, TIBC, and TP.	No change - same intended use.
Calibration traceability	Traceable to SRM 937 via NCCLS proposed standard method as defined in NCCLS document H17-P3 modified according to ICSH.	Traceable to SRM 937 via NCCLS approved standard method as defined in NCCLS document H17-A2.
Manufacturer's Selected Measurement Procedure	The proposed method for determination of iron and total iron binding capacity, NCCLS document H17-P3, modified according to the International Committee for Standardization in Hematology (ICSH) recommendation to use ferene dye. The modified H17-P method incorporates the application of alumina as the chelating agent for excess Fe+3.	The approved method for determination of serum iron, total iron binding capacity and percent transferrin saturation, NCCLS document H17-A2 using ferene dye. The H17-A method incorporates the use of magnesium carbonate (MgCO3) as the chelating agent for excess Fe+3.
Reference Interval	250 – 450 µg/dL	Males: 261 – 462 µg/dL; Females: 265 – 497 µg/dL
Reportable range	6 - 650 µg/dL	85 - 650 µg/dL
Sample type	Serum	No change - serum.
Basic principle	Two point colorimetric rate	No change - two point colorimetric rate.
Instrumentation	VITROS Chemistry Systems	No change - VITROS Chemistry Systems.

Study Proving Substantial Equivalence:

The document states: "Equivalence was demonstrated using manufactured reagents along with quality control fluids, proficiency samples and human serum samples with measured TIBC values spanning the assay range." This is the core of the "study" for this type of submission.

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

Sample Size for Test Set: The document mentions "human serum samples with measured TIBC values spanning the assay range," but does not provide a specific number for the sample size.
Data Provenance: The provenance is "human serum samples." The country of origin and whether they are retrospective or prospective is not specified. Given the context of a 510(k) summary for an in-vitro diagnostic, these are typically clinical samples, likely from a diverse population or at least representative of the target user base (e.g., US patients if for US market), but this is not explicitly stated. It is implicitly retrospective as the samples would have been collected prior to the study.

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

This question is not applicable. For a chemistry assay measuring TIBC, the "ground truth" is established by a reference method or validated laboratory procedure, not by a panel of human experts in the way it is for image-based AI/ML devices. The predicate device's performance, and traceability to SRM 937 via NCCLS approved standard methods, serves as the benchmark.

4. Adjudication method

Not applicable for a chemistry assay.

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 in vitro diagnostic chemistry assay, not an AI-assisted diagnostic tool requiring human interpretation.

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

Not applicable. This is a standalone chemistry assay, meaning it provides a quantitative result directly, rather than an "algorithm" augmenting human performance. Its performance is inherent to the assay itself.

7. The type of ground truth used

The "ground truth" for this type of assay is derived from:

Comparison to the predicate device's performance.
Traceability to SRM 937 (Standard Reference Material) via NCCLS approved standard methods (H17-A2 for the modified device, H17-P3 for the predicate). This essentially means the accuracy is tied to recognized international standards for iron measurement.
"Measured TIBC values spanning the assay range" implies these values were determined by a reference method.

8. The sample size for the training set

Not applicable. This is a chemistry assay that does not usually involve a "training set" in the machine learning sense. The assay method is developed and validated through chemical principles and analytical studies, not statistical learning from a dataset.

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

Not applicable for the reasons stated above.

Summary

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JUN 15 2006

Image /page/0/Picture/1 description: The image shows the logo for Ortho-Clinical Diagnostics, a Johnson & Johnson company. The logo features a symbol on the left, followed by the text "Ortho-Clinical Diagnostics" in a stylized font. Below the company name, it says "a Johnson & Johnson company" in a smaller, cursive font.

100 Indigo Creek Drive Rochester, New York 14626-5101

510(k) Summary

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.

The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________

1. Submitter Ortho-Clinical Diagnostics, Inc. name, 100 Indigo Creek Drive MC00881 address, Rochester, New York 14626-5101 contact Phone: (585) 453-4253 FAX: (585) 453-3368 Email: dphilli2@ocdus.jnj.com
  Contact Person: Darlene J. Phillips
1. Preparation May 24, 2006 date
1. Device Trade or Proprietary Name: name VITROS Chemistry Products TIBC Kit VITROS Chemistry Products Calibrator Kit 4

Common Name: TIBC test Classification Name: Iron binding capacity test system (21 CFR 862.1415).

Common Name: Calibrator Kit 4 Classification Name: Calibrator (21 CFR 862.1150)

The VITROS TIBC assay (modified device) is substantially equivalent to the 4. Predicate device VITROS TIBC assay (original). This assay was originally cleared under the KODAK EKTACHEM product branding (K931493).
Continued on next page

Ortho-Clinical Diagnostics, Inc.

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510(k) Summary, Continued

5. Device description

The VITROS TIBC assay is performed using the VITROS Chemistry Products TIBC Kit, VITROS Chemistry Products Fe Slides, and the VITROS Chemistry Products Calibrator Kit 4 on VITROS Chemistry Systems.

The VITROS TIBC Kit consists of VITROS TIBC Columns (containing alumina) and VITROS Iron Saturating Reagent.

The transferrin-bound iron contained in the eluate represents the total iron-binding capacity of the sample.

Device intended use

Slides quantitatively measures total iron-binding capacity (TIBC) in serum.

For in vitro diagnostic use only.

VITROS Chemistry Products Calibrator Kit 4 is used in the calibration of the VITROS Chemistry Systems for the quantitative measurement of ALB, BuBc, Fe, TBIL, TIBC, and TP.

VITROS Chemistry Products TIBC Kit with VITROS Chemistry Products Fe

Continued on next page

SPECIAL 510(K) SUBMISSION VITROS TIBC Kit and Calibrator Kit 4

Ortho-Clinical Diagnostics, Inc.

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510(k) Summary, Continued

The VITROS TIBC assay (modified device) is substantially equivalent to the 7. Comparison to predicate predicate, VITROS TIBC assay (original), which was cleared by the FDA device (K931493) for in vitro diagnostic use.

DeviceCharacteristic	Modified DeviceVITROS TIBC assay(modified)	Predicate DeviceVITROS TIBC assay (original)
Intended Use	No change	For in vitro diagnostic use only.VITROS Chemistry Products TIBC Kitwith VITROS Chemistry Products FeSlides quantitatively measures totaliron-binding capacity (TIBC) in serum.VITROS Chemistry Products CalibratorKit 4 is used in the calibration ofVITROS Chemistry Systems for thequantitative measurement of ALB,BuBc, Fe, TBIL, TIBC, and TP.
Calibrationtraceability	Traceable to SRM 937 viaNCCLS approved standardmethod as defined in NCCLSdocument H17-A2.	Traceable to SRM 937 via NCCLSproposed standard method as defined inNCCLS document H17-P3 modifiedaccording to ICSH.
Manufacturer'sSelectedMeasurementProcedure	The approved method fordetermination of serum iron, totaliron binding capacity and percenttransferrin saturation, NCCLSdocument H17-A2 using ferenedye. The H17-A methodincorporates the use of magnesiumcarbonate (MgCO3) as thechelating agent for excess Fe+3.	The proposed method for determinationof iron and total iron binding capacity,NCCLS document H17-P3, modifiedaccording to the InternationalCommittee for Standardization inHematology (ICSH) recommendation touse ferene dye4. The modified H17-Pmethod incorporates the application ofalumina as the chelating agent forexcess Fe+3.
Reference Interval	Males: 261 – 462 µg/dLFemales: 265 – 497 µg/dL	250 – 450 µg/dL
Reportable range	85 - 650 µg/dL	6 - 650 µg/dL
Sample type	No change	Serum
Basic principle	No change	Two point colorimetric rate
Instrumentation	No change	VITROS Chemistry Systems

Table 1 List of Assay Characteristics: Comparison to Predicate Device

Continued on next page

. .. . ..

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510(k) Summary, Continued

The information presented in the pre-market notification demonstrates that the 8.Conclusions performance of the VITROS TIBC assay (modified device) for use with human serum is substantially equivalent to the cleared predicate device.

Equivalence was demonstrated using manufactured reagents along with quality control fluids, proficiency samples and human serum samples with measured TIBC values spanning the assay range.

The information presented in the premarket notification provides a reasonable assurance that the VITROS TIBC assay (modified device) for use with human serum is safe and effective for the stated intended use.

SPECIAL 510(K) SUBMISSION VITROS TIBC Kit and Calibrator Kit 4

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows a circular logo with an abstract bird design in the center. The bird is composed of three curved lines that suggest feathers or wings. Encircling the bird is text that reads 'DEPARTMENT OF HEALTH & HUMAN SERVICES USA'. The text is arranged along the circumference of the circle, with the bird design positioned in the center.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 15 2006

Darlene Phillips, RAC Regulatory Affairs Associate Ortho-Clinical Diagnostics 100 Indigo Creek Drive Rochester, NY 14626-5101

Re: K061464

Trade/Device Name: VITROS Chemistry Products TIBC Kit VITROS Chemistry Products Calibrator Kit 4 Regulation Number: 21 CFR§862.1415 Regulation Name: Iron-binding capacity test system Regulatory Class: Class II Product Code: JMO, JIX Dated: May 24, 2006 Received: May 25, 2006

Dear Ms. Phillips:

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, Orug. 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 misbrandi, mand 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 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Party 200),

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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 (240) 276-0484. 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/industry/support/index.html.

Sincerely yours,

Alberto Gutz

Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name:

Kole 14

VITROS Chemistry Products TIBC Kit VITROS Chemistry Products Calibrator Kit 4

Indications for Use:

VITROS Chemistry Products Calibrator Kit 4 is used to calibrate VITROS Chemistry Systems for the quantitative measurement of ALB, BuBc, Fe, TBIL, TIBC, and TP.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 80) Subpart D)

AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off

Page 1 of 1

Office of In Vitro Diagnostic Device Evaluation and Safety

Kob1464

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.