The Sentinel UIBC Liquid (Unsaturated Iron Binding Capacity) assay is intended to measure the unsaturated iron-binding capacity in serum and plasma. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia. CFR 862.1415

Device Description

The Sentinel UIBC Liquid described in this 510(k) submission is composed of reagents and standard, packaged and distributed in the same kit. The device is intended to be sold as an in vitro test for professional use. Serum is added to an alkaline buffer/reductant solution containing a known concentration of iron to saturate the available binding sites on transferrin. The iron that remains free after transferrin saturation is reduced to a ferrous state and then complexed by Ferene-S to form a stable complex, of which the color intensity is measured at 580-600nm. UIBC is therefore determined by subtracting the quantity of unbound iron from the total added quantity.

AI/ML Overview

The document describes the Sentinel UIBC Liquid device and its comparison to a predicate device. Here's a breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria." However, it presents a method comparison study as evidence of performance. The implicit acceptance criterion for substantial equivalence is a strong correlation with the predicate device.

Performance Metric	Acceptance Criteria (Implicit)	Reported Device Performance
Correlation (r)	High correlation with predicate	0.9144
Regression (y=mx+q)	Slope near 1, intercept near 0	y = 1.024x + 14.64

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

Sample Size for Test Set: 60 serum samples
Data Provenance: Not explicitly stated, but it's a clinical evaluation of human serum samples, likely prospective for the purpose of the 510(k) submission. No country of origin is mentioned.

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

This type of information is not applicable and not provided in the document. For in vitro diagnostic devices like the Sentinel UIBC Liquid, "ground truth" is typically established by the results from a legally marketed predicate device, not by expert consensus in the same way it would be for image-based diagnostic AI.

4. Adjudication Method for the Test Set

Not applicable. The ground truth for this type of device is the measurement from the predicate device, not a subjective assessment 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 document describes an in vitro diagnostic device for laboratory analysis, not an AI-assisted diagnostic tool for human readers.

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

This is an in vitro diagnostic assay, meaning its performance is inherently standalone (algorithm/reagent only). The method comparison study is effectively a standalone performance evaluation against a gold standard (the predicate device).

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

The ground truth for the performance evaluation was the results obtained from the predicate device (Roche UIBC). For this type of IVD, the predicate device's performance is considered the established method against which the new device is compared for substantial equivalence.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set in the conventional sense. The device's performance is based on chemical principles and reagent formulations.

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

Not applicable, as there is no training set for this type of device.

Summary

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NOV 1 7 2005

510k Summary Sentinel UIBC Liquid

KOSIIII K Number:___

1. Submitter's information: Mr. Ugo De Luca Managing Director Sentinel CH Srl Via Principe Eugenio 20155 Milan, Italy
  Tel.: +39 02 345514 1 Fax: +39 02 345514 64 e-mail: sentinel@sentinel.it
1. Contact person: Mr. Davide Spada International Product Specialist Sentinel CH Srl Via Principe Eugenio 20155 Milan, Italy
  Tel.: +39 02 345514 1 Fax: +39 02 345514 64 e-mail: spada@sentinel.it
1. Date summary prepared: 10 November 2005

4. Device name and classification

The Sentinel UIBC Liquid described in this 510(k) consists of reagents and standard, packaged and distributed in one kit. The device is intended to be sold as an in-vitro test for professional use.

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Image /page/1/Picture/0 description: The image shows the word "SENTINEL" in bold, black letters. Below the word, there is a series of small dots that appear to be a stylized design element. The font is sans-serif and the overall impression is clean and modern.

Product name and classification information are provided in Table 4.1 below.

Trade/Device Name	Regulation Number	Regulation name	Classification panel	Regulatory class	Product Code
Sentinel UIBC Liquid	21 CFR862.1415	UIBC	ClinicalChemistry	I	JMO

Device names and classification of Sentinel UIBC I iguid Tahlo 4 1

5. Device description

Serum is added to an alkaline buffer/reductant solution containing a known concentration of iron to saturate the available binding sites on transferrin. The iron that remains free after transferrin saturation is reduced to a ferrous state and then complexed by Ferene-S to form a stable complex, of which the color intensity is measured at 580-600nm. UIBC is therefore determined by subtracting the quantity of unbound iron from the total added quantity.

6. Intended Use

The Sentinel UIBC Liquid (Unsaturated Iron Binding Capacity) assay is intended to measure the unsaturated iron-binding capacity in serum. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia. CFR 862.1415

Comparison with Predicate Devices 7.

Table 7, 1 lists the predicate device for the Sentinel product included in this submission, and provides information on the regulatory status of the predicate device, including the 510(k) number.

Sentinel TradeDevice Name	Predicate DeviceName	Predicate DeviceManufacturer	Predicatedevice (k)	FDA clear-ance date
Sentinel UIBCLiquid	Roche UIBC	Roche	K770748*	06/01/1977

Table 7.1 Predicate device for Sentinel UIBC Liquid

The Roche UIBC - Predicate Device – was cleared via Hycel, INC. (K0770748). Roche aquired Hycel on June 8, 1979.

Table 7.2 below report a comparison of the Sentinel UIBC Liquid with the Predicate Device Roche UIBC. No substantial differences can be noted. The two devices are intended to be used on Automatic Analyzers: the predicate device with the Roche/Hitachi analyzers, the Sentinel UIBC Liquid on the Abbott AEROSET and ARCHITECT analyzers.

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	Design Feature &
1	Sample Type	Human serum and plasma(only heparin salts)	Same
2	Principle	• Transferrin saturation witha known iron amount;· quantitation of Free iron;· UIBC determined bysubtracting the quantity ofunbound iron from the totaladded quantity	Same
3	Chromogen	Ferene-S	FerroZine
	Calibration	Against aqueous standard	Same
	Linearity	up to 500 µg/dL	Same
6	Reference Range	110-370 µg/dL	Same
	Instrumentation	Abbott AEROSET andAbbott ARCHITECT c8000analyzers	Roche / Hitachi AutomaticAnalyzers

Table 7.2 Comparison with Predicate Device

Performance Data 8.

Performance evaluations included sensitivity, intra- and inter-assay precision, linearity and method comparison. In the method comparison study evaluating 60 serum samples, the correlation (r, y=mx+q)) of the Sentinel UIBC Liquid on the Abbott AEROSET to the predicate device Roche UIBC was 0.9144, y=1.024x + 14.64.

9. Conclusion

The performance and safety data presented in this premarket notification support a finding of substantial equivalence between the Sentinel UIBC Liquid and the predicate devices specified in this submission.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (USA). The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV 1 7 2005

Mr. Davide Spada Application Specialist Sentinel CH Srl Via Principe Eugenio, 5 20155 Milan, Italy

Re: K051111 Trade/Device Name: Sentinel UIBC Liquid Regulation Number: 21 CFR 862.1415 Regulation Name: Iron-binding capacity test system Regulatory Class: Class I Product Code: JOF Dated: October 18, 2005 Received: November 8, 2005

Dear Mr. Spada:

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 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 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 Part 820).

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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 Gutierrez, Ph.D.

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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510(k) Number (if known): _ K05 ll | /

Device Name: _________________________________________________________________________________________________________________________________________________________________ Sentinel UIBC Liquid

Indications For Use:

ﺮ ﻋﻤﺮﺍ

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 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

Office of In Vitro Diggnostic Device Evaluation and Safety

510(k) K052111

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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.