K Number

Device Name

SENTINEL UIBC LIQUID

Manufacturer

SENTINEL CH. SRL

Date Cleared

2005-11-17

(199 days)

Product Code

JQF JOF

Regulation Number

862.1415

Intended Use

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K770748

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description details a chemical assay based on color intensity measurement, with no mention of AI or ML technologies.

Therapeutic

No
The device is an in vitro diagnostic (IVD) assay designed to measure unsaturated iron-binding capacity, which is used for diagnosis and treatment of anemia, not for direct therapeutic intervention.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that "Iron-binding capacity measurements are used in the diagnosis and treatment of anemia," indicating the device's role in diagnosing a medical condition.

SaMD (Software as a Medical Device)

The device description explicitly states it is composed of "reagents and standard, packaged and distributed in the same kit," indicating it is a chemical assay kit, not a software-only device.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use explicitly states it's "intended to measure the unsaturated iron-binding capacity in serum and plasma." Serum and plasma are biological samples taken from the body.
Device Description: The description details a test that involves adding serum to reagents and measuring a color intensity to determine UIBC. This is a classic description of an in vitro test.
"in vitro test for professional use": The device description explicitly states it is intended to be sold as an "in vitro test for professional use."
CFR 862.1415: The intended use references CFR 862.1415, which is the regulation for "Iron-binding capacity test system." This regulation falls under Part 862 - Clinical Chemistry Test Systems, which are IVDs.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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

Product codes (comma separated list FDA assigned to the subject device)

JMO, JOF

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

professional use

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K770748

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

Image /page/0/Picture/0 description: The image shows the words "SENTINEL DIAGNOSTICS" stacked on top of each other. The word "SENTINEL" is in a larger, bold font, while the word "DIAGNOSTICS" is in a smaller font. The text is black and the background is white.

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.

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
Sentinel UIBC Liquid	21 CFR
862.1415	UIBC	Clinical
Chemistry	I	JMO

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

5. Device description

6. Intended Use

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 Trade
Device Name | Predicate Device
Name | Predicate Device
Manufacturer | Predicate
device (k) | FDA clear-
ance date |
|-------------------------------|--------------------------|----------------------------------|-------------------------|-------------------------|
| Sentinel UIBC
Liquid | 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.

Image /page/2/Picture/0 description: The image shows the word "SENTINEL" in bold, black letters. The letters are large and spaced closely together. Below the word, there is a faint, dotted line that runs the length of the word. The background is white.

	Design Feature &
1	Sample Type	Human serum and plasma
(only heparin salts)	Same
2	Principle	• Transferrin saturation with
a known iron amount;
· quantitation of Free iron;
· UIBC determined by
subtracting the quantity of
unbound iron from the total
added 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 and
Abbott ARCHITECT c8000
analyzers	Roche / Hitachi Automatic
Analyzers

Table 7.2 Comparison with Predicate Device

Performance Data 8.

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.

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).

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 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

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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