SENTINEL IRON LIQUID

K051115 · Sentinel Ch. Srl · JIY · Aug 25, 2005 · Clinical Chemistry

Device Facts

• Record ID: K051115
• Device Name: SENTINEL IRON LIQUID
• Applicant: Sentinel Ch. Srl
• Product Code: JIY · Clinical Chemistry
• Decision Date: Aug 25, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1410
• Device Class: Class 1

Intended Use

The Sentinel Iron Liquid is a direct colorimetric in vitro diagnostic assay for the quantitative determination of Iron without deproteinization in human serum and plasma (heparin salts, only). Iron (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia, hemochromatosis (a disease associated with widespread deposit in the tissues of two iron-containing pigments, hemosiderin and hemosfuscin, and characterized by pigmentation of the skin), and chronic renal disease.

Device Story

Sentinel Iron Liquid is an in vitro diagnostic reagent kit for professional use. It measures iron levels in human serum and heparinized plasma samples. Principle of operation: pH 4.0 buffer releases iron from transferrin; iron is reduced to ferrous state; reacts with Ferene-S to form a stable colored complex. Color intensity is proportional to iron concentration. A masking agent eliminates copper interference. The assay is performed on automated clinical chemistry analyzers (e.g., Abbott AEROSET, ARCHITECT). Healthcare providers use the quantitative results to diagnose and monitor iron-related conditions like anemia, hemochromatosis, and chronic renal disease, facilitating clinical management of patient iron status.

Clinical Evidence

Performance evaluations included sensitivity, intra-assay precision, inter-assay precision, and method comparison studies. No clinical trial data on patient outcomes provided; bench testing only.

Technological Characteristics

Direct colorimetric assay; pH 4.0 buffer system; Ferene-S chromogen; masking agent for copper interference. Reagent-based chemistry for use on automated clinical analyzers. No software or electronic components integral to the reagent kit itself.

Indications for Use

Indicated for quantitative determination of non-heme iron in human serum and heparinized plasma. Used in diagnosis and treatment of iron deficiency anemia, hemochromatosis, and chronic renal disease.

Regulatory Classification

Identification

An iron (non-heme) test system is a device intended to measure iron (non-heme) in serum and plasma. Iron (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia, hemochromatosis (a disease associated with widespread deposit in the tissues of two iron-containing pigments, hemosiderin and hemofuscin, and characterized by pigmentation of the skin), and chronic renal disease.

Predicate Devices

• IL Test Iron (k972363)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Sentinel Diagnostics. The word "SENTINEL" is written in large, bold, black letters. Below it, the word "DIAGNOSTICS" is written in smaller, thinner letters.

**AUG 2 5 2005**

# 510k Summary Sentinel Iron Liquid

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1. Submitter's information: Mr. Ugo De Luca Managing Director Sentinel CH Srl Via Principe Eugenio 20155 Milan, Italy

Tel.: [phone] Fax: [phone] e-mail: [e-mail]

- Mr. Davide Spada 2. Contact person: Application Specialist Sentinel CH Srl Via Principe Eugenio 20155 Milan, Italy Tel.: [phone] Fax: [phone] e-mail: [e-mail]
- 3. Date summary prepared: 21 August 2005

## 4. Device name and classification

The Sentinel Iron 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.

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 |
|-------------------|-------------------|---------------------------|----------------------|------------------|--------------|
| Iron Liquid | 21 CFR 862.1410 | Direct Colorimetric, Iron | Clinical Chemistry | I | CFM |

Device names and classification of Iron Liquid Table 4.1

### Device description 5.

The Iron 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.

The Iron Liquid is a direct colorimetric in vitro diagnostic assay for the quantitative determination of iron without deproteinization in human serum and plasma (heparin salt, only). In a pH 4.0 buffer system, iron is released from transferin to which it is bound, and then quantitatively reduced to a ferrous state. The iron forms with Ferene-S a stable colored complex of which the color intensity is proportional to the amount of iron in the sample. Particular reaction conditions and a specific masking agent eliminate the interference from copper.

Sentinel Iron Liquid

Image /page/0/Picture/20 description: The image shows the logo for Sentinel Diagnostics. The logo consists of the word "SENTINEL" in large, bold letters, with the word "DIAGNOSTICS" in smaller letters underneath. To the right of the text is a black graphic that resembles a mountain range or a series of peaks.

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Image /page/1/Picture/0 description: The image shows the logo for Sentinel Diagnostics. The word "SENTINEL" is in large, bold, sans-serif font on the top line. Below that, in a smaller, lighter font, is the word "DIAGNOSTICS."

#### Intended Use 6.

The Sentinel Iron Liguid is a direct colorimetric in vitro diagnostic assay for the quantitative determination of Iron without deproteinization in human serum and plasma (heparin salts, only).

Iron (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia, hemochromatosis (a disease associated with widespread deposit in the tissues of two iron-containing pigments, hemosiderin and hemofuscin, and characterized by pigmentation of the skin), and chronic renal disease, CFR 862.1410

### 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.

| Table 7.1 Predicate device for Sentinel UIBC Liquid Diagnostic Assay |
|----------------------------------------------------------------------|
|----------------------------------------------------------------------|

| Sentinel Trade<br>Device Name | Predicate Device<br>Name | Predicate Device<br>Manufacturer | Predicate<br>device (k) | FDA clear-<br>ance date |
|-------------------------------|--------------------------|------------------------------------------|-------------------------|-------------------------|
| Iron Liquid | IL Test Iron | Instrumentation<br>Laboratory<br>Company | K972363 | 15 Aug 1997 |

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.

| # | Design Feature | New Device Iron Liquid | Predicate Device IL Test Iron |
|---|-----------------|-----------------------------------------------------------|----------------------------------------------|
| 1 | Sample Type | Human serum and plasma<br>(only heparin salts) | Same |
| 2 | Technology | Direct colorimetric without<br>deproteinization | End Point, Colorimetric |
| 3 | Manufacturer | Sentinel | Same |
| 4 | Instrumentation | Abbott AEROSET and<br>Abbott ARCHITECT c8000<br>analyzers | IL Lab 600/900/1800 Plus<br>Chemistry System |

# Table 7.2 Comparison with Predicate Device

#### 8. Performance Data

Performance evaluations included sensitivity, intra- and inter-assay precision and method comparison.

#### 9. Conclusion

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

Sentinel Iron Liquid

Image /page/1/Picture/18 description: The image shows the logo for Sentinel Diagnostics. The logo has the word "SENTINEL" in large, stylized font on the top line. Below that, in a smaller font, is the word "DIAGNOSTICS". To the right of the words is a black graphic that looks like a mountain range.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

AUG 25 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: k051115

Trade/Device Name: Sentinel Iron Liquid Regulation Number: 21 CFR 862.1410 Regulation Name: Iron (non-heme) test system Regulatory Class: Class I, reserved Product Code: JIY Dated: July 13, 2005 Received: August 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) ruls letter will anow you to ought messing of substantial equivalence of your device to a legally premarked predication: "The PDs 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 [phone]. 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 I va may ovania of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Carol C. Benson

Carol C. Benson, M.A. Acting 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): | k051115 |
|---------------------------|---------|
|---------------------------|---------|

Sentinel Iron Liquid Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The Sentinel Iron Liquid is a direct colorimetric in vitro diagnostic assay for the quantitative determination of Iron without deproteinization in human serum and plasma (heparin salts, only).

Iron (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia, hemochromatosis (a disease associated with widespread deposit in the tissues of two iron-containing pigments, hemosiderin and hemofuscin, and characterized by pigmentation of the skin), and chronic renal disease.

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)

CAC

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K051115

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