SENTINEL UIBC LIQUID

K051111 · Sentinel Ch. Srl · JQF · Nov 17, 2005 · Clinical Chemistry

Device Facts

• Record ID: K051111
• Device Name: SENTINEL UIBC LIQUID
• Applicant: Sentinel Ch. Srl
• Product Code: JQF · Clinical Chemistry
• Decision Date: Nov 17, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1415
• Device Class: Class 1

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. For prescription use only.

Device Story

Sentinel UIBC Liquid is a quantitative spectrophotometric reagent pack for use on Abbott AEROSET and ARCHITECT c8000 analyzers. The system measures unsaturated iron-binding capacity (UIBC) in human serum or plasma. The assay saturates transferrin with a known excess of iron in an alkaline buffer; remaining free iron is reduced and complexed by the chromophore Ferene-S. The analyzer measures the decrease in free iron concentration spectrophotometrically. Used by laboratory professionals in clinical settings. Output is a UIBC value (µg/dL), which clinicians use to assess iron status and manage anemia.

Clinical Evidence

Bench testing only. Precision studies showed intra-assay imprecision <3% and inter-assay imprecision 4-9.6%. Linearity was established over the assay range with recovery within 4% of expected values. Analytical specificity testing showed no interference from hemoglobin (up to 200 mg/dL), bilirubin (up to 50 mg/dL), or triglycerides (up to 1000 mg/dL). Method comparison against the predicate device using 59-60 clinical samples showed high correlation (R=0.999 on Architect; R=0.9144 on Aeroset).

Technological Characteristics

Quantitative spectrophotometric assay. Reagents: Tris buffer (pH 8.6), Ferene-S chromophore (22.0 mM), and iron standard (90 µM Fe+3). Calibration traceable to NIST SRM 3126a. Designed for automated use on Abbott AEROSET and ARCHITECT c8000 analyzers. Standards referenced: CLSI EP05-A2 (precision) and CLSI EP06-A (linearity).

Indications for Use

Indicated for patients requiring measurement of unsaturated iron-binding capacity in serum and plasma to assist in the diagnosis and treatment of anemia.

Regulatory Classification

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.

Predicate Devices

• Roche UIBC (K770748)

Submission Summary (Full Text)

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

- 2. Contact person: Mr. Davide Spada International Product Specialist Sentinel CH Srl Via Principe Eugenio 20155 Milan, Italy
Tel.: [phone] Fax: [phone] e-mail: [e-mail]

- 3. 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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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 CFR<br>862.1415 | UIBC | Clinical<br>Chemistry | I | JMO |

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

#### 5. 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.

#### 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 Trade<br>Device Name | Predicate Device<br>Name | Predicate Device<br>Manufacturer | Predicate<br>device (k) | FDA clear-<br>ance date |
|-------------------------------|--------------------------|----------------------------------|-------------------------|-------------------------|
| Sentinel UIBC<br>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.

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

## 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 [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 Division 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,

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

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

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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