VITROS CHEMISTRY PRODUCTS TIBC KIT, MODEL 886 7541; CALIBRATOR KIT 4, MODEL 120 4668

K061464 · Ortho-Clinical Diagnostics, Inc. · JMO · Jun 15, 2006 · Clinical Chemistry

Device Facts

• Record ID: K061464
• Device Name: VITROS CHEMISTRY PRODUCTS TIBC KIT, MODEL 886 7541; CALIBRATOR KIT 4, MODEL 120 4668
• Applicant: Ortho-Clinical Diagnostics, Inc.
• Product Code: JMO · Clinical Chemistry
• Decision Date: Jun 15, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1415
• Device Class: Class 1

Intended Use

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. For in vitro diagnostic use only.

Device Story

VITROS TIBC assay measures total iron-binding capacity in serum samples. Process involves pretreating sample with excess iron citrate to saturate apotransferrin sites; applying sample to alumina column to adsorb unbound iron; depositing eluate onto VITROS Fe Slide. System performs two reflection density measurements at 600 nm at one and five minutes. Software uses two-point rate math model to calculate TIBC based on reflectance change. Used in clinical laboratory settings by trained personnel. Output provides quantitative TIBC values to assist physicians in diagnosing anemia-related conditions and iron poisoning.

Clinical Evidence

Bench testing only; verification and validation activities performed per design control requirements to confirm performance claims following internal procedural updates.

Technological Characteristics

In vitro diagnostic reagent kit for TIBC analysis. Fundamental scientific technology unchanged. Performance claims updated based on internal calibrator value assignment and reportable range procedures.

Indications for Use

Indicated for in vitro diagnostic quantitative measurement of TIBC in serum to aid in differential diagnosis of anemia, iron deficiency anemia, thalassemia, sideroblastic anemia, and iron poisoning.

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

• VITROS TIBC assay (K931493)

Submission Summary (Full Text)

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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: [phone] FAX: [phone] Email: [e-mail]
Contact Person: Darlene J. Phillips

- 2. Preparation May 24, 2006 date
- 3. 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.

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.

6. 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.

| Device<br>Characteristic | Modified Device<br>VITROS TIBC assay<br>(modified) | Predicate Device<br>VITROS TIBC assay (original) |
|--------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | No change | For <i>in vitro</i> diagnostic use only.<br>VITROS Chemistry Products TIBC Kit<br>with VITROS Chemistry Products Fe<br>Slides quantitatively measures total<br>iron-binding capacity (TIBC) in serum.<br>VITROS Chemistry Products Calibrator<br>Kit 4 is used in the calibration of<br>VITROS Chemistry Systems for the<br>quantitative measurement of ALB,<br>BuBc, Fe, TBIL, TIBC, and TP. |
| Calibration<br>traceability | Traceable to SRM 937 via<br>NCCLS approved standard<br>method as defined in NCCLS<br>document H17-A2. | Traceable to SRM 937 via NCCLS<br>proposed standard method as defined in<br>NCCLS document H17-P3 modified<br>according to ICSH. |
| Manufacturer's<br>Selected<br>Measurement<br>Procedure | The approved method for<br>determination of serum iron, total<br>iron binding capacity and percent<br>transferrin saturation, NCCLS<br>document H17-A2 using ferene<br>dye. The H17-A method<br>incorporates the use of magnesium<br>carbonate (MgCO3) as the<br>chelating agent for excess Fe+3. | The proposed method for determination<br>of iron and total iron binding capacity,<br>NCCLS document H17-P3, modified<br>according to the International<br>Committee for Standardization in<br>Hematology (ICSH) recommendation to<br>use ferene dye4. The modified H17-P<br>method incorporates the application of<br>alumina as the chelating agent for<br>excess Fe+3. |
| Reference Interval | Males: 261 – 462 µg/dL<br>Females: 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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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 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:

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.

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

AND/OR

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

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

Division Sign-Off

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Office of In Vitro Diagnostic Device Evaluation and Safety

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