VITROS CHEMISTRY PRODUCTS TRFRN REAHENT; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 20; VITROS CHEMISTRY PRODUCTS PROTEIN

K042477 · Ortho-Clinical Diagnostics, Inc. · DDG · Nov 19, 2004 · Immunology

Device Facts

• Record ID: K042477
• Device Name: VITROS CHEMISTRY PRODUCTS TRFRN REAHENT; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 20; VITROS CHEMISTRY PRODUCTS PROTEIN
• Applicant: Ortho-Clinical Diagnostics, Inc.
• Product Code: DDG · Immunology
• Decision Date: Nov 19, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5880
• Device Class: Class 2

Intended Use

VITROS Chemistry Products TRFRN Reagent is used to quantitatively measure transferrin (TRFRN) concentration in human serum and plasma. VITROS Calibrator kit 20 is used to calibrate VITROS 5,1 FS Chemistry System for quantitative measurement of transferrin, C3, C4, IgA and IgM. VITROS Chemistry Products Protein Performance Verifiers I, II and III are assayed controls used to monitor the performance of transferrin, C3, C4, IgA and IgM Reagents on the FS 5,1 Chemistry Systems.

Device Story

VITROS Chemistry Products TRFRN Reagent is an immunoturbidimetric assay for quantitative measurement of transferrin in human serum and plasma; used on VITROS 5,1 FS Chemistry System. Reagents 1 and 2 (goat anti-sera to human transferrin) are mixed with patient samples; antibody/antigen complexes increase solution turbidity; turbidity measured spectrophotometrically at 340 nm. Concentration determined via stored calibration curve. System operated by laboratory personnel in clinical settings. Output provides quantitative transferrin levels to assist clinicians in diagnostic decision-making. Includes calibrators and assayed controls for performance monitoring.

Clinical Evidence

Bench testing only. Performance validated through correlation studies with the predicate device (n=not specified, r=0.986, slope=0.96, intercept=-0.24 mg/dL). Additional bench studies included precision, analytical sensitivity, specificity, and expected values.

Technological Characteristics

Immunoturbidimetric assay; liquid reagents (Reagent 1: polymer/buffer/salt; Reagent 2: goat anti-human transferrin). Spectrophotometric detection at 340 nm. Calibrators and controls derived from processed human serum. Traceable to IRMM/IFCC CRM 470. Designed for VITROS 5,1 FS Chemistry System. Standards: NCCLS EP5-A, EP7-A, EP9-A, C28.

Indications for Use

Indicated for the quantitative measurement of transferrin in human serum and plasma for diagnostic purposes. Used on VITROS 5,1 FS Chemistry Systems.

Regulatory Classification

Identification

A transferrin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the transferrin (an iron-binding and transporting serum protein) in serum, plasma, and other body fluids. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia.

Predicate Devices

• IMMAGE® Immunochemistry System TRF Transferrin Reagent (K963427)
• VITROS Chemistry Products Performance Verifiers I and II (K041720)

Submission Summary (Full Text)

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## NOV 1 9 2004

### 3.0 510(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.

K04 2471 The assigned 510(k) number is: _

#### 3.1 Submitter name, address, contact

Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, New York 14626-5101 Phone: [phone] Fax: [phone]

Contact Person: Darlene J. Phillips

#### 3.2 Date of Preparation:

September 10, 2004

#### 3.3 Device Proprietary Names:

Trade Names VITROS Chemistry Products TRFRN Reagent VITROS Chemistry Products Calibrator Kit 20 VITROS Chemistry Products Protein Performance Verifiers I, II and III

Common Name Transferrin assay

#### 3.4 Classification Names

Classification Name: Transferrin test system (866.5880): Class: II (Performance standards)

Classification Name: Calibrator (862.1150): Class II The Clinical Chemistry and Toxicology Panel of the FDA has placed calibrators in Class II.

Classification Name: Quality Control material (assayed and unassayed) (862,1660): Class I: The Clinical Chemistry and Toxicology Panel of the FDA has placed Quality Control material (assayed and unassayed) for clinical chemistry in Class I. Since this device is an assayed control, it meets the reserved criteria under Section 510(1) of the Food, Drug, and Cosmetic Act.

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#### 3.5 Predicate device

- The VITROS Chemistry Products TRFRN Reagent and VITROS Chemistry 3.5.1 Products Calibrator Kit 20 are substantially equivalent to the IMMAGE® Immunochemistry System TRF Transferrin Reagent on the Beckman IMMAGE® Immunochemistry System.
- 3.5.2 The VITROS Chemistry Products Protein Performance Verifiers I, II and III are substantially equivalent to the VITROS Chemistry Products Performance Verifiers I and II.

#### 3.6 Device description

The VITROS 5.1 FS Chemistry System is a fully automated clinical chemistry analyzer intended for use in the in vitro determination of various analytes in human specimens (serum, plasma, urine, and cerebrospinal fluid). The VITROS 5,1 FS System is designed for use with VITROS Chemistry Products MicroTip and Thin Film assays.

The system is comprised of four main elements:

- The VITROS 5,1 FS Chemistry System instrumentation, which provides automated 1 use of the chemistry reagents. The VITROS 5,1 FS Chemistry System was cleared for market by a separate 510(k) premarket notification (K031924).
- 2 The VITROS Chemistry Products MicroTip range of liquid reagent products (in this case VITROS Chemistry Products TRFRN Reagent, VITROS Chemistry Products Calibrator Kit 20 and VITROS Chemistry Products Protein Performance Verifiers I. II and III), which are combined by the VITROS 5,1 FS Chemistry System to perform the VITROS TRFRN assay.
- 3 The VITROS Chemistry Products Thin Film range of dry products, which are dry, multilayered, analytical elements, coated on polyester supports. The thin film products each have their own 510(k) clearance numbers and were cleared for market for use on the VITROS 5,1 FS Chemistry System through submission of information required by the ODE Guidance Document: "Data For Commercialization Of Original Equipment Manufacturer, Secondary and Generic Reagents For Automated Analyzers". The required information was provided in the VITROS 5,1 FS Chemistry System premarket notification (K031924).
- Common reagents used by multiple assays on the VITROS System (in this case, 4 VITROS Chemistry Products FS Diluent Pack 2).

The VITROS System and reagents are designed specifically for use with the VITROS Chemistry Products range of products. Continued on next page

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#### Device intended use 3.7

#### VITROS Chemistry Products TRFRN Reagent 3.7.1

For in vitro diagnostic use only. VITROS Chemistry Products TRFRN Reagent is used to quantitatively measure transferrin (TRFRN) concentration in human serum and plasma.

#### VITROS Chemistry Products Calibrator Kit 20 3.7.2

For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 20 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of transferrin, C3, C4, IgA, IgG and IgM.

#### VITROS Chemistry Products Protein Performance Verifiers I, II and III 3.7.3

For in vitro diagnostic use only. VITROS Chemistry Products Protein Performance Verifiers are assayed controls used to monitor the performance of TRFRN, C3, C4, IgA, IgG and IgM Reagents on VITROS 5,1 FS Chemistry Systems.

#### 3.8 Comparison to predicate device

- 3.8.1 The VITROS Chemistry Products TRFRN Reagent and VITROS Chemistry Products Calibrator Kit 20 are substantially equivalent to the IMMAGE® Immunochemistry System TRF Transferrin Reagent on the Beckman IMMAGE® Immunochemistry System (predicate device) which was cleared by the FDA (K963427) for IVD use.
The relationship between the VITROS TRFRN assay and the predicate device, determined by the least squares linear regression is:

VITROS TRFRN assay = 0.96x X - 0.24 mg/dL,

with a correlation coefficient of 0.986,

where X is the IMMAGE Transferrin assay on the Beckman IMMAGE Immunochemistry analyzer.

In addition to the above mentioned correlation study, studies were performed to determine the precision, analytical sensitivity, specificity and expected values of the VITROS TRFRN assay, (refer to VITROS TRFRN Reagent Instructions For Use in Section 8 for summaries of the results of these studies).

Continued on next page

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- Table 1 lists the characteristics of the VITROS TRFRN assay (new device) and the Table 1 IMMAGE Transferrin assay (predicate device).

| Device<br>Characteristic | VITROS TRFRN assay<br>(New Device) | IMMAGE Transferrin assay<br>(Predicate Device) |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For in vitro diagnostic use only.<br>VITROS Chemistry Products<br>TRFRN Reagent is used to<br>quantitatively measure transferrin<br>(TRFRN) concentration in human<br>serum. | TRF Reagent, when used in<br>conjunction with IMMAGE®<br>Immunochemistry Systems and<br>Calibrator 1, is intended for the<br>quantitative determination of<br>Transferrin (TRF) in human serum<br>by rate nephelometry. |
| Method | Immunoturbidimetry | Rate nephelometry |
| Reportable Range | 80.00 - 750.00 mg/dL | 75 - 750 mg/dL |
| Instrumentation | VITROS 5,1 FS Chemistry Systems | Beckman IMMAGE<br>Immunochemistry Systems |
| Sample types | Serum and plasma | Serum |
| Reactive Ingredient | Goat anti-sera to human transferrin | Processed goat sera |

- 3.8.2 The VITROS Chemistry Products Protein Performance Verifiers I, II and III are substantially equivalent to the VITROS Chemistry Products Performance Verifiers (predicate device) which were cleared by the FDA (K041720) for IVD use.
- Table 2 Table 2 lists the similarities and differences of the device characteristics between the VITROS Protein Performance Verifiers with the predicate device, VITROS Performance Verifiers I and II.

| Device<br>Characteristic | New device | Predicate device |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For in vitro diagnostic use only.<br>VITROS Chemistry Products Protein<br>Performance Verifiers are assayed<br>controls used to monitor the<br>performance of TRFRN, C3, C4,<br>IgA, IgG and IgM Reagents on<br>VITROS 5,1 FS Chemistry Systems. | For in vitro diagnostic use only.<br>VITROS Performance Verifier is<br>an assayed control used to<br>monitor performance on VITROS<br>Chemistry Systems. |
| Matrix of Performance<br>Verifiers | A base matrix of human serum to<br>which inorganic salts, buffers and<br>preservatives have been added. | A base matrix of freeze-dried<br>human serum to which enzymes,<br>electrolytes, stabilizers,<br>preservatives and other organic<br>analytes have been added. |
| Performance Verifier Levels | Low, Medium and High | Low and High |

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#### 3.9 Conclusions

The data presented in the premarket notification provide a reasonable assurance that the VITROS TRFRN assay and the VITROS Chemistry Products Protein Performance Verifiers are safe and effective for the stated intended uses and are substantially equivalent to the cleared predicate devices.

Equivalence to the predicates was demonstrated using commercially available reagents along with patient samples.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its wings or body. The bird is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV 1 9 2004

Ms. Darlene J. Phillips, RAC Regulatory Affairs Associate Ortho-Clinical Diagnostics 100 Indigo Creek Drive Rochester, NY 14626-5101

Re: k042477

Trade/Device Name: VITROS Chemistry Products TRFRN Reagent VITROS Chemistry Products Calibrator Kit 20 VITROS Chemistry Products Protein Performance Verifiers I, II and III Regulation Number: 21 CFR 866.5880 Regulation Name: Transferrin immunological test system Regulatory Class: Class II Product Code: DDG, JIT, JJX Dated: September 10, 2004 Received: September 13, 2004

Dear Ms Phillips:

We have reviewed your Section 510(k) premarket notification of intent to market the devices referenced above and have determined the devices are 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 these devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (PMA), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your devices 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 devices comply 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 Part 801); good manufacturing practice requirements as set

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Page 2 – Ms. Darlene J. Phillips

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control pro risions (seeting your devices as described in your Section 510(k) I ms letter will anow you to begin makemage yoursence of your devices to legally premarket nothroamon. - The PDFs in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801), If you desire specific at ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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/dsma/dsmamain.html

Sincerely yours,

Zohaff. Bestoof

Robert L. Becker, Jr., M.D., PhD Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety

Center for Devices and Radiological Health

Enclosure

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# 1.0 Indications for Use

| 510(k) Number<br>(if known): | K042477 |
|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | VITROS Chemistry Products TRFRN Reagent<br>VITROS Chemistry Products Calibrator Kit 20<br>VITROS Chemistry Products Protein Performance Verifiers I, II and III |
| Indications for Use: | For in vitro diagnostic use only. VITROS Chemistry Products TRFRN<br>Reagent is used to quantitatively measure transferrin (TRFRN) concentration<br>in human serum and plasma.<br><br>For in vitro diagnostic use. VITROS Chemistry Products Calibrator Kit 20 is<br>used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative<br>measurement of transferrin, C3, C4, IgA, IgG and IgM.<br><br>For in vitro diagnostic use only. VITROS Chemistry Products Protein<br>Performance Verifiers are assayed controls used to monitor the performance<br>of TRFRN, C3, C4, IgA, IgG and IgM Reagents on VITROS 5,1 FS<br>Chemistry Systems. |
| Prescription Use<br>(Part 21 CFR 801 Subpart D) | <div> <span style="text-decoration: overline;">✓</span> </div> |

AND/OR

| Over-The-Counter Use<br>(21 CFR 807 Subpart C) | |
|------------------------------------------------|--|
|------------------------------------------------|--|

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF
NEEDED)Concurrence of CDRH, Office of Device Evaluation (ODE)

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Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K042477

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