VITROS CHEMISTRY PRODUCTS RF REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 16, VITROS CHEMISTRY PRODUCTS FS

K041863 · Ortho-Clinical Diagnostics, Inc. · DHR · Sep 20, 2004 · Immunology

Device Facts

• Record ID: K041863
• Device Name: VITROS CHEMISTRY PRODUCTS RF REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 16, VITROS CHEMISTRY PRODUCTS FS
• Applicant: Ortho-Clinical Diagnostics, Inc.
• Product Code: DHR · Immunology
• Decision Date: Sep 20, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5775
• Device Class: Class 2

Intended Use

VITROS RF Reagent is used to quantitatively measure rheumatoid factor concentration in human serum and plasma. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis. Calibrator kit 16 is used in conjunction with VITROS FS calibrator I to calibrate VITROS 5,1 FS Chemistry System. Performance Verifiers I and II are assayed controls used to monitor the performance of RF reagent on the FS 5,1 Chemistry System.

Device Story

VITROS RF Reagent is an immunoturbidimetric assay for quantitative measurement of rheumatoid factor (RF) in human serum and plasma. The device utilizes latex particles coated with human IgG; in the presence of RF, an antigen-antibody reaction causes agglutination. The system measures the resulting absorbance change at 575 nm, which is proportional to RF concentration. The assay is performed on the VITROS 5,1 FS Chemistry System. The device is intended for clinical laboratory use by trained personnel. Results are used by clinicians to aid in the diagnosis of rheumatoid arthritis. The system includes calibrators and assayed performance verifiers to ensure measurement accuracy and monitor reagent performance.

Clinical Evidence

Bench testing only. Performance was validated through comparative studies against the predicate device using patient samples. Key metrics include a correlation coefficient of 0.986 (VITROS RF = 0.904 x X - 4.045). Additional validation included precision, specificity, linearity, antigen excess, and lower limit of detection studies.

Technological Characteristics

Immunoturbidimetric assay; latex particles coated with human IgG. Instrumentation: VITROS 5,1 FS Chemistry System. Wavelength: 575 nm. Sample types: serum and plasma (heparin and EDTA). Performance verifiers consist of freeze-dried human serum base with purified human proteins, bovine serum albumin, and preservatives.

Indications for Use

Indicated for use as an aid in the diagnosis of Rheumatoid Arthritis in patients requiring quantitative measurement of rheumatoid factor in serum or plasma.

Regulatory Classification

Identification

A rheumatoid factor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the rheumatoid factor (antibodies to immunoglobulins) in serum, other body fluids, and tissues. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis.

Predicate Devices

• Cobas Integra Reagent Cassette for Rheumatoid Factors II (RF-II) assay (K000534)
• VITROS Chemistry Products Performance Verifiers I and II (K904768)

Submission Summary (Full Text)

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# Chapter 1 – Summary Information

### 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: K041863

| 1. Submitter name, address, contact | Ortho-Clinical Diagnostics, Inc.<br>100 Indigo Creek Drive<br>Rochester, New York 14626-5101<br>[phone]<br><br>Contact Person: Marlene A. Hanna |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Preparation date | Date 510(k) prepared: July 8, 2004 |
| 3. Device name | Trade or Proprietary Name:<br>VITROS Chemistry Products RF Reagent<br>VITROS Chemistry Products Calibrator Kit 16<br>VITROS Chemistry Products FS Calibrator 1<br>VITROS Chemistry Products RF Performance Verifiers I and II<br><br>Common Name: RF assay<br><br>Classification Name: Rheumatoid factor immunological test system (866.5775):<br>Class: II (performance standards)<br><br>Classification Name: Quality Control material (assayed and unassayed) (862.1660):<br>Class I (general controls). Since this device is an assayed control, it meets the reserved criteria under Section 510(l) of the Food, Drug, and Cosmetic Act. |

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### 510(k) Summary, Continued

- a. The VITROS Chemistry Products RF assay is substantially equivalent to the 4. Predicate Cobas Integra Reagent Cassette for Rheumatoid Factors II (RF-II) assay. Device
b. The VITROS Chemistry Products RF Performance Verifiers I and II are substantially equivalent to the VITROS Chemistry Products Performance Verifiers I and II.

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

- 1. The VITROS 5.1 FS Chemistry System instrumentation, which provides automated 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 RF Reagent, VITROS Chemistry Products Calibrator Kit 16 and VITROS Chemistry Products FS Calibrator 1, VITROS Chemistry Products RF Performance Verifiers I and II), which are combined by the VITROS 5,1 FS Chemistry System to perform the VITROS RF 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).
- 4. Common reagents used by multiple assays on the VITROS System (in this case, VITROS Chemistry Products FS Diluent Pack 2 and VITROS Chemistry Products FS Reconstitution Diluent).

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

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#### 6. Device a. VITROS Chemistry Products RF Reagent: For in vitro diagnostic use only. intended VITROS Chemistry Products RF Reagent is used to quantitatively measure rheumatoid factor (RF) concentration in human serum and plasma. use

b. VITROS Chemistry Products Calibrator Kit 16 and VITROS Chemistry Products FS Calibrator 1: For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 16 is used in conjunction with VITROS FS Calibrator 1 to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of rheumatoid factor (RF).

c. VITROS Chemistry Products RF Performance Verifiers I and II: For in vitro diagnostic use only. VITROS Chemistry Products RF Performance Verifiers I and II are assayed controls used to monitor the performance of RF Reagent on VITROS 5,1 FS Chemistry Systems.

#### 7. Comparison to predicate device(s):

#### Reagent Pack and Calibrators

ース アート スリー レディー ストー ストー ストー ベット ショップ アイデリア アイデリア アイデリア ア

The VITROS Chemistry Products RF Reagent and VITROS Chemistry Products Calibrator Kit 16 and FS Calibrator 1 are substantially equivalent to the Cobas Integra Reagent Cassette for Rheumatoid Factors II (RF-II) assay (predicate device) which was cleared by the FDA (K000534) for IVD use.

The relationship between the VITROS RF and the predicate device, determined by least squares linear regression, is:

VITROS RF = 0.904 x X - 4.045 (IU/mL),

with a correlation coefficient of 0.986, where X is the Cobas Integra Reagent Cassette for Rheumatoid Factors II (RF-II) assay.

In addition to the above mentioned correlation studies were performed to determine the precision, specificity, linearity, antigen excess, lower limit of detection, and expected values of the VITROS RF assay, (refer to the VITROS RF Reagent Instructions for Use for summaries of the results of these studies).

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Ortho-Clinical Diagnostics, Inc.

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### 510(k) Summary, Continued

Table 1 lists the characteristics of the assays performed using the VITROS RF assay and the Cobas Integra Reagent Cassette for Rheumatoid Factors II (RF-II) assay.

Table 1

Table 1 lists the characteristics of the VITROS RF (new device) and the RF (predicate device)

| Device<br>Characteristic | VITROS RF<br>(New device) | RF<br>(Predicate device) |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For in vitro diagnostic use<br>only. VITROS Chemistry<br>Products RF Reagent is<br>used to quantitatively<br>measure rheumatoid factor<br>(RF) concentration in<br>human serum and plasma. | The cassette COBAS<br>INTEGRA Rheumatoid<br>Factors II (RF-II) contains<br>an in vitro diagnostic<br>reagent system intended for<br>use on COBAS INTEGRA<br>systems for the quantitative<br>immunological<br>determination of human<br>rheumatoid factors in<br>serum and plasma. |
| Method | Immunoturbidimetric | Immunoturbidimetric |
| Reportable Range | 6-120 IU/mL | 0-120 IU/mL |
| Sample Type | Serum and Plasma (heparin<br>and EDTA) | Serum and Plasma<br>(heparin, EDTA, Citrate) |
| Reactive Ingredient | Latex particles coated with<br>human IgG | Latex particles coated with<br>human IgG |
| Instrumentation | VITROS 5,1 FS Chemistry<br>System | COBAS INTEGRA<br>Systems |
| Wavelength | 575 nm | 583 nm |

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#### 510(k) Summary, Continued

### Performance Verifiers

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

The VITROS Chemistry Products RF Performance Verifiers I and II are substantially equivalent to the VITROS Chemistry Products Performance Verifiers (predicate device) which were cleared by the FDA (K904768) for IVD use.

Table 2 lists the similarities and differences of the device characteristics between the VITROS RF Performance Verifiers I and II with the predicate device the VITROS Performance Verifiers I and II.

| Device<br>Characteristic | VITROS RF (New Device) | RF (Predicate Device) |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For in vitro diagnostic use<br>only. VITROS Chemistry<br>Products RF Performance<br>Verifiers I and II are assayed<br>controls used to monitor the<br>performance of RF Reagent<br>on VITROS 5,1 FS<br>Chemistry Systems. | For in vitro diagnostic use only.<br>VITROS Chemistry Products<br>Performance Verifiers I and II are<br>assayed controls used to monitor<br>the performance of VITROS<br>Chemistry Systems. |
| Matrix | A base matrix of freeze-dried<br>human serum to which<br>purified human proteins,<br>bovine serum albumin and<br>preservative have been<br>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<br>Verifier Levels | Low and High | Low and High |

Table 2

#### Conclusions

:

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

- Equivalence to predicate(s) 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 with three lines representing its body and wings. The eagle is facing left. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Marlene A. Hanna, RAC Regulatory Affairs Associate Ortho-Clinical Diagnostics, Inc. Regualtory Affairs MC00881 100 Indigo Creek Drive Rochester, New York 14626-5101

SEP 2 0 2004

k041863 Re:

Trade/Device Name: VITROS Chemistry Products RF Reagent, VITROS Chemistry Products Calibrator Kit 16, VITROS Chemistry Products FS Calibrator 1, VITROS Chemistry Products RF Performance Verifiers I and II, Regulation Number: 21 CFR § 866.5775 Regulation Name: Rheumatoid Factor Immunological Test System Regulatory Class: II Product Code: DHR, JIT, JJX Dated: July 8, 2004 Received: July 9, 2004

Dear Ms. Hanna:

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 for use suated in the energes, 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, de necs mat have been resuire approval of a premarket approval application (PMA). and Cosmetre Frev (10) - 100 (100) - 100 (2008) - 10 the general controls provisions of the Act. The r ou may , atest provisions of the Act include requirements for annual registration, listing of general volurols profice, 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 If your device is clubsition (600 as controls. Existing major regulations affecting your device can may oc subject of sach adamons and Regulations (CFR), Parts 800 to 895. In addition, FDA be found in Title 21, Coooooements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be advisou that I Dr o local that your device complies with other requirements of the Act that I Dri has Intacted and regulations administered by other Federal agencies. You must of any I each statutes and regaranents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice CI IC Part 6077, adoming (21 OF Creaty systems (QS) regulation (21 CFR Part 820). This letter requirenches as bet form in the ug your device as described in your Section 510(k) premarket will anow you to begin marketing your intral equivalence of your device to a legally marketed

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Page 2

If you desire specific information about the application of labeling requirements to your device, r you desire op the promotion and advertising of your device, please contact the Office of In or queetions on and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). regulation other general information on your responsibilities under the Act from the Tou may ooutin other generational 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,

Robert L. Becker Jr.

Robert L. Becker, Jr., M.D., Ph. 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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### Indications for Use

KO4 1863

510(k) Number (if known):

Device Name(s):

Indications for Use:

VITROS Chemistry Products RF Reagent VITROS Chemistry Products Calibrator Kit 16 VITROS Chemistry Products FS Calibrator 1 VITROS Chemistry Products RF Performance Verifiers I and II

For in vitro diagnostic use only. VITROS Chemistry Products RF Reagent is used to quantitatively measure rheumatoid factor (RF) concentration in human serum and plasma. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis.

For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 16 is used in conjunction with VITROS FS Calibrator 1 to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of rheumatoid factor (RF).

For in vitro diagnostic use only. VITROS Chemistry Products RF Performance Verifiers I and II are assayed controls used to monitor the performance of RF Reagent on VITROS 5,1 FS Chemistry Systems.

V Prescription Use _ (Per 21 CFR 801 Subpart D)

AND/OR

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

、

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Mana Chan

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K041863