VITROS CHEMISTRY PRODUCTS IGG, IGA AND IGM REAGENTS; VITROS CHEMISTRY PRODUCT CALIBRATOR KIT 20; VITROS CHEMISTRY PRODUC

K042475 · Ortho-Clinical Diagnostics, Inc. · CFN · Nov 10, 2004 · Immunology

Device Facts

• Record ID: K042475
• Device Name: VITROS CHEMISTRY PRODUCTS IGG, IGA AND IGM REAGENTS; VITROS CHEMISTRY PRODUCT CALIBRATOR KIT 20; VITROS CHEMISTRY PRODUC
• Applicant: Ortho-Clinical Diagnostics, Inc.
• Product Code: CFN · Immunology
• Decision Date: Nov 10, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5510
• Device Class: Class 2

Intended Use

For in vitro diagnostic use only. VITROS Chemistry Products IgG Reagent is used to quantitatively measure immunoglobulin G (IgG) concentration in human serum and plasma. For in vitro diagnostic use only. VITROS Chemistry Products IgA Reagent is used to quantitatively measure immunoglobulin A (IgA) concentration in human serum and plasma. For in vitro diagnostic use only. VITROS Chemistry Products IgM Reagent is used to quantitatively measure immunoglobulin M (IgM) concentration in human serum and plasma. 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, IgG, IgA and IgM. For in vitro diagnostic use only. VITROS Chemistry Products Protein Performance Verifiers I, II, and III are assayed controls used to monitor the performance of TRFRN, C3, C4, IgG, IgA and IgM Reagents on VITROS 5,1 FS Chemistry Systems.

Device Story

The VITROS Chemistry Products IgG, IgA, and IgM Reagents are liquid reagents used on the VITROS 5,1 FS Chemistry System to perform immunoturbidimetric assays. The system automates the combination of reagents with patient serum or plasma samples. The device measures the concentration of specific immunoglobulins; results are used by clinicians to assess patient protein levels. The system also utilizes a dedicated Calibrator Kit 20 for system calibration and Protein Performance Verifiers (I, II, and III) to monitor assay performance. The device is intended for use in clinical laboratory settings by trained personnel. By providing quantitative data on immunoglobulin levels, the device assists in the diagnosis and monitoring of various disease states related to immune function.

Clinical Evidence

Bench testing only. Precision evaluated per NCCLS EP5-A; linearity per EP6-A; interference per EP7-A. Method comparison against predicate (n=129-139 samples) showed correlation coefficients >0.99. Reference ranges established using 114-116 healthy subjects.

Technological Characteristics

Immunoturbidimetric assay; goat antisera to human IgG, IgA, or IgM; polymer-based reagent. Calibrators and controls consist of processed human serum in buffer with preservatives/inorganic salts. Designed for VITROS 5,1 FS Chemistry Systems (automated clinical chemistry analyzer).

Indications for Use

Indicated for the quantitative measurement of IgG, IgA, and IgM concentrations in human serum and plasma for in vitro diagnostic use.

Regulatory Classification

Identification

An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

Predicate Devices

• Dade Behring N antisera to human immunoglobulins (IgG, IgA, and IgM) (K860894)
• Dade Behring N Protein Standards SL (K012470)
• Dade Behring N/T Protein controls SL (K002804)

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.

64 2475 The assigned 510(k) number is: _

- Ortho-Clinical Diagnostics, Inc. 1. Submitter 100 Indigo Creek Drive name, Rochester, New York 14626-5101 address. [phone] contact Contact Person: Marlene A. Hanna Email: mhanna1 @ocdus.jnj.com
- Date 510(k) prepared: September 10, 2004 2. Preparation Date
- Trade or Proprietary Name(s): Device 3. VITROS Chemistry Products IgG Reagent name(s) VITROS Chemistry Products IgA Reagent VITROS Chemistry Products IgM Reagent VITROS Chemistry Products Calibrator Kit 20 VITROS Chemistry Products Protein Performance Verifiers I, II, and III

Common Name(s): Immunoglobulin G (IgG) assay Immunoglobulin A (IgA) assay Immunoglobulin M (IgM) assay

Classification Name(s): Immunoglobulins A, G, M, D, and E immunological test system (866.5510): Class: II (performance standards).

Calibrator (862.1150): Calibrator Kit 20: Class II.

Quality Control material (assayed and unassayed) (862.1660): Class I (general controls). Since these devices (Protein Performance Verifiers I, II, and III) are assayed controls, they meet the reserved criteria under Section 510(1) of the Food, Drug, and Cosmetic Act.

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#### 510(k) Summary, Continued

- a. The VITROS Chemistry Products IgG, IgA, and IgM Reagents and 4. Predicate Calibrator Kit 20 are substantially equivalent to the Dade Behring N Devices Antisera to Human Immunoglobulins (IgG, IgA, and IgM) and Dade Behring N Protein Standard SL (human).
- b. The VITROS Chemistry Products Protein Performance Verifiers I, II, and III are substantially equivalent to the Dade Behring N/T Protein Controls S/L.
- 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 IgG, IgA, and IgM Reagents and 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 IgG, IgA, and IgM assays.
- 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 (BSA/ Saline).

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

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#### 510(k) Summary, Continued

#### VITROS Chemistry Products IgG Reagent: For in vitro diagnostic use only. 6. Device(s) VITROS Chemistry Products IgG Reagent is used to quantitatively measure intended immunoglobulin G (IgG) concentration in human serum and plasma. use

VITROS Chemistry Products IgA Reagent: For in vitro diagnostic use only. VITROS Chemistry Products IgA Reagent is used to quantitatively measure immunoglobulin A (IgA) concentration in human serum and plasma.

VITROS Chemistry Products IgM Reagent: For in vitro diagnostic use only. VITROS Chemistry Products IgM Reagent is used to quantitatively measure immunoglobulin M (IgM) concentration in human serum and plasma.

VITROS Chemistry Products Calibrator Kit 20: 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, IgG, IgA and IgM.

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

#### 7. Comparison

#### to predicate

device(s):

#### IgG, IgA, and IgM Reagents and Calibrator Kit 20

The VITROS Chemistry Products IgG, IgA, and IgM Reagents and VITROS Chemistry Products Calibrator Kit 20 are substantially equivalent to K860894, the Dade Behring N Antisera to Human Immunoglobulins (IgG, IgA, and IgM), and K012470, Dade Behring N Protein Standard SL (predicate devices) which were cleared by the FDA for IVD use.

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# IgG Reagent and Calibrators

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

$$\text{VITROS IgG} = 0.98\text{x} + 91.2 \text{ (mg/dL)}, 1$$

with a correlation coefficient of 0.995, where X is the Dade Behring N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) assay.

#### IgA Reagent and Calibrators

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

$$\text{VIIIROS IgA} = 1.07\text{x} - 3.03 \text{ (mg/dL)},$$

with a correlation coefficient of 0.999, where X is the Dade Behring N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) assay.

#### IgM Reagent and Calibrators

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

VITROS IgM = $1.02x + 1.1$ (mg/dL),

with a correlation coefficient of 0.998, where X is the Dade Behring N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) assay.

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

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Table 1 lists the characteristics of the assays performed using the VITROS IgG, IgA, and IgM assays and the Dade Behring N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) assay.

- Table 1 lists the characteristics of the VITROS IgG, IgA, and IgM Reagent (new Table 1 devices) and the DADE IgG, IgA, and IgM assays (predicate device).

| Device<br>Characteristic | VITROS IgG, IgA and IgM<br>(New device) | DADE IgG, IgA, and IgM<br>(Predicate device) |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For in vitro diagnostic use only.<br>VITROS Chemistry Products<br>IgG , IgA, and IgM Reagents are<br>used to quantitatively measure<br>immunoglobulin G (IgG),<br>immunoglobulin A (IgA), and<br>immunoglobulin M(IgM)<br>concentration in human serum. | In vitro diagnostic reagents for<br>the quantitative determination<br>of immunoglobulins (IgG,<br>IgA, and IgM) in human<br>serum as well as of IgG in<br>human CSF. |
| Method | Immunoturbidimetric | Immunoturbidimetric |
| Reportable<br>Range: | | |
| IgG: | 270 - 2700 mg/dL | 140 - 4600 mg/dL |
| IgA: | 40 - 800 mg/dL | 25 - 800 mg/dL |
| IgM: | 25 - 400 mg/dL | 20 - 640 mg/dL |
| Sample Type | Human Serum | Human Serum |
| Reactive<br>Ingredients | | |
| IgG: | Goat antisera to human IgG | Rabbit antisera to human IgG |
| IgA: | Goat antisera to human IgA | Rabbit antisera to human IgA |
| IgM: | Goat antisera to human IgM | Rabbit antisera to human IgM |
| Instrumentation | VITROS 5,1 FS Chemistry<br>System | DADE BN ProSpec |

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#### 510(k) Summary, Continued

#### Performance Verifiers

The VITROS Chemistry Products Protein Performance Verifiers I, II, and III are substantially equivalent to the Dade Behring N/T Protein Controls SL (predicate device) which was cleared by the FDA (K012468) for IVD use.

Table 2 lists the similarities and differences of the device characteristics between the VITROS Protein Performance Verifiers I, II, and III with the predicate device, the Dade Behring N/T Protein Controls SL.

| Device<br>Characteristic | VITROS Protein Performance<br>Verifiers<br>(New Device) | DADE Protein Controls<br>(Predicate Device) |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For in vitro diagnostic use only.<br>VITROS Chemistry Products<br>Protein Performance Verifiers I, II,<br>and III are assayed controls used to<br>monitor the performance of<br>TRFRN, C3, C4, IgG, IgA and<br>IgM Reagents on VITROS 5,1 FS<br>Chemistry Systems. | For in vitro diagnostic use only.<br>N/T Protein Controls S/L is for use<br>as accuracy and precision assayed<br>controls in the determination of the<br>following human serum proteins<br>by immunonephelometry with<br>BN™ Systems: IgG1-4, IgA, IgM,<br>C3c, C4, Transferrin, Albumin, α1-<br>antitrypsin, α2-macroglobulin,<br>Haptoglobin, α1-acid glycoprotein,<br>Prealbumin, Hemopexin,<br>Ceruloplasmin, RbP, Ig/L-chain<br>lambda & Kappa, β2-<br>microglobulin, soluable<br>Transferrin Receptor (sTfR),<br>Ferritin, IgE, Total protein. |
| Matrix | Processed human serum to which<br>inorganic salts, buffers, and<br>preservatives have been added. | Human serum with stabilizers and<br>preservatives. |
| Form | Liquid | Liquid |
| Volume | 1 mL per vial | 1 mL per vial |

Table 2

The data presented in the premarket notification provide a reasonable assurance Conclusions that the VITROS IgG, IgA, and IgM reagents, Calibrator Kit 20, 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 predicate(s) was demonstrated using commercially available reagents along with patient samples.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/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 wings and tail feathers. The eagle is positioned to the right of the text, which is arranged in a circular pattern around the left side of the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

Public Health Service

NOV 1 0 2004

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Marlene A. Hanna Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, NY 14626

k042475 Re:

Trade/Device Name: VITROS Chemistry Products IgG Reagent VITROS Chemistry Products IgM Reagent VITROS Chemistry Products IgA Reagent VITROS Chemistry Products Calibrator Kit 20 VITROS Chemistry Products Protein Performance Verifiers I, II, and III Regulation Number: 21 CFR 866.5510 Regulation Name: Immunoglobulins A, G, M, D, E immunological test system Regulatory Class: Class II Product Code: CFN, JIX, JJY Dated: September 10, 2004 Received: September 13, 2004

Dear Ms. Hanna:

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 the 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 vour 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 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your devices as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed

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Page 2 -

predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific information about the application of labeling requirements to your devices, or questions on the promotion and advertising of your devices, 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 Totallary 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,

Robert H. Becker f

Robert L. Becker, Jr., MD, Ph.D Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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| Indications for Use for the IgG assay | |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number (if known): | K042475 |
| Device Name(s): | VITROS Chemistry Products IgG Reagent<br>VITROS Chemistry Products Calibrator Kit 20<br>VITROS Chemistry Products Protein Performance Verifiers I, II, and III |
| Indications for Use: | For <i>in vitro</i> diagnostic use only. VITROS Chemistry Products IgG Reagent is used to quantitatively measure immunoglobulin G (IgG) concentration in human serum and plasma.<br><br>For <i>in vitro</i> 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, IgG, IgA and IgM.<br><br>For <i>in vitro</i> diagnostic use only. VITROS Chemistry Products Protein Performance Verifiers I, II, and III are assayed controls used to monitor the performance of TRFRN, C3, C4, IgG, IgA and IgM Reagents on VITROS 5,1 FS Chemistry Systems. |

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

Maria M Chan

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Division Sign-Off

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K042475

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| Indications for Use for the IgA assay |
|---------------------------------------|
|---------------------------------------|

| 510(k) Number (if known): | K042475 |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name(s): | VITROS Chemistry Products IgA 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 IgA Reagent is used to quantitatively measure immunoglobulin A (IgA) concentration in human serum and plasma.<br><br>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, IgG, IgA and IgM.<br><br>For in vitro diagnostic use only. VITROS Chemistry Products Protein Performance Verifiers I, II, and III are assayed controls used to monitor the performance of TRFRN, C3, C4, IgG, IgA and IgM Reagents on VITROS 5,1 FS Chemistry Systems. |

Prescription Use______________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (Per 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)

Page 1 of 1

ia m chan

Division Sign-Off

ാffice of In Vitro Diagnostic Device Evaluation and Safety

310(k) K042475

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# Indications for Use for the IgM assay

| 510(k) Number (if known): | K042475 |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name(s): | VITROS Chemistry Products IgM 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 IgM Reagent is used to quantitatively measure immunoglobulin M (IgM) concentration in human serum and plasma.<br><br>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, IgG, IgA and IgM.<br><br>For in vitro diagnostic use only. VITROS Chemistry Products Protein Performance Verifiers I, II, and III are assayed controls used to monitor the performance of TRFRN, C3, C4, IgG, IgA and IgM Reagents on VITROS 5,1 FS Chemistry Systems. |

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

AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (Per 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)

Page 1 of 1

m cher
Division Sign-Off

**Division Sign-Off**

Office of In Vitro Dlagnostic Davice Evaluation and Safety

s10(k) K04 2475