VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE REAGENT PACK 3, ANF CALIBRATORS

K984321 · Ortho-Clinical Diagnostics, Inc. · CDD · Jan 22, 1999 · Clinical Chemistry

Device Facts

• Record ID: K984321
• Device Name: VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE REAGENT PACK 3, ANF CALIBRATORS
• Applicant: Ortho-Clinical Diagnostics, Inc.
• Product Code: CDD · Clinical Chemistry
• Decision Date: Jan 22, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1810
• Device Class: Class 2

Intended Use

1 & 2. The VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/2 and the VITROS Immunodiagnostic Products Vitamin B12/Folate Reagent Pack 3 - for the in vitro quantitative measurement of vitamin B12 in human serum and plasma (EDTA or heparin) to aid in the differential diagnosis of anemia. 3. The VITROS Immunodiagnostic Products Vitamin B12 Calibrators - for in vitro use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of vitamin B12 in human serum and plasma (EDTA or heparin).

Device Story

VITROS Immunodiagnostic Products Vitamin B12 assay is an in vitro diagnostic test for quantitative measurement of vitamin B12 in human serum and plasma. The device utilizes the VITROS Immunodiagnostic System, an automated instrumentation platform. The assay employs a solid-phase immunoassay principle using coated microwells and enzyme-labeled tracers, replacing the radioassay (57Co) method used in predicate devices. The system processes 30 μL samples over a 58-minute incubation period at 37°C. Output is a quantitative concentration value (pg/mL) used by clinicians to aid in the differential diagnosis of anemia. The system is intended for professional use in clinical laboratory settings.

Clinical Evidence

Clinical performance was evaluated by comparing the VITROS Vitamin B12 assay to the Bio-Rad Quantaphase II B12 Radioassay using patient specimens across a variety of clinical categories. Correlation was established using Deming's Regression. Analytical studies included sensitivity, specificity, precision, and dilution testing. No specific p-values or confidence intervals were provided in the summary, but the data demonstrated substantial equivalence to the predicate device.

Technological Characteristics

Solid-phase immunoassay using enzyme-labeled tracers; automated on VITROS Immunodiagnostic System. Calibration range: 0-2000 pg/mL. Sample volume: 30 μL. Incubation: 58 minutes at 37°C. Sample types: serum, plasma (EDTA or heparin).

Indications for Use

Indicated for in vitro quantitative measurement of vitamin B12 in human serum and plasma (EDTA or heparin) to aid in the differential diagnosis of anemia.

Regulatory Classification

Identification

A vitamin B12 test system is a device intended to measure vitamin B12 in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.

Predicate Devices

• Bio-Rad Quantaphase II B12 Radioassay (K935286)

Submission Summary (Full Text)

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K984321

JAN 22 1999

# 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: _______________________________________________________________________________________________________________________________________________

1. Submitter name, address, contact Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, New York 14626-5101 [phone]

Contact Person: Anne Zavertnik

Date 510(k) prepared: November 30th, 1998

#### 2. Device Name

#### Vitamin B12 assay

Trade or Proprietary Name: VITROS Immunodiagnostic Products Vitamin B12 assay Common Name: Vitamin B12 assay

Classification Name: Vitamin B12 assay for the in vitro quantitative measurement of vitamin B12 in human serum and plasma (EDTA or heparin).

#### 3. Predicate Device

The VITROS Immunodiagnostic Products Vitamin B12 assay is substantially equivalent to Bio-Rad Quantaphase II B12 Radioassay.

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# 510(k) Summary, continued

### 4. Device Description

The VITROS Immunodiagnostic System uses luminescence as the signal in the quantitative and semi-quantitative determination of selected analytes in human body fluids, commonly serum, plasma and urine. Coated microwells are used as the solid phase separation system.

The system is comprised of three main elements:

- 1. The VITROS Immunodiagnostic Products range of products, in this case VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/2, VITROS Immunodiagnostic Products Vitamin B12/Folate Reagent Pack 3, VITROS Immunodiagnostic Products Vitamin B12 Calibrators and the VITROS Immunodiagnostic System.
- 2. The VITROS Immunodiagnostic System instrumentation, which provides automated use of the immunoassay kits. The VITROS Immunodiagnostic System was cleared for market by a separate 510(k) pre-market notification (K962919).
- Common reagents used by the VITROS System in each assay. The VITROS 3. Immunodiagnostic Products Signal Reagent and VITROS Immunodiagnostic Products Universal Wash Reagent were cleared as part of the VITROS Immunodiagnostic Products Total T3 510(k) pre-market notification (K984310).

The VITROS System and common reagents are dedicated specifically only for use with the VITROS Immunodiagnostic Products range of immunoassay products.

### 5. Device Intended Use

The VITROS Vitamin B12 assay is intended for the in vitro quantitative measurement of vitamin B12 in human serum and plasma (EDTA or heparin), to aid in the differential diagnosis of anemia.

### 6. Comparison to Predicate Device

The VITROS Immunodiagnostic Products Vitamin B12 assay is substantially equivalent to Bio-Rad Quantaphase II B12 Radioassay (predicate device), which was cleared by FDA (K935286) for IVD use.

The relationship between the VITROS Vitamin B12 assay and the predicate device, determined by Deming's Regression, is:

VITROS Vitamin B12 assay =0.984 x Bio-Rad Quantaphase II B12 Radioassay + 9.59 (pg/mL).

Comparisons of the VITROS Vitamin B12 assay and the predicate device were performed with samples from a variety of clinical categories.

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# 510(k) Summary, continued

In addition to the studies mentioned above, tests were performed to obtain analytical sensitivity, specificity, precision, dilution and expected values. Refer to the VITROS Vitamin B12 assay package insert for VITROS Vitamin B12 assay results.

Table 1 lists the similarities and differences of the device characteristics between the VITROS Vitamin B12 assay with the predicate device, Bio-Rad Quantaphase II B12 Radioassay.

| Device | VITROS Vitamin B12 | Predicate |
|------------------------------------|------------------------------------|-------------------------------|
| Characteristic | assay | Device |
| Calibration range | 0 - 2000 pg/mL | 0 - 2000 pg/mL |
| Basic principle | Solid phase immunoassay | Radioassay |
| Tracer | Enzyme labeled | 57Co |
| Instrumentation | VITROS<br>Immunodiagnostic System | Gamma Counter |
| Sample type | Serum, plasma (EDTA or<br>heparin) | Serum, plasma (EDTA) |
| | Sample volume | 30 μL |
| Incubation time and<br>temperature | 58 minutes at 37° C | 1 hour at room<br>temperature |

### Table 1 List of the assay characteristics

#### 7. Conclusions

The data presented in the pre-market notification demonstrate that the VITROS Vitamin B12 assay performs substantially equivalent to the predicate device, which was cleared by FDA (K935286) for IVD use.

Equivalence was demonstrated using currently commercially available reagents along with patient specimens covering a variety of clinical categories.

The data presented in the premarket notification provide a reasonable assurance that the VITROS Vitamin B12 assay is safe and effective for the stated intended use.

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Public Health Service

JAN 22 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Anne Zavertnik Regulatory Affairs Associate Ortho-Clinical Diagnostics A•Johnson & Johnson Company 100 Indigo Creek Drive Rochester, New York 14626-5101

Re: K984321 Trade Name: VITROS Immunodiagnostic Products Vitamin B12 Assay Product Code: CDD Regulatory Class: II II IIS Dated: December 2, 1998 Received: December 3, 1998

Dear Ms. Zavertnik:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

Steven I. Gutman, M.D, M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Statement of Intended Use

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| 510(k) Number (if known): | K984321 |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Page | 1 of 1 |
| Device Name: | 1. VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/2 2. VITROS Immunodiagnostic Products Vitamin B12/Folate Reagent Pack 3 3. VITROS Immunodiagnostic Products Vitamin B12 Calibrators |
| Indications for Use: | 1 & 2. The VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/2 and the VITROS Immunodiagnostic Products Vitamin B12/Folate Reagent Pack 3 - for the <i>in vitro</i> quantitative measurement of vitamin B12 in human serum and plasma (EDTA or heparin) to aid in the differential diagnosis of anemia.<br><br>3. The VITROS Immunodiagnostic Products Vitamin B12 Calibrators - for <i>in vitro</i> use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of vitamin B12 in human serum and plasma (EDTA or heparin). |

and the same of the same of the same of the same of the states of the states and

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use (Per 21 CFR 801.109) | <div style="text-align:center;">OR</div> | Over-The-Counter Use |
|---------------------------------------|------------------------------------------|----------------------|
|---------------------------------------|------------------------------------------|----------------------|

(Optional Format 1-2-96)
(Division Sign-Off)
Division of Clinical Laboratory Devices

| 510(k) Number | K984321 |
|---------------|---------|
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