VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL REAGENT PACK AND CALIBRATORS AND METABOLISM CONTROLS

K060480 · Ortho-Clinical Diagnostics · CGR · Jul 3, 2006 · Clinical Chemistry

Device Facts

• Record ID: K060480
• Device Name: VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL REAGENT PACK AND CALIBRATORS AND METABOLISM CONTROLS
• Applicant: Ortho-Clinical Diagnostics
• Product Code: CGR · Clinical Chemistry
• Decision Date: Jul 3, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1205
• Device Class: Class 2

Intended Use

VITROS Immunodiagnostic Cortisol Reagent Pack For the in vitro quantitative measurement of cortisol in human serum, plasma (heparin or EDTA) or urine. VITROS Immunodiagnostic Products Cortisol Calibrators For the in vitro use in the calibration of the VITROS Immunodiagnsotic System for the quantitative measurement of cortisol in human serum, plasma (heparin or EDTA) or urine. VITROS Immunodiagnostic Products Metabolism Controls For the in vitro use in monitoring the performance of the VITROS Immunodiagnostic System when used for the measurement of cortisol in human serum, plasma (heparin or EDTA) or urine.

Device Story

The VITROS Immunodiagnostic Cortisol Reagent Pack is an in vitro diagnostic assay used on the VITROS Immunodiagnostic System to measure cortisol concentration in human serum, plasma, or urine. The device utilizes a competitive immunoassay technique where cortisol in the sample competes with HRP-labeled cortisol conjugate for binding sites on a biotinylated sheep anti-cortisol polyclonal antibody. The complex is captured on coated microwells. A luminogenic substrate and electron transfer agent are added; HRP catalyzes light production, which is inversely proportional to the cortisol concentration. The system is operated by laboratory personnel in a clinical setting. The output is a quantitative cortisol concentration, which healthcare providers use to assess adrenal status. The device includes reagent packs, calibrators, and metabolism controls.

Clinical Evidence

Bench testing only. Performance was demonstrated using manufactured reagents, positive and negative controls, and testing of human samples throughout the assay range to confirm substantial equivalence to the predicate device.

Technological Characteristics

Solid-phase immunoassay using coated microwells. Detection via luminescence. Reagents include sheep polyclonal anti-cortisol antibody and enzyme-labeled tracer. Instrumentation: VITROS Immunodiagnostic System. Sample volume: 25µL. Incubation: 30 minutes at 37°C. Reportable range: 4.39 to 1700 nmol/L.

Indications for Use

Indicated for the quantitative measurement of cortisol in human serum, plasma (heparin or EDTA), or urine to aid in the assessment of adrenal status.

Regulatory Classification

Identification

A cortisol (hydrocortisone and hydroxycorticosterone) test system is a device intended to measure the cortisol hormones secreted by the adrenal gland in plasma and urine. Measurements of cortisol are used in the diagnosis and treatment of disorders of the adrenal gland.

Predicate Devices

• VITROS Immunodiagnostic Products Cortisol Assay (K983990)

Reference Devices

• VITROS Immunodiagnostic System (k962919)
• VITROS Immunodiagnostic Products Total T3 Reagent Pack and Calibrators (k964310)
• VITROS Immunodiagnostic Products Total β-hCG Reagent Pack and Calibrators (k970894)

Submission Summary (Full Text)

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Ortho-Clinical Diagnostics

a *fohnson* *fohnson* company

100 Indigo Creek Drive

Coster, New York 4

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: Ko60480

#### Submitter Name, Address and Contact 1

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

Leah Van De Water Contact Person:

#### 2 Preparation Date

Date 510(k) prepared: February 22, 2006

#### 3 Device Name

- VITROS Immunodiagnostic Products Cortisol Reagent Pack Common Name: Cortisol Reagent Pack Classification Name: Cortisol(Hydrocortisone and Hydroxycorticosterone) Test System (862.1205), Class II
- VITROS Immunodiagnostic Products Cortisol Calibrators Common Name: Cortisol Calibrators Classification Name: Calibrator (862.1150), Class II
- VITROS Immunodiagnostic Products NT-proBNP Metabolism Controls Common Name: Metabolism Controls Classification: Quality control material (862.1660), Class I

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#### 4 Predicate Device

The VITROS Immunodiagnostic Products Cortisol Assay is substantially equivalent to the VITROS Immunodiagnostic Products Cortisol Assay (K983990-original formulation). The only modifications made to the proposed VITROS Immunodiagnostic Products Cortisol Assay are to the VITROS Immunodiagnostic Products Cortisol Reagent Pack. There are no modifications being made to the VITROS Immunodiagnostic Products Cortisol Calibrators or the VITROS Immunodiagnostic Products Metabolism Controls, which were previously cleared under K983990.

#### 5 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 and plasma. Coated microwells are used as the solid phase separation system.

The system is comprised of there main elements:

- The VITROS Immunodiagnostic Products range of immunoassay . products in this case VITROS Immunodiagnostic Products Cortisol Reagent Pack, VITROS Immunodiagnostic Products Cortisol Calibrators (cleared under K983990) and VITROS Immunodiagnostic Products Metabolism Controls (cleared under K983990), which are combined by the VITROS Immunodiagnostic System to perform the VITROS Cortisol assay.
- . 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 Immunodiagnostic Products Signal Reagent and VITROS Immunodiagnostic Products Universal Wash Reagent were cleared as part of the VITROS Immunodiagnostic Products Total T3 Reagent Pack and VITROS Immunodiagnostic Products Total T3 Calibrators 510(k) premarket notification (K964310).

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Note: High Sample Diluent B was cleared as part of the VITROS Immunodiagnostic Products Total ß-hCG Reagent Pack and VITROS Immunodiagnostic Products Total B-hCG Calibrators 510(k) premarket notification (K970894).

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

#### 6 Device Intended Use

### VITROS Immunodiagnostic Cortisol Reagent Pack

For the in vitro quantitative measurement of cortisol in human serum, plasma (heparin or EDTA) or urine.

## VITROS Immunodiagnostic Products Cortisol Calibrators

For the in vitro use in the calibration of the VITROS Immunodiagnsotic System for the quantitative measurement of cortisol in human serum, plasma (heparin or EDTA) or urine.

VITROS Immunodiagnostic Products Metabolism Controls

For the in vitro use in monitoring the performance of the VITROS Immunodiagnostic System when used for the measurement of cortisol in human serum, plasma (heparin or EDTA) or urine.

#### 7 Comparison to Predicate Device

The VITROS Immunodiagnostic Products Cortisol Reagent Pack is substantially equivalent to VITROS Immunodiagnostic Products Cortisol Reagent Pack (K983990) cleared by the FDA for in vitro diagnostic use.

Table 1 lists the characteristics of the VITROS Cortisol Reagent Pack (new formulation) and the VITROS Cortisol Reagent Pack (K983990original formulation). There are no modifications to the current VITROS Immunodiagnostic Products Cortisol Calibrators (cleared under K983990), and VITROS Immunodiagnostic Products Metabolism Controls (cleared under K983990).

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| Device<br>Characteristic | Predicate Device<br>VITROS Cortisol Reagent<br>Pack<br>(K983990-Current) | New Device<br>VITROS Cortisol Reagent<br>Pack<br>(Modified) |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Reportable Range | 0 to 1700 nmol/L | 4.39 to 1700 nmol/L |
| Sample type | Serum, plasma (EDTA or heparin) or urine. | Serum plasma (EDTA or heparin) or urine. |
| Biotinylated Antibody<br>Reagent | <b>Antibody</b><br>Sheep polyclonal anti-cortisol antibody biotinylated antibody reagent (pool of two bleeds from a single sheep immunized in-house at Pollards Wood) | <b>Antibody</b><br>Sheep polyclonal anti-cortisol antibody biotinylated antibody reagent (pool of eight bleeds from two sheep immunized in-house at Pollards Wood) |
| | Concentration of Antibody<br>1.5 mg/Kg | Concentration of Antibody<br>0.5 mg/Kg |
| HRP Conjugate Reagent | Contains Bovine Alpha<br>Globulin | Removed Bovine Alpha<br>Globulin<br>Added ANS (8-anilino-1-<br>napthalenesulfonic acid) to<br>correct for azide |
| Basic principle | Solid phase immunoassay | Solid phase immunoassay |
| Tracer | Enzyme labeled | Enzyme labeled |
| Instrumentation | VITROS Immunodiagnostic<br>System | VITROS Immunodiagnostic<br>System |
| Sample volume | 25µL | 25µL |
| Incubation time and<br>temperature | 30 minutes at 37°C | 30 minutes at 37°C |

# Table 1 List of VITROS Cortisol Reagent Pack Characteristics: Comparison to Predicate Device

#### 10 Conclusions

The information presented in the pre-market notification demonstrates that the performance of the proposed VITROS Immunodiagnostic Products Cortisol Assay is substantially equivalent to the cleared predicate device.

Equivalent performance was demonstrated using manufactured reagents, positive and negative controls and testing human samples throughout the assay range.

The information presented in the premarket notification provides a reasonable assurance that the proposed VITROS Cortisol Assay is safe and effective for the stated intended use.

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Image /page/4/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three stripes forming its body and wings. The eagle faces right and has its wings spread. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. U.S.A." is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

# Ms. Leah Van De Water Regulatory Affairs Associate Ortho-Clinical Diagnostics 100 Indigo Creek Dr. Rochester, NY 14626-5101

Re: k060480

> Trade/Device Name: VITROS Immunodiagnostic Products Cortisol Reagent Pak VITROS Immunodiagnostic Products Cortisol Calibrator VITROS Immunodiagnostic Products Metabolism Controls Regulation Number: 21 CFR§862.1205 Regulation Name: Cortisol (hydrocortisone and hydroxycorticosterone) test system Regulatory Class: Class II Product Code: CGR, JIS, JJX Dated: June 16, 2006 Received: June 19, 2006

JUL - 3 2006

Dear Ms. Water:

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 Amendmants, 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 device, subject to the general controls provisions of the Act The general controls provisions of the Act include requirements for annual registration, into rece 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 (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 820).

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## Page 2 -

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 the momber [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Albert
Albert S.
Ph.D.

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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## ATTACHMENT B

# Indications for Use

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------510(k) Number (if known):

Device Name:

VITROS Immunodiagnostic Products Cortisol Reagent Pack VITROS Immunodiagnostic Products Cortisol Calibrator VITROS Immunodiagnostic Products Metabolism Controls

Indications for Use:

The measurement of cortisol in human serum, plasma (heparin or EDTA) or urine aids in the assessment of adrenal status.

Prescription Use (Per 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

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

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