VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL ASSAY

K983990 · Ortho-Clinical Diagnostics, Inc. · CGR · Dec 29, 1998 · Clinical Chemistry

Device Facts

• Record ID: K983990
• Device Name: VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL ASSAY
• Applicant: Ortho-Clinical Diagnostics, Inc.
• Product Code: CGR · Clinical Chemistry
• Decision Date: Dec 29, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1205
• Device Class: Class 2

Intended Use

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

Device Story

VITROS Cortisol assay is an in vitro diagnostic test for quantitative cortisol measurement in human serum, plasma, or urine. The system utilizes a solid-phase immunoassay principle on the VITROS Immunodiagnostic System. The assay employs a sheep polyclonal anti-cortisol antibody and a biotinylated antibody reagent. The system automates the processing of samples, reagents, and calibrators. Healthcare providers use the resulting cortisol concentration values to assist in clinical decision-making regarding adrenal function and related metabolic conditions. The device is intended for use in clinical laboratory settings by trained personnel.

Clinical Evidence

Bench testing only. Performance was evaluated through analytical sensitivity, specificity, precision, dilution studies, and method comparison against the predicate device using Deming's regression (VITROS = 0.83 x Abbott TDx + 16.1 nmol/L). No clinical prospective or retrospective studies were required for this 510(k) clearance.

Technological Characteristics

Solid-phase immunoassay; utilizes VITROS Immunodiagnostic System instrumentation. Reagents include sheep polyclonal anti-cortisol antibody and biotinylated antibody. Calibration range: 3-1700 nmol/L. Sample types: serum, plasma (EDTA/heparin), or urine. Automated system operation.

Indications for Use

Indicated for in vitro quantitative measurement of cortisol in human serum, plasma (EDTA or heparin), or urine for clinical diagnostic purposes.

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

• Abbott TDx Cortisol assay (K854419)

Submission Summary (Full Text)

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# 1. Chapter 1 - Summary Information

## 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in
t CHP 807 97 100 1000 1000 1000 and 21 CHP 807 92 This summary of STO(L) salety and CHOCHO. 1990 and 21 CFR 807.92

The assigned 510(k) number is: 4983990

### 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 6, 1998

#### 2. Device Name

2. Device Name Common Name: Cortisol assay Common Name: Corusol assay for the in virro quantitative measurement of cortisol
Classification Name: CORTISOL assay for the in virro quantitative measurement of cortisol Classification Nama (heparin or EDTA) or urine.

#### 3. Predicate Device

3. Predicate Device
The VITROS Immunodiagnostic Products Cortisol assay is substantially equivalent to ABBOTT TDx Cortisol assay.

#### 4. Device Description

4. Device Description and semi-quantitative determination of selected analytes in human body fluids, commonly and semi-qualifiative technination of verse of the solid phase separation system.

The system is comprised of three main elements:

- e system is complised of the main creatures (in this case VITROS Immunodiagnostic The VITROS Immunodiagnosa Prosic VITROS Immunodiagnostic Products CORTISOL Products Cortisor Reagent Pass, VITROS of Continent Metabolism Controls, which are Canbiators, and VITROS Immunodiagnostic System to perform the VITROS Cortisol assay).
1-1

-

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## 510K Summary, Continued

- 2. The VITROS Immunodiagnostic System instrumentation, which provides automated
System of the Children Carmers of Campension System was cleared for The VITROS immunodiagnostic System - Immunodiagnostic System was cleared for market by a separate 510(k) pre-market notification (K962919).
- 3. Common reagents used by the VITROS System in each assay. The VITROS Common reagents used by the VIS TICS ent, VTTROS Immundiagnostic Products Immunodiagnosus Products of gian Reagents "Products Tigh Sample Diluent B
Universal Wash Reagent and VITROS Immunodiagnostic Hish Sample Dilucy I Universal Wash Reagent and VITROS Immunodiagnostic Products Total T3 510(k) premarket notification (K984310).

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

#### 5. Device Intended Use

The VITROS CORTISOL assay is intended for the in vitro quantitative measurement of cortisol in human serum or plasma (EDTA or heparin) or urine.

#### 6. Comparison to Predicate Device

The VITROS Immunodiagnostic Products Cortisol assay is substantially equivalent Abboth The VITROS immunodiagnostic I rocess Corress and over of DA (K854419) for IVD use. =

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

VITROS Cortisol assay = 0.83 x Abbott TDx Cortisol assay = 16.1 nmol/L VITROS Cortisons of the VITROS Cortisol assay and the predicate device were performed with samples from a variety of clinical categories.

In addition to the study mentioned above, tests were performed to obtain analytical sensitivity, spficity, prsion, dilution and expected values. Refer to the VITROS Cortisol assay package insert for VITROS Cortisol assay results.

Table 1 lists the similarities and differences of the device characteristics between the VITROS CORTISOL assay with the predicate device, Abbott TDX Cortisol assay.

| Device<br>Characteristic | VITROS CORTISOL<br>assay | Predicate<br>Device |
|--------------------------|--------------------------|-------------------------|
| Calibration range | 3 - 1700 nmol/L | 3- 1655 nmol/L |
| Basic principle | Solid phase immunoassay | Solid phase immunoassay |
| Tracer | Enzyme labeled | Fluorescein labeled |

#### Table 1 List of the assay characteristics

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## 510K Summary, Continued

| | Table 1 (continued) | |
|--|---------------------|--|
| | | |

| Device<br>Characteristic | VITROS CORTISOL<br>assay | Predicate<br>Device |
|--------------------------|----------------------------------------------------------------------------------|--------------------------------------------------------------------------|
| Instrumentation | VITROS<br>Immunodiagnostic System | Abbott TDx |
| Sample type | Serum, plasma (EDTA or<br>heparin) or urine | Serum, plasma or urine |
| Antibody | Sheep polyclonal anti-<br>cortisol antibody<br>biotinylated antibody<br>reagent. | Mouse monoclonal and<br>Goat polyclonal anti- cortisol antibody reagent. |

#### 7. Conclusions

The data presented in the pre-market notification demonstrate that the VITROS Cortisol assay performs substantially equivalent to the cleared predicate device.

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 Cortisol assay is safe and effective for the stated intended use.

fr

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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird-like figure.

DEC 29 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Anne Zavertnik Regulatory Affairs Associate Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Canal Ponds Rochester, NY 14626-5101

K983990 Re:

R963790
Trade Name: Vitros Immunodiagnostic Products Cortisol Assay Regulatory Class: II Product Code: CGR Dated: December 8, 1998 Received: December 9, 1998

Dear Ms. Zavertnik:

We have reviewed your Section 510(k) notification of intent to market the device esferenced We have reviewed your Security notificals to substantially equivalent (for the indications for above and we nave determined the covices in ed predicate devices marketed in interstate use stated in the enclosure) to logally manacted produced be dedical Device Amendments, commerce prior to May 26, 1770, the characerdance with the provisions of the Federal
or to devices that have been reclassified in accordance with the device, whices to or to devices that have been reclassince in association withing of the devices anbiect to the Food, Drug, and Cosment Act (Act. The general controls provisions of the Act include general collulus provisions of the relises, 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 (Premarket Approval), it may of sucree to ved in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Fars 800 to 695. Tr subscribed in the requirements, as set forth in the Quality System Current Good Manufacturing Provation (21 CFR Part 820) and that, Regulation (QS inspections, the Food and Drug Administration (FDA) will verify such unfough periode QS mspocation, as e e GMP regulation may result in regulatory action. In assumptions. I and o to ish further announcements concerning your device in the Federal addition, I DA may pather farmse 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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Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device Under the Clinical Laboratory improvement Annelation of if it does, you should contact
may require a CLLA complexity categorization. To determine if it index.7655. may require a CLIA complexity calogorization (CDC) at [phone].
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) This letter will allow you to begin mailscang your actively of your device to a
premarket notification. The FDA finding of substantial equivalence of your device to a premarket notification. The FUA industry of substancial equivalence of 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
CFF Partification in the discussion line lausses, please sentest the Office of If you desire specific anyon in your disgustic devices), please contact the Office of
and additionally 809.10 for in 2001 in Hilmolic devices on the promotion and and additionally 809.10 for in vita untile of coussions on the promotions and Compliance at (301) 5944386. Auduction the Office of Compliance at [phone].
advertising of your device, please contractive becames as premarket Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CPR 807.97). Other general information on your responsibilities under the notification" (21 CFK 807.77). Other gealited intonation on on Assistance at its toll free Act may be obtained from the DNA of ST or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Autman

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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| | Page 1 of 1 |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number (if known): | K 983990 |
| Device Name: | VITROS Immunodiagnostic Products Cortisol Reagent Packs<br>and VITROS Immunodiagnostic Products Cortisol Calibrators. |
| | VITROS Immunodiagnostic Products Metabolism Controls |
| Indications for Use: | For in vitro quantitative measurement of cortisol in human<br>serum, plasma (EDTA or heparin) or urine. |
| | For in vitro use in monitoring the performance of the VITROS<br>Immunodiagnostic System when used for the measurement of<br>cortisol in human serum, plasma (EDTA or heparin) or urine. |

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|------------------------------------------------------------------|
| | <div align="right">(Division Sign-Off)</div> |
| | <div align="right">Division of Clinical Laboratory Devices</div> |
| | <div align="right">510(k) Number K983950</div> |
| Prescription Use<br>(Per 21 CFR 801.109) | OR Over-The-Counter Use<br>(Optional Format 1-2-96) |

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