NICHOLS ADVANTAGE CORTISOL

K042689 · Nichols Institute Diagnostics · CGR · Dec 9, 2004 · Clinical Chemistry

Device Facts

• Record ID: K042689
• Device Name: NICHOLS ADVANTAGE CORTISOL
• Applicant: Nichols Institute Diagnostics
• Product Code: CGR · Clinical Chemistry
• Decision Date: Dec 9, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1205
• Device Class: Class 2

Intended Use

The Nichols Advantage® Cortisol assay is intended for use with the Nichols Advantage® Specialty System for the quantitative determination of cortisol concentrations in human serum, EDTA plasma and urine. Measurements of cortisol are used in the diagnosis and treatment of disorders of the adrenal gland. The Nichols Advantage Cortisol Assay Calibrators are intended for adjustment of the stored curve for the Nichols Advantage Cortisol assay.

Device Story

The Nichols Advantage Cortisol assay is a chemiluminescent competitive binding immunoassay designed for use on the Nichols Advantage Specialty System. It processes human serum, EDTA plasma, or extracted urine samples to quantify cortisol concentrations. The system utilizes magnetic particles coated with avidin to facilitate the competitive binding reaction. The assay is performed in a clinical laboratory setting by trained personnel. The system provides quantitative results, which clinicians use to diagnose and manage adrenal gland disorders. By measuring cortisol levels, the device assists in identifying hormonal imbalances, thereby supporting clinical decision-making regarding patient treatment plans.

Clinical Evidence

No clinical trials were performed. Evidence consists of bench testing, including precision (NCCLS EP5-A), interference (NCCLS EP7-P), and method comparison (NCCLS EP9-A). Method comparison against a commercial RIA (n=150) showed a correlation of r=0.97 (95% CI 0.96-0.98) with a Deming regression of y = 0.70x + 2.5. Analytical sensitivity is ≤0.8 μg/dL; functional sensitivity is ≤2.0 μg/dL. Interference testing showed no significant impact from hemoglobin, triglycerides, bilirubin, or albumin.

Technological Characteristics

Chemiluminescent competitive binding immunoassay. Uses avidin-coated magnetic particles. Requires 12 µL of serum, EDTA plasma, or extracted urine. Incubation: 36 minutes at 37°C. Analytical sensitivity ≤0.8 µg/dL. Designed for use with the Nichols Advantage Specialty System.

Indications for Use

Indicated for quantitative determination of cortisol in human serum, EDTA plasma, and urine to aid in the diagnosis and treatment of adrenal gland disorders.

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

• Diagnostic Product Corporation Coat-A-Count Cortisol RIA (K810891)

Submission Summary (Full Text)

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# K04268

#### 510(k) Summary 12.0

This summary of safety and effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

### 1. Name of Manufacturer, Contact Person and Date Summary Prepared:

Nichols Institute Diagnostics 1311 Calle Batido San Clemente, CA 92673 Phone: [phone] FAX: [phone] Contact Person: Jimmy Wong, Manager of Clinical and Technical Affairs Date Prepared: Sept. 3, 2003

### 2. Device Name:

| Trade/Proprietary Name: | Nichols Advantage® Cortisol |
|-------------------------|-----------------------------------------------------------------|
| Device Name: | Cortisol radioimmunoassay |
| Device Description: | Cortisol (hydrocortisone and hydroxycorticosterone) test system |
| Classification: | 2 |
| Regulation Number: | 862.1205 |
| Product Code: | CGR, Clinical Chemistry |

#### Diagnostic Product Corporation Coat-A-Count Cortisol 3. Predicate Device:

### 4. Device Description:

The Nichols Advantage Cortisol assay contains sufficient reagents for 100 tests. The assay is a chemiluminescent competitive binding assay for cortisol in human serum, plasma, and urine.

### 5. Intended Use:

The Nichols Advantage® Cortisol assay is intended for use with the Nichols Advantage® Specialty System for the quantitative determination of cortisol concentrations in human serum, EDTA plasma and urine. Measurements of cortisol are used in the diagnosis and treatment of disorders of the adrenal gland.

### 6. Comparison to Predicate Device:

The Nichols Advantage Cortisol (Y) was compared to the DPC Coat-A-Count Cortisol RIA (X) previously cleared by the FDA (K810891, 4/14/81). One hundred fifty (150) serum samples in which the clinical diagnosis were unknown were assayed in duplicate by both methods following each manufacturers' directions. The range observed with method "X" was 1.9 to 68.2 µg/dL; range for method "Y" was 2.8 to 49.5 µg/dL. Deming regression analysis of these data vielded an equation of Y = 0.70X + 2.5 (95% Cl for slope and intercept were 0.67 to 0.73, and 1.9 to 3.2, respectively). Pearson's correlation coefficient (r) of the paired data was 0.97.

#### 7. Similarities:

- Specimen type is identical for both methods. .
- Both assays use cortisol calibrators, are based upon competitive binding technology, and . both report values using the same units: uq/dL.
- Both assays use a specific antibody to cortisol to measure the hormone in serum or plasma ● samples, and after extraction in urine samples.

#### 8. Differences:

The following differences pertain to differences in immunoassay technology and do not affect the intended uses of each assay.

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| Feature | Nichols Advantage Cortisol | DPC Coat-A-Count Cortisol |
|-----------------------------------|---------------------------------------------------|------------------------------------------------------|
| Sample Size: | 12 µL serum or EDTA plasma and<br>extracted urine | 25 µL serum or heparin plasma<br>and extracted urine |
| Binding Technology | Magnetic particles - avidin coated | Antibody coated tubes |
| Incubation steps and temperature: | 36 minutes @ 37°C | 45 minutes @ 37°C |
| Analytical sensitivity | ≤0.8 µg/dL | 0.2 µg/dL |
| Sample Bias | Heparinized values are lower | EDTA values are higher |

#### Comparison of Performance Characteristics 9.

| Feature | Nichols Advantage Cortisol | DPC Coat-A-Count Cortisol |
|----------------------------|----------------------------|---------------------------|
| Within-Run Precision (%CV) | 3.6-8.7% | 3.0-5.1% |
| Total Precision (%CV) | 7.1-17.4% | 4.0-6.4% |
| Recovery | 97-109% | 91-100% |
| Linearity | 94-107% | 92-101% |

Conclusions: These data, which were provided to FDA, demonstrate safety and effectiveness of the Nichols Advantage Cortisol for its intended in vitro diagnostic use. Furthermore, based on performance characteristics, the Nichols Advantage Cortisol assay is substantially equivalent to the predicate method.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three curved lines that resemble a human figure, possibly representing health and well-being. The text is in all caps and reads "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)".

Public Health Service

DEC - 9 2004

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Jimmy Wong Manager, Clinical and Technical Affairs Nichols Institute Diagnostics 1311 Calle Batido San Clemente, CA 92673

k042689 Re: Trade/Device Name: Nichols Advantage Cortisol Regulation Number: 21 CFR 862.1205 Regulation Name: Cortisol (hydrocortisone and hydroxycorticosterone) test system Regulatory Class: Class II Product Code: CGR, JIT Dated: September 20, 2004 Received: September 29, 2004

Dear Mr. Wong:

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 cornmerce 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 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 (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 Part 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-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Sincerly, yours,

Cornelia B. Looks

Cornelia B. Rooks, MA Acting 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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Nichols Advantage Cortisol 510K Nov. 19, 2004

## Indications for Use

510(k) Number (if known): K042689

Device Name: Nichols Advantage Cortisol

Indications For Use:

The Nichols Advantage® Cortisol assay is intended for use with the Nichols Advantage® Specialty System for the quantitative determination of cortisol concentrations in human serum, EDTA plasma and urine. Measurements of cortisol are used in the diagnosis and treatment of disorders of the adrenal gland.

The Nichols Advantage Cortisol Assay Calibrators are intended for adjustment of the stored curve for the Nichols Advantage Cortisol assay.

Prescription Use × (Part 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)

Carol C Benson
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ision Sign

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K042689