NICHOLS ADVANTAGE CHEMILUMINESCENCE FERRITIN IMMUNOASSAY

K984186 · Nichols Institute Diagnostics · DBF · Feb 2, 1999 · Immunology

Device Facts

• Record ID: K984186
• Device Name: NICHOLS ADVANTAGE CHEMILUMINESCENCE FERRITIN IMMUNOASSAY
• Applicant: Nichols Institute Diagnostics
• Product Code: DBF · Immunology
• Decision Date: Feb 2, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5340
• Device Class: Class 2

Intended Use

The Nichols Advantage® Chcmiluminescence Ferritin Immunoassay is intended for use on the Nichols Advantage® Specialty System for the quantitative determination of ferritin in human serum or plasma.

Device Story

The Nichols Advantage® Chemiluminescence Ferritin Immunoassay is a two-site chemiluminescence assay used on the Nichols Advantage® Specialty System. It processes human serum or plasma samples to quantify ferritin levels. The device utilizes streptavidin-coated magnetic particles as a solid phase and chemiluminometric technology based on acridinium esters. The assay is performed in a clinical laboratory setting by trained personnel. The system provides quantitative results that assist healthcare providers in diagnosing iron deficiency anemia and iron overload. By measuring ferritin, the device helps clinicians assess iron status, enabling appropriate clinical management of patients with suspected iron-related disorders.

Clinical Evidence

Bench testing only. Performance characteristics include intra-assay precision (%CV 3.9-4.9%) and inter-assay precision (%CV 5.9-12.2%). Method comparison against the predicate showed a correlation coefficient (r) of 0.98 with a linear regression equation of y = 0.94x - 4.7 ng/mL. Recovery ranged from 94-104% and parallelism from 99-114%. High dose hook effect was observed at concentrations greater than 16,000 ng/mL.

Technological Characteristics

Two-site chemiluminescence immunoassay. Uses streptavidin-coated magnetic particles for solid-phase separation. Employs acridinium ester-based chemiluminometric detection. Incubation at 37°C for 30 minutes. Requires 150 microliters of sample. Designed for use on the Nichols Advantage® Specialty System.

Indications for Use

Indicated for the quantitative determination of ferritin in human serum or plasma to aid in the diagnosis of iron deficiency anemia and iron overload.

Regulatory Classification

Identification

A ferritin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the ferritin (an iron-storing protein) in serum and other body fluids. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency amemia.

Predicate Devices

• Chiron Diagnostics ACS:180 Ferritin +C Assay (K905770)

Submission Summary (Full Text)

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FEB 2 1999

Nichols Institute Diagnostics Nichols Advantage® Ferritin 510(k) Notification

# 11.0 510(k) SUMMARY

This summary of 510(k) safety and effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

| 510(k) Number: | not known | K984186 |
|----------------|-----------|---------|
|----------------|-----------|---------|

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

Nichols Institute Diagnostics 33051 Calle Aviador San Juan Capistrano, CA 92675-4703 Phone: [phone] Fax: [phone]

Contact Person: Jimmy Wong Date Prepared: November 20, 1998

# 2. Device Name

| Trade/Proprietary Name: | Nichols Advantage® Chemiluminescence Ferritin<br>Immunoassay |
|-------------------------|--------------------------------------------------------------|
| Common/Usual Name: | Ferritin Assay |
| Classification Name: | Ferritin Immunological Test System |

# 3. Predicate Device:

We claim substantial equivalence to the Chiron Diagnostics ACS:/80° Automated. We claim substantial +C Assay (K905770, Cleared March 12, 1991).

## 4. Device Description:

The Nichols Advantage® Ferritin Assay is a two-site chcmiluminescence assay for use with the Nichols Advantage® Specialty System

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## 5. Intended Use

The Nichols Advantage® Chcmiluminescence Ferritin Immunoassay is intended for use on the Nichols Advantage® Specialty System for the quantitative determination of ferritin in human serum or plasma.

#### 6. Comparison to predicate device:

The Nichols Advantage® Ferritin Assay is substantially equivalent to other products in commercial distribution for similar use. Most notably, it is substantially equivalent to the Chiron Diagnostics ACS:180 Ferritin Immunoassay.

The following tables compare the Nichols Advantage Ferritin Assay with the predicate device, Chiron Diagnostics ACS:180 Ferritin Immunoassay .

#### Similarities:

- Intended Use: For the quantitative determination of ferritin in human serum or plasma ● (Nichols Advantage Ferritin Assay); in serum (Chiron Diagnostics ACS:180 Ferritin Immunoassay).
- Both assays use specific antibodies to bind ferritin. ●
- Both assays use human serum for the test sample. ●
- Both assays use chemiluminometric technology based on acridinium esters. .
- The sensitivity of both assays is sufficient to measure ferritin levels found in normal, . iron deficient and iron overload patients.

| Feature | Nichols Advantage®<br>Ferritin | ACS:180® Automated<br>Chemiluminescence<br>System Ferritin +C<br>Assay |
|-------------|------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sample Size | 150 microliters | 25 microliters |
| Calibration | Two point calibration every two<br>weeks (maximum) of stored<br>working calibration curve; or<br>when controls out of range. | Two point calibration every<br>15 days of stored working<br>calibration curve; or when<br>controls out of range. |
| Solid Phase | Streptavidin-coated magnetic<br>particles. Streptavidin-biotin<br>separation technology. | Mouse monoclonal anti-ferritin<br>antibodies covalently coupled<br>to paramagnetic particles.<br>Antibody sandwich-formation<br>separation technology. |
| Incubation | 30 minutes at 37°C | 7.5 minutes at 37°C |
| Sensitivity | 2 ng/mL in serum or plasma | 0.5 ng/mL in serum |

#### Differences:

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Nichols Institute Diagnostics
Nichols Advantage® Ferritin 510(k) Notification

# Performance Characteristics:

.

..............................................................................................................................................................................

| FEATURE | Nichols Advantage®<br>Chemiluminescence Ferritin | | | Chiron Diagnostics ACS:180®<br>Ferritin +C Assay | | |
|--------------------------------------|--------------------------------------------------|----|------|--------------------------------------------------|----|-----|
| Intra-Assay | Mean<br>(ng/mL) | n | %CV | Mean<br>(ng/mL) | n | %CV |
| | 16 | 20 | 4.6 | 13 | 24 | 2.8 |
| | 48 | 20 | 3.9 | 55 | 24 | 2.8 |
| | 159 | 20 | 4.4 | 163 | 24 | 2.7 |
| | 437 | 20 | 4.9 | 360 | 24 | 3.6 |
| Inter-Assay | Mean<br>(ng/mL) | n | %CV | Mean<br>(ng/mL) | n | %CV |
| | 19 | 20 | 12.2 | 13 | 8 | 5.0 |
| | 47 | 20 | 7.2 | 55 | 8 | 6.1 |
| | 153 | 20 | 6.3 | 163 | 8 | 4.9 |
| | 372 | 20 | 5.9 | 360 | 8 | 5.1 |
| Recovery | 94 - 104 | | | 93 - 112 | | |
| Parallelism | 99 - 114 | | | 92 - 112 | | |
| High Dose Hook Effect | Greater than 16,000 ng/mL | | | 80,000 ng/mL | | |
| Specificity and<br>Cross-Reactivity: | | | | | | |
| Spleen Ferritin | 100% | | | Not Determined | | |
| Liver Ferritin | 100% | | | 106% | | |
| Method Comparison | | | | | | |
| Range of Results | 2.3 ng/mL to 608 ng/mL | | | 7.0 ng/mL to 663 ng/mL | | |
| Linear Regression Equation | $y = 0.94x - 4.7 ng/mL$ | | | | | |
| Correlation Coefficient (r) | 0.98 | | | | | |
| | | | | | | |
| | | | | | | |

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2 1999 FEB

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Jimmy Wong Manager, Clinical and Technical Affairs NICHOLS INSTITUTE DIAGNOSTICS 33051 Calle Aviador San Juan Capistrano, CA 92675-4703

Re: K984186 Trade Name: Nichols Advantage® Chemiluminescence Ferritin Immunoassay Regulatory Class: II Product Code: DBF November 20, 1998 Dated: November 23, 1998 Received:

Dear Mr. Wong:

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 The general controls provisions of the provisions of the Act. 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 Requlations, 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 requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. this response to your premarket notification Please note: 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 Putman

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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# INDICATIONS FOR USE STATEMENT

#### 510(k) Number (if known): K984186

Device Name: Nichols Advantage® Chemiluminescence Ferritin Immunoassay

Indications For Use:

The Nichols Advantage® Chemiluminescence Ferritin Immunoassay is designed for use with the Nichols Advantage® Specialty System for the quantitative determination of ferritin in human serum or plasma. This assay is intended to aid in the diagnosis of iron deficiency anemia and iron overload.

Peter E. Mayeri

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use レ (Per 21 CFR 801.109) OR

Over-The-Counter Use (Optional Format 1-2-96)