FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL

K103676 · Fujirebio Diagnostics,Inc. · OIU · Jul 19, 2011 · Immunology

Device Facts

• Record ID: K103676
• Device Name: FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL
• Applicant: Fujirebio Diagnostics,Inc.
• Product Code: OIU · Immunology
• Decision Date: Jul 19, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.6010
• Device Class: Class 2

Intended Use

The HE4 EIA is an enzyme immunometric assay for the quantitative determination of HE4 in human serum. The assay is to be used as an aid in monitoring recurrence or progressive disease in patients with epithelial ovarian cancer. Serial testing for patient HE4 assay values should be used in conjunction with other clinical methods used for monitoring ovarian cancer. Fujirebio Diagnostics Tumor Marker Control is intended for use as an assayed control serum to monitor the precision of laboratory testing procedures for the analytes listed in the lot specific assigned values sheet.

Device Story

The Fujirebio Diagnostics Tumor Marker Control is a multi-analyte, lyophilized human serum-based control material used to monitor the precision of laboratory testing procedures for HE4 and other tumor markers (AFP, CA 15-3, CA 19-9, CA 125, CEA, Ferritin, PSA, Free PSA). It replaces the control previously supplied with the HE4 EIA kit (k072939). The control is reconstituted with distilled or deionized water and analyzed alongside patient samples using a microplate reader. Laboratory personnel use the control to verify the performance and precision of the HE4 EIA assay. By ensuring the assay is performing within established target ranges, the device helps clinicians maintain the reliability of serial HE4 testing, which is used as an aid in monitoring recurrence or progressive disease in patients with epithelial ovarian cancer.

Clinical Evidence

No clinical data. Bench testing only. Precision/reproducibility study conducted over 10 days with 2 operators, 2 runs per day, and 2 replicates per run. Stability testing performed per CEN 13640, including accelerated, real-time, open-vial, and freeze/thaw (up to 9 cycles) studies.

Technological Characteristics

Lyophilized human serum-based control material. Contains preservatives (MIT 0.1 g/L) and stabilizers (Methylamine 7.5 g/L, Sucrose 60 g/L). Reconstituted with 3.0 mL distilled/deionized water. Stability: 18 months at 2–8°C (lyophilized); 14 days at 2–8°C or 60 days at ≤ -20°C (reconstituted).

Indications for Use

Indicated for use as an assayed control serum to monitor the precision of laboratory testing procedures for specific analytes in human serum. For in vitro diagnostic use only.

Regulatory Classification

Identification

A tumor-associated antigen immunological test system is a device that consists of reagents used to qualitatively or quantitatively measure, by immunochemical techniques, tumor-associated antigens in serum, plasma, urine, or other body fluids. This device is intended as an aid in monitoring patients for disease progress or response to therapy or for the detection of recurrent or residual disease.

Special Controls

*Classification.* Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled “Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA,” and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.

Predicate Devices

• HE4 EIA (K072939)

Reference Devices

• Fujirebio Diagnostics Tumor Marker Control (k101809)

Submission Summary (Full Text)

{0}------------------------------------------------

Premarket Notification (510(k)) HE4 EIA Control Replacement

' ﻣ

ﺮ

Image /page/0/Picture/2 description: The image shows the logo for FUJIREBIO Diagnostics, Inc. The logo consists of a stylized graphic to the left of the company name. The graphic is a geometric shape with black and white sections. The text "FUJIREBIO Diagnostics, Inc." is in a bold, sans-serif font.

### 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: K103676

# Submitter Information

| Address: | Fujirebio Diagnostics, Inc.<br>201 Great Valley Parkway<br>Malvern, PA 19355 |
|---------------------------|------------------------------------------------------------------------------|
| Contact person: | Diana L Dickson<br>[phone]<br>[e-mail] |
| Summary preparation date: | July 18, 2011 |
| Name of Device: | |
| 510(k) number: | K072939 |
| Trade/Proprietary Name: | HE4 EIA Kit |
| Common/Usual Name: | Tumor-associated Antigen Immunological Test System. |
| Regulation Number: | 21 CFR §866.6010 |
| Regulatory Class: | Class II |
| Product Code: | OIU, epithelial ovarian tumor associated antigen test (HE4) |
| 510(k) number: | K101809 |
| Trade/Proprietary Name: | Fujirebio Diagnostics Tumor Marker Control |
| Common/Usual Name: | Quality control material (assayed and unassayed). |
| Regulation Number: | 21 CFR 862.1660 |
| Regulatory Class: | Class I, reserved |
| Product Code: | JJY, Multi-Analyte Controls, All kinds, (Assayed) |
| Predicate Device: | |
| HE4 EIA (K072939) | |

{1}------------------------------------------------

Image /page/1/Figure/1 description: The image shows the logo for Fujirebio Diagnostics, Inc. The logo consists of a stylized symbol on the left, followed by the company name in bold, sans-serif font. Below the company name is the text "Diagnostics, Inc." in a smaller font size.

### Purpose of Submission

The purpose of the Fujirebio Diagnostics Tumor Marker Control (for use with HE4 EIA) 510(k) submission is to replace the current HE4 EIA kit controls (cleared under K072939) with the Fujirebio Diagnostics Tumor Marker Control (cleared under K101809).

The Fuiirebio Diagnostics Tumor Marker Controls are used for validation of each HE4 EIA assay series. The HE4 EIA results should be considered valid if the mean HE4 values of control duplicates are within the specified HE4 EIA ranges indicated on the Assigned Value Sheet provided with the Fujirebio Diagnostics Tumor Marker Controls.

### Intended Use of the Fujirebio Diagnostics Tumor Marker Control

For In Vitro Diagnostic Use Only.

Fujirebio Diagnostics Tumor Marker Control is intended for use as an assayed control serum to monitor the precision of laboratory testing procedures for the analytes listed in the lot specific assigned values sheet.

A comparison of the features of the Fujirebio Diagnostics Turnor Marker Control and the Predicate Device are as follows:

| Similarities | | | | |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| | Fujirebio Diagnostics Tumor<br>Marker Control<br>(K101809) | HE4 EIA kit controls<br>(K072939) | | |
| Intended Purpose | Validation of each HE4 EIA assay<br>series.<br>The HE4 EIA results should be<br>considered valid if the mean HE4<br>values of control duplicates are<br>within the specified HE4 E!A<br>ranges | Validation of each HE4 EIA assay<br>series.<br>The HE4 EIA results should be<br>considered valid if the mean HE4<br>values of control duplicates are<br>within the specified HE4 EIA<br>ranges | | |
| Supplier | Manufactured by Fujirebio<br>Diagnostics | Manufactured by Fujirebio<br>Diagnostics | | |
| Matrix | Human Serum | Human Serum | | |
| Form | Lyophilized | Lyophilized | | |
| HE4 Analyte | Purified, recombinant antigen | Purified, recombinant antigen | | |
| Control Levels | 2 | 2 | | |
| Storage (unopened) | Store the kit at 2-8°C. | Store the kit at 2-8°C. | | |
| Shelf Life (unopened) | 18 months | 18 months | | |

{2}------------------------------------------------

Premarket Notification (510(k)) HE4 EIA Control Replacement

:"

ن

Image /page/2/Picture/1 description: The image shows the logo for "FUJIREBIO Diagnostics, Inc.". The logo consists of a stylized graphic to the left of the text. The graphic is a combination of black and white shapes with vertical lines. The text "FUJIREBIO" is in bold, and "Diagnostics, Inc." is below it in a smaller font.

| Differences | | | | |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|--|--|
| | Fujirebio Diagnostics Tumor<br>Marker Control<br>(K101809) | HE4 EIA kit controls<br>(K072939) | | |
| Controls Supplied | Sold Separately | Sold with HE4 EIA kit | | |
| Analyte (s) | HE4 (Human Epididymis Protein 4)<br>AFP (Alpha-Fetoprotein)<br>CA 15-3<br>CA 19-9<br>CA 125<br>CEA (Carcinoembryonic Antigen)<br>Ferritin<br>HE4 (Human Epididymis Protein 4)<br>PSA (Prostate Specific Antigen)<br>Free PSA | HE4 (Human Epididymis Protein 4) | | |
| Target HE4<br>Concentrations | 75 and 500 pM* | 50 and 400 pM* | | |
| Target HE4 Ranges | Ranges of expected results<br>indicated on the Assigned Value<br>Sheet provided with the Fujirebio<br>Diagnostics Tumor Marker<br>Controls. | Ranges of expected results are<br>indicated on the vial labels. | | |
| Reconstitution Volume | 3.0 mL distilled or deionized water | 1.0 mL distilled or deionized water | | |
| Stability after | 14 days at 2-8°C | 4 weeks at 2-8°C | | |
| Reconstitution | 60 days at -20°C or below | 4 months at -20°C or below | | |

*Target concentration differences are acceptable - the claimed HE4 EIA range is 15 – 900 pM, with an upper limit of normal of 150 pM. (Refer to HE4 E!A package insert)

# Value Assignment comparisons:

| Fujirebio Diagnostics Tumor Marker<br>Control<br>(K101809) | HE4 EIA kit controls<br>(K072939) |
|---------------------------------------------------------------------------------|----------------------------------------------------------|
| 24 replicate analyses collected in 4<br>independent runs | 26 replicate analyses collected in 2<br>independent runs |
| Different HE4 EIA kit reagent combinations<br>in each run | Same HE4 EIA kit reagent combination in<br>each run |
| CV <8% within run.<br>Mean value for each run within ± 2SD for<br>other 3 runs. | Total CV% $≤$ 5 |
| Assigned range for HE4 EIA | Assigned range |
| Control Level 1: | HE4 EIA kit Control Level 1: |
| Total Mean ± 2SD but not less than ± 30% | Total Mean ± 30% |
| Assigned range for HE4 EIA | Assigned range |
| Control Level 2: | HE4 EIA kit Control Level 2: |
| Total Mean ± 2SD but not less than ± 25% | Total Mean ± 20% |

{3}------------------------------------------------

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

・・

Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern. Inside the circle is a stylized image of a human figure, possibly representing a family or individual, with flowing lines suggesting movement or progress.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Fujirebio Diagnostics, Inc. c/o Ms. Diana Lyn Dickson Regulatory Affairs Manager 201 Great Valley Parkway Malvern, PA 19355

JUL 1 9 2011

Re: k103676

Trade/Device Name: HE4 EIA kit

Fujirebio Diagnostics Tumor Marker Control Regulation Number: 21 CFR §866.6010 Regulation Name: Tumor-associated Antigen Immunological Test Regulatory Class: Class II Product Code: OIU, JJY Dated: July 7, 2011 Received: July 8, 2011

Dear Ms. Dickson:

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 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 class II (Special Controls), 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); medical device reporting (reporting of

{4}------------------------------------------------

Page 2 - Ms. Diana Lyn Dickson

medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in vour 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 advice for your device on our labeling regulation (21 CFR Parts 801 and 809), 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" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/industry/support/index.html.

Sincerely yours,

é m cham

Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

# Indications for Use

510(k) Number (if known): k103676

Device Name: HE4 EIA

Indications For Use:

The HE4 EIA is an enzyme immunometric assay for the quantitative determination of HE4 in human serum. The assay is to be used as an aid in monitoring recurrence or progressive disease in patients with epithelial ovarian cancer. Serial testing for patient HE4 assay values should be used in conjunction with other clinical methods used for monitoring ovarian cancer.

Prescription Use

(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 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)

Reena Philip

Division Sign-Off

X

| Office of In Vitro.Diagnostic | |
|-------------------------------|---------|
| Device Evaluation and Safety | |
| 510K | k103676 |

Page 1 of 2

510K __

{6}------------------------------------------------

# Indications for Use

510(k) Number (if known): k103676

Device Name: Fujirebio Diagnostics Tumor Marker Controls

Indications For Use:

For In Vitro Diagnostic Use Only.

Fujirebio Diagnostics Tumor Marker Control is intended for use as an assayed control serum to monitor the precision of laboratory testing procedures for the analytes listed in the lot specific assigned values sheet.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 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)

Reena Philip

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510K

Page 2 of 2