SANGUI BIOTECH, INC. EPO (ERYTHROPOIETIN) ELISA KIT

K992799 · Sangui Biotech, Inc. · GGT · Jun 7, 2000 · Hematology

Device Facts

• Record ID: K992799
• Device Name: SANGUI BIOTECH, INC. EPO (ERYTHROPOIETIN) ELISA KIT
• Applicant: Sangui Biotech, Inc.
• Product Code: GGT · Hematology
• Decision Date: Jun 7, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7250
• Device Class: Class 2

Indications for Use

The intended use of this product is the quantitative determination of erythropoietin levels in human serum. This assay is intended as an aid in the diagnosis of anemias and polycythemias. With the advent of the administration of recombinant erythropoietin as a biologic therapy to increase red blood cell mass, an erythropoietin assay may be used also to aid in the prediction and monitoring of response to recombinant erythropoietin treatment in persons with anemias.

Device Story

Sangui BioTech EPO ELISA is a quantitative in vitro diagnostic immunoassay for human serum. Device utilizes two-site sandwich ELISA principle; biotin-coupled capture antibodies and horseradish peroxidase-labeled detection antibodies bind to EPO in patient samples. Performed in clinical laboratory settings by trained personnel. Healthcare providers use quantitative EPO results to diagnose anemias/polycythemias and monitor patient response to recombinant erythropoietin therapy. Benefits include objective measurement of EPO levels to guide clinical management of red blood cell mass.

Clinical Evidence

Comparative study of 126 patient serum samples analyzed using both subject and predicate devices. Results showed a correlation coefficient (R) of 0.96. Sample range: 5 to 291 mU/mL EPO.

Technological Characteristics

2-site immunometric (sandwich) ELISA; solid phase coated with avidin; biotin-coupled capture antibodies; horseradish peroxidase-labeled detection antibodies; microwell format.

Indications for Use

Indicated for quantitative determination of erythropoietin in human serum to aid in diagnosis of anemias and polycythemias, and to predict/monitor response to recombinant erythropoietin therapy in patients with anemias.

Regulatory Classification

Identification

A erythropoietin assay is a device that measures the concentration of erythropoietin (an enzyme that regulates the production of red blood cells) in serum or urine. This assay provides diagnostic information for the evaluation of erythrocytosis (increased total red cell mass) and anemia.

Special Controls

*Classification.* Class II. The special control for this device is FDA's “Document for Special Controls for Erythropoietin Assay Premarket Notification (510(k)s).”

Predicate Devices

• Nichols Institute Diagnostics EPO [Erythropoietin] Assay (60-4205)

Submission Summary (Full Text)

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

## SECTION 10:

# 510 (k) SUMMARY

K992799

Name of Contact Person: John J. Kiang Business and Product Development Consultant Former President, Director and CEO and Founder (1996 - November 1998) Licensed Clinical Chemist Scientist (CA)

Name of Proposed Device: Sangui BioTech, Inc. EPO [Erythropoietin] ELISA

Common name of the device: Erthyropoietin Assay

Classification name: EPO [Erythropoietin] Assay

Name of Predicate Device: Nichols Institute Diagnostics EPO [Erythropoletin] Assay Name of Tredicate Device Nicholo motiolo motions bumber: 60-4205, to which this firm claims substantial equivalency.

Description of the proposed device: Quantitative determination of EPO [Erythropoietin] in human serum. This immunoassay is based on the principles of the two site "sandwich" Enzyme-Linked ImmunoSorbent Assay (ELISA).

Intended Use of the proposed device: The intended use of this product is the quantitative Intended out of the propoietin levels in human serum. This assay is intended as an aid uelemination of erythropolean lovols in haman cordination of the administration of recombinant erythropoietin as a biologic therapy to increase red blood cell mass, an recombinatic crythropoleum as and in the prediction and monitoring of response to recombinant erythropoietin treatment in persons with anemias.

Technological characteristics: Similarities:

The intended use. D

- Both kits are based on the 2-site immunometric (sandwich) assay principles. 0
- The anitbodies used, which consists of a carboxyl-terminal mouse monoclonal 0 antibody and an affinity purified region-restricted amino-terminal sheep antibody.
- Solid phase, both are coated with avidin. D
- Capture Antibodies are coupled with biotin.

Technological characteristics: Differences:

- Sensitivity the analytical proposed device is 2.0 mU/mL vs. 0.7 mU/mL for the 0 predicate device. The limitation of the proposed device in sensitivity has been proumented in the labeling of the proposed device, i.e. Paragraph 4, Page 7 of the Package Insert, following the Guidance Document of the FDA.
- Incubation or reaction time for the immunoassay. 0
- Standard range for the Sangui kit and the predicate device (Nichols Institute 0 Diagnostics)
- o Sample size.
- Tag antibody: horseradish peroxidase labeled vs. acridinium ester labeled. 0
- Solid Phase microwell vs. bead. 0
- Suggested normal ranges. 0

Based on the study on one hundred twenty-six (126) patient sera analyzed using both the Desco on the bloady on one nedicate device, a correlation coefficient (R) of 0.96 was obtained with a proposed device and the productions as a so. The samples studied ranged from 5 to 291 mU/mL of EPO (Erythropoietin) in the Nichols Institute Diagnostics' kit. The data clearly demonstrates excellent correlation between the two devices.

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

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) in the USA. The logo features a stylized eagle with three swooping lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.

# JUN - 7 2000

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. John J. Kiang Business and Product Development Consultant Sangui Biotech, Inc. 1508 Brookhollow Drive Santa Ana, California 92705

K992799 Re:

Trade Name: Sangui BioTech, Inc. EPO [Erythropoietin] ELISA Kit Regulatory Class: III Product Code: GGT Dated: November 11, 1999 Received: November 15, 1999

Dear Mr. Kiang:

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 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, 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 regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response 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.

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

## Page 2

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" (21CFR 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 Sutman

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

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

#### Section 6c:

Statement of Indications for Use

510 (k) Number:

Device Name:

Sangui BioTech, Inc. EPO [Erythropoietin] ELISA Kit

### Indications For Use:

The intended use of this product is the quantitative determination of erythropoietin levels in human serum. This assay is intended as an aid in the diagnosis of anemias and polycythemias. With the advent of the administration of recombinant erythropoietin as a biologic therapy to increase red blood cell mass, an erythropoietin assay may be used also to aid in the prediction and monitoring of response to recombinant erythropoietin treatment in persons with anemias.

(PLEASE DO NOT WRITE BELOW THIS LINE

CONTINUE ON ANOTHER PAGE IF
NEEDED)Concurrence of CBRH, Office of Device Evaluation (ODE)

Peter E. Maher

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K982799

ﺴﺘﺎ Prescription Use (Per 21 CFR 801.109) OR

Over-The Counter Use

(Optional Format 1-2-96)