SANGUI BIOTECH, INC. CALCITONIN ELISA KIT

K982491 · Sangui Biotech, Inc. · JKR · Sep 3, 1998 · Clinical Chemistry

Device Facts

• Record ID: K982491
• Device Name: SANGUI BIOTECH, INC. CALCITONIN ELISA KIT
• Applicant: Sangui Biotech, Inc.
• Product Code: JKR · Clinical Chemistry
• Decision Date: Sep 3, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1140
• Device Class: Class 2

Indications for Use

The intended use of this product is the quantitative determination of Calcitonin in human serum. The principles of the two site "sandwich" Enzyme-Linked ImmunoSorbent Assay (ELISA). Calcitonin measurements are used in the diagnosis and treatment of diseases involving the thyroid and parathyroid glands, including carcinoma and hyperparathyroidism (excessive activity of the parathyroid gland).

Device Story

Sangui BioTech Calcitonin ELISA is an in vitro diagnostic kit for quantitative measurement of Calcitonin in human serum. Device utilizes two-site sandwich ELISA principle; employs biotinylated monoclonal capture antibody and enzyme-labeled monoclonal detection antibody. Performed in clinical laboratory settings by trained personnel. Healthcare providers use results to assist in diagnosing and monitoring thyroid and parathyroid conditions, specifically carcinoma and hyperparathyroidism. Provides quantitative data to support clinical decision-making regarding disease management.

Clinical Evidence

Clinical performance evaluated via comparative study of 77 patient serum samples using subject device and predicate Scantibodies IRMA assay. Results demonstrated high correlation with R=0.99, slope=0.940, and intercept=6.6. Sample range 0.8 to 3,113 pg/mL.

Technological Characteristics

In vitro diagnostic ELISA kit. Two-site sandwich immunoassay. Solid phase uses biotinylated monoclonal antibody. Detection uses enzyme-labeled monoclonal antibody. Quantitative measurement of Calcitonin in human serum.

Indications for Use

Indicated for quantitative determination of Calcitonin in human serum to aid in diagnosis and treatment of thyroid and parathyroid gland diseases, including carcinoma and hyperparathyroidism.

Regulatory Classification

Identification

A calcitonin test system is a device intended to measure the thyroid hormone calcitonin (thyrocalcitonin) levels in plasma and serum. Calcitonin measurements are used in the diagnosis and treatment of diseases involving the thyroid and parathyroid glands, including carcinoma and hyperparathyroidism (excessive activity of the parathyroid gland).

Predicate Devices

• Scantibodies Calcitonin Assay Immunoradiometric (IRMA) Assay (Coated Bead Technology) (Part Number: 3KG552)

Reference Devices

• Nichols Institute Diagnostics Calcitonin Chemiluminescence Assay

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of Sangui BioTech, Inc. along with the date SEP 3 1998. The logo is a circular emblem with the words "SANGUI BIOTECH" around the edge. The text "Sangui BioTech, Inc." is written in a simple, sans-serif font. The date is written in a similar font and is located above the company name.

K982491

1508 Brookhollow Drive, Suite 354 Santa Ana, California 92705 USA 714-429-7807 (Voice) 714-429-7808 (Fax)

## SECTION 10:

## 510 (k) SUMMARY

Name of Contact Person: John J. Kiang

Name of Proposed Device: Sangui BioTech, Inc. Calcitonin ELISA

Common name of the device: in vitro Diagnostic Kit

Classification name: Radioimmunoassay, Calcitonin

Name of Predicate Device: Scantibodies Calcitonin Assay Immunoradiometric (IRMA) Assay (Coated Bead Technology) Part Number: 3KG552, to which this firm claims substantial equivalency.

Description of the proposed device: Quantitative determination of Calcitonin 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 determination of Calcitonin in human serum.

Technological characteristics: Similarities:

- the intended use ට
- Both kits are based on immunometric (sandwich) assay principles.
- Analytical sensitivity. 0
- Standard range for the Sangui kit and the predicate device (Scantibodies) 0

Technological characteristics: Differences:

- Sample size
- Incubation or reaction time for the immunoassay.
- Tag antibody: enzyme label monoclonal antibody vs. radiolabeled purified polyclonal antibody. Capture antibody: biotinylated monoclonal antibody vs. direct purified polyclonal antibody coated beads.
- മ Solid Phase.

Based on the study on seventy-seven (77) patient sera analyzed using both the proposed device and the predicate device, a correlation coefficient (R) of 0.99 was obtained with a slope of 0.940 and an intercept of 6.6. The samples studied ranged from 0.8 to 3,113 pg/mL of Calcitonin in the Scantibodies' kit. The data clearly demonstrates excellent correlation between the two devices. Further, another predicate device, the Nichols Institute Diagnostics Calcitonin Chemiluminescence Assay, currently manufactured by Nichols Institute Diagnostic, a Division of Quest Diagnostics, Inc., , San Juan Capistrano, CA.92675, uses the same antibodies (monoclonal) and the same epitopes, as this proposed device.

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle or bird symbol, with three curved lines forming the body and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The text is in all caps and appears to be in a sans-serif font.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

3 1998 SP

John J. Kiang, M.S. President and CEO Sanqui BioTech, Inc. 1508 Brookhollow Drive, Suite 354 Santa Ana, California 92705

Re: K982491 Sanqui BioTech, Inc. Calcitonin ELISA Diagnostic Kit Regulatory Class: II Product Code: JKR Dated: July 15, 1998 Received: July 17, 1998

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 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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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. ਸੈ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: 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 requlations.

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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 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/dsmamain.html".

Sincerely yours,
Steven Litman

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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| Section 6c: | Statement of Indications for Use |
|-----------------|----------------------------------|
| 510 (k) Number: | K982491 |

Device Name: Sangui BioTech, Inc. Calcitonin ELISA Kit

Indications For Use:

inations i of 650.
The intended use of this product is the quantitative determination of Calcitonin in human The Intended asse of the principles of the principles of the two site "sandwich" Enzyme-Calcitonin measurements are used in the Linked ImmunoSorbent Assay (ELISA). diagnosis and treatment of diseases involving the thyroid and parathyroid glands, including carcinoma and hyperparathyroidism (excessive activity of the parathyroid gland).

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEQED) Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

Prescription Use
(Per 21 CFR 801.109)

Over-The Counter Use_

(Optional Format 1-2-96)

(Division Sign-Off)
Division of Clinical Laboratory vices
510(k) Number. K 982491