(48 days)
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Nichols Institute Diagnostics Calcitonin Chemiluminescence Assay
No
The description focuses on a standard immunoassay (ELISA) for quantitative determination of Calcitonin, with no mention of AI, ML, or related concepts. The performance study compares the device to a predicate using correlation, which is typical for quantitative assays and does not indicate AI/ML.
No
This device is for the quantitative determination of Calcitonin in human serum, used in the diagnosis and treatment (monitoring) of diseases, not for direct therapeutic intervention.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that "Calcitonin measurements are used in the diagnosis and treatment of diseases involving the thyroid and parathyroid glands." This indicates that the device aids in the diagnosis of medical conditions.
No
The device description clearly indicates it is an immunoassay based on ELISA principles, which is a laboratory-based wet chemistry method requiring physical reagents and equipment, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "quantitative determination of Calcitonin in human serum." This involves testing a sample taken from the human body (serum) in vitro (outside the body) to provide information for diagnosis and treatment.
- Device Description: The description details an "immunoassay based on the principles of the two site 'sandwich' Enzyme-Linked ImmunoSorbent Assay (ELISA)." ELISA is a common technique used in IVD devices to detect and quantify substances in biological samples.
- Sample Type: The device analyzes "human serum," which is a biological sample.
- Purpose: The results are used "in the diagnosis and treatment of diseases involving the thyroid and parathyroid glands." This directly aligns with the purpose of IVD devices, which is to provide information for diagnostic or therapeutic purposes.
The information provided clearly indicates that this device is designed to perform a test on a biological sample outside of the body to aid in medical decision-making, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of this product is the quantitative determination of Calcitonin in human serum. This immunoassay is based on 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).
Product codes
JKR
Device Description
Quantitative determination of Calcitonin in human serum. This immunoassay is based on the principles of the two site "sandwich" Enzyme-Linked ImmunoSorbent Assay (ELISA).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Thyroid and parathyroid glands
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Correlation coefficient (R) of 0.99, slope of 0.940, intercept of 6.6.
Predicate Device(s)
Scantibodies Calcitonin Assay Immunoradiometric (IRMA) Assay (Coated Bead Technology) Part Number: 3KG552
Reference Device(s)
Nichols Institute Diagnostics Calcitonin Chemiluminescence Assay
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1140 Calcitonin test system.
(a)
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).(b)
Classification. Class II.
0
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.
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.
1
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 (770) 488-7655.
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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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 ...........
3
| 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