(48 days)
The intended use of this product is the quantitative determination of Calcitonin in human 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).
Quantitative determination of Calcitonin in human serum. This immunoassay is based on the principles of the two site "sandwich" Enzyme-Linked ImmunoSorbent Assay (ELISA).
Here's an analysis of the provided information to describe the acceptance criteria and study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) submission for the Sangui BioTech, Inc. Calcitonin ELISA primarily relies on demonstrating substantial equivalence to a predicate device. The key acceptance criterion is a strong correlation between the new device and the predicate.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| High correlation (R value) with predicate device | R = 0.99 (with Scantibodies Calcitonin Assay) |
| Slope close to 1.0 | Slope = 0.940 |
| Intercept close to 0 | Intercept = 6.6 |
| Consistent measurement across relevant range | Samples ranged from 0.8 to 3,113 pg/mL (in predicate kit) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Seventy-seven (77) patient sera.
- Data Provenance: The document does not explicitly state the country of origin. It is a retrospective comparison study as existing patient sera were analyzed using both devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of study does not involve "experts" in the traditional sense for ground truth establishment. The ground truth here is the measurement obtained from the predicate device (Scantibodies Calcitonin Assay Immunoradiometric (IRMA) Assay), which is considered the established standard. Therefore, no external experts were used to establish ground truth for this comparison.
4. Adjudication Method for the Test Set
Not applicable. This was a direct comparison of analytical results between two devices, not a scenario requiring adjudication of imaging interpretations or clinical outcomes. The predicate device's results served as the reference.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
Not applicable. This is an in vitro diagnostic device (ELISA kit) for quantitative determination of Calcitonin. It does not involve human readers interpreting images or clinical cases, nor does it involve AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, this is an inherent standalone performance study. The Calcitonin ELISA kit is a laboratory-based assay, and its performance is evaluated based on its own analytical results compared to a reference method, without human "in-the-loop" decision-making during the analytical process itself. The "algorithm" here is the biochemical reaction and measurement process of the ELISA kit.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The ground truth used was the results obtained from a legally marketed predicate device, the Scantibodies Calcitonin Assay Immunoradiometric (IRMA) Assay. This is often referred to as a "comparative ground truth" or "reference method" in analytical performance studies for in vitro diagnostic devices. Additionally, the document mentions another predicate, the Nichols Institute Diagnostics Calcitonin Chemiluminescence Assay, uses the same antibodies and epitopes, further bolstering the claim of equivalence.
8. The Sample Size for the Training Set
Not explicitly stated, nor is a "training set" relevant in the context of this 510(k) submission. This is a comparison of a finished device's performance against a predicate, not a machine learning model requiring training. Any internal development or optimization of the Sangui BioTech ELISA kit would have occurred prior to this submission and would not be typically detailed as a "training set" in this manner.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of this 510(k) submission for an ELISA kit comparison. The development of the ELISA kit itself would involve established chemical and biological principles and optimization processes, rather than ground truth labeling for a training set.
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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.
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 (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 ...........
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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
§ 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.