(23 days)
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No
The summary describes a standard immunoassay (ELISA) for quantitative determination of ACTH, with no mention of AI or ML technologies in the intended use, device description, or performance studies.
No
The device is an in vitro diagnostic (IVD) immunoassay designed for measuring ACTH levels, not for treating a disease or condition.
Yes
The device is described as an "immunoassay" for the "quantitative determination of ACTH [Adrenocorticotropic Hormone] in human EDTA plasma," which is used to measure a specific substance in the body, indicating it's used to help diagnose or monitor a medical condition.
No
The device description clearly indicates it is an immunoassay based on ELISA principles, which is a laboratory-based test involving physical reagents and equipment, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "quantitative determination of ACTH [Adrenocorticotropic Hormone] in human EDTA plasma." This involves testing a sample taken from the human body (plasma) in vitro (outside the body) to gain information about a medical condition or state (ACTH levels).
- Device Description: The description reinforces the intended use and specifies the method used (ELISA), which is a common technique for in vitro diagnostic testing.
- Performance Studies: The performance studies compare the device's results to a predicate device for measuring ACTH in patient plasma, further indicating its use for diagnostic purposes.
- Key Metrics: The mention of "Sensitivity" is a common metric used to evaluate the performance of diagnostic tests.
- Predicate Device: The identification of a predicate device (Nichols Institute Diagnostics ACTH Radioisotopic Assay) which is also an assay for measuring ACTH, strongly suggests that the proposed device is intended for the same diagnostic purpose.
All these elements align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
N/A
Intended Use / Indications for Use
The intended use of this product is the quantitative determination of ACTH [Adrenocorticotropic Hormone] in human EDTA plasma. This immunoassay is based on the principles of the two site "sandwich" Enzyme-Linked ImmunoSorbent Assay (ELISA).
Product codes (comma separated list FDA assigned to the subject device)
CKG
Device Description
Quantitative determination of ACTH in human EDTA plasma. This immunoassay is based on the principles of the two site "sandwich" Enzyme-Linked ImmunoSorbent Assay (ELISA).
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Based on the study on one hundred seventeen (117) patient plasma analyzed using both the proposed device and the predicate device, a correlation coefficient (R) of 0.995 was obtained with a slope of 0.976 and an intercept of 4.2. The samples studied ranged from 1.5 to 1,045 pg/mL of ACTH in the Nichols Institute Diagnostics' kit. The data clearly demonstrates excellent correlation between the two devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity -- the analytical proposed device is 0.5 vs. 1 pg/mL for the predicate device
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Nichols Institute Diagnostics ACTH [Adrenocorticotropic Hormone] Radioisotopic Assay Catalog Number: 40-2194 or 40-2195
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 862.1025 Adrenocorticotropic hormone (ACTH) test system.
(a)
Identification. An adrenocorticotropic hormone (ACTH) test system is a device intended to measure adrenocorticotropic hormone in plasma and serum. ACTH measurements are used in the differential diagnosis and treatment of certain disorders of the adrenal glands such as Cushing's syndrome, adrenocortical insufficiency, and the ectopic ACTH syndrome.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows a date, AUG 1 9 1998, in a simple, sans-serif font. The letters and numbers are printed in black ink. The date is formatted as month, day, and year.
Image /page/0/Picture/1 description: The image shows a sequence of handwritten digits and a letter. The sequence starts with the letter 'K', followed by the numbers '982608'. The numbers are written in a connected manner, with some of the digits slightly overlapping each other. The handwriting style appears to be cursive.
Sanqui BioTech, Inc .
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. ACTH [Adrenocorticotropic Hormone] ELISA
Common name of the device: in vitro Diagnostic Kit
Classification name: Radioimmunoassay, ACTH
Name of Predicate Device: Nichols Institute Diagnostics ACTH [Adrenocorticotropic Hormone] Radioisotopic Assay Catalog Number: 40-2194 or 40-2195, to which this firm claims substantial equivalency.
Description of the proposed device: Quantitative determination of ACTH in human EDTA plasma. 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 ACTH in human EDTA plasma.
Technological characteristics: Similarities:
- ប The intended use
- Both kits are based on immunometric (sandwich) assay principles. o
- Sample size and type. ០
- The antibodies used, which consist of a mouse monoclonal antibody and a ប goat polvclonal antibody.
- Suggested normal range for the Sangui kit and the predicate device (Nichols ា Institute Diagnostics).
- Solid phase, both are coated with avidin [microwell vs. bead] ්ය
- Capture antibodies are coupled with biotin.
Technological characteristics: Differences:
- Sensitivity -- the analytical proposed device is 0.5 vs. 1 pg/mL for the predicate device
- Incubation or reaction time for the immunoassay. o
- Standard range for the Sangui kit and the predicate device (Nichols Institute 0 Diagnostics)
- Tag antibody: enzyme labeled vs. radiolabeled o
- · Tag antibody: 1-24 epitope vs. 1-17 epitope.
Based on the study on one hundred seventeen (117) patient plasma analyzed using both the proposed device and the predicate device, a correlation coefficient (R) of 0.995 was obtained with a slope of 0.976 and an intercept of 4.2. The samples studied ranged from 1.5 to 1,045 pg/mL of ACTH 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 USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the seal is a stylized symbol of three human figures connected by a common line, representing the department's focus on people and their well-being. The figures are depicted in a simple, abstract manner.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG | 9 1998
John J. Kianq, M.S. · President and CEO Sangui BioTech, Inc. 1508 Brookhollow Drive, Suite 354 Santa Ana, California 92705
Re : K982608 ACTH (Adrenocorticotropic Hormone) ELISA Kit Regulatory Class: II Product Code: CKG Dated: July 24, 1998 Received: July 27, 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 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 Requlations, Title 21, Parts 800 to 895. ਕੇ 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 Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. 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.
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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 leqally 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 premarket notification" (21 CFR 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 (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: | ||
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| All American And American Andrews Andrews Andrews Andress of the American Andrews of the American Andrews of the American Company of the American Company of the American Comp |
K982608 510 (k) Number: ___
Device Name:
Sangui BioTech, Inc. ACTH [Adrenocorticotropic Hormone] ELISA Kit
Indications For Use:
The intended use of this product is the quantitative determination of ACTH [Adrenocorticotropic Hormone] in human EDTA plasma. This immunoassay is based on the principles of the two site "sandwich" Enzyme-Linked ImmunoSorbent Assay (ELISA).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF
NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| --------------------- | -- |
Division of Clinical Laboratory Devices
| 510(k) Number | K982608 |
|---|---|
| --------------- | --------- |
| Prescription Use (Per 21 CFR 801.109) | OR | Over-The Counter Use (Optional Format 1-2-96) |
|---|---|---|
| --------------------------------------- | ---- | ----------------------------------------------- |