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).

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).

AI/ML Overview

The provided text describes the Sangui BioTech, Inc. ACTH ELISA kit and its substantial equivalence to a predicate device. The information primarily focuses on the device's technical characteristics and the study conducted to demonstrate its performance.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criterion, though not explicitly stated as a numerical threshold in the document, is implied by the goal of demonstrating substantial equivalency to the predicate device. The primary performance metric used to establish this is the correlation coefficient (R) between the proposed device and the predicate device.

Acceptance Criteria	Numerical Target (Implied by Substantial Equivalency)	Reported Device Performance
Correlation (R)	High correlation (close to 1) between proposed device and predicate device	0.995

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: One hundred seventeen (117) patient plasma samples.
Data Provenance:
- Country of Origin: Not specified in the provided text.
- Retrospective or Prospective: Not specified in the provided text. It is simply stated that "patient plasma analyzed using both the proposed device and the predicate device."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the text. The study compares the proposed device's performance against a "predicate device" (Nichols Institute Diagnostics ACTH Radioisotopic Assay), not against a 'ground truth' established by human experts in the traditional sense of a diagnostic interpretation study. The predicate device's results are effectively the reference standard in this comparison.

4. Adjudication Method for the Test Set

This information is not applicable/not provided in the context of this type of study. The study compares quantitative results from two devices, not subjective interpretations requiring adjudication.

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

This information is not applicable/not provided. The study is a comparison of two in vitro diagnostic (IVD) kits, not an AI-assisted diagnostic imaging or interpretation study involving human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This study is inherently a standalone performance assessment of the device (an ELISA kit) as it's an in vitro diagnostic test. The device itself performs the quantitative determination; there is no human-in-the-loop component for the device's operation in the context of this evaluation. The comparison is between two automated assay systems.

7. The Type of Ground Truth Used

In this context, the "ground truth" or reference standard for comparison is the results obtained from the predicate device: Nichols Institute Diagnostics ACTH Radioisotopic Assay. The data used for comparison ranged from 1.5 to 1,045 pg/mL of ACTH as measured by the predicate device.

8. The Sample Size for the Training Set

This information is not provided and is generally not applicable to the evaluation of an ELISA kit in the same way it would be for a machine learning algorithm. An ELISA kit is a biochemical assay, not an algorithm that requires a "training set" to learn from data.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no "training set" for an ELISA kit in the context of its development and validation.

Summary

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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.

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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 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:
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:

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

(Division Sign-Off)
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Division of Clinical Laboratory Devices

510(k) Number	K982608
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Prescription Use (Per 21 CFR 801.109)	OR	Over-The Counter Use (Optional Format 1-2-96)
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Regulation Number and Section

§ 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.