SANGUI BIOTECH, INC. INTACT-PTH (PARATHYROID HORMONE) ELISA by SANGUI BIOTECH, INC.

The intended use of this product is the quantitative determination of Intact Parathyroid Hormone (PTH) in human serum. This immunoassay is based on the principles of the two site "sandwich" Enzyme-Linked ImmunoSorbent Assay (ELISA). The measurement of parathyroid hormone levels in the disease states is intended for the differential diagnosis of hypercalcemia and hypocalcemia resulting from the disorders of calcium metabolism.

Device Description

Quantitative determination of Intact Parathyroid Hormone (PTH) in human serum. This immunoassay is based on the principles of the two site "sandwich" Enzyme-Linked ImmunoSorbent Assay (ELISA).

AI/ML Overview

The provided document describes a 510(k) premarket notification for the "Sangui BioTech, Inc. INTACT-PTH [Parathyroid Hormone] ELISA" kit. This submission is for demonstrating substantial equivalence to a predicate device, not a de novo clearance requiring extensive clinical studies with specific acceptance criteria in the typical sense of a new medical device. The "acceptance criteria" here refers to the criteria for demonstrating substantial equivalence.

Here's an analysis based on the document:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (for Substantial Equivalence to Predicate)	Reported Device Performance	Comments
Primary Criterion: Correlation with Predicate Device	Correlation coefficient (R) of 0.99 with the Nichols Institute Diagnostics Allégro® Intact PTH (Parathyroid Hormone) kit.	This high correlation indicates excellent agreement between the proposed device and the predicate device.
Secondary Criteria: Regression Analysis	Slope of 0.997 and an intercept of 2.9 (compared to the predicate device).	A slope close to 1 and an intercept close to 0 indicate a very similar measurement scale and accuracy relative to the predicate.
Range of Measurement	Samples studied ranged from 3.2 to 805 pg/mL of intact PTH (as measured by the Nichols' kit).	Demonstrates performance across a wide clinical range.
Intended Use	Quantitative determination of Intact Parathyroid Hormone (PTH) in human serum, for differential diagnosis of hypercalcemia and hypocalcemia.	Matches the intended use of a legally marketed predicate device.
Technological Characteristics - Similarities	Two-site "sandwich" ELISA principle, polyclonal goat antibodies purified via affinity chromatography, immunometric assay principles, analytical sensitivity.	The proposed device shares fundamental technological bases with predicate devices (Nichols Allégro and DSL ACTIVE ™ I-PTH ELISA).

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: One hundred and twenty-three (123) patient sera.
Data Provenance: Not specified, but generally for 510(k) submissions, given the commercial nature of the companies involved (Sanqui BioTech, Nichols Institute Diagnostics, Diagnostic Systems Laboratories, Inc.), it is highly likely that the data was collected in a prospective manner for the purpose of this submission, or involved retrospective analysis of banked clinical samples. The country of origin is not explicitly stated.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This type of information is generally not applicable for a 510(k) submission where the goal is to demonstrate substantial equivalence to an existing device. "Ground truth" in this context is established by the predicate device's measurement, which is assumed to be the accepted standard. No independent experts are typically used to establish a separate "ground truth" for a comparative study like this. The predicate device itself serves as the reference.

4. Adjudication method for the test set

Not applicable. This was a direct comparison study between a new device and a predicate device, not a study requiring adjudication of expert interpretations. The "ground truth" was the measurement provided by the legally marketed predicate device.

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 device is an in vitro diagnostic (IVD) kit for measuring a hormone, not an imaging device or an AI diagnostic tool that assists human readers. Therefore, an MRMC study and discussions of human reader improvement with AI are not relevant to this submission.

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

This concept is also not applicable. The device is a laboratory assay kit. Its "performance" is its ability to accurately measure PTH in a sample. The study demonstrated its performance by comparing its measurements to those of a predicate device. There is no "algorithm only" or "human-in-the-loop" concept in the traditional sense for this type of IVD kit; a human performs the assay according to instructions.

7. The type of ground truth used

The ground truth for the performance evaluation was the measurements obtained from the legally marketed predicate device (Nichols Institute Diagnostics Allégro® Intact PTH kit). The assumption in a 510(k) is that the predicate device provides accurate and clinically acceptable measurements.

8. The sample size for the training set

Not applicable. This is an immunoassay kit (ELISA), not a machine learning or AI model that requires a "training set." The development of the assay (e.g., antibody selection, optimize reagents) would involve internal R&D studies, but these are not referred to as "training sets" in this context.

9. How the ground truth for the training set was established

Not applicable, as there is no "training set" in the context of this device's development or the 510(k) submission for substantial equivalence.

Summary

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

DEC 2 3 1997

510 (k) SUMMARY SECTION 9:

Name of Contact Person: John J. Kiang or Patrick Onishi.

Name of Proposed Device: Sangui BioTech, Inc. INTACT-PTH [Parathyroid Hormone1 ELISA

Common name of the device: Intact PTH (Parathyroid hormone) in vitro Diagnostic Kit

Classification name: Radioimmunoassay, Parathyroid hormone

Name of Predicate Device: Nichols Institute Diagnostics Allégro® Intact PTH (Parathyroid Hormone) kit, to which this firm claims substantial equivalency.

Description of the proposed device: Quantitative determination of Intact Parathyroid Hormone (PTH) 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 Intact Parathyroid Hormone (PTH) in human serum.

Technological characteristics: Similarities:

the intended use o
The antibodies used, which are all polycolonal antibodies from goats and are all o purified via affinity chromatography.
Both kits are based on immunometric (sandwich) assay principles. ර
Analytical sensitivity. o

Technological characteristics: Differences:

Sample size o
Incubation or reaction time for the immunoassay.
Tag [ enzyme label antibody vs. radiolabeled antibody].
Solid Phase.

Based on the study on one hundred and twenty-three (123) 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 0.997 and an intercept of 2.9. The samples studied ranged from 3.2 to 805 pg/mL of intact PTH in the Nichols' kit. The data clearly demonstrates excellent correlation between the two devices. Further, another predicate device, the ACTIVE ™ I-PTH ELISA kit, currently manufactured by Diagnostic Systems Laboratories, Inc. (DSL), Webster, Texas 77598-4217, uses the same principle, ELISA, as this proposed device.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 2 3 1997

John J. Kianq, M.S. · President and CEO Sanqui BioTech, Inc. 1508 Brookhollow Drive 92705 Santa Ana, California

K974306 Re : INTACT-PTH [Parathyroid Hormone] ELISA Diagnostic Kit Requlatory Class: II Product Code: CEW November 13, 1997 Dated: November 31, 1997 Received:

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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ರ್ಗ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. 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 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 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
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 Sitman

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:

K974306

Device Name:

Sangui BioTech, Inc. INTACT-PTH (Parathyroid Hormone) ELISA

Indications For Use:

UMclardy Montgomery

ivision of Clinical I

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

Prescription Use
(Per 21 CFR 801.109)

Over-The Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 862.1545 Parathyroid hormone test system.

(a)
Identification. A parathyroid hormone test system is a device intended to measure the levels of parathyroid hormone in serum and plasma. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia (abnormally high levels of calcium in the blood) and hypocalcemia (abnormally low levels of calcium in the blood) resulting from disorders of calcium metabolism.(b)
Classification. Class II.