The intended use of this product is the quantitative determination of erythropoietin levels in human serum. This assay is intended as an aid in the diagnosis of anemias and polycythemias. With the advent of the administration of recombinant erythropoietin as a biologic therapy to increase red blood cell mass, an erythropoietin assay may be used also to aid in the prediction and monitoring of response to recombinant erythropoietin treatment in persons with anemias.

Device Description

Quantitative determination of EPO [Erythropoietin] in human serum. This immunoassay is based on the principles of the two site "sandwich" Enzyme-Linked ImmunoSorbent Assay (ELISA).

AI/ML Overview

Here's an analysis of the provided text regarding the Sangui BioTech, Inc. EPO [Erythropoietin] ELISA kit:

The provided text is a 510(k) summary for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive, standalone clinical study for a novel device. Therefore, much of the information typically found in a detailed acceptance criteria and study report for a new device (like a machine learning model) is not explicitly present.

However, we can extract the relevant information and infer some aspects based on the context of a 510(k) submission for an in vitro diagnostic (IVD) device.

Acceptance Criteria and Study Details for Sangui BioTech, Inc. EPO ELISA Kit

Given the context of a 510(k) submission for an ELISA kit, the primary "acceptance criterion" is typically substantial equivalence to a legally marketed predicate device. This is often demonstrated through a correlation study comparing the performance of the new device to the predicate device using patient samples.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criterion (Inferred from 510(k) IVD norms)	Reported Device Performance (from text)
Correlation	High correlation (e.g., R ≥ 0.95 or similar for quantitative assays) between the proposed device and the predicate device results on patient samples.	Correlation coefficient (R) of 0.96 with a regression equation Y = 1.05X + 3.0.
Accuracy / Agreement	Close agreement between the measured values of the proposed and predicate devices. (Often implied by correlation and regression).	The regression equation (Y = 1.05X + 3.0) and high correlation suggest good agreement, where Y is the proposed device and X is the predicate.
Sensitivity	Analytical sensitivity sufficient for intended use. (While a difference is noted, it is documented in labeling).	Proposed device sensitivity: 2.0 mU/mL. Predicate device sensitivity: 0.7 mU/mL. The limitation of the proposed device's sensitivity is documented in the labeling.

Important Note: The 510(k) summary explicitly lists "The data clearly demonstrates excellent correlation between the two devices" as the primary conclusion, fulfilling the requirement for substantial equivalence.

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

Sample Size: One hundred twenty-six (126) patient sera samples.
Data Provenance: Not explicitly stated as retrospective or prospective, nor the country of origin. However, for a 510(k) for an IVD kit, these are typically clinical samples collected from a relevant patient population, likely from a local US population if the submission is for US market clearance. The samples studied ranged from 5 to 291 mU/mL of EPO as measured by the predicate.

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

This concept is not directly applicable in the context of this 510(k) submission for an ELISA kit comparison. The "ground truth" for the comparison study is the measurement obtained from the predicate device (Nichols Institute Diagnostics EPO Assay), which is an already legally marketed and accepted device. There are no human experts "establishing ground truth" by interpreting images or clinical data in this type of study.

4. Adjudication Method for the Test Set

Not applicable. This is a quantitative assay comparison study, not an imaging-based diagnostic study requiring expert adjudication of reader interpretations.

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 (IVD) device (ELISA kit) and does not involve AI or human readers interpreting outputs in the way an imaging AI diagnostic might.

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

This is an inherently standalone device as it is an laboratory assay kit. The performance described (correlation with the predicate) represents the performance of the device itself (the "algorithm" or assay chemistry) without human-in-the-loop performance in the sense of a clinical decision-making aid requiring interpretation.

7. The Type of Ground Truth Used

The "ground truth" for this comparative study is the results obtained from the legally marketed predicate device (Nichols Institute Diagnostics EPO Assay). The study aimed to show that the new Sangui BioTech kit produced results that were statistically equivalent to those of the predicate device.

8. The Sample Size for the Training Set

Not applicable. ELISA kits, especially in this context, are not "trained" in the machine learning sense. The assay's parameters (e.g., antibody concentrations, incubation times) are developed through laboratory optimization processes, not by feeding data into a training algorithm.

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

Not applicable, as there is no "training set" or "ground truth for training" in the machine learning sense for this type of device. The assay development involves standard biochemical and immunological optimization.

Summary

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SECTION 10:

510 (k) SUMMARY

K992799

Name of Contact Person: John J. Kiang Business and Product Development Consultant Former President, Director and CEO and Founder (1996 - November 1998) Licensed Clinical Chemist Scientist (CA)

Name of Proposed Device: Sangui BioTech, Inc. EPO [Erythropoietin] ELISA

Common name of the device: Erthyropoietin Assay

Classification name: EPO [Erythropoietin] Assay

Name of Predicate Device: Nichols Institute Diagnostics EPO [Erythropoletin] Assay Name of Tredicate Device Nicholo motiolo motions bumber: 60-4205, to which this firm claims substantial equivalency.

Description of the proposed device: Quantitative determination of EPO [Erythropoietin] 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 Intended out of the propoietin levels in human serum. This assay is intended as an aid uelemination of erythropolean lovols in haman cordination of the administration of recombinant erythropoietin as a biologic therapy to increase red blood cell mass, an recombinatic crythropoleum as and in the prediction and monitoring of response to recombinant erythropoietin treatment in persons with anemias.

Technological characteristics: Similarities:

The intended use. D

Both kits are based on the 2-site immunometric (sandwich) assay principles. 0
The anitbodies used, which consists of a carboxyl-terminal mouse monoclonal 0 antibody and an affinity purified region-restricted amino-terminal sheep antibody.
Solid phase, both are coated with avidin. D
Capture Antibodies are coupled with biotin.

Technological characteristics: Differences:

Sensitivity the analytical proposed device is 2.0 mU/mL vs. 0.7 mU/mL for the 0 predicate device. The limitation of the proposed device in sensitivity has been proumented in the labeling of the proposed device, i.e. Paragraph 4, Page 7 of the Package Insert, following the Guidance Document of the FDA.
Incubation or reaction time for the immunoassay. 0
Standard range for the Sangui kit and the predicate device (Nichols Institute 0 Diagnostics)
o Sample size.
Tag antibody: horseradish peroxidase labeled vs. acridinium ester labeled. 0
Solid Phase microwell vs. bead. 0
Suggested normal ranges. 0

Based on the study on one hundred twenty-six (126) patient sera analyzed using both the Desco on the bloady on one nedicate device, a correlation coefficient (R) of 0.96 was obtained with a proposed device and the productions as a so. The samples studied ranged from 5 to 291 mU/mL of EPO (Erythropoietin) 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 (HHS) in the USA. The logo features a stylized eagle with three swooping lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.

JUN - 7 2000

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. John J. Kiang Business and Product Development Consultant Sangui Biotech, Inc. 1508 Brookhollow Drive Santa Ana, California 92705

K992799 Re:

Trade Name: Sangui BioTech, Inc. EPO [Erythropoietin] ELISA Kit Regulatory Class: III Product Code: GGT Dated: November 11, 1999 Received: November 15, 1999

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 legally marketed predicate 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 Regulations, Title 21, Parts 800 to 895. A 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 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 regulations.

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Page 2

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" (21CFR 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/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

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:

Device Name:

Sangui BioTech, Inc. EPO [Erythropoietin] ELISA Kit

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE

CONTINUE ON ANOTHER PAGE IF
NEEDED)Concurrence of CBRH, Office of Device Evaluation (ODE)

Peter E. Maher

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K982799

ﺴﺘﺎ Prescription Use (Per 21 CFR 801.109) OR

Over-The Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 864.7250 Erythropoietin assay.

(a)
Identification. A erythropoietin assay is a device that measures the concentration of erythropoietin (an enzyme that regulates the production of red blood cells) in serum or urine. This assay provides diagnostic information for the evaluation of erythrocytosis (increased total red cell mass) and anemia.(b)
Classification. Class II. The special control for this device is FDA's “Document for Special Controls for Erythropoietin Assay Premarket Notification (510(k)s).”