MIDSTREAM ONESTEP PREGNANCY HOME TEST by SYNTRON BIORESEARCH, INC.

The Midstream and Besure Plus pregnancy test is a sandwich solid phase dye-conjugate non-enzyme immunoassay. As the specimen is added to the reaction device, the gold-solantibody conjugate binds to the hCG in the specimen forming an antibody-antigen complex. This complex binds to the anti-hCG antibody in the positive reaction zone and produces a purple-pink color band when hCG concentration is equal or greater than 25 mIU/ml. In the absence of hCG, there is no purple-pink line in the positive reaction zone. The reaction mixture continues to flow through the absorbent device, pass the positive reaction zone, producing a purple-pink color band, demonstrating that the reagents and device are functioning correctly.

AI/ML Overview

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance (Midstream OneStep)
Correlation with predicate device (Besure Plus OneStep hCG test)	100% correlation
Correlation with clinical diagnosis	100% correlation

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

Sample Size: 102 consumers (females) participated.
- 93 had a confirmed clinical diagnosis of non-pregnancy.
- 9 had a confirmed clinical diagnosis of pregnancy.
Data Provenance: The data appears to be prospective, as consumers were specifically recruited to use both tests and compare results. The country of origin is not explicitly stated, but the company (Syntron Bioresearch, Inc.) is based in Carlsbad, CA, suggesting a US origin.

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

The ground truth for the test set was established by physicians.
The number of physicians is not explicitly stated.
Their specific qualifications (e.g., years of experience, specialization) are not provided, only that they provided "clinical diagnosis."

4. Adjudication Method for the Test Set:

The document implies a direct comparison, where consumers used both the Midstream OneStep test and the Besure Plus OneStep pregnancy test, and then their results were compared to the "clinical diagnosis submitted by physician."
There's no explicit mention of an adjudication panel or a specific adjudication method like "2+1" or "3+1" for discrepancies between the device and the clinical diagnosis. The implication is that the clinical diagnosis served as the definitive ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. This study focuses on the performance of a new device (Midstream OneStep) against a predicate device (Besure Plus OneStep) and clinical diagnosis, rather than comparing human reader performance with and without AI assistance. The device itself is a diagnostic test, not an AI-assisted diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Yes, a standalone study was done. The "Midstream OneStep Pregnancy Home Test" results were obtained directly by consumers using the device. This represents the performance of the device without explicit human intervention or interpretation beyond the consumer reading the test result. The results were then compared to the predicate device and clinical diagnosis.

7. The Type of Ground Truth Used:

The primary ground truth used was clinical diagnosis, as submitted by a physician.
Additionally, the predicate device (Besure Plus OneStep immunoassay) also served as a comparative ground truth for the new device.

8. The Sample Size for the Training Set:

This document describes a clinical performance study for a new device, not the development or training of an algorithm. Therefore, there is no mention of a training set or its sample size. The tests described are immunoassay kits, which do not typically involve machine learning training sets in their development and validation for this type of regulatory submission.

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

As this is not an AI/algorithm study, the concept of a training set and its ground truth establishment is not applicable to this document.

Summary

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K963341

DEC – 2 – 2 (996

Summary of Safety and Effectiveness

1. Company:

Syntron Bioresearch, Inc. 2774 Loker Avenue West Carlsbad, CA 92008 Phone: 619.930.2200 Charles Yu August 18, 1996

2. Date Prepared:

Midstream OneStep pregnancy test is Syntron Bioresearch, Inc. name for OTC use of solid phase immunoassay in vitro diagnostic test kit for the qualitative determination of human Chorionic Gonadotropin (hCG) in urine. Midstream OneStep pregnancy test is based on comparative data with Besure Plus OneStep immunoassay, an assay for human Chorionic Gonadotropin currently being marketed.

The Principle of Midstream and Besure Plus Pregnancy Test is as follows:

The Two Protocols Are

	Besure Plus OneStepPregnancy Test	Midstream OneStepPregnancy Test
Incubation	5minutes	5minutes
Reagent	No	No
Step	1 Step	1 Step
Cutoff	25 mIU/ml	25 mIU/ml
Urine Cup	No	No

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The Midstream OneStep Pregnancy Home Test was performed by 102 consumers: females selected between the ages of 18 and 49 years old, pregnant and non-pregnant, were told to use midstream test and BeSure Plus pregnancy test and compare both results obtained. Confirmation of clinical status was also based on the clinical diagnosis submitted by physician.

Of the 102 samples tested. 93 had a confirmed clinical diagnosis of non-pregnancy and 9 had a diagnosis of pregnancy. Test results obtained by the consumers showed a 100% correlation between midstream pregnancy test with Syntron's Besure Plus OneStep hCG test. Physician report also indicated a 100% correlation between midstream test and clinical diagnosis.

A survey was conducted on the consumers' educational background who had participated in our pregnancy studies. Of the 102 consumers, approximately 8% of the people have bachelor degrees. 75% of the consumers have high school education and various training in vocational schools. The remaining 17% of the consumers have only junior high school education.

The results form also indicated consumer remarks on the performance of the midstream test. Their remarks are:

A. Two test are virtually the same.
B. Quick & easy.
C. Simple test.
D. Easy to use.
E. Clear signal.
F. Good test.

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PatientI.D.	Midstream OneStephCG Pregnancy Test	Besure PlusPregnancy Test	Clinical Diagnosis
1.	-	-	Non-Pregnant
2.	-	-	Non-Pregnant
3.	-	-	Non-Pregnant
4.	-	-	Non-Pregnant
5.	-	-	Non-Pregnant
6.	-	-	Non-Pregnant
7.	-	-	Non-Pregnant
8.	-	-	Non-Pregnant
9.	+	+	Pregnant
10.	-	-	Non-Pregnant
11.	-	-	Non-Pregnant
12.	-	-	Non-Pregnant
13.	-	-	Non-Pregnant
14.	-	-	Non-Pregnant
15.	+	+	Pregnant
16.	-	-	Non-Pregnant
17.	-	-	Non-Pregnant
18.	-	-	Non-Pregnant
19.	-	-	Non-Pregnant
20.	-	-	Non-Pregnant
21.	-	-	Non-Pregnant
22.	-	-	Non-Pregnant
23.	+	+	Pregnant
24.	-	-	Non-Pregnant
25.	-	-	Non-Pregnant
26.	-	-	Non-Pregnant
27.	-	-	Non-Pregnant
28.	-	-	Non-Pregnant
29.			Non-Pregnant
PatientI.D.	Midstream OneStephCG Pregnancy Test	Besure PlusPregnancy Test	Clinical Diagnosis
30.	-	-	Non-Pregnant
31.	-	-	Non-Pregnant
32.	-	-	Non-Pregnant
33.	-	-	Non-Pregnant
34.	-	-	Non-Pregnant
35.	-	-	Non-Pregnant
36.	-	-	Non-Pregnant
37.	-	-	Non-Pregnant
38.	-	-	Non-Pregnant
39.	-	-	Non-Pregnant
40.	-	-	Non-Pregnant
41.	-	-	Non-Pregnant
42.	-	-	Non-Pregnant
43.	-	-	Non-Pregnant
44.	-	-	Non-Pregnant
45.	-	-	Non-Pregnant
46.	-	-	Non-Pregnant
47.	-	-	Non-Pregnant
48.	-	-	Non-Pregnant
49.	-	-	Non-Pregnant
50.	-	-	Non-Pregnant
51.	-	-	Non-Pregnant
52.	-	-	Non-Pregnant
53.	-	-	Non-Pregnant
54.	-	-	Non-Pregnant
55.	-	-	Non-Pregnant
56.	-	-	Non-Pregnant
57.	-	-	Non-Pregnant
58.	-	-	Non-Pregnant
PatientI.D.	Midstream OneStephCG Pregnancy Test	Besure PlusPregnancy Test	Clinical Diagnosis
59.	+	+	Pregnant
60.	-	-	Non-Pregnant
61.	-	-	Non-Pregnant
62.	-	-	Non-Pregnant
63.	-	-	Non-Pregnant
64.	+	+	Pregnant
65.	-	-	Non-Pregnant
66.	-	-	Non-Pregnant
67.	-	-	Non-Pregnant
68.	-	-	Non-Pregnant
69.	-	-	Non-Pregnant
70.	-	-	Non-Pregnant
71.	-	-	Non-Pregnant
72.	-	-	Non-Pregnant
73.	-	-	Non-Pregnant
74.	-	-	Non-Pregnant
75.	-	-	Non-Pregnant
76.	-	-	Non-Pregnant
77.	-	-	Non-Pregnant
78.	-	-	Non-Pregnant
79.	-	-	Non-Pregnant
80.	-	-	Non-Pregnant
81.	-	-	Non-Pregnant
82.	-	-	Non-Pregnant
83.	-	-	Non-Pregnant
84.	-	-	Non-Pregnant
85.	-	-	Non-Pregnant
86.	-	-	Non-Pregnant
87.	-	-	Non-Pregnant
Patient I.D.	Midstream OneStephCG Pregnancy Test	Besure PlusPregnancy Test	Clinical Diagnosis
88.	-	-	Non-Pregnant
89.	-	-	Non-Pregnant
90.	-	-	Non-Pregnant
91.	-	-	Non-Pregnant
92.	-	-	Non-Pregnant
93.	-	-	Non-Pregnant
94.	+	+	Pregnant
95.	-	-	Non-Pregnant
96.	+	+	Pregnant
97.	-	-	Non-Pregnant
98.	-	-	Non-Pregnant
99.	-	-	Non-Pregnant
100.	-	-	Non-Pregnant
101.	-	-	Non-Pregnant
102.	-	-	Non-Pregnant

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Regulation Number and Section

§ 862.1155 Human chorionic gonadotropin (HCG) test system.

(a)
Human chorionic gonadotropin (HCG) test system intended for the early detection of pregnancy —(1)Identification. A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class II.(b)
Human chorionic gonadotropin (HCG) test system intended for any uses other than early detection of pregnancy —(1)Identification. A human chorionic goadotropin (HCG) test system is a device intended for any uses other than early detection of pregnancy (such as an aid in the diagnosis, prognosis, and management of treatment of persons with certain tumors or carcinomas) is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class III.(3)
Date PMA or notice of completion of a PDP is required. As of the enactment date of the amendments, May 28, 1976, an approval under section 515 of the act is required before the device described in paragraph (b)(1) may be commercially distributed. See § 862.3.