The FactPLUS® One Step Pregnancy Test is an over-the-counter in vitro diagnostic immunoassay intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine. This device is the same device as ADVANCE® Pregnancy Test, with a labeling modification that provides for reading the test in three minutes without affecting the accuracy, sensitivity or specificity of the test.

FactPLUS Cne Step Pregnancy Test is indicated for consumer use to detect pregnancy as early as first day of a missed period, using a direct urine stream sampling mode. Test results can be read after three minutes. Some positives appear as soon as one minute, neaative results are confirmed in three minutes.

Device Description

The FactPLUS One Step Pregnancy Test is an elongated "Test Stick" constructed of two pieces of molded plastic which house the internal chemistry strip. The chemistry strip contains a conjugate site, an antibody reaction site and a test control site. There are three openings on the upper surface of the Test Stick:

"Urine Well" .
"Result Window" .
"Control Window" .

Urine is absorbed through the Urine Well and travels along the test membrane to the Result Window (reaction site) and finally to the Control Window. The conjugate (anti-α hCG antibody) present on the membrane is mobilized by the urine flow. If hCG molecules are present in the urine, an hCG/conjugate/complex is formed. The mobilized hCG/conjugate/ complex continues to migrate along the strip to the reaction site where it binds with the anti-ß hCG antibody present on the vertical bar and the polyclonal antibody present on the horizontal bar causing both bars to turn pink. The appearance of pink color on both intersecting bars create the plus sign or "pregnant" result. This reaction generally appears within three minutes. Some positives appear as soon as one minute; however, negative results are confirmed in three minutes.

In the absence of hCG molecules, the conjugate remains unbound and attaches only to the antibody present on the horizontal bar, causing it to turn pink. The appearance of only one reaction bar constitutes the minus or ("not pregnant") result. The urine continues to migrate until it reaches the Control Window where it reacts with a special dye causing a red color to appear. The red color in the CW is an indication that enough urine was added to the device. It takes approximately five minutes after the addition of urine for the Control Window to turn red. A labeling modification and optimization of the test antibodies, enable the results to be read sooner than previous versions of the test and eliminates the restriction of waiting for red color in the Control Window before reading the results.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the FactPLUS® One Step Pregnancy Test, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Stated Goal)	Reported Device Performance (FactPLUS® One Step)
Accuracy at 3 minutes	100% agreement with 5-minute reading (ADVANCE®)
Accuracy at 1 minute (for positive results)	98% agreement with 5-minute reading (ADVANCE®)
Specificity	100% agreement with current labeling directions (ADVANCE®)
Sensitivity	100% agreement with current labeling directions (ADVANCE®)
Consumer interpretation accuracy at 3 minutes	98% (147 out of 150 volunteers)

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

Accuracy, Specificity, Sensitivity Laboratory Test: The text states, "Accuracy was performed using hCG-positive and hCG-negative female clinical urine specimens across three different lots of marketed ADVANCE." It does not specify the exact number of specimens/samples used for these laboratory tests.
Consumer Clinical Study:
- Sample Size: 150 female volunteers.
- Data Provenance: Prospective. The volunteers were "recruited from a Central New Jersey location."

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

Laboratory Tests (Accuracy, Specificity, Sensitivity): The text mentions "Results were confirmed by running another currently marketed pregnancy test simultaneously." However, it does not specify the number or qualifications of experts involved in establishing the ground truth for the lab tests. It implies a comparison against a reliable reference method (another marketed test).
Consumer Clinical Study: The ground truth for the consumer study was the "correct interpretation" of the test results by the consumers themselves, as assessed by the study design, presumably against a known positive/negative status of the volunteer based on the hCG levels in their urine. There's no mention of experts establishing a separate ground truth for this segment beyond the inherent "correctness" of the test's binary outcome.

4. Adjudication Method for the Test Set

Laboratory Tests: No explicit adjudication method (like 2+1 or 3+1) is mentioned. The comparison was against "another currently marketed pregnancy test."
Consumer Clinical Study: Not applicable in the traditional sense, as the evaluation was of the consumers' ability to interpret the test, not of the device's reading requiring expert consensus.

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

No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not done. This device is a manual, over-the-counter diagnostic test, not an AI-assisted diagnostic tool.

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

Again, this is not applicable. The FactPLUS® One Step Pregnancy Test is a non-AI, in-vitro diagnostic immunoassay. Its "standalone" performance is essentially its laboratory performance for accuracy, sensitivity, and specificity, which was indeed evaluated. The consumer study evaluated human-in-the-loop performance (user interpretation).

7. The Type of Ground Truth Used

Laboratory Tests (Accuracy, Specificity, Sensitivity):
- For accuracy, it was a comparison against readings at a longer, established time (5 minutes with ADVANCE®) and confirmed by "another currently marketed pregnancy test." This suggests a reference method/established test comparison acting as the ground truth.
- The "hCG-positive and hCG-negative female clinical urine specimens" implies that the true hCG status of these specimens was known. This would be a form of laboratory-confirmed ground truth (e.g., quantitative hCG levels).
Consumer Clinical Study: The ground truth was the known positive or negative status of the volunteers (based on their hCG levels), against which the consumers' interpretations were compared.

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of machine learning. This device does not use machine learning, so there is no training set for an algorithm. The "training" or optimization referred to is likely in the chemical formulation and labeling, not an AI model.

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

As there is no training set for a machine learning algorithm, this question is not applicable. The "optimization of the test antibodies" refers to product development, not AI training.

Summary

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Jul 2 9 1996

510(k) SUMMARY per 21CFR 807.92(c)

June 14, 1996

Trade name -	FactPLUS® One Step Pregnancy Test
Common name -	Consumer Use Home Pregnancy Test
Classification name-	Human Chorionic Gonadotropin (hCG) Test System

Statement

Information supporting claims of substantial equivalence, as defined under the Federal Food Drug and Cosmetic Act, respecting safety and effectiveness is summarized below. For the convenience of the reviewer, this summary is formatted in accordance with the Agency's final rule... "510(k) Summaries and 510(k) Statements." (21CFR 807) and can be used to provide a substantial equivalence summary to anyone requesting it from the Agency.

Modified device name: FactPLUS® One Step Pregnancy Test .
. Predicate device name: ADVANCE® Pregnancy Test

Intended Use

Indications

Safety

Home pregnancy tests for detection of hCG in urine have been safely used and in commercial distribution for over two decades. In vitro diagnostic hCG urine tests which do not come in contact with the body are not generally associated with safety issues. Home-use pregnancy tests are categorized as "waived" status under the 1988 Clinical Laboratory and Improvement Amendment (CLIA).

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510(k) SUMMARY (continued) XI.

Device Description

"Urine Well" .
"Result Window" .
"Control Window" .

Substantial Equivalence

The FactPLUS® One Step is substantially equivalent to, and is the same device as, the currently marketed ADVANCE® Pregnancy Test with a modification to the labeling for reading the results sooner. Results obtained in three minutes and some positives as soon as 1 minute, per the FactPLUS One Step labeling are substantially equivalent to results obtained in five minutes per the current ADVANCE labeling.

The proposed and the marketed devices have the same intended use, technology, performance characteristics, chemistry, component materials, and test analyte. The device can be used the first day of missed period, any time of the day.

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510(k) SUMMARY (continued) XI.

Performance Data

Substantial equivalence was demonstrated in laboratory validation studies which tested for accuracy, specificity and sensitivity at the new time frame.

Accuracy was performed using hCG-positive and hCG-negative female clinical urine specimens across three different lots of marketed ADVANCE. Test results read according to the modified labeling directions at (three minutes) and according to the current labeling directions (five minutes), demonstrated 100% agreement. Test results read at the one minute time frame demonstrated 98% agreement. Results were confirmed by running another currently marketed pregnancy test simultaneously.

Additionally, laboratory testing for both sensitivity and specificity read according to the modified and current labeling directions, demonstrated 100% agreement.

Consumer Testing

A consumer clinical study was conducted to verify that consumers could obtain accurate test results when performing the FactPLUS One Step test according to modified directions for reading the test at three minutes. The consumer population consisted of 150 female volunteers recruited from a Central New Jersey location. The volunteers were between the ages of 18 to 45, from various income, educational and employment backgrounds. One hundred forty-seven (147) of one hundred fifty volunteers who were instructed to read the test results at three minutes, performed the test and interpreted the results correctly for an overall accuracy rate of 98%.

Conclusion

The FactPLUS Pregnancy Test with modified directions has been shown to be substantially equivalent to the currently marketed ADVANCE Pregnancy Test in laboratory validation testing for accuracy, sensitivity, specificity demonstrating 99%, 100% & 100% respectively.

Additionally, results of consumer clinical testing demonstrated that the FactPLUS One Step can be performed and correctly interpreted by consumers at three minutes with an overall accuracy rate of 98%.

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.