The ABBOTT Advisor One-Step Pregnancy Test is a self-performing immunoassay designed for the qualitative determination of human chorionic gonadotropin (hCG) in urine for early detection of pregnancy.

The ABBOTT Advisor One-Step Pregnancy Test is an over-the counter in vitro test which can be used by the consumer to detect pregnancy as early as the first day of her missed period, using a direct urine stream sampling method. Some positive results appear as soon as three minutes, however, all results are confirmed when the Test Timer turns pink/red. The Test Timer will turn pink/red approximately 5 minutes after the urine has been added to the test device.

Device Description

The ABBOTT Advisor One-Step Pregnancy Test is an elongated device composed of two pieces of molded plastic which contain the internal test strip. The three openings on the device are the Urine Well, the Result Window and the Test Timer. The Result Window and the Test Timer are protected with a clear seal to prevent potential contamination caused by splashing urine.

The ABBOTT self-performing immunoassay for hCG in urine is based on the principle of a two site immunometric assay. Urine is added to the Urine Well, where it migrates through the Absorbent Pad to the Conjugate Pad portion of the test strip. As the urine moves through the Coniugate Pad, it mobilizes the mouse monoclonal anti-alpha hCG antibody coated colloidal particles. Any hCG present in the urine sample combines with the anti-alpha hCG antibody on the colloidal particle.

The urine, now containing an hCG-antibody-colloid complex and unbound colloid, continues to move up the test strip to the Result Window which contains immobilized polyclonal anti-BhCG on a vertical (Patient) bar and anti-mouse/anti-βhCG on a horizontal (Control) bar. The color generated is proportional to the concentration of hCG in the urine sample. Anti-hCG (mouse monoclonal) coated colloidal particles bind to the anti-mouse antibody immobilized on the Control Bar which indicates the assay is performing properly. A positive sign (+) indicates the presence of hCG. Low hCG concentration samples may display a "T" result, which is also interpreted as positive. The absence of detectable hCG will result in a negative sign (-). The assay is complete when the "Test Timer" indicator changes to pink or red, approximately three minutes after the start of the assay.

AI/ML Overview

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from Predicate Device)	Reported Device Performance (ABBOTT Advisor One-Step Pregnancy Test)
Consumer Use Accuracy: 98%	98% (146 out of 149 subjects correctly interpreted results)
Laboratory Use Accuracy: 100%	100% (50/50 hCG-positive and 50/50 hCG-negative specimens correctly identified)
Time to Assay Result: 3 minutes (some positives seen in 1 minute)	5 minutes (some positives seen in 3 minutes)
End of Assay Color Change: Yes (Do not wait for signal before reading results)	Yes (Wait to read results until Test Timer changes color)

Note: The acceptance criteria for "Time to Assay Result" and "End of Assay Color Change" are based on the predicate device's characteristics, as the Abbott device is aiming for substantial equivalence. The Abbott device has a modified time-to-result requirement compared to the predicate.

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

Laboratory Accuracy Test Set:
- Sample Size: 100 specimens (50 hCG-positive, 50 hCG-negative).
- Data Provenance: Clinical urine specimens. The document doesn't specify the country of origin but states the testing was performed by "Advanced Care Products." Given the context of a US 510(k) submission, it's highly likely to be US-based. Retrospective.
Consumer Testing Test Set:
- Sample Size: 149 female volunteers.
- Data Provenance: Volunteers recruited from a "central New Jersey location." Prospective.

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

Laboratory Accuracy Test Set: The document does not explicitly state the number or qualifications of experts used to establish the ground truth.
- Ground Truth Confirmation:
  - hCG-positive samples were confirmed using the "Hybritech ICON pregnancy test."
  - hCG-negative specimens were confirmed using the "FactPLUS® Cup and Dropper Pregnancy Test."
- It's implied that these reference tests provided the ground truth, likely interpreted by trained laboratory personnel, but no explicit "expert" count or qualification is given.
Consumer Testing Test Set: The ground truth for this test was the actual presence or absence of hCG in the volunteers' urine, as determined by laboratory methods (implied through the "correct results" phrasing). The consumer's interpretation was compared against this objective ground truth. No specific "experts" were used to establish the ground truth for the volunteers beyond standardized laboratory tests.

4. Adjudication Method for the Test Set

Laboratory Accuracy Test Set: Not explicitly stated. The confirmation with reference tests (Hybritech ICON and FactPLUS Cup and Dropper) suggests a direct comparison rather than an adjudication process between multiple readers of the Abbott device.
Consumer Testing Test Set: Not applicable. The consumers themselves were the "readers," and their interpretation was compared against a laboratory-determined ground truth. There was no adjudication among consumer interpretations reported.

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

No, a multi-reader, multi-case (MRMC) comparative effectiveness study was not explicitly described. The studies focused on:

Device performance against ground truth in a lab setting.
Consumer ability to correctly use and interpret the device's results.

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

Yes, the "Laboratory Accuracy testing" essentially describes standalone performance, as the device was tested with known hCG-positive and hCG-negative samples, and the results were read by trained personnel against objective ground truth. The consumer testing also evaluates the device's standalone performance in the hands of the intended user, even though a human is "interpreting" the result.

7. The Type of Ground Truth Used

Laboratory Accuracy Test Set: Reference standard tests (Hybritech ICON pregnancy test for positive, FactPLUS® Cup and Dropper Pregnancy Test for negative). This is considered a form of "reference test consensus" or "established reference method."
Consumer Testing Test Set: The actual presence or absence of hCG in the urine, determined by objective laboratory testing (implied by the comparison to "correct results").

8. The Sample Size for the Training Set

The document does not describe a separate training set or machine learning algorithm. This device is an immunoassay, not an AI/ML-driven device. Therefore, the concept of a "training set" in the context of machine learning is not applicable here. The device's "training" or development would have involved optimizing its chemical components and design characteristics.

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

As this is not an AI/ML device, the concept of a "training set" and its ground truth in that context is not applicable. The device's performance is based on its chemical and physical design.

Summary

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JAN 2 4 1997

Image /page/0/Picture/2 description: The image shows a sequence of handwritten characters. The characters are K970082. The characters are written in black ink on a white background. The numbers are slightly rounded.

[510(k)] Summary of Safety and Effectiveness Information Supporting a Substantially Equivalent Determination

ABBOTT Advisor® One-Step Pregnancy Test

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[510(k)] Summary of Safety and Effectiveness Information Supporting a Substantially Equivalent Determination

Trade Name	ABBOTT Advisor One-Step Pregnancy Test
Common Name	Consumer Use Home Pregnancy Test
Classification Name	Human Chorionic Gonadotropin (hCG)Test System
Device Classification	Class II
Predicate Device Name	FactPLUS® One Step Pregnancy Test(K962521)

The following information as presented in the 510(k) Notification for the ABBOTT Advisor One-Step Pregnancy Test constitutes data supporting a substantially equivalent determination.

Intended Use

The ABBOTT Advisor One-Step Pregnancy Test is a self-performing immunoassay designed for the qualitative determination of human chorionic gonadotropin (hCG) in urine for early detection of pregnancy.

Indications

Device Description

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Statement of Substantial Equivalence

The ABBOTT Advisor One-Step Pregnancy Test is substantially equivalent to. and is the same device as the currently marketed FactPLUS® One Step Pregnancy Test (K962521) which is manufactured by Abbott Laboratories and distributed for over-the-counter sale by Direct Access Diagnostics, Bridgewater, New Jersey.

The intended use, technology, methodology, test chemistry, test analyte, component materials, sensitivity, specificity, and accuracy are the same for both the Abbott and the Direct Access Diagnostics devices. The devices can be used the first day of a missed period or menses, and at any time of the day.

The only differences between the Abbott and Direct Access Diagnostics devices are the name, the packaging and labeling format, and a modification to the labeled time to result requirement. Although some positive results may be seen as soon as 3 minutes from the start of the assay, customers are instructed to read the results when the Test Timer turns pink/red (approximately 5 minutes from beginning the test). A comparison of Similarities and Differences can be found in Table 1, page 9.

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Table 1 Substantial Equivalence Similarities and Differences

COMPARATORS	ADVISOR ONE-STEPPREGNANCY TEST(SUBJECT)	FACT PLUS ONE STEPPREGNANCY TEST(PREDICATE)
Visual Result PresentationPositive SignalNegative Signal	Plus (+) Sign ·Minus (-) Sign	Plus (+) SignMinus (-) Sign
Urine Collection & Mode ofAddition	Direct Urine Stream	Direct Urine Stream
AnalytehCG	Same	Same
Specimen TypeHuman Urine	Same	Same
Intended UseHome Pregnancy Test	Same	Same
TechnologyQualitative - sandwichcolloidal particleimmunoassay	Same	Same
Time to Assay Result	5 minutes(some positives seen in 3minutes)	3 minutes(some positives seen in 1minute)
ComponentsSingle unit test device (allreagents contained on atest strip within)	Same	Same
End of AssayColor Change	Yes - Test TimerShows adequate sampleWait to read results	Yes *Do not wait for signalbefore reading results
Strip ChemistryConjugate - MonoclonalAnti-αhCG Antibody	Same	Same
Patient BarPolyclonal Anti-βhCGAntibody	Same	Same
Control BarPolyclonal Anti-βhCGAntibody and PolyclonalAnti-Mouse	Same	Same
Consumer UseAccuracy	98%	98%
Laboratory UseAccuracy	100%	100%

Do not need to wait for signal before reading results

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Performance Data

Accuracy testing was perfomed by Advanced Care Products using hCG-positive and hCG-negative female clinical urine specimens across three different lots of the Abbott device. which is currently marketed under the brand name of FactPLUS® One Step Pregnancy Test.

The device correctly identified 50/50 hCG-positive and 50/50 hCG-negative specimens. Tests were read immediately after the Test Timer turned pink fed, approximately 5 minutes after the start of the test. The hCG-positive samples were confirmed to be positive with the Hybritech ICON pregnancy test. The hCG-negative specimens were confirmed to be negative with the FactPLUS® Cup and Dropper Pregnancy Test. At three minutes agreement was 100% with the ICON and FactPLUS devices.

Consumer Testing

A clinical study was conducted to verify that consumers could obtain accurate test results when using the Abbott manufactured device according to the provided instructions. The consumer population consisted of 149 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. Correct results were obtained by one hundred forty six (146) of one hundred forty nine (149) subjects for an overall accuracy of 98%. Subjects reported little difficulty with understanding the test instructions. Ninety-two percent reported that the instructions were "very easy to understand" and all subjects (100%) indicated that the instructions were "somewhat" or "very easy to understand.

Conclusion

The ABBOTT Advisor One-Step Pregnancy Test is substantially equivalent, and is in fact the same device as the FactPLUS® One Step Pregnancy Test, distributed by Direct Access Diagnostics. Laboratory testing indicates accuracy of 100%, sensitivity and specificity of 100% each.

Results of consumer clinical testing demonstrated that the Abbott device can be performed and correctly interpreted by consumers with an overall accuracy rate of 98%.

Prepared and Submitted January 8, 1997 by:

Abbott Laboratories Karen L. Gates ADD Regulatory Affairs Abbott Park, IL. 60064

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.