FACT PLUS ONE STEP PREGNANCY TEST by ABBOTT LABORATORIES

The Fact plus® One Step Pregnancy Test is a qualitative, consumer home-use, in vitro diagnostic immunoassay for the detection of human chorionic gonadotropin (hCG) in human urine for the early detection of pregnancy.

Device Description

The intended use of both pregnancy tests is as a qualitative, consumer home-use, in vitro diagnostic immunoassay for the detection of human chorionic gonadotropin (hCG) in human urine. The modified device has demonstrated comparable performance characteristics to the predicate device.

AI/ML Overview

This document is a 510(k) summary, which typically does NOT include detailed study results and acceptance criteria. Instead, it states that the modified device's performance is comparable to the predicate device and that this information is documented in the Design History File. Therefore, most of the requested information cannot be extracted from the provided text.

Here is what can be inferred:

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

Acceptance Criteria: Not explicitly stated in this document. The document states "the modifications made to the predicate device...have not changed the original intended use or performance characteristics of the Fact plus One Step Pregnancy Test." This implies the acceptance criteria for the modified device would be to meet the established performance characteristics of the predicate device.
Reported Device Performance: Not explicitly stated in this document. It only mentions that the "modified device has demonstrated comparable performance characteristics to the predicate device."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not available in the provided text. The document refers to a "Design History File" where this information would be maintained.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable/available. This is an in vitro diagnostic test for hCG, not an image interpretation task requiring expert readers. The ground truth for such tests would typically be established by a reference method (e.g., more sensitive laboratory-based hCG detection or clinical outcomes).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/available. See point 3.

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 device, not an AI-assisted diagnostic tool that would involve human readers.

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

This is a standalone in vitro diagnostic kit (consumer home-use). Its performance is inherently "standalone" in the sense that the result is read by the user directly from the device. The document implies a performance study (comparing to the predicate) was conducted, but details are not provided.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not explicitly stated, but for an hCG test, the ground truth would typically be established by:
- Reference laboratory hCG assays (e.g., quantitative serum hCG).
- Confirmation of pregnancy through clinical follow-up or other methods.

8. The sample size for the training set

Not available in the provided text. This is an in vitro diagnostic, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. Performance studies are conducted.

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

Not applicable. See point 8.

Summary

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Special 510(k) Summary Fact plus® One Step Pregnancy Test

Information Supporting a Substantially Equivalent Determination

The conformance to Design Control as presented in the Special 510(k) for the Fact plus One Step Pregnancy Test documents that the modifications made to the predicate device to prepare the modified device have not changed the original intended use or performance characteristics of the Fact plus One Step Pregnancy Test.

Prepared and Submitted February 5, 1999 by:

Abbott Laboratories Katherine M. Wortley, Ph.D. Regulatory Specialist ADD Regulatory Affairs 1-847-938-7707 Bldg. AP31, Dept. 9V6 200 Abbott Park Road Abbott Park, IL 60064-6200

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/1/Picture/2 description: The image shows the date February 2, 1999. The month is represented by the abbreviation FEB. The day is the number 2, and the year is 1999.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Katherine M. Wortley, Ph.D. Regulatory Specialist ADD Regulatory Affairs Abbott Laboratories Diagnostic Division Dept. 9V6 Building AP31 200 Abbott Park Road Abbott Park, Illinois 60064-6200

Re: K990373

Trade Name: Fact Plus One Step Pregnancy Test Regulatory Class: II Product Code: LCX Dated: February 5, 1999 Received: February 8, 1999

Dear Dr. Wortley:

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 (OS) 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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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/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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510(k) Number (if known): __

Device Name: Fact plus® One Step Pregnancy Test

Indications For Use:

K990373

Sean Cooper
(Division Sign-Off)

vision of Clinical I aboratory Devices 510(k) Number 190372

(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) OR

Over-The

Over-The-Counter Use

(Optional Format 1-2-96)

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.