(14 days)
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No
The summary describes a standard immunoassay for pregnancy detection and does not mention any AI or ML components.
No
This device is an in vitro diagnostic immunoassay for detecting pregnancy, not for treating a condition or disease.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states "in vitro diagnostic immunoassay for the detection of human chorionic gonadotropin (hCG)...for the early detection of pregnancy." The "Device Description" section also refers to it as an "in vitro diagnostic immunoassay."
No
The device is described as an "in vitro diagnostic immunoassay" which is a physical test kit, not a software-only device.
Yes, based on the provided text, the Fact plus® One Step Pregnancy Test is an IVD (In Vitro Diagnostic).
Here's why:
- The "Intended Use / Indications for Use" section explicitly states: "...in vitro diagnostic immunoassay for the detection of human chorionic gonadotropin (hCG) in human urine..."
- The "Device Description" section also states: "...in vitro diagnostic immunoassay for the detection of human chorionic gonadotropin (hCG) in human urine."
Both sections clearly identify the device as an "in vitro diagnostic immunoassay," which falls under the definition of an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes
LCX
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
consumer home-use
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The modified device has demonstrated comparable performance characteristics to the predicate device. This information is documented in the Design History File for the assay, maintained at Abbott Laboratories.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
§ 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.
0
2/22/99
Image /page/0/Picture/1 description: The image shows a handwritten string of characters, "K990373". The characters are written in a dark ink, and the handwriting is somewhat stylized. The string appears to be a code or serial number.
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.
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. This information is documented in the Design History File for the assay, maintained at Abbott Laboratories.
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
1
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:
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.
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)