(54 days)
Not Found
Not Found
No
The summary describes a simple, one-step pregnancy test that detects hCG in urine. There is no mention of AI, ML, image processing, or any other technology that would suggest the use of AI/ML. The device description and performance study sections are also not found, further indicating a lack of complex computational elements.
No
This device is a diagnostic test for pregnancy, not a therapeutic device designed to treat a disease or condition.
Yes
This device is for the "detection of human chorionic gonadotropin(hCG) in urine with a hCG Cut-off of 25 mIU/ml and is an aid in the early detection of pregnancy." Detecting a specific substance to aid in the detection of a condition (pregnancy) falls under the definition of a diagnostic device.
No
The device description is not found, but the intended use clearly describes a "pregnancy test" that detects hCG in urine. This strongly implies a physical test strip or similar hardware component, not a software-only device.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's a "pregnancy test for the detection of human chorionic gonadotropin (hCG) in urine." Detecting substances in bodily fluids (like urine) to diagnose or aid in the diagnosis of a condition (like pregnancy) is a core function of IVDs.
- Analyte: It detects hCG, which is a biological marker.
- Sample Type: It uses urine, which is a biological sample.
- Purpose: It's an "aid in the early detection of pregnancy," which is a diagnostic purpose.
The fact that it's for "over-the-counter and/or professional use" further supports its classification as an IVD, as IVDs are used in various settings, including home use and clinical settings.
N/A
Intended Use / Indications for Use
The Texas FIRST SIGH test is a 3 minute one step pregnancy test for the dectection of human chorionic gonadotropin(hCG) in urine with a hCG Cut-off of 25 mIU/ml and is an aid in the early detection of pregnancy. This test is for over-the-counter and/or professional use.
Product codes
LCX
Device Description
Not Found
Mentions image processing
Not Found
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
Not Found
Intended User / Care Setting
over-the-counter and/or professional 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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 20 1997
Charles Gill Director, Research & Development Texas Immunology, Inc. 5400 Spur 248 University Business Park, Bldg. 2, Suite 6 Tyler, Texas 75707
K973208 Re : First Sign II Requlatory Class: Product Code: LCX Auqust 26, 1997 Dated: Received: August 27, 1997
Dear Mr. Gill:
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 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 The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਉ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) 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 In addition, FDA may publish further announcements action. 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 atborized in your tial 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/dsmamain.html".
sincerely yours,
Steven Pitman
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
2
2.2
510(k) Number (if known):
FIRST SIGN Device Name:
Indications For Use:
Iamunology The Texas FIRST SIGH test is a 3 minute one step pregnancy test dectection human chorionic for the of gonadotropin(hCG) in urine with a hCG Cut-off of 25 mIU/ml and is an aid in the early detection of pregnancy. This test is for over-the-counter and/or professional use.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number.
2973208
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter-Use
(Optional Format 1-2-96)