(28 days)
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No
The summary describes a standard over-the-counter pregnancy test that detects HCG in urine. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No.
The device is a diagnostic test for pregnancy and does not provide any therapy or treatment.
Yes
Explanation: The device detects HCG in urine to confirm pregnancy, which is a diagnostic purpose to identify a physiological condition.
No
The summary describes a physical "QuickStream Pregnancy Test" which detects HCG in urine, indicating it is a hardware-based test kit, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to detect HCG in urine to confirm pregnancy. This is a diagnostic test performed on a sample taken from the body (in vitro).
- Nature of the Test: It detects a specific biological marker (HCG) in a biological sample (urine) to diagnose a condition (pregnancy). This is the core function of an IVD.
- Over-the-Counter Use: While it's an over-the-counter device, it still falls under the definition of an IVD as it's used for diagnostic purposes by individuals.
The other sections (Device Description, Mentions image processing, etc.) are not relevant to determining if a device is an IVD. The key is the intended use and the nature of the test being performed.
N/A
Intended Use / Indications for Use
Over-the-Counter HCG (pregnancy) tests are for those individuals who, for any reason, believe they may be pregnant. This test detects HCG in urine. HCG is a hormone produced by the placenta shortly after implantation. Since HCG is present in the urine of a pregnant woman, it is an excellent marker for confirming pregnancy. Early identification is important in the management of pregnancy. This condition must be identified so that fetal exposure to potentially harmful circumstance may be minimized or eliminated. Many individuals hesitate to seek clinical confirmation of this condition (pregnancy) due to medical examination costs and appointment scheduling difficulties. This device offers an alternative to the initial office visit and will allow for more rapid initiation of pre-natal care upon confirmation tests by trained clinical technicians.
Product codes
LCX
Device Description
QuickStream Pregnancy Test
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
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Intended User / Care Setting
Over the Counter
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)
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 caduceus symbol, which is often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The logo is presented in black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Carl Monqiovi Director of Operations Phamatech 9265 Activity Road #112 San Diego, California 92126
MAR | | 1998
Re : K980532 QuickStream One Step Pregnancy Test Regulatory Class: II Product Code: LCX Dated: February 9,1998 Received: February 11, 1998
Dear Mr. Mongiovi:
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 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 Requlations, 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 (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 ... - requlations.
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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 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 Slutman
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
INDICATIONS FOR USE
Applicant: Phamatech
510(k) Number (if known):(k) 980532
Device Name: QuickStream Pregnancy Test
Indications for Use:
Over-the-Counter HCG (pregnancy) tests are for those individuals who, for any reason, believe they may be pregnant. This test detects HCG in urine. HCG is a hormone produced by the placenta shortly after implantation. Since HCG is present in the urine of a pregnant woman, it is an excellent marker for confirming pregnancy. Early identification is important in the management of pregnancy. This condition must be identified so that fetal exposure to potentially harmful circumstance may be minimized or eliminated. Many individuals hesitate to seek clinical confirmation of this condition (pregnancy) due to medical examination costs and appointment scheduling difficulties. This device offers an alternative to the initial office visit and will allow for more rapid initiation of pre-natal care upon confirmation tests by trained clinical technicians.
PLEASE DO NOT WRITE BELOW THIS LINE
Concurrence of CDRH Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K980532 |
Division Sign-Off
Division of Clinical Laboratory Devices
| 510(k) Number: | |
|---|---|
| ----------------------- | -- |
| Prescription Use:
| Per 21 CFR 801.109 | OR Over the Counter |
|---|---|
| ----------------------------------------- | --------------------- |