(164 days)
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No
The summary describes a qualitative immunoassay test kit, which is a chemical-based test and does not involve AI/ML technology. There are no mentions of AI, ML, image processing, or data sets typically associated with AI/ML devices.
No
The device is a diagnostic test kit for determining hCG concentration, not a device used for treatment or therapy.
Yes
The device is used for the "rapid determination of hCG concentration in both serum and urine for early detection of pregnancy," which is a diagnostic purpose.
No
The device is described as a "test kit" and a "qualitative, two sites sandwich immunoassay test kit," which are descriptions of physical components used for a chemical reaction, not software.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The description explicitly states it's a "qualitative, two sites sandwich immunoassay test kit for rapid determination of hCG concentration in both serum and urine for early detection of pregnancy." This clearly indicates it's used to test samples taken from the body (serum and urine) in vitro (outside the body) to diagnose a condition (pregnancy).
- Clinical Lab Use: The intended user is a "clinical lab," which is a common setting for IVD testing.
The definition of an IVD is a medical device that is used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device fits that definition perfectly.
N/A
Intended Use / Indications for Use
MiniStrip/ Serum and Urine Combo HCG test is a qualitative, two sites sandwich immunoassay test kit for rapid determination of hCG concentration in both serum and urine for early detection of pregnancy. This test kit is used to obtain a visual and qualitative result and is for clinical lab used only.
Product codes
JHI
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
clinical lab used only.
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)
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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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR - 9 1998
Dennis S.L. Hong, B.Sc.,B.M.L.Sc. Assistant Manager International Newtech Development Inc. 1629 Fosters Way Delta, B.C. Canada V3M ട്ടേ7
K974060 Re: One-Step Ministrip/Serum and Urine Combo hCG Requlatory Class: II Product Code: JHI March 19, 1998 Dated: Received: March 24, 1998
Dear Mr. Hong:
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. ಕ್ಷ 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 requlation 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 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 qeneral 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 Sitman
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
) Number (if known): [K974060](https://510k.innolitics.com/search/K974060)
Ice Name: Ministrip / Serum and Urine Combo HCG Test
cations For Use:
MiniStrip/ Serum and Urine Combo HCG test is a qualitative, two sites sandwich
immunoassay test kit for rapid determination of hCG concentration in both serum
and urine for early detection of pregnancy. This test kit is used to obtain a visual
and qualitative result and is for clinical lab used only.
(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. [K974060](https://510k.innolitics.com/search/K974060)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)