(164 days)
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No
The document describes a standard, visual, qualitative pregnancy test kit and contains no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No
The device is a test kit for detecting pregnancy, which is a diagnostic purpose, not a therapeutic one. It does not treat or alleviate any condition.
Yes
The device is described as a "test kit for the determination of HCG in urine specimens and in turn for the early detection of pregnancy," which directly relates to diagnosing pregnancy.
No
The device description clearly states it is a "test kit" for determining HCG in urine specimens, which implies a physical, hardware-based test (like a dipstick or cassette) and not a software-only solution.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "test kit for the determination of... in urine specimens and in turn for the early detection of pregnancy." This involves testing a biological sample (urine) outside of the body to diagnose a condition (pregnancy).
- Device Description: The device description reiterates the same purpose, confirming it's a test kit for analyzing a biological sample.
These characteristics are fundamental to the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
One Step Midstream Style HCG Pregnancy Test is a test kit for the determination of One Brep Midsh Cam Biye 1100 room and and in urine specimens and in turn for the early detection of pregnancy. This test kit is used to obtain a visual and qualitative results for home use.
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
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)
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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
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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/10 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
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 657
K974059 Re : One-Step Midstream Style hCG Pregnancy Test Requlatory Class: II Product Code: LCX March 20, 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. A substantially equivalent determination assumes compliance with --the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Druq 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 Reqister. 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 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 Litman
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
| Labels | Values |
|---|---|
| 510(k) Number (if known): | K974059 |
| Device Name: | One Step Midstream Style HCG Pregnancy Test |
| Indications For Use: |
One Step Midstream Style HCG Pregnancy Test is a test kit for the determination of One Brep Midsh Cam Biye 1100 room and and in urine specimens and in turn for the early detection of pregnancy. This test kit is used to obtain a visual and qualitative results for home use.
(PLEASE DO NOT WRITE BELQW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division on Cins Laboratory Levices
510(k) Number. K974059
Over-The-Counter Use
Prescription Use (Per 21 CFR 801.109) OR
(Optional Formal 1-2-96)