(65 days)
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No
The summary describes a simple, qualitative, over-the-counter urine test kit that relies on visual interpretation, with no mention of AI, ML, image processing, or complex data analysis.
No
Explanation: This device is for in vitro diagnostic use, specifically for the detection of hCG to indicate pregnancy. It provides diagnostic information but does not administer treatment or therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states "for the in vitro diagnostic use" and "for the early detection of pregnancy," which are diagnostic purposes.
No
The device description clearly indicates a "Test Kit" in a "Cassette Format," which are physical components, not software. The intended use also describes an "in vitro diagnostic use" involving urine specimens, further confirming a physical test.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" explicitly states: "One Step urine hCG (cassette format) Pregnancy Test is for the in vitro diagnostic use". This is the most direct indicator.
- Detection of Analyte: The test is designed for the "detection of hCG (human Chorionic Gonadotropin) presence in female urine specimens". Detecting an analyte (hCG) in a biological sample (urine) is a core function of IVDs.
- Purpose: The purpose is "for the early detection of pregnancy". This is a diagnostic purpose, providing information about a physiological state.
The other sections, while providing details about the device and its use, do not contradict or negate the explicit statement of "in vitro diagnostic use" in the intended use section.
N/A
Intended Use / Indications for Use
One Step urine hCG (cassette format) Pregnancy Test is for the in vitro diagnostic use --- for the detection of hCG (human Chorionic Gonadotropin) presence in female urine specimens and in turn for the early detection of pregnancy. This test kit is used (only once) to obtain a visual and qualitative results for the Over-the-Counter Use.
Product codes
LCX
Device Description
Urine HCG (Cassette format) One Step Test Kit
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
Over-the-Counter 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)
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Reference Device(s)
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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.
0
Image /page/0/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all caps. The text is in a bold, sans-serif font. The words are arranged on a single line and centered in the image.
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
Food and Drug Administration 098 Gaither Road Rockville MD 20850
JAN 0 3 2003
Dr. David Lee. MCIC, FCACB Director, Regulatory Affairs IND Diagnostic Inc. 1629 Fosters Way Delta. B.C. CANADA V3M 6S7
K023638 Re:
Trade/Device Name: Urine RCG (Cassette Format) One Step Test Kit Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: LCX Dated: November 25, 2002 Received: December 10, 2002
Dear Dr. Lee:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA), 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820).
1
This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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 Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
2
Device Name: Urine HCG (Cassette format)
One Step Test Kit
Indications For Use:
One Step urine hCG (cassette format) Pregnancy Test
is for the in vitro diagnostic use --- for the detection of hCG (human Chorionic Gonadotropin) presence in female urine specimens and in turn for the early detection of pregnancy.
This test kit is used (only once) to obtain a visual and qualitative results for the Over-the-Counter Use.
Oilll
Dr. David Lee, MCIC, FCACB, Certified Clinical Biochemist.
October 31, 2002
Director,
Regulatory Affairs,
IND Diagnostic Inc.,
1629 Fosters Way, Delta, B. C.,
CANADA V3M 6S7
email davidlee@ind.ca
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)