(44 days)
Not Found
No
The summary describes a simple qualitative immunoassay for pregnancy detection and contains no mention of AI, ML, image processing, or data sets typically associated with AI/ML development.
No.
The device is used for diagnosis (detection of hCG for pregnancy), not for treating a disease or condition.
Yes
The device is described as aiding in the early determination of pregnancy, which is a diagnostic purpose, even though a final diagnosis requires additional methods.
No
The 510(k) summary describes a physical test device (Artron One-Step hCG Urinary Pregnancy Test Device) for detecting hCG in urine, which is a hardware-based diagnostic test, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative detection of human chorionic gonadotropin (hCG) in urine." This involves testing a sample taken from the human body (urine) in vitro (outside the body) to provide information about a physiological state (pregnancy).
- Nature of the Test: It's a "One-Step hCG Urinary Pregnancy Test Device," which is a classic example of an IVD. These tests analyze biological samples to detect specific substances.
- Regulatory Context: The mention of "over-the-counter use as well as professional use" and the inclusion of a "Predicate Device(s) (K number(s) and name(s))" strongly indicate that this device is subject to regulatory oversight for medical devices, specifically IVDs. The K number (K000017) is a premarket notification number, which is a requirement for many medical devices, including IVDs, before they can be marketed in the US.
Therefore, based on the provided information, the Artron One-Step hCG Urinary Pregnancy Test Device fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Artron One-Step hCG Urinary Pregnancy Test Device is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine to help in the early determination of pregnancy. The device is designed for over-the-counter use as well as professional use.
For a final diagnosis of pregnancy, a more specific alternative clinical method must be used to obtain a confirmed analytical result.
Product codes
LCX, JHI
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
over-the-counter use as well as professional use
Description of the training set, sample size, data source, and annotation protocol
Not Found
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): 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.
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.
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 eagle with three overlapping wings, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB 1 7 2006
Mr. Jerry Zheng Vice President Artron Laboratories Inc. 3938 North Fraser Way Burnaby, BC V5J 5H6 Canada
K060019 Re:
K000017
Trade/Device Name: Artron One-Step human Chorionic Gonadotropin (hCG) Urinary Pregnancy Test Device (Artron One-Step hCG strip/cassette/midtream) Regulation Number: 21 CFR §862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: LCX, JHI Dated: December 20, 2005 Received: January 4, 2006
Dear Mr. Zheng:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreate) to regard) to regard to the Medical Device Amendments, or to conninered pror to this 2011/17/20, in accordance with the provisions of the Federal Food, Drug, devices that have over require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, diererore, manov as 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 n may be subject to Bach adde of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA oun or loand in There announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r toase or acrisou and i termination that your device complies with other requirements of the Act that I Dr has Intactions and regulations administered by other Federal agencies. You must or any I 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 (QS) regulation (21 CFR Part 820).
1
Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) I ills letter will anow you to begin mancellig of substantial equivalence of your device to a legally premarks notification: "The I DTP interlig to 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, If you desire specific mostion and advertising of your device, please contact the Office of In of questions on the promotion and Safety at (240) 276-0484. Also, please note the v Itro Diagnoution 2010 anding by reference to premarket notification" (21CFR Part 807.97). regulation entitiou, "Misoranians of your responsibilities under the Act from the I ou inay of amall 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/industry/support/index.html.
Sincerely yours,
Alberto G
Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
2
Artron One-Step Human Chorionic Gonadotropin (hCG) Urinary Pregnancy Test Device
Indications for Use 510(k) Number:
Device Name:
uman Chorionic Gonadotropin (hCG) Urinary Pregnancy Test Device
(Artron One-Step hCG strip/cassette/midstream)
Indications for Use:
Artron One-Step hCG Urinary Pregnancy Test Device is intended for the qualitative Arton One beep 100 borionic gonadotropin (hCG) in urine to help in the early determination of pregnancy. The device is designed for over-the-counter use as well as professional use.
For a final diagnosis of pregnancy, a more specific alternative clinical method must be used to obtain a confirmed analytical result.
Image /page/2/Picture/8 description: The image shows the words "Prescription Use" followed by a blank line with an "X" on it. Below that, the text "(Part 21 CFR 801 Subpart D)" is visible. The text is in bold font.
AND/OR Over-The-Counter Use × (21 CFR 801 Subpart C)
(Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ann Chappie
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K060019