(56 days)
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No
The 510(k) summary describes a standard immunoassay pregnancy test and contains 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 tool for pregnancy detection, not a treatment or therapy.
Yes
The device is described as a "qualitative, two sites sandwich immunoassay test device designed for the determination of human chorionic gonadotropin (hCG) concentration in urine samples, and therefore is an aid in the early detection of pregnancy." This function of measuring hCG concentration to aid in pregnancy detection directly fits the definition of a diagnostic device.
No
The device is described as a "test device" in a "cassette format," which strongly implies a physical, hardware-based diagnostic test, not a software-only solution.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "determination of human chorionic gonadotropin (hCG) concentration in urine samples." This involves testing a sample taken from the human body in vitro (outside the body).
- Purpose: The purpose is to aid in the "early detection of pregnancy," which is a diagnostic purpose.
- Method: It uses a "qualitative, two sites sandwich immunoassay test device," which is a common method for in vitro diagnostic tests.
Therefore, based on the provided information, the IND One Step hCG Pregnancy Test - Cassette Format fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
IND One Step hCG Pregnancy Test - Cassette Format is a qualitative, two sites sandwich immunoassay test device designed for the determination of human chorionic gonadotropin (hCG) concentration in urine samples, and therefore is an aid in the early detection of pregnancy. These test devices are intended for professional use.
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
professional 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
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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with three stylized lines representing the wings and body.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 1 6 2005
Mr. Jason Peng Regulatory Affairs Manager IND Diagnostic Inc. 1629 Fosters Way Delta, B.C. V3M 6S7 Canada
Re: K050741
Trade/Device Name: IND One Step hCG Pregnancy Test- Cassette Format Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: JHI Dated: March 18, 2005 Received: March 21, 2005
Dear Mr. Peng:
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 (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and in your to ough finding of substantial equivalence of your device to a legally promative notification - - e 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, rr you don't spections and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the I va may other baller generers, 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,
Carol C. Benem
Carol C. Benson, M.A. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
| 510(k) Number (if known): | K050741 |
|---|---|
| Device Name: | IND One Step hCG Pregnancy Test - Cassette Format |
| Indications For Use: | IND One Step hCG Pregnancy Test - Cassette Format is a qualitative, two sites sandwich immunoassay test device designed for the determination of human chorionic gonadotropin (hCG) concentration in urine samples, and therefore is an aid in the early detection of pregnancy. These test devices are intended for professional use. |
Prescription Use × (Part 21 CFR 801 Subpart D) 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 In Vitro Diagnostic Devices (OIVD)
Alberto Sols
(Division Sign-Off) (Division of Clinical Laboratory Devices 510(k) Number.
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