(104 days)
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Not Found
No
The summary describes a standard immunoassay test for hCG 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 described as an "aid in the early detection of pregnancy" and is for "in-vitro diagnostic use only," indicating it is used for diagnosis, not treatment.
Yes.
The document states "For in-vitro diagnostic use only," explicitly classifying it as a diagnostic device.
No
The device description clearly indicates it is a physical immunoassay test device (strip, cassette, midstream formats) for detecting hCG in urine/serum, which involves hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
The text explicitly states:
- "For in-vitro diagnostic use only." This is a direct declaration of its intended use.
- The intended use describes the device as a test designed for the determination of hCG concentration in urine and/or serum samples, which are biological samples tested in vitro (outside the body).
- The device is described as an "immunoassay test device," which is a common type of IVD.
N/A
Intended Use / Indications for Use
One Step hCG Pregnancy Urine Test device 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 available in strip, cassette and midstream formats are intended for over-the-counter (OTC) use. The test devices in cassette and strip format are for professional use as well. For in-vitro diagnostic use only.
One Step hCG Pregnancy Urine/Serum Test device is a qualitative, two sites sandwich immunoassay test device designed for the determination of human chorionic gonadotropin (hCG) concentration in urine and serum samples, and therefore is an aid in the early detection of pregnancy. These test devices available in strip and cassette formats are intended for professional use only. For in-vitro diagnostic use only.
Product codes (comma separated list FDA assigned to the subject device)
JHI, 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
Over-The-Counter Use and Professional Use for the Urine Test.
Professional Use only for the Urine/Serum Test.
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.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is surrounded 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
Dr. Jimmy Liang General Manger Bioscreen Medical Inc. RR1 Box 1045A Mildred, PA 18632
MAY 2 3 2005
K050305 Re:
Trade/Device Name: One Step hCG Pregnancy Urine Test Formats: Strip, Cassette and Midstream One Step hCG Pregnancy Urine/Serum Test Formats: Strip and Cassette Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system
Regulatory Class: Class II Product Code: JHI, LCX Dated: April 11, 2005 Received: April 11, 2005
Dear Dr. Liang:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection 31 (a) } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enorosale) to regally the Medical Device Amendments, or to conniferee prior to May 20, 1776, the encordance with the provisions of the Federal Food, Drug, devices that have been roomstiled in wore approval of a premarket approval application (PMA). alla Cosmetic Act (71ct) that do novice, subject to the general controls provisions of the Act. The Tournal controls provisions of the Act include requirements for annual registration, listing of general controls provisions of mactice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (dos as o) trols. Existing major regulations affecting your device It may be subject to Such additions comise reservlations (CFR), Parts 800 to 895. In addition, FDA can oc found in Ther 21, Courcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I least be advised that I Dris assumes a your device complies with other requirements of the Act that I DA has made a decermination administered by other Federal agencies. You must of any I cutures and regaranents, including, but not limited to: registration and listing (21 comply with an the Ave STequirements 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 his letter will anow you to begin marketing your ntial equivalence of your device to a legally premarket notification. The I Driving or between 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, If you desire specific information advartising of your device, please contact the Office of In of questions on the promotion and Safety at (240) 276-0484. Also, please note the VINO Diagnostic Dortos Drailian by reference to premarket notification" (21 CFR Part 807.97). Tegulation chitted, "Misoranant on your responsibilities under the Act from the You may outlif onlici general informational 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
2
Indications for Use
510(k) Number (if known): K050305
| Device Name: | One Step hCG Pregnancy Urine Test |
|---|---|
| Formats: | Strip, Cassette and Midstream |
Indications For Use:
One Step hCG Pregnancy Urine Test device 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 available in strip, cassette and midstream formats are intended for overthe-counter (OTC) use. The test devices in cassette and strip format are for professional use as well. For in-vitro diagnostic use only.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ x (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) sille
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
Page 1 of 2
510(k)
3
Indications for Use
510(k) Number (if known): K050305
One Step hCG Pregnancy Urine/Serum Test Device Name: Formats: Strip and Cassette
One Step hCG Pregnancy Urine/Serum Test device is a Indications For Use: qualitative, two sites sandwich immunoassay test device designed for the determination of human chorionic gonadotropin (hCG) concentration in urine and serum samples, and therefore is an aid in the early detection of pregnancy. These test devices available in strip and cassette formats are intended for professional use only. For in-vitro diagnostic use only.
Prescription Use X (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)
Rute Chelen
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
Ko50305 510(k) -
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