(67 days)
Not Found
Not Found
No
The summary describes a qualitative test for hCG, which is a standard biochemical assay and does not mention any AI/ML components or image processing.
No
The device is a diagnostic test for detecting pregnancy, not a therapeutic device for treating a condition.
Yes
The device is intended to detect the presence of hCG in serum or urine to diagnose pregnancy, which falls under the definition of a diagnostic test.
No
The device description clearly states it is a "qualitative test intended to detect the presence of human chorionic gonadotropin (hCG) in the serum or urine". This indicates a physical test kit or strip that interacts with biological samples, not a software-only device.
Yes, based on the provided information, the Poly stat Serum/Urine hCG Test is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is a "qualitative test intended to detect the presence of human chorionic gonadotropin (hCG) in the serum or urine". This involves testing biological samples (serum or urine) in vitro (outside of the body).
- Device Description: The device description reiterates the same purpose of detecting hCG in serum or urine, confirming the in vitro nature of the test.
IVD devices are defined as reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. Detecting hCG in serum or urine to determine pregnancy falls squarely within this definition.
N/A
Intended Use / Indications for Use
The Poly stat Serum/Urine hCG Test is a qualitative test intended to detect the presence of human chorionic gonadotropin (hCG) in the serum or urine of women who are suspected to be pregnant. The device is for the early detection of pregnancy.
Product codes
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
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
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
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 depiction of an eagle or bird-like figure, with three distinct head profiles layered on top of each other. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR 1 8 2003
Ms. Helen Landicho, RAC Director Regulatory Affairs Alidex, Inc. 12277 134th CT., N.E., #100 Redmond, WA 98052
Re: K030430
Trade/Device Name: The Poly stat Serum/Urine hCG Test Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: JHI Dated: February 5, 2003 Received: February 10, 2003
Dear Ms. Landicho:
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).
1
Page 2 -
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). You may obtain other general information on your responsibilities under the Act 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
SECTION 12,0 INDICATIONS FOR USE STATEMENT
510(k) Number: K030430
Device Name: The Poly stat Serum/Urine hCG Test
Indications For Use:
The Poly stat Serum/Urine hCG Test is a qualitative test intended to detect the presence of human chorionic gonadotropin (hCG) in the serum or urine of women who are suspected to be pregnant. The device is for the early detection of pregnancy.
(PLEASE NO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
R. Charles for Jean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices 0304 36 7 510(k) Number _
V Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use
Alidex, Inc.