(69 days)
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No
The 510(k) summary describes a simple urine-based pregnancy test and contains no mention of AI, ML, image processing, or complex algorithms typically associated with AI/ML medical devices.
No
The device is intended to detect the presence of hCG to determine pregnancy, which is a diagnostic purpose, not a therapeutic one. It does not treat or alleviate any condition.
Yes
The device is intended to "detect the presence of human chorionic gonadotropin (hCG) in the urine of women who are suspected to be pregnant," which is a diagnostic purpose.
No
The summary describes a "Poly stat hCG Test" intended to detect hCG in urine. This strongly suggests a physical test kit or strip, which is a hardware device, not software. The lack of a device description or mention of software further supports this conclusion.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is for detecting the presence of human chorionic gonadotropin (hCG) in urine.
- Nature of the Test: Detecting a substance (hCG) in a bodily fluid (urine) is a classic example of an in vitro diagnostic test. It's performed outside of the living body to provide information about a person's health status (in this case, pregnancy).
The definition of an IVD generally involves tests performed on specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening. The Poly stat hCG Test fits this description perfectly.
N/A
Intended Use / Indications for Use
The Poly stat hCG Test is intended to detect the presence of human chorionic gonadotropin (hCG) in the urine of women who are suspected to be pregnant. The device is for the early detection of pregnancy.
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
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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
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Key Metrics
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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/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract image of an eagle with three stripes representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 1 6 2001
Ms. Helen Landicho, RAC Director Regulatory Affairs Bion Diagnostic Sciences, Inc. 12277 134th Ct., N.E. Redmond, WA 98052
K012559 Trade/Device Name: The Poly stat hCG Test Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: JHI Dated: August 6, 2001 Received: August 8, 2001
Dear Ms. Kindell:
Re:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass black in the 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 I ou may , and controls 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 If your device is exassinod (600 as controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 r lease be deviloed that I Draination that your device complies with other requirements of the Act that I Drillas intatutes and regulations administered by other Federal agencies. You must or any I catales and registered and registments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It in the quality systems (21 CFR Part 820); and if applicable, the electronic forth in the quind) 05 control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
oty stat hCG Test
SECTION 12.0 INDICATIONS FOR USE STATEMENT
510(k) Number: K012559
Device Name: The Poly stat hCG Test
Indications For Use:
The Poly stat hCG Test is intended to detect the presence of human chorionic gonadotropin (hCG) in the 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)
Kesia Alexander for Sean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K012559
V Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
lion Diagnostic Sciences, Inc.
: