Description
U.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Devices and Radiological Health
Scope & Applicability
Product Classes
2Generic type device intended for home use as an in vitro diagnostic (IVD) test for the qualitative measurement of hCG.
IVD device clinical studies conducted on de-identified specimens
Stakeholders
3Individual who performs testing on the predicate device in a comparison study.
Providing new information to subjects who have completed their active participation.
Lay persons performing the test in a home-use study
Regulatory Context
Attributes
2The type of measurement intended for home use IVD hCG tests.
Required label element for outsourcing facilities
Identified Hazards
Hazards
1Evaluation of substances that may affect test results
Related CFR Sections (5)
- 21CFR862.1155§ 862.1155 Human chorionic gonadotropin (HCG) test system.
(a) Human chorionic gonadotropin (HCG) test system intended for the early detection of pregnancy —Read full regulation →
- 21CFR807.87§ 807.87 Information required in a premarket notification submission.
Each premarket notification submission shall contain the following information:Read full regulation →
- 21CFR809.10§ 809.10 Labeling for in vitro diagnostic products.
(a) The label for an in vitro diagnostic product shall state the following information, except where such information is not applicable, or as otherwise specified in a standard for a particular product class or as provided in paragraph (e) of this section. Section 201(k) of the act provides that “a Read full regulation →
- 21CFR807.92§ 807.92 Content and format of a 510(k) summary.
(a) A 510(k) summary shall be in sufficient detail to provide an understanding of the basis for a determination of substantial equivalence. FDA will accept summaries as well as amendments thereto until such time as FDA issues a determination of substantial equivalence. All 510(k) summaries shall conRead full regulation →
- 21CFR807.93§ 807.93 Content and format of a 510(k) statement.
See Also (8)
- Acceptance of Clinical Data to Support Medical Device Applications and Submissions: Frequently Asked Questions: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Review Guidelines for Oxygen Generators and Oxygen Equipment for Emergency Use (Status: Final)
- CPG Sec. 398.450 Applicability of Positive Beam Limitation (PBL) Requirements When PBL is Provided on "Other than Stationary General Purpose" Radiographic System (Status: Final)
- CPG Sec. 300.600 Commercial Distribution with Regard to Premarket Notification (Section 510(k)) (Status: Final)
- CPG Sec. 325.100 Karaya Gum Powder and Related Devices for Use by Ostomates (Status: Final)
- Device Labeling Guidance #G91-1 (Blue Book Memo) (Status: Final)
- CPG Sec. 350.100 Packaging Technologies and Tamper-Resistant Packaging Requirements for Contact Lens Solutions and Tablets (Status: Final)
- Guidance for the Content of Premarket Notifications for Biopsy Devices Used in Gastroenterology and Urology (Status: Final)