FDA Product Code DHA: System, Test, Human Chorionic Gonadotropin
Under FDA product code DHA, human chorionic gonadotropin test systems are cleared for the detection of pregnancy and the monitoring of hCG-producing conditions.
These immunoassays detect hCG — the hormone produced by the placenta after implantation — in urine or serum. They are used for pregnancy confirmation, ectopic pregnancy diagnosis, monitoring of gestational trophoblastic disease, and tumor marker surveillance.
DHA devices are Class II medical devices, regulated under 21 CFR 862.1155 and reviewed by the FDA Chemistry panel.
Leading manufacturers include Abbott Laboratories, Ortho-Clinical Diagnostics and Siemens Healthcare Diagnostics, Inc..
FDA 510(k) Cleared System, Test, Human Chorionic Gonadotropin Devices (Product Code DHA)
About Product Code DHA - Regulatory Context
510(k) Submission Activity
72 total 510(k) submissions under product code DHA since 1986, with 72 receiving FDA clearance (average review time: 117 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 5 in the prior period.
DHA devices are reviewed by the Chemistry panel. Browse all Chemistry devices →