JHI · Visual, Pregnancy Hcg, Prescription Use
Clinical Chemistry · 21 CFR 862.1155 · Class 2
Overview
| Product Code | JHI |
|---|---|
| Device Name | Visual, Pregnancy Hcg, Prescription Use |
| Regulation | 21 CFR 862.1155 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
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. 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.
Classification Rationale
For early detection of pregnancy: Class II. For any uses other than early detection of pregnancy: Class III.
Recent Cleared Devices (20 of 375)
Showing 20 most recent of 375 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K241919 | Innovita HCG Pregnancy Rapid Combo Test | Innovita (Tangshan) Biological Technology Co., Ltd. | Aug 2, 2024 | SESE |
| K203272 | Alltest Pregnancy Rapid Combo Test Cassette | Hangzhou AllTest Biotech Co., Ltd. | Jan 31, 2022 | SESE |
| K172322 | Atellica IM Total hCG (ThCG) | Siemens Healthcare Diagnostics, Inc. | Mar 29, 2018 | SESE |
| K172257 | TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format) | True Diagnostics, Inc. | Dec 22, 2017 | SESE |
| K152768 | Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip | Assure Tech. Co., Ltd. | Feb 24, 2016 | SESE |
| K130456 | WUNDER PREGNANCY TEST | James Nguyen | Apr 8, 2014 | SESE |
| K132834 | FASTEP S10 HCG SERUM/URINE COMBO TEST | Polymed Therapeutics, Inc. | Jan 9, 2014 | SESE |
| K131166 | SOFIA(R) HCG FIA | Quidel Corp. | Aug 2, 2013 | SESE |
| K123844 | CHEMTRUE HCG PREGNANCY URINE DIPSTICK, HCG PREGNANCY URINE CASSETTE TEST, AND HCG COMBO SERUM/URINE CASSETTE TEST | Chemtron Biotech, Inc. | May 30, 2013 | SESE |
| K112101 | FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS | Polymed Therapeutics, Inc. | Jul 17, 2012 | SESE |
| K112315 | HOME PREGNANCY TEST | Newscen Coast Bio-Pharmaceutical Co., Ltd. | Apr 23, 2012 | SESE |
| K102175 | RAPIDVUE HCG TEST | Quidel Corporation | Aug 25, 2010 | SESE |
| K072264 | FASTPACK HCG IMMUNOASSAY | Qualigen, Inc. | Dec 6, 2007 | SESE |
| K071030 | BIONEXIA HCG PREGNANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS, MODELS 08-HCGC AND 02-HCGC | Applied Dna Technologies, Inc. | Jun 29, 2007 | SESE |
| K070921 | BIONEXIA HCG PREGNANCY CASSETTE AND DIPSTICK TESTS, MODEL 08-HCG AND 02-HCG | Applied Dna Technologies, Inc. | Jun 29, 2007 | SESE |
| K061257 | DBEST HCG PANEL TEST KIT | Ameritek USA, Inc. | May 4, 2007 | SESE |
| K062361 | INNOVACON HCG UKTRA TEST DEVICE | Innovacon, Inc. | Oct 23, 2006 | SESE |
| K050955 | LIFESIGN DXPRESS, MODEL LSR2000 | Princeton BioMeditech Corp. | Jan 23, 2006 | SESE |
| K052694 | ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES. | Ind Diagnostic, Inc. | Dec 16, 2005 | SESE |
| K051841 | WH ACCU TEST ONE-STEP URINE/SERUM COMBO PREGNANCY TEST | W.H.P.M., Inc. | Aug 22, 2005 | SESE |
Top Applicants
- Quidel Corp. — 19 clearances
- Abbott Laboratories — 15 clearances
- Hybritech, Inc. — 14 clearances
- Pacific Biotech, Inc. — 13 clearances
- Leeco Diagnostics, Inc. — 10 clearances
