Sofia
The listed hCG FIA corresponds to the Sofia hCG FIA named in the FDA filing. The filing describes it as an immunofluorescence-based lateral-flow assay for qualitative detection of human…
The listed hCG FIA corresponds to the Sofia hCG FIA named in the FDA filing. The filing describes it as an immunofluorescence-based lateral-flow assay for qualitative detection of human chorionic gonadotropin in urine.
Its stated use is to aid early detection of pregnancy, and the filing specifies prescription use, including point-of-care sites.
Listed Item
Sofia hCG 50T, US
Assay Process
A urine specimen is placed in the test cassette, which is then used with the Sofia Analyzer. The analyzer scans the strip and displays a positive, negative or invalid result.
Who Else Makes It
Concentrated in Zhejiang (5), Guangdong (3), Beijing (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Biotest Biotech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 41 |
| Abon Biopharm (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 17 |
| Planet(Shanghai) International Co., Ltd. | Shanghai | Shanghai | Exporter | 93 |
| Hangzhou AllTest Biotech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 48 |
| Assure Tech. (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 48 |
| Guangzhou Wondfo Biotech Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 44 |
| W.h.p.m. Bioresearch & Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 37 |
| Beijing Choice Electronic Technololgy Co., Ltd. | Beijing | Beijing | Repacker / relabeller | 30 |
| Taizhou Chenguang Import AND Export Trading Co., Ltd. | Taizhou | Jiangsu | Exporter | 25 |
| Chong Qing Teco Huayi Pharm. Co. | Shapingba Dist. | Chongqing | Contract manufacturer | 18 |
| Anhui Deepblue Medical Technology Co., Ltd. | Hefei | Anhui | Contract manufacturer | 16 |
| Hangzhou Aichek Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 13 |
Showing 12 of 16. All 16 manufacturers in China registered for Visual, Pregnancy Hcg, Prescription Use
Record
| Listed by | Quidel Corp., United States |
|---|---|
| FDA product code | JHI |
| Device type | Visual, Pregnancy Hcg, Prescription Use |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1155 |
| Establishment | Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K131166 |
| Record published | 2016-09-15 |
| Record revised | 2025-05-23 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| hCG FIA | In distribution | |
| hCG FIA | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| McKesson | Mckesson Medical-Surgical Inc. | 7 |
| Cardinal Health | Cardinal Health 200, LLC | 7 |
| Rapid Response | Btnx Inc. | 7 |
| Visual, Pregnancy Hcg, Prescription Use | W.h.p.m., Inc. | 6 |
| Preview | Wondfo USA Co., Ltd. | 6 |
| Sure-Vue | Fisher Scientific Company L.L.C. | 6 |
| Wondfo | Wondfo USA Co., Ltd. | 6 |
| Aimstep Pregnancy | Germaine Laboratories, Inc. | 5 |
| AlereTM | Alere San Diego, Inc. | 5 |
| Detector hCG | Immunostics, Inc. | 5 |
| QuickVue | Quidel Corp. | 5 |
| Medline | Medline Industries, Inc. | 5 |
Showing 12 of 113. All products under Visual, Pregnancy Hcg, Prescription Use
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K131166 | 2013-08-02 |
| K102175 | 2010-08-25 |
| K020801 | 2002-05-17 |
| K020799 | 2002-05-17 |
| K974052 | 1997-12-19 |
| K973841 | 1997-12-01 |
| K973858 | 1997-11-26 |
| K972748 | 1997-08-29 |
| K972742 | 1997-08-29 |
| K954273 | 1995-10-16 |
| K945969 | 1995-01-27 |
| K932042 | 1993-06-29 |
| K925435 | 1992-12-03 |
| K913122 | 1991-08-16 |
| K894790 | 1989-10-25 |
| K890615 | 1989-04-18 |
| K882086 | 1988-07-28 |
| K881595 | 1988-05-27 |
| K844082 | 1984-11-21 |
| K842692 | 1984-09-05 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2010-11-23 | Not classified | Pending | The recall was initiated after Quidel Corporation determined that a small number of QuickVue One-Step hCG Urine kits have been incorrectly packaged with QuickVue H. pylori gll cassettes inside the kit boxes. These foil pouches and test cass | 3624 kits = 90,600 tests total | 2012-06-26 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.