Atellica™ IM ThCG
The Atellica IM Total beta hCG assay quantifies human chorionic gonadotropin in serum as an aid to early pregnancy detection. It is used with the Atellica IM laboratory analyzer. The…
The Atellica IM Total beta hCG assay quantifies human chorionic gonadotropin in serum as an aid to early pregnancy detection. It is used with the Atellica IM laboratory analyzer.
The sandwich immunoassay combines a labeled anti-hCG antibody reagent with a solid phase of antibody coated paramagnetic particles. The reagent pack includes the assay’s master curve and test definition for use by the analyzer.
Listed Item
HCG Total (ThCG) – Atellica IM – RGT – 450T
Pack Configurations
The primary reagent is supplied as a 90 test ReadyPack or five ReadyPacks totaling 450 tests. Associated dilution reagents are available separately. The specified assay range is 2.6 to 1000 mIU/mL.
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 | Siemens Healthcare Diagnostics Inc, United States |
|---|---|
| FDA product code | JHI |
| Device type | Visual, Pregnancy Hcg, Prescription Use |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1155 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K172322 |
| Record published | 2018-06-05 |
| Record revised | 2023-07-06 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Store upright, Protect from light; Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 10995689 | 5 | In distribution | |
| 10995690 | In distribution | ||
| 11206261 | 5 | 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 |
|---|---|
| K172322 | 2018-03-29 |
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 |
|---|---|---|---|---|---|
| 2011-12-15 | Not classified | Process control | A potential for false positive or increase in borderline results with patients and commercially available negative control material. | 48,578 Kits (25 tests / kit) | 2015-03-30 |
| 2008-04-04 | Not classified | Component design/selection | False negative hCG results due to decreased sensitivity | 8180 | 2012-03-15 |
| 2007-10-17 | Not classified | Employee error | False positive hCG results | 3065 kits | 2012-03-15 |
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.