TRUEdraw
TRUEdraw is a reusable lancet holder used with a sterile, single-use lancet to obtain a capillary blood sample. The filing describes sampling from the fingertip or forearm using the clear…
TRUEdraw is a reusable lancet holder used with a sterile, single-use lancet to obtain a capillary blood sample. The filing describes sampling from the fingertip or forearm using the clear end cap.
The device is intended for repeated use by one patient and is not suitable for healthcare professionals using it with multiple patients. It is a lancing base rather than the disposable lancet itself.
Listed Item
Foster & Thrive TRUEdraw Lancing Device
Patient Use
The clearance describes the forearm as an alternative sampling site. Testing included lancet-change verification and evaluation of mechanical performance and sharps-injury risks. The device remains intended for one patient.
Who Else Makes It
Concentrated in Zhejiang (5), Tianjin (5), Jiangsu (4). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jetcrown Industrial (Dong Guan) Ltd. | Guangdong | Guangdong | Contract manufacturer | 3 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Ningbo Chibanda IMP &EXP Co., Ltd. | Ningbo | Zhejiang | Manufacturer | 59 |
| Bestreat Safety & First AID Solution Co., Ltd. | Wuhan | Hubei | Manufacturer | 35 |
| Andon Health Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 22 |
| Promisemed Hangzhou Meditech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 21 |
| Vivachek Biotech (Hangzhou) Co., Ltd. | Hangzhou, Zhuji | Zhejiang | Contract manufacturer | 21 |
| Shenzhen Yuwen E-Commerce Co., Ltd. | Shenzhen | Guangdong | Repacker / relabeller | 19 |
| Guangdong Transtek Medical Electronics Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 11 |
| Shanghai Carelife International Trading Co., Ltd. | Jinqiao Pudong | Shanghai | Specification developer | 11 |
| Sterilance Medical (Suzhou) Inc. | Suzhou | Jiangsu | Contract manufacturer | 8 |
| Tianjin Empecs Medical Device Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 8 |
Showing 12 of 21. All 21 manufacturers in China registered for Multiple Use Blood Lancet For Single Patient Use Only
Record
| Listed by | Trividia Health, Inc., United States |
|---|---|
| FDA product code | QRL |
| Device type | Multiple Use Blood Lancet For Single Patient Use Only |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4850 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K221072 |
| Record published | 2020-12-14 |
| Record revised | 2024-08-30 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Store at room temperature. Store without a lancet inserted. |
| Packaging | Case of 50 |
| Distribution end date | 2024-08-28 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Good Neighbor Lancing Device | In distribution | |
| TRUEdraw Lancing Device | In distribution | |
| Rite Aid TRUEdraw Lancing Device | In distribution | |
| CVS TRUEdraw Lancing Device | In distribution | |
| TRUEdraw Lancing Device | In distribution | |
| Sunmark TRUEdraw Lancing Device | Withdrawn | |
| HealthMart TRUEdraw Lancing Device | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Twist Lancet (23G) | Shandong Lianfa Medical Plastic Products Co., Ltd. | 24 |
| Auvon | Shenzhen Yuwen E-Commerce Co., Ltd. | 18 |
| Twist Lancet (28G) | Shandong Lianfa Medical Plastic Products Co., Ltd. | 13 |
| Twist Lancet (30G) | Shandong Lianfa Medical Plastic Products Co., Ltd. | 12 |
| Twist Lancet (26G) | Shandong Lianfa Medical Plastic Products Co., Ltd. | 11 |
| Care Touch | Tianjin Huahong Technology Co., Ltd. | 10 |
| TysonBio | Shandong Lianfa Medical Plastic Products Co., Ltd. | 8 |
| Accu-Chek Fastclix | Roche Diabetes Care, Inc. | 8 |
| Right Lance | Beijing Ruicheng Medical Supplies Co., Ltd. | 5 |
| Huahong | Tianjin Huahong Technology Co., Ltd. | 5 |
| One +Step | Shandong Lianfa Medical Plastic Products Co., Ltd. | 4 |
| Accu-Chek Coaguchek Softclix | Roche Diabetes Care, Inc. | 4 |
Showing 12 of 103. All products under Multiple Use Blood Lancet For Single Patient Use Only
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K221072 | 2022-10-18 |
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.