Architect
Quantia B2-Microglobulin Calibrator
12manufacturers in China registered for this device type
24catalogue numbers in this listing
4510(k) clearances naming this product code
9recalls on this code
Who Else Makes It
Concentrated in Zhejiang (3), Guangdong (3), Jilin (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Acon Biotech (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 29 |
| Flextronics Industrial (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 5 |
| Yasee Biomedical Inc | Qingdao | Shandong | Contract manufacturer | 5 |
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Vivachek Biotech (Hangzhou) Co., Ltd. | Hangzhou, Zhuji | Zhejiang | Contract manufacturer | 21 |
| Guangdong Transtek Medical Electronics Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 11 |
| Tianjin Empecs Medical Device Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 8 |
| BD Rapid Diagnostics (Suzhou) Co., Ltd. | China (Jiangsu) Pilot Free Trade Zone Suzhou Area | Manufacturer | 6 | |
| Sejoy Biomedical Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 5 |
| Beijing Genesee Biotech, Inc. | Beijing | Beijing | Manufacturer | 4 |
| Human Metabolomics Institute, Inc. | Shenzhen | Guangdong | Manufacturer | 4 |
| Changsha Sinocare Inc. | Changsha | Hunan | Manufacturer | 2 |
Record
| Listed by | Abbott Laboratories, United States |
|---|---|
| FDA product code | JJX |
| Device type | Single (Specified) Analyte Controls (Assayed And Unassayed) |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1660 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K040879 |
| Record published | 2016-09-09 |
| Record revised | 2023-09-21 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Do not freeze.; Handling environment temperature up to 29 °C; Storage environment temperature 2 to 8 °C |
| Distribution end date | 2023-06-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6K49-02 | In distribution | |
| 3L41-14 | In distribution | |
| 2K41-10 | In distribution | |
| 3L41-10 | In distribution | |
| 06K4151 | In distribution | |
| 3L41-16 | In distribution | |
| 5P83-01 | In distribution | |
| 06K4504 | In distribution | |
| 6K89-20 | In distribution | |
| 06K3941 | In distribution | |
| 6K99-40 | In distribution | |
| 3L41-12 | In distribution | |
| 06K4704 | In distribution | |
| 6K53-21 | In distribution | |
| 06K5322 | In distribution | |
| 2K48-01 | In distribution | |
| 3L53-01 | Withdrawn | |
| 8K41-11 | Withdrawn | |
| 8K41-02 | Withdrawn | |
| 2K44-35 | Withdrawn | |
| 2K44-25 | Withdrawn | |
| 2K45-35 | Withdrawn | |
| 2K45-25 | Withdrawn | |
| 2K44-20 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Vitros | Ortho-Clinical Diagnostics, Inc. | 55 |
| Validate | LGC Clinical Diagnostics, Inc. | 37 |
| Architect | Abbott Medical | 23 |
| BioPlex 2200 | Bio-Rad Laboratories Inc. | 22 |
| Architect | Abbott Ireland | 18 |
| Liquichek | Bio-Rad Laboratories Inc. | 17 |
| Alinity | Abbott Medical | 17 |
| Alinity | Abbott Ireland | 15 |
| Fora | Fora Care Inc. | 15 |
| Pregnancy-Skreen | Biochemical Diagnostics, Inc. | 14 |
| Accurun® | LGC Clinical Diagnostics, Inc. | 14 |
| Plasma Control | Chromsystems Instruments & Chemicals Gmbh | 9 |
Showing 12 of 907. All products under Single (Specified) Analyte Controls (Assayed And Unassayed)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K041687 | 2004-08-18 |
| K970527 | 1997-03-03 |
| K935611 | 1994-06-21 |
| K863126 | 1986-09-15 |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2020-04-01 | Class III | Employee error | Error in the renewal documentation process for license in Mexico. All in date ARCHITECT C Peptide Reagents, Calibrators and Controls are being recalled until a new license is obtained. | 65 kits total | 2020-09-01 |
| 2019-05-24 | Class III | Under Investigation by firm | Presence of a time dependent, stability drift in patient and control results returned from ARCHITECT BNP testing. | 6,623 units | 2021-04-01 |
| 2019-04-09 | Class III | Under Investigation by firm | Devices were delivered without the required dry ice. | 1 unit | 2019-12-20 |
| 2014-04-30 | Class II | Under Investigation by firm | HbA1c Calibrators LN 4P52-02, lot 45063UQ12 may contain a value sheet for a different HbA1c calibrator lot. If calibrator lot 45063UQ12 is used in the calibration of the HbA1c assay using values from an incorrect calibrator value sheet then | 183 calibrator kits | 2016-12-28 |
| 2014-02-12 | Class II | Under Investigation by firm | Abbott has confirmed that a performance shift in the ARCHITECT Intact PTH assay has the potential to generate falsely elevated results on patient samples. Results generated with impacted lots may demonstrate a positive shift relative to tho | List Number 8K25-10: 9,463 control kits | 2015-05-22 |
| 2008-09-05 | Not classified | Error in labeling | The values listed in the Architect LH MasterCheck, Lot 82520 data sheet are incorrect. When MasterChecks do not perform as intended, the integrity of the system cannot be verified and patient results would not be generated. Other commercia | 30 kits | 2010-03-18 |
| 2008-02-27 | Not classified | Nonconforming Material/Component | Testing material becomes unstable at the recommeded storage temperature. Some of the Architect Free T4 MasterCheck and Total T4 MasterCheck lots are not stable at the recommended storage condition of 2 to 8 degrees Celsius through expirati | 197 units | 2008-11-05 |
| 2008-02-27 | Not classified | Nonconforming Material/Component | Testing material becomes unstable at the recommeded storage temperature. Some of the Architect Free T4 MasterCheck and Total T4 MasterCheck lots are not stable at the recommended storage condition of 2 to 8 degrees Celsius through expirati | 128 units | 2008-11-05 |
| 2007-07-06 | Not classified | Other | The Architect Prolactin MasterChecks may not be stable at the recommended storage conditions of 2 to 8 degrees C through the expiration dating (15 months). The MasterChecks may exceed the suggested tolerance limits listed in the Reportable | 57 kits | 2008-05-18 |
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.