Architect
Lipid Multiconstituent Calibrator
3manufacturers in China registered for this device type
11catalogue numbers in this listing
3510(k) clearances naming this product code
3recalls on this code
Who Else Makes It
Concentrated in Jilin (1), Guangdong (1), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Getein Biotech, Inc. | Nanjing | Jiangsu | Manufacturer | 19 |
Record
| Listed by | Abbott Laboratories, United States |
|---|---|
| FDA product code | JIX |
| Device type | Calibrator, Multi-Analyte Mixture |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1150 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K981706 |
| Record published | 2016-06-06 |
| Record revised | 2024-11-11 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Handling environment temperature up to 29 °C; Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1E66-04 | In distribution | |
| 1E65-05 | In distribution | |
| 3E16-02 | In distribution | |
| 6K30-10 | In distribution | |
| 1E69-03 | In distribution | |
| 1E31-20 | In distribution | |
| 1E71-02 | In distribution | |
| 1E64-02 | In distribution | |
| 6K31-10 | In distribution | |
| 5P56-01 | In distribution | |
| 5P04-01 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Stat Profile | Nova Biomedical Corporation | 54 |
| BioPlex 2200 | Bio-Rad Laboratories Inc. | 32 |
| Plasma Calibrator Set | Chromsystems Instruments & Chemicals Gmbh | 22 |
| Phoenix Diagnostics | Phoenix Diagnostics, Inc. | 20 |
| Nova | Nova Biomedical Corporation | 15 |
| Plasma Calibration Standard | Chromsystems Instruments & Chemicals Gmbh | 15 |
| Phoenix Diagnostics, Inc. | Phoenix Diagnostics, Inc. | 15 |
| Alinity | Abbott Medical | 10 |
| Synchron | Beckman Coulter, Inc. | 9 |
| Architect | Abbott Medical | 9 |
| Urine Calibration Standard | Chromsystems Instruments & Chemicals Gmbh | 8 |
| Serum Calibration Standard | Chromsystems Instruments & Chemicals Gmbh | 8 |
Showing 12 of 229. All products under Calibrator, Multi-Analyte Mixture
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K123372 | 2013-01-14 |
| K103403 | 2011-02-04 |
| K981706 | 1998-07-09 |
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Abbott Laboratories | 510(k) number | 2008-04-24 | Not classified | Error in labeling | An incorrect Magnesium calibrator 2 value (CAL 2) was provided for Clinical Chemistry Iron/Magnesium Calibrator lot number 54187M200. Use of the incorrect Magnesium CAL 2 value causes quality control and patient magnesium results to be re | 1287 | 2009-07-09 |
| Abbott Laboratories | 510(k) number | 2007-08-10 | Not classified | Material/Component Contamination | Incorrect Calibrator values: changes in a raw material used in the Bilirubin Calibrator value assignment process contributed to variability in the preparation of the standard. | 7,033 units total worldwide | 2012-04-19 |
| Abbott Laboratories Diagnostic Div | 510(k) number | 2005-12-23 | Not classified | Other | The two Multiconstituent Calibrator (MCC) lot numbers 19906M200 and 20879M100 failed to meet product performance expectations throughout the labeled expiration period, as a result of the shortened expiration dating, two lots are now expired | 13961 | 2012-04-24 |
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 |
|---|---|---|---|---|---|
| 2008-09-12 | Not classified | Component design/selection | The field action was initiated after an investigation for the Total Bilirubin reagents (List Number 8G62 and List Number 6L45) determined that the matrix of the secondary standard used in the value assignment of the calibrator is sensitive | 7,101 units worldwide (2,267 units in US). | 2012-04-24 |
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.