Architect
Activated Alanine Aminotransferase
3manufacturers in China registered for this device type
3catalogue numbers in this listing
3510(k) clearances naming this product code
4recalls on this code
Who Else Makes It
Concentrated in Zhejiang (1), Jilin (1), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Orient Gene Biotech | Huzhou | Zhejiang | Contract manufacturer | 86 |
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Biobase Biodustry(Shandong)Co., Ltd. | Jinan | Shandong | Manufacturer | 70 |
Record
| Listed by | Abbott Laboratories, United States |
|---|---|
| FDA product code | CKA |
| Device type | Nadh Oxidation/Nad Reduction, Alt/Sgpt |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1030 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2018-07-31 |
| Record revised | 2024-02-21 (version 2) |
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 |
|---|---|---|
| 8L92-21 | In distribution | |
| 7D56-21 | In distribution | |
| 8L92-41 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Biobase | Biobase Biodustry(Shandong)Co., Ltd. | 18 |
| Alanine Aminotransferase (ALT) | Randox Laboratories Limited | 10 |
| Synermed® | Infrared Laboratory Systems LLC | 7 |
| JAS Diagnostics | Drew Scientific, Ltd. | 6 |
| Carolina Liquid Chemistries Corp.® Alanine Aminotransferase Reagent KIT ST240 | Carolina Liquid Chemistries | 4 |
| Synchron | Beckman Coulter, Inc. | 4 |
| Architect | Abbott Ireland | 4 |
| Architect | Abbott Medical | 3 |
| Alinity | Abbott Ireland | 3 |
| Pointe Scientific ALT (Sgpt) Liquid | Horiba Instruments Incorporated | 3 |
| Vitros | Ortho-Clinical Diagnostics, Inc. | 3 |
| Alanine Aminotransferase acc. to Ifcc without pyridoxal phosphate activation | Roche Diagnostics Gmbh | 2 |
Showing 12 of 57. All products under Nadh Oxidation/Nad Reduction, Alt/Sgpt
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K890698 | 1989-04-10 |
| K861002 | 1986-04-21 |
| K812926 | 1981-11-06 |
Recalls
4 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2021-06-10 | Class II | Under Investigation by firm | There is a potential for 15% under-recovery on Activated Alanine Aminotransferase (A-ALT) samples greater than 1,200 U/L. In addition there is a potential for a >10% shift in patient results with samples containing bilirubin concentrations | 4,727 units |
| 2021-06-10 | Class II | Under Investigation by firm | There is a potential for >10% under-recovery on Activated Alanine Aminotransferase (A-ALT) samples greater than 1,200 U/L. In addition there is a potential for a >10% shift in patient results with samples containing bilirubin concentrations | 2,212 units |
| 2021-06-10 | Class II | Under Investigation by firm | There is a potential for >10% under-recovery on Activated Alanine Aminotransferase (A-ALT) samples greater than 1,200 U/L. In addition there is a potential for a >10% shift in patient results with samples containing bilirubin concentrations | 36 units |
| 2021-06-10 | Class II | Under Investigation by firm | There is a potential for >10% under-recovery on Activated Alanine Aminotransferase (A-ALT) samples greater than 1,200 U/L. In addition there is a potential for a >10% shift in patient results with samples containing bilirubin concentrations | 1,603 units |
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.