Dimension Clinical Chemistry System A1C Kit
The Dimension A1C reagent kit measures glycated hemoglobin in anticoagulated human venous whole blood on the Dimension clinical chemistry system. Results support diabetes diagnosis,…
The Dimension A1C reagent kit measures glycated hemoglobin in anticoagulated human venous whole blood on the Dimension clinical chemistry system. Results support diabetes diagnosis, identification of people at risk of diabetes and monitoring of long term blood glucose control in people with diabetes.
The assay uses a turbidimetric inhibition immunoassay to measure hemoglobin A1c. Three liquid reagents are supplied ready for use in Dimension Flex cartridges. The analyzer reports results as percent HbA1c on the DCCT/NGSP scale and as mmol/mol on the IFCC scale.
Listed Item
A1C Reagent Kit
Analytical Range
The HbA1c reporting range is 3.8% to 14.0%, equivalent to 18 to 130 mmol/mol. The assay is intended for the compatible Dimension analyzer and the specified anticoagulated venous whole blood sample.
Who Else Makes It
All of them in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medconn Medical Technology Co., Ltd. | Shanghai | Shanghai | Manufacturer | 2 |
| Shanghai Medconn Biotechnology Co., Ltd. | Jinshan District | Shanghai | Manufacturer | 2 |
Record
| Listed by | Siemens Healthcare Diagnostics Inc, United States |
|---|---|
| FDA product code | PDJ |
| Device type | Hemoglobin A1c Test System |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1373 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K173909 |
| Record published | 2018-12-06 |
| Record revised | 2021-11-18 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10720883 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| D-100 | Bio-Rad Laboratories Inc. | 4 |
| Architect | Abbott Medical | 3 |
| D-10 | Bio-Rad Laboratories Inc. | 3 |
| Afinion HbA1c Dx | Abbott Diagnostics Technologies AS | 2 |
| Tina-quant Hemoglobin A1cDx Gen.3 | Roche Diagnostics Gmbh | 2 |
| Alinity | Abbott Medical | 1 |
| HbA1c Assay | Sekisui Diagnostics, LLC | 1 |
| Dimension Vista System Flex reagent cartridge A1C KIT | Siemens Healthcare Diagnostics Inc | 1 |
| Eluent 80B | Arkray USA, Inc. | 1 |
| BioHermes Automated Glycohemoglobin Analyzer | Wuxi Biohermes BIO & Medical Technology Co., Ltd. | 1 |
| Diluent 80 | Arkray USA, Inc. | 1 |
| Eluent 80A | Arkray USA, Inc. | 1 |
Showing 12 of 18. All products under Hemoglobin A1c Test System
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K200256 | 2021-07-02 |
| K173909 | 2018-07-13 |
| K171771 | 2017-12-04 |
Recalls
3 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 |
|---|---|---|---|---|
| 2026-06-08 | Class II | Under Investigation by firm | The potential for intermittent well-to-well bias on the A1c_E assay on the Atellica CH and Atellica CI analyzer which could cause falsely depressed or falsely elevated HbA1c patient results. | 24,077 units |
| 2026-02-23 | Class II | Process control | A potential for depressed results for Atellica CH A1c_E when processing Atellica CH RCRP on the same analyzer. Customers processing A1c_E and RCRP on separate analyzers are not impacted by the recall. The frequency and magnitude of the nega | 21,291 units (9750 US, 11541 OUS) |
| 2022-02-09 | Class II | Device Design | Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality control (QC), patient samples, and calibrator results. | 6606 |
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.