Accelerator
Accelerator APS Input / Output Module
7manufacturers in China registered for this device type
2catalogue numbers in this listing
1510(k) clearance
9recalls on this code
Who Else Makes It
Concentrated in Zhejiang (2), Guangdong (2), Jiangsu (1). 2 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 |
| Dongguan BAO Kang Dian ZI KE JI Limited | Dongguan | Guangdong | Contract manufacturer | 24 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Zhejiang Gene Science Co., Ltd. | Shaoxing | Zhejiang | Manufacturer | 31 |
| Foshan Zike Technology Co., Ltd. | Foshan | Guangdong | Manufacturer | 9 |
| Tianjin Empecs Medical Device Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 8 |
| Shanghai Bestcovered Limited | Shanghai | Shanghai | Manufacturer | 2 |
Record
| Listed by | Abbott Laboratories, United States |
|---|---|
| FDA product code | JQP |
| Device type | Calculator/Data Processing Module, For Clinical Use |
| Device class | Class 1 |
| Regulation | 21 CFR 862.2100 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K093318 |
| Record published | 2023-09-15 |
| Record revised | 2025-06-11 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 07L0102 | In distribution | |
| 07L0101 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| SoftPathDx | SCC Soft Computer | 69 |
| SoftMolecular | SCC Soft Computer | 67 |
| SoftFlowCytometry | SCC Soft Computer | 67 |
| SoftBiochemistry | SCC Soft Computer | 67 |
| SoftCytogenetics | SCC Soft Computer | 67 |
| SoftMic | SCC Soft Computer | 65 |
| SoftLab | SCC Soft Computer | 64 |
| SoftTrack | SCC Soft Computer | 61 |
| SoftHLA | SCC Soft Computer | 61 |
| SoftGenomics | SCC Soft Computer | 51 |
| SoftGenePortal | SCC Soft Computer | 48 |
| SoftTotalQC | SCC Soft Computer | 28 |
Showing 12 of 140. All products under Calculator/Data Processing Module, For Clinical Use
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K790543 | 1979-05-03 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Abbott Laboratories | 510(k) number | 2018-09-07 | Class II | Component change control | The firm identified customer sites where modules which the safety pacemaker label is missing. Information regarding the label included in the Operations Manual has been updated to specify: 1) the risk of malfunction applies to anyone with a | 159 devices | 2021-02-02 |
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 |
|---|---|---|---|---|---|
| 2008-10-27 | Not classified | Software design | When an ARCHITECT c16000 System is connected to an ACCELERATOR APS System, the software on the ACCELERATOR APS System may not generate an error warning when a Sample Presentation/Sample Queue error occurs, which could result in contaminatio | 15 units | 2009-12-02 |
| 2008-09-09 | Not classified | Device Design | ACCELERATOR APS Centrifuge Module being recalled due to potential for micro-cracks to form over time in the metal centrifuge rotor buckets that may cause the centrifuge buckets to disconnect from the rotor in the centrifuge during centrifug | 6 | 2010-10-04 |
| 2007-10-25 | Not classified | Software design | Sample/Patient Mis-identification: Two issues identified related to the ACCELERATOR Decision Manager (ADM), to include: 1) Sample Identification (SID) and/or Patient Identification (PID) numbers that contain more than 12 characters are trun | 19 units. | 2008-04-01 |
| 2007-10-10 | Not classified | Software design | Sample problems; Five issues identified related to software utilized by the ACCELERATOR APS System Input/Output Module, to include: Under three specific conditions, the post-aspiration radio-frequency identification (RF ID) read of the tube | 1 unit. | 2008-03-10 |
| 2007-05-15 | Not classified | Other | Product’s hinged lid can fall, if not fully opened as designed, representing a potential injury hazard to the operator. | 1 unit. | 2007-11-27 |
| 2003-11-17 | Not classified | Other | Sample Identification (SID) numbers of a bar coded sample may be truncated, or shortened, after being scanned by the bar code reader (e.g. an actual SID of 123456 is shortened to 1234) | 148 | 2004-10-28 |
| 2003-11-17 | Not classified | Other | Sample Identification (SID) numbers of a bar coded sample may be truncated, or shortened, after being scanned by the bar code reader (e.g. an actual SID of 123456 is shortened to 1234) | 223 | 2004-10-28 |
| 2003-09-30 | Not classified | Other | Audible alarm occurs before aspiration potentially resulting in operator injury or results assigned to wrong patient for STAT samples. | 133 | 2004-04-07 |
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.