SmartCycler Dx System
Cepheid SmartCycler Dx is a real-time PCR instrument and software platform. The listed version 1.7B configuration is associated with the Smart GBS assay, which amplifies and detects Group B…
Cepheid SmartCycler Dx is a real-time PCR instrument and software platform. The listed version 1.7B configuration is associated with the Smart GBS assay, which amplifies and detects Group B Streptococcus DNA using fluorescent hybridization.
The platform combines a thermal-cycling instrument with software for running and reading assay tests. The GUDID identity describes the Smart GBS and SmartCycler Dx configuration together, keeping the device scope tied to that assay family.
Listed Item
Smart GBS AND Smartcycle DX System AND Software, Version 1.7B
Assay and Platform
In the named Smart GBS pairing, the assay amplifies target DNA and detects it through fluorescent hybridization. The instrument provides the cycling and optical measurement used by the assay.
The Dx software version identifies a particular SmartCycler configuration. Assay chemistry determines the target and result format, so the Smart GBS description applies to that pairing rather than every platform use.
Who Else Makes It
All of them in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Macro & Micro-Test MED-Tech Co., Ltd. | Nantong | Jiangsu | Manufacturer | 11 |
| Suzhou Tianlong Biotechnology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 5 |
Record
| Listed by | Cepheid, United States |
|---|---|
| FDA product code | NJR |
| Device type | Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test |
| Device class | Class 1 |
| Regulation | 21 CFR 866.3740 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer, Exporter |
| 510(k) | K062948 |
| Record published | 2018-07-03 |
| Record revised | 2025-07-14 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Storage environment temperature -20 to 60 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SC2500N19-1 | In distribution | |
| SC2500N15-1 | In distribution | |
| SC2500N16-1 | In distribution | |
| SC2500N6-1 | In distribution | |
| SC2500N18-1 | In distribution | |
| SC2500N12-1 | In distribution | |
| SC2500N3-1R | In distribution | |
| SC2500N4-1 | In distribution | |
| SC2500N2-1 | In distribution | |
| SC2500N1-1 | In distribution | |
| SC2500N14-1 | In distribution | |
| SC2500N4-1R | In distribution | |
| SC2500N13-1 | In distribution | |
| SC2500N3-1 | In distribution | |
| SC2500N17-1 | In distribution | |
| SC2500N5-1 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Freeze-dried Group B Streptococcus Nucleic Acid Detection Kit(Fluorescence PCR) | Jiangsu Macro & Micro-Test MED-Tech Co., Ltd. | 3 |
| Panther Fusion® | Hologic, Inc. | 3 |
| Xpert GBS LB | Cepheid | 2 |
| Xpert® | Cepheid | 2 |
| Alethia™ Group B Streptococcus | Meridian Bioscience, Inc. | 1 |
| AmpliVue | Quidel Corp. | 1 |
| Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EP | Jiangsu Macro & Micro-Test MED-Tech Co., Ltd. | 1 |
| Revogene GBS LB | Meridian Bioscience, Inc. | 1 |
| NeuMoDxTM GBS Test Strip | Neumodx Molecular, Inc. | 1 |
| Solana | Diagnostic Hybrids, Inc. | 1 |
| Aries® GBS Assay | Luminex Corporation | 1 |
| Group B Streptococcus Nucleic Acid Detection Kit(Fluorescence PCR) | Jiangsu Macro & Micro-Test MED-Tech Co., Ltd. | 1 |
Showing 12 of 19. All products under Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K222638 | 2023-09-27 |
| K203429 | 2022-05-09 |
| K121539 | 2012-11-02 |
| K062948 | 2006-12-08 |
| K060540 | 2006-07-25 |
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 |
|---|---|---|---|---|---|
| 2011-04-01 | Not classified | Software design | A mismatch of Patient ID or Sample ID and the Host Order from the hosted LIS and its requested test results could occur when running in batch mode and cartridges are introduced in rapid succession. | 16 US, 3 ROW | 2011-06-20 |
| 2007-09-05 | Not classified | Release of Material/Component prior to receiving test results | Labeling Error: Some cartridges may be mislabeled as “Xpert EV” instead of “Xpert GBS”. (The information embedded in the barcode label on the cartridge is correct for Xpert GBS and brings up the GBS assay definition file) | 105 | 2008-04-04 |
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.