510(k) · Cleared
ClearedSmart GBS and Smartcycle DX System and Software, Version 1.7B
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cepheid · NJR Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
Cleared on Dec 8, 2006 as substantially equivalent to K022504 (Infectio Diagnostic, Inc., 2002) after a 71-day review. Its family tree reaches back 3 generations to 1994. 14 later devices descend from it.
- Decided
- Dec 8, 2006
- Review
- 71 days
- Class
- Class I
- Product code
- NJR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K936112 (1994). 14 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK936112 Strep B OiaBiostar, Inc. · 1994
- 2 generations backK991828 Strep B OiaBiostar, Inc. · 1999
- 1 generation backK022504 Idi-Strep B AssayInfectio Diagnostic, Inc. · 2002
- This deviceK062948 Smart GBS and Smartcycle DX System and Software, Version 1.7BCepheid · 2006
- Descendant · cites it directly · 4 of its ownK112125 Illumigene Group B Streptococcus ,External Control KitMeridian Bioscience, Inc. · 2011
- Descendant · cites it directly · 4 of its ownK090191 Handylab GBS Assay, Handylab Jaguar Instrument, Handylab Dna…Handylab, Inc. · 2010
- Descendant · cites it directly · 2 of its ownK121539 Xpert GBS LB Genexpert DX Systems (GX-I, GX-IV) Genexpert DX Systems…Cepheid · 2012
- Descendant · 2 generations on · 2 of its ownK111860 BD Max GBS Assay, BD Max InstrumentBecton, Dickinson & CO · 2012 · Recalled
- Descendant · 3 generations on · 1 of its ownK170557 GenePOC GBS LBGenepoc, Inc. · 2017
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K112125Illumigene Group B Streptococcus ,External Control KitMeridian Bioscience, Inc. · 2011 · cites it directly4descendants
- K090191Handylab GBS Assay, Handylab Jaguar Instrument, Handylab Dna Extraction Strip, Handylab…Handylab, Inc. · 2010 · cites it directly4descendants
- K121539Xpert GBS LB Genexpert DX Systems (GX-I, GX-IV) Genexpert DX Systems (GX-Xvi) Genexpert…Cepheid · 2012 · cites it directly2descendants
- K111860BD Max GBS Assay, BD Max InstrumentBecton, Dickinson & CO · 2012 · 2 generations on2descendants
- K170557GenePOC GBS LBGenepoc, Inc. · 2017 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K936112 | Strep B Oia | Biostar, Inc. | 1994 | — |
| −2 | K991828 | Strep B Oia | Biostar, Inc. | 1999 | — |
| −1 | K022504 | Idi-Strep B Assay | Infectio Diagnostic, Inc. | 2002 | — |
| 0 (this device) | K062948 | Smart GBS and Smartcycle DX System and Software, Version 1.7B | Cepheid | 2006 | — |
| +1 | K112125 | Illumigene Group B Streptococcus ,External Control Kit | Meridian Bioscience, Inc. | 2011 | — |
| +1 | K090191 | Handylab GBS Assay, Handylab Jaguar Instrument, Handylab Dna Extraction Strip… | Handylab, Inc. | 2010 | — |
| +1 | K121539 | Xpert GBS LB Genexpert DX Systems (GX-I, GX-IV) Genexpert DX Systems (GX-Xvi)… | Cepheid | 2012 | — |
| +2 | K111860 | BD Max GBS Assay, BD Max Instrument | Becton, Dickinson & CO | 2012 | 7 |
| +3 | K170557 | GenePOC GBS LB | Genepoc, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NJR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NJR device
- #1 K222638 Xpert® Xpress GBS, GeneXpert® Dx System…score 7.0 · 4 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K022504 | Idi-Strep B AssaySummary page 1…Microbiology Predicate Devicec: I DI-Strep B Assay [5 I 0(k) no. K022504] Device Description: The Cepheid Smart CBS Assay is a rapid, DNA test for detecting CBS DNA from vaginal/rectal swab specimens… | 2002 |
| † | K060540 | Xpert, Genexpert DX System | 2006 |
What descends from it? (14)
See all 144 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112125 | Illumigene Group B Streptococcus ,External Control Kit | 2011 | 4 |
| K090191 | Handylab GBS Assay, Handylab Jaguar Instrument, Handylab Dna Extraction Strip, Handylab… | 2010 | 4 |
| K121539 | Xpert GBS LB Genexpert DX Systems (GX-I, GX-IV) Genexpert DX Systems (GX-Xvi) Genexpert… | 2012 | 2 |
| K102314 | 3M Integrated Cycler (110V) & (220V) | 2010 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 4.1 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K112125 (Meridian Bioscience, Inc., 2011) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K022504.
How does its category compare?
All NJR devicesNJR Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NJR
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · NJR
87in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NJR
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NJR
14in 2024
MAUDE reports naming product code NJR, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 1 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 1 | 0 |
| 2012 | 3 | 162 | 2 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 1 | — | 1 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 1 |
| 2018 | 3 | 87 | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 1 | — | 1 | 3 |
| 2023 | 1 | — | 0 | 8 |
| 2024 | 0 | — | 2 | 14 |
| 2025 | 0 | — | 1 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Ccpheid Smart GBS Assay performed on the Cepheid SmartCycler Dx System is a qualitative in vitro diagnostic test designed to detect Group B Streptococcus (GBS) DNA from vaginal/rectal swab specimens and Lim broth cultures. The test utilizes real-time polymerase chain reaction (PCR) for a unique gene-specific sequence amplification of Streptococcus agalactiaerecovered from clinical samples and fluorogenic target specific hybridization for the…
Read the full statement (158 words)
The Ccpheid Smart GBS Assay performed on the Cepheid SmartCycler Dx System is a qualitative in vitro diagnostic test designed to detect Group B Streptococcus (GBS) DNA from vaginal/rectal swab specimens and Lim broth cultures. The test utilizes real-time polymerase chain reaction (PCR) for a unique gene-specific sequence amplification of Streptococcus agalactiaerecovered from clinical samples and fluorogenic target specific hybridization for the detection of the amplified DNA. Results from the Smart GBS Assay are intended for use as a method for rapid detection of GBS colonization in antepartum and intrapartum women.
* The use of the Smart GBS for intrapartum screening should not preclude the use of other strategies (e.g., antepartum testing). Intrapartum Smart GBS results are useful to identify candidates for intrapartum antibiotic prophylaxis when administration of intravenous antibiotics is not delayed pending results.
* The Smart GBS assay does not provide susceptibility results. Culture isolates are needed for performing susceptibility testing as recommended for penicillin-allergic women.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062948 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062948: Smart GBS and Smartcycle DX System and Software, Version 1.7B.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062948
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026