510(k) · Cleared
ClearedIdi-Strep B Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Infectio Diagnostic, Inc. · NJR Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
Cleared on Nov 18, 2002 as substantially equivalent to K991828 (Biostar, Inc., 1999) after a 112-day review. Its family tree reaches back 2 generations to 1994. 17 later devices descend from it.
- Decided
- Nov 18, 2002
- Review
- 112 days
- Class
- Class I
- Product code
- NJR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K936112 (1994). 17 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK936112 Strep B OiaBiostar, Inc. · 1994
- 1 generation backK991828 Strep B OiaBiostar, Inc. · 1999
- This deviceK022504 Idi-Strep B AssayInfectio Diagnostic, Inc. · 2002
- Descendant · cites it directly · 14 of its ownK062948 Smart GBS and Smartcycle DX System and Software, Version 1.7BCepheid · 2006
- Descendant · 2 generations on · 4 of its ownK112125 Illumigene Group B Streptococcus ,External Control KitMeridian Bioscience, Inc. · 2011
- Descendant · 2 generations on · 4 of its ownK090191 Handylab GBS Assay, Handylab Jaguar Instrument, Handylab Dna…Handylab, Inc. · 2010
- Descendant · 2 generations on · 2 of its ownK121539 Xpert GBS LB Genexpert DX Systems (GX-I, GX-IV) Genexpert DX Systems…Cepheid · 2012
- Descendant · 3 generations on · 2 of its ownK111860 BD Max GBS Assay, BD Max InstrumentBecton, Dickinson & CO · 2012 · Recalled
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K062948Smart GBS and Smartcycle DX System and Software, Version 1.7BCepheid · 2006 · cites it directly14descendants
- K112125Illumigene Group B Streptococcus ,External Control KitMeridian Bioscience, Inc. · 2011 · 2 generations on4descendants
- K090191Handylab GBS Assay, Handylab Jaguar Instrument, Handylab Dna Extraction Strip, Handylab…Handylab, Inc. · 2010 · 2 generations on4descendants
- K121539Xpert GBS LB Genexpert DX Systems (GX-I, GX-IV) Genexpert DX Systems (GX-Xvi) Genexpert…Cepheid · 2012 · 2 generations on2descendants
- K111860BD Max GBS Assay, BD Max InstrumentBecton, Dickinson & CO · 2012 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K936112 | Strep B Oia | Biostar, Inc. | 1994 | — |
| −1 | K991828 | Strep B Oia | Biostar, Inc. | 1999 | — |
| 0 (this device) | K022504 | Idi-Strep B Assay | Infectio Diagnostic, Inc. | 2002 | — |
| +1 | K062948 | Smart GBS and Smartcycle DX System and Software, Version 1.7B | Cepheid | 2006 | — |
| +2 | K112125 | Illumigene Group B Streptococcus ,External Control Kit | Meridian Bioscience, Inc. | 2011 | — |
| +2 | K090191 | Handylab GBS Assay, Handylab Jaguar Instrument, Handylab Dna Extraction Strip… | Handylab, Inc. | 2010 | — |
| +2 | K121539 | Xpert GBS LB Genexpert DX Systems (GX-I, GX-IV) Genexpert DX Systems (GX-Xvi)… | Cepheid | 2012 | — |
| +3 | K111860 | BD Max GBS Assay, BD Max Instrument | Becton, Dickinson & CO | 2012 | 7 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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? (2)
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 |
|---|---|---|---|
| * | K991828 | Strep B OiaSummary page 2…ete samples. Substantial Equivalence: The lnfectio Diagnostic Inc. IDI~Strep B™ assay has been found to be substantially equivalent to the Thermo BioStar™ STREP B OIA® (K991828) and to broth culture. All assays detect GBS; the 101-Strep B™ assay determines the presence of GBS through PCR amplification and… | 1999 |
| * | — | broth culture Named without a submission number |
What descends from it? (17)
See all 172 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 8 years and passes through 2 companies; a new generation was cleared every 5.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K062948 (Cepheid, 2006) has gone furthest, with 14 descendants of its own.
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?
IDI-Strep B™ assay is a qualitative in vitro diagnostic test for the rapid detection of Group B streptococcus (GBS) DNA in vaginal/rectal specimens from prepartum or intrapartum women. The test performed on the Smart Cycler® automated analyzer utilizes polymerase chain reaction (PCR) for the amplification of a cfb gene sequence of GBS recovered from clinical samples and fluorogenic target-specific hybridization for the detection of the amplified DNA.
IDI-Strep B™ assay can be used to establish GBS colonisation status of prepartum and intrapartum women.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022504 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022504: Idi-Strep B Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022504
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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