510(k) · Cleared
ClearedVelogene Genomic Identificationassay for Vre
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Id Biomedical Corp. · NIJ System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species
Cleared on May 1, 2002 as substantially equivalent to K941444 (Remel Co., 1994) and 1 other predicate after a 69-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- May 1, 2002
- Review
- 69 days
- Class
- Class II
- Product code
- NIJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K941444 (1994). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK941444 Bhi Agar with VancomycinRemel Co. · 1994
- This deviceK020576 Velogene Genomic Identificationassay for VreId Biomedical Corp. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K941444 | Bhi Agar with Vancomycin | Remel Co. | 1994 | — |
| 0 (this device) | K020576 | Velogene Genomic Identificationassay for Vre | Id Biomedical Corp. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 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 NIJ? 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 NIJ device
- #1 K243405 Xpert vanAscore 9.0 · 3 generations · no Class I recall
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 |
|---|---|---|---|
| * | K941444 | Bhi Agar with VancomycinSummary page 3…TE DEVICES The predicate devices for ID Biomedical’s Velogene™ Genomic Identification Assay for VRE kit are: e Brain Heart Infusion (BHI) Agar with 6 pg/mL vancomycin, #K941444, Remel e BHI Agar with 6 pg/mL vancomycin, #K964560, Hardy Diagnotics Both are NCCLS approved tests for the detection of Vancomy… | 1994 |
| * | K964560 | Bhi W/Vancomycin AgarSummary page 3…s Velogene™ Genomic Identification Assay for VRE kit are: e Brain Heart Infusion (BHI) Agar with 6 pg/mL vancomycin, #K941444, Remel e BHI Agar with 6 pg/mL vancomycin, #K964560, Hardy Diagnotics Both are NCCLS approved tests for the detection of Vancomycin Resistant Enterococci (VRE). SUMMARY OF SUBSTAN… | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- 1 of the 2 ancestors has a recall of any class.
How does its category compare?
All NIJ devicesNIJ System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NIJ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · NIJ
Too few NIJ 510(k)s in any year since 2007 to give a median.
Recalls per year · NIJ
No recall names NIJ since 2007.
Adverse event reports per year · NIJ
No MAUDE report names NIJ since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
For the visual or spectrophotometric detection of the vand and vanB genes in determining
vancomycin resistance in enterococei isolated from culture.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K020576 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020576: Velogene Genomic Identificationassay for Vre.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020576
Report an extraction error
Are you the manufacturer?
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