510(k) · Cleared
ClearedEmit 2000 Vancomycin Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Behring, Inc. · LEH Radioimmunoassay, Vancomycin
Cleared on May 10, 2002 as substantially equivalent to K881040 (Syva Co., 1988) after a 67-day review. Its family tree reaches back 1 generation to 1988. 1 later device descends from it.
- Decided
- May 10, 2002
- Review
- 67 days
- Class
- Class II
- Product code
- LEH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K881040 (1988). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK881040 Emit Vancomycin AssaySyva Co. · 1988
- This deviceK020692 Emit 2000 Vancomycin AssayDade Behring, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK043386 Vitros Chemistry Products Vanc Reagent, Calibrator Kit 11 and TDM…Ortho-Clinical Diagnostics, Inc. · 2005 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K043386Vitros Chemistry Products Vanc Reagent, Calibrator Kit 11 and TDM Performance Verifiers…Ortho-Clinical Diagnostics, Inc. · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K881040 | Emit Vancomycin Assay | Syva Co. | 1988 | — |
| 0 (this device) | K020692 | Emit 2000 Vancomycin Assay | Dade Behring, Inc. | 2002 | — |
| +1 | K043386 | Vitros Chemistry Products Vanc Reagent, Calibrator Kit 11 and TDM Performance… | Ortho-Clinical Diagnostics, Inc. | 2005 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 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 LEH? 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 LEH device
- #1 K222439 Atellica® CH Phencyclidine (Pcp), Atellica® CH…score 7.0 · 5 generations · no Class I recall
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 |
|---|---|---|---|
| * | K881040 | Emit Vancomycin AssaySummary page 1…ate of Preparation: March 1, 2002 Name of Product: Emit® 2000 Vancomycin Assay FDA Classification Name: Vancomycin Test System Predicate Device: Emit® Vancomycin Assay (K881040) Device Description: The Emit® 2000 Vancomycin Assay is a homogeneous enzyme immunoassay intended for use in the quantitative a… | 1988 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K043386 | Vitros Chemistry Products Vanc Reagent, Calibrator Kit 11 and TDM Performance Verifiers… | 2005 | 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?
How does its category compare?
All LEH devicesLEH Radioimmunoassay, Vancomycin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LEH
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · LEH
Too few LEH 510(k)s in any year since 2007 to give a median.
Recalls per year · LEH
2in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LEH
14in 2025
MAUDE reports naming product code LEH, 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 | — | 2 | 4 |
| 2008 | 1 | — | 0 | 12 |
| 2009 | 0 | — | 0 | 25 |
| 2010 | 0 | — | 0 | 48 |
| 2011 | 0 | — | 0 | 55 |
| 2012 | 0 | — | 0 | 80 |
| 2013 | 1 | — | 0 | 73 |
| 2014 | 0 | — | 0 | 40 |
| 2015 | 0 | — | 0 | 26 |
| 2016 | 2 | — | 0 | 10 |
| 2017 | 0 | — | 0 | 15 |
| 2018 | 0 | — | 0 | 17 |
| 2019 | 0 | — | 2 | 13 |
| 2020 | 0 | — | 0 | 14 |
| 2021 | 0 | — | 0 | 11 |
| 2022 | 0 | — | 0 | 7 |
| 2023 | 1 | — | 0 | 11 |
| 2024 | 0 | — | 0 | 14 |
| 2025 | 0 | — | 0 | 14 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Emit® 2000 Vancomycin Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of vancomycin in human serum or plasma. Measurements obtained are used in the diagnosis and treatment of vancomycin overdose and in monitoring the level of vancomycin to ensure appropriate therapy.
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/K020692 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020692: Emit 2000 Vancomycin Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020692
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