510(k) · Cleared

Cleared

Emit 2000 Vancomycin Calibrators

K020845510(k) TraditionalCleared May 8, 200254-day reviewClass II21 CFR 862.3200

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Dade Behring, Inc. · DLJ Calibrators, Drug Specific

Cleared on May 8, 2002 as substantially equivalent to K881040 (Syva Co., 1988) after a 54-day review. Its family tree reaches back 1 generation to 1988. 1 later device descends from it.

Decided: May 8, 2002
Review: 54 days
Class: Class II
Product code: DLJ
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.

By dateBy generation

Root · 1 generation backK881040 Emit Vancomycin AssaySyva Co. · 1988
This deviceK020845 Emit 2000 Vancomycin CalibratorsDade 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)	K020845	Emit 2000 Vancomycin Calibrators	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

FIG. 1 — Lineage of K020845, 1988–2005Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 DLJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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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	Applicant	Decided	Recalls
*	K881040	Emit Vancomycin Assay Summary page 1 …ncomycin Calibrator: Calibrator, drug specific Classification Number: Class II (862.3200) 3. Identiﬁcatidn of the Legally Marketed Device: Emit® Vancemycin Calibrator (K881040) 4. Device Description: Emit® 2000 Vancomycm Calibrators are liquid, six-level calibrators prepared from vancomyein, buffer and…	Syva Co.	1988	—

Also cleared against K881040: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K043386	Vitros Chemistry Products Vanc Reagent, Calibrator Kit 11 and TDM Performance Verifiers…	Ortho-Clinical Diagnostics, Inc.	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?

Its one ancestor has no recall.
Of its descendants, K043386 (Ortho-Clinical Diagnostics, Inc., 2005) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K881040.

How does its category compare?

All DLJ devices

DLJ Calibrators, Drug Specific: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DLJ

1in 2013

2007high 1 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DLJ

Too few DLJ 510(k)s in any year since 2007 to give a median.

Recalls per year · DLJ

2in 2011

2007high 2 (2011) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DLJ

3in 2025

2007high 6 (2011) · low 0 (2007)2025

MAUDE reports naming product code DLJ, 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	—	0	0
2008	1	—	0	0
2009	1	—	0	0
2010	0	—	1	0
2011	0	—	2	6
2012	0	—	0	5
2013	1	—	0	1
2014	0	—	0	0
2015	0	—	0	0
2016	0	—	0	0
2017	0	—	0	1
2018	0	—	0	2
2019	0	—	0	0
2020	0	—	0	1
2021	0	—	0	0
2022	0	—	0	1
2023	0	—	0	0
2024	0	—	0	1
2025	0	—	0	3
2026	0	—	0	—

What is it indicated for?

The Emit® 2000 Vancomycin Calibrators are intended for use with the Emit® 2000 Vancomycin Assay as a reference for use in determining vancomycin levels in human serum or plasma.

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/K020845 · printed Nov 5, 2026

Cite this page

510(k) Report. “K020845: Emit 2000 Vancomycin Calibrators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K020845

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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