510(k) · Cleared

Cleared

Immulite 2000, Immulite 2500 Vancomycin

K063045510(k) TraditionalCleared Dec 5, 200662-day reviewClass II21 CFR 862.3950

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

Diagnostic Products Corp. · LEH Radioimmunoassay, Vancomycin

Cleared on Dec 5, 2006 as substantially equivalent to K955851 (Abbott Laboratories, 1996) after a 62-day review. Its family tree reaches back 1 generation to 1996.

Decided: Dec 5, 2006
Review: 62 days
Class: Class II
Product code: LEH
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K955851 (1996). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK955851 Axsym Vancomycin IIAbbott Laboratories · 1996
This deviceK063045 Immulite 2000, Immulite 2500 VancomycinDiagnostic Products Corp. · 2006

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K955851	Axsym Vancomycin II	Abbott Laboratories	1996	—
0 (this device)	K063045	Immulite 2000, Immulite 2500 Vancomycin	Diagnostic Products Corp.	2006	—

FIG. 1 — Lineage of K063045, 1996–2006Source: 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 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

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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
*	K955851	Axsym Vancomycin II Summary page 3 …#: 3005250747 Comparison to the Predicate A summary of the features of the IMMULITE 2000/IMMULITE 2500 Vancomycin ssay and the predicate device (AxSYM® Vancomycin II) (K955851) is presented below. Item IMMULITE 2000/2500 AxSYM Vancomycin 11 Assay Type Immunoa…	Abbott Laboratories	1996	—

Also cleared against K955851: 3 other devices →

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?

Its one ancestor has no recall.
3 other devices also cite its predicate K955851.

How does its category compare?

All LEH devices

LEH Radioimmunoassay, Vancomycin: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LEH

1in 2023

2007high 2 (2016) · low 0 (2007)2026

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

2007high 2 (2007) · low 0 (2008)2026

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

Adverse event reports per year · LEH

14in 2025

2007high 80 (2012) · low 4 (2007)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?

IMMULITE® 2000 Vancomycin assay is intended for use as follows:

For in vitro diagnostic use with the IMMULITE 2000 Analyzer - for the quantitative measurement of vancomycin in serum and plasma (EDTA or heparinized), as an aid in monitoring the therapeutic administration of this antibiotic.

The IMMULITE® 2500 Vancomycin assay is intended for use as follows:

For in vitro diagnostic use with the IMMULITE 2500 Analyzer- for the quantitative measurement of vancomycin in serum and plasma (EDTA or heparinized), as an aid in monitoring the therapeutic administration of this antibiotic.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K063045 · printed Nov 6, 2026

Cite this page

510(k) Report. “K063045: Immulite 2000, Immulite 2500 Vancomycin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063045

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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