510(k) · Cleared

Recalled · 2010

Architect Ivancomycin Reagents and Architect Ivancomycin Calibrators, Models: 1P30-25 and 1P30-01

K072036510(k) TraditionalCleared Mar 19, 2008238-day reviewClass II21 CFR 862.3950Recalls 1

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

Biokit, S.A. · LEH Radioimmunoassay, Vancomycin

Cleared on Mar 19, 2008 as substantially equivalent to K955851 (Abbott Laboratories, 1996) after a 238-day review. Its family tree reaches back 1 generation to 1996. 1 later device descends from it. It has been recalled once.

Decided: Mar 19, 2008
Review: 238 days
Class: Class II
Product code: LEH
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K955851 (1996). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK955851 Axsym Vancomycin IIAbbott Laboratories · 1996
This deviceK072036 Architect Ivancomycin Reagents and Architect Ivancomycin…Biokit, S.A. · 2008
Descendant · cites it directly · 0 of its ownK123947 Architect IvancomycinBiokit, S.A. · 2013

Most influential descendants

Showing 1 of 1 · See all

K123947Architect IvancomycinBiokit, S.A. · 2013 · cites it directly0descendants

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)	K072036	Architect Ivancomycin Reagents and Architect Ivancomycin Calibrators, Models…	Biokit, S.A.	2008	—
+1	K123947	Architect Ivancomycin	Biokit, S.A.	2013	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2013	1	0

FIG. 1 — Lineage of K072036, 1996–2013Source: 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 1 ….3200 Device Classification: Class II Classification Panel: Toxicology Product Code: DLJ Legally marketed device to which equivalency is claimed: AxSYM Vancomycin 11 (K95585 1) ARCHITECT iNancomycin Page 1 of 2 510(K) Submission…	Abbott Laboratories	1996	—

Also cleared against K955851: 3 other devices →

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
K123947	Architect Ivancomycin	Biokit, S.A.	2013	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Sep 13, 2010	Not classified	Z-0629-2011	Other	The assay may produce falsely elevated vancomycin results. Inaccurate test results may result in inappropriate patient treatment.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K123947 (Biokit, S.A., 2013) has gone furthest, with 0 descendants of its own.
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. 2008, this device’s year, is highlighted.

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?

The ARCHITECT iVancomycin assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of vancomycin in human serum or plasma on the ARCHITECT i System with STAT protocol capability. The ARCHITECT iVancomycin assay is used in the diagnosis and treatment of vancomycin overdose and in monitoring levels of vancomycin to help ensure appropriate therapy.

The ARCHITECT iVancomycin Calibrators are for the calibration of the ARCHITECT i System with STAT protocol capability when used for the quantitative determination of vancomycin in human serum or plasma.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K072036 · printed Nov 6, 2026

Cite this page

510(k) Report. “K072036: Architect Ivancomycin Reagents and Architect Ivancomycin Calibrators, Models: 1P30-25 and 1P30-01.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072036

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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