510(k) · Cleared

Cleared

Axsym Phenobarbital

K940596510(k) TraditionalCleared Jun 21, 1994131-day reviewClass II21 CFR 862.3660

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

Abbott Laboratories · LGQ Fluorescence Polarization Immunoassay, Phenobarbital

Cleared on Jun 21, 1994 after a 131-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided: Jun 21, 1994
Review: 131 days
Class: Class II
Product code: LGQ
Recalls: None
Predicates: 0

2 later devices descend from it, 1 citing it directly.

This deviceK940596 Axsym PhenobarbitalAbbott Laboratories · 1994
Descendant · cites it directly · 1 of its ownK081231 Architect Iphenobarbital Reagents and Architect Iphenobarbital…Abbott Laboratories · 2008
Descendant · 2 generations on · 0 of its ownK210858 VITROS Chemistry Products PHBR SlidesOrtho-Clinical Diagnostics, Inc. · 2021

Most influential descendants

Showing 2 of 2 · See all

K081231Architect Iphenobarbital Reagents and Architect Iphenobarbital Calibrators, Models 1P33…Abbott Laboratories · 2008 · cites it directly1descendant
K210858VITROS Chemistry Products PHBR SlidesOrtho-Clinical Diagnostics, Inc. · 2021 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K940596	Axsym Phenobarbital	Abbott Laboratories	1994	—
+1	K081231	Architect Iphenobarbital Reagents and Architect Iphenobarbital Calibrators…	Abbott Laboratories	2008	—
+2	K210858	VITROS Chemistry Products PHBR Slides	Ortho-Clinical Diagnostics, Inc.	2021	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0
2021	1	0

FIG. 1 — Lineage of K940596, 1994–2021Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LGQ? 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K081231	Architect Iphenobarbital Reagents and Architect Iphenobarbital Calibrators, Models 1P33…	Abbott Laboratories	2008	1

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?

Of its descendants, K081231 (Abbott Laboratories, 2008) has gone furthest, with 1 descendant of its own.

How does its category compare?

All LGQ devices

LGQ Fluorescence Polarization Immunoassay, Phenobarbital: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LGQ

FDA has decided no LGQ device since 2007.

Median 510(k) review, days · LGQ

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

Recalls per year · LGQ

No recall names LGQ since 2007.

Adverse event reports per year · LGQ

2in 2013

2007high 3 (2012) · low 0 (2007)2025

MAUDE reports naming product code LGQ, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	3
2013	—	2
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

https://510kreport.com/device/K940596 · printed Nov 3, 2026

Cite this page

510(k) Report. “K940596: Axsym Phenobarbital.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K940596

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026