510(k) · Cleared

Cleared

Axsym Phenytoin Assay

K935375510(k) TraditionalCleared Jun 21, 1994225-day reviewClass II21 CFR 862.3350

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

Abbott Laboratories · LGR Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total)

Cleared on Jun 21, 1994 after a 225-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided: Jun 21, 1994
Review: 225 days
Class: Class II
Product code: LGR
Recalls: None
Predicates: 0

1 later device descends from it, 1 citing it directly.

This deviceK935375 Axsym Phenytoin AssayAbbott Laboratories · 1994
Descendant · cites it directly · 0 of its ownK080696 Architect Iphenytoin Reagents and Architech Iphenytoin Calibrators…Abbott Laboratories · 2008

Most influential descendants

Showing 1 of 1 · See all

K080696Architect Iphenytoin Reagents and Architech Iphenytoin Calibrators with Models 1P34, and…Abbott Laboratories · 2008 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K935375	Axsym Phenytoin Assay	Abbott Laboratories	1994	—
+1	K080696	Architect Iphenytoin Reagents and Architech Iphenytoin Calibrators with Models…	Abbott Laboratories	2008	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0

FIG. 1 — Lineage of K935375, 1994–2008Source: 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 LGR? 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? (1)

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

Number	Device	Applicant	Decided	Descendants
K080696	Architect Iphenytoin Reagents and Architech Iphenytoin Calibrators with Models 1P34, and…	Abbott Laboratories	2008	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?

Of its descendants, K080696 (Abbott Laboratories, 2008) has gone furthest, with 0 descendants of its own.

How does its category compare?

All LGR devices

LGR Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LGR

FDA has decided no LGR device since 2007.

Median 510(k) review, days · LGR

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

Recalls per year · LGR

No recall names LGR since 2007.

Adverse event reports per year · LGR

1in 2010

2007high 1 (2009) · low 0 (2007)2025

MAUDE reports naming product code LGR, 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	—	1
2010	—	1
2011	—	0
2012	—	0
2013	—	0
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/K935375 · printed Nov 4, 2026

Cite this page

510(k) Report. “K935375: Axsym Phenytoin Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K935375

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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