510(k) Report

510(k) · Cleared

Cleared

Innofluor Phenytoin Assay System

K955562510(k) TraditionalCleared Jan 24, 199649-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

Oxis Intl., Inc. · LGR Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total)

Cleared on Jan 24, 1996 after a 49-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.

Decided
Jan 24, 1996
Review
49 days
Class
Class II
Product code
LGR
Recalls
None
Predicates
0

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

Descendants, by year cleared 2005: 1 descendant cleared2009: 1 descendant cleared2007: 1 descendant cleared2010: 1 descendant cleared1995200020052010201520202025
  1. This deviceK955562 Innofluor Phenytoin Assay SystemOxis Intl., Inc. · 1996
  2. Descendant · cites it directly · 3 of its ownK051211 QMS Zonisamide Reagents, Calibrators and ControlsSeradyn, Inc. · 2005
  3. Descendant · 2 generations on · 1 of its ownK062966 QMS Lamotrigine Assay (Reagents), Calibrators & ControlsSeradyn, Inc. · 2007
  4. Descendant · 3 generations on · 0 of its ownK101305 Ark Lamotrigine Assay, Calibrator & ControlArk Diagnostics, Inc. · 2010
  5. Descendant · 2 generations on · 0 of its ownK091884 Ark Zonisamide Assay, Ark Zonisamide Calibrator, and Ark Zonisamide…Ark Diagnostics, Inc. · 2009

Most influential descendants

Showing 4 of 4 · See all
  • K051211QMS Zonisamide Reagents, Calibrators and ControlsSeradyn, Inc. · 2005 · cites it directly3descendants
  • K062966QMS Lamotrigine Assay (Reagents), Calibrators & ControlsSeradyn, Inc. · 2007 · 2 generations on1descendant
  • K101305Ark Lamotrigine Assay, Calibrator & ControlArk Diagnostics, Inc. · 2010 · 3 generations on0descendants
  • K091884Ark Zonisamide Assay, Ark Zonisamide Calibrator, and Ark Zonisamide Contro, Models…Ark Diagnostics, Inc. · 2009 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K955562Innofluor Phenytoin Assay SystemOxis Intl., Inc.1996—
+1K051211QMS Zonisamide Reagents, Calibrators and ControlsSeradyn, Inc.2005—
+2K062966QMS Lamotrigine Assay (Reagents), Calibrators & ControlsSeradyn, Inc.2007—
+3K101305Ark Lamotrigine Assay, Calibrator & ControlArk Diagnostics, Inc.2010—
+2K091884Ark Zonisamide Assay, Ark Zonisamide Calibrator, and Ark Zonisamide Contro…Ark Diagnostics, Inc.2009—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200710
200910
201010
FIG. 1 — Lineage of K955562, 1996–2010Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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? (4)

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

NumberDeviceApplicantDecidedDescendants
K051211QMS Zonisamide Reagents, Calibrators and ControlsSeradyn, Inc.20053

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, K051211 (Seradyn, Inc., 2005) has gone furthest, with 3 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

2009: 12010: 1
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—01
20100—01
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Oxis Intl., Inc.

11 FDA decisions under this applicant name. See the company

  • K972331Innofluor Gentamicin Assay SystemOxis Intl., Inc. · 1997
  • K972330Innofluor Phenobarbital Assay SystemOxis Intl., Inc. · 1997
  • K970509Innoflour Calibrator Reagent SetOxis Intl., Inc. · 1997
  • K970510Innoflour Topiramate Reagent SetOxis Intl., Inc. · 1997
  • K970517Innofluor Topiramate Control SetOxis Intl., Inc. · 1997

Recent decisions in LGR

The LGR category page

  • K955873Acs Phenytoin AssayCiba Corning Diagnostics Corp. · 1996
  • K953840Axsym Phenytoin IIAbbott Laboratories · 1995
  • K946328TDX (R)/Tdxflx (R) Phenytoin IIAbbott Laboratories · 1995
  • K943313Phenytoin Fpia Reagent Set and CalibratorsSigma Diagnostics, Inc. · 1994
  • K935375Axsym Phenytoin AssayAbbott Laboratories · 1994

https://510kreport.com/device/K955562 · printed Nov 4, 2026

Cite this page

510(k) Report. “K955562: Innofluor Phenytoin Assay System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K955562

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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