510(k) Report

510(k) · Cleared

Cleared

QMS Amikacin Reagents

K052815510(k) TraditionalCleared Nov 1, 200528-day reviewClass II21 CFR 862.3035

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

Seradyn, Inc. · KLQ Radioimmunoassay, Amikacin

Cleared on Nov 1, 2005 as substantially equivalent to K802669 (Abbott Laboratories, 1980) after a 28-day review. Its family tree reaches back 1 generation to 1980.

Decided
Nov 1, 2005
Review
28 days
Class
Class II
Product code
KLQ
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K802669 (1980). No later device cites it as a predicate yet.

K802669 · Cybrex Amikacin · Abbott Laboratories · 1980198019851990199520002005
K802669 · Cybrex Amikacin · Abbott Laboratories · 19800
  1. Root · 1 generation backK802669 Cybrex AmikacinAbbott Laboratories · 1980
  2. This deviceK052815 QMS Amikacin ReagentsSeradyn, Inc. · 2005
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K802669Cybrex AmikacinAbbott Laboratories1980—
0 (this device)K052815QMS Amikacin ReagentsSeradyn, Inc.2005—
FIG. 1 — Lineage of K052815, 1980–2005Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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

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 KLQ? 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
Get a 510(k) Report

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.

TypeNumberDeviceApplicantDecidedRecalls
*K802669Cybrex Amikacin
Summary page 1
…mikacin overdose and in monitoring levels of amikacin to ensure appropriate therapy. LEGALLY MARKETED DEVICE TO WHICH EQUIVALENCY IS CLAIMED Abbott TDx/TDxFLx Amikacin (K802669) DESCRIPTION OF DEVICE The QMS® Amikacin assay system is a homogeneous assay utilizing particle agglutination technology and is…
Abbott Laboratories1980—

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.

How does its category compare?

All KLQ devices

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

FDA decisions per year · KLQ

FDA has decided no KLQ device since 2007.

Median 510(k) review, days · KLQ

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

Recalls per year · KLQ

No recall names KLQ since 2007.

Adverse event reports per year · KLQ

1in 2025

2012: 32021: 12023: 12025: 1
2007high 3 (2012) · low 0 (2007)2025

MAUDE reports naming product code KLQ, 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—00
20100—00
20110—00
20120—03
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—01
20220—00
20230—01
20240—00
20250—01
20260—0—

What is it indicated for?

The QMS® Amikacin assay is intended for the quantitative determination of amikacin in human serum or plasma on automated clinical chemistry analyzers.

The results obtained are used in the diagnosis and treatment of amikacin overdose and in monitoring levels of amikacin to ensure appropriate therapy.

Indications for use as stated in the FDA summary.

More from Seradyn, Inc.

28 FDA decisions under this applicant name. See the company

  • K070645Seradyn QMS TopiramateSeradyn, Inc. · 2007
  • K062966QMS Lamotrigine Assay (Reagents), Calibrators & ControlsSeradyn, Inc. · 2007
  • K062204Architect Cortisol AssaySeradyn, Inc. · 2006
  • K060998QMS TobramycinSeradyn, Inc. · 2006
  • K060709Multigent GentamicinSeradyn, Inc. · 2006

Recent decisions in KLQ

The KLQ category page

  • K033884Randox AmikacinRandox Laboratories, Ltd. · 2004
  • K955570Innofluor Amikacin Assay SystemOxis Intl., Inc. · 1996
  • K903100Innofluor (TM) Amikacin Reagent SetInnotron of Oregon, Inc. · 1990
  • K894517FPR Amikacin KitColony Laboratories, Inc. · 1989
  • K852317Cobas FP Reagen for Amikacin & Amikacin CalibratorRoche Diagnostic Systems, Inc. · 1985

https://510kreport.com/device/K052815 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052815: QMS Amikacin Reagents.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052815

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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