510(k) Report

510(k) · Cleared

Cleared

Quantikine Ivd Erythropoietin Enzyme Linked Immunosorbent Assay (Elisa)

K936016510(k) TraditionalCleared Jul 19, 1994215-day reviewClass II21 CFR 864.7250

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

R&D Systems, Inc. · GGT Assay, Erythropoietin

Cleared on Jul 19, 1994 after a 215-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.

Decided
Jul 19, 1994
Review
215 days
Class
Class II
Product code
GGT
Recalls
None
Predicates
0

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

Descendants, by year cleared 2006: 1 descendant cleared2024: 1 descendant cleared2019: 1 descendant cleared1990200020102020
  1. This deviceK936016 Quantikine Ivd Erythropoietin Enzyme Linked Immunosorbent Assay…R&D Systems, Inc. · 1994
  2. Descendant · cites it directly · 2 of its ownK052223 Access Epo AssayBeckman Coulter, Inc. · 2006 · Recalled
  3. Descendant · 2 generations on · 0 of its ownK240182 Access EPOBeckman Coulter, Inc. · 2024
  4. Descendant · 2 generations on · 0 of its ownK183088 ADVIA Centaur Erythropoietin (EPO) assayAxis-Shield Diagnostics Limited · 2019 · Recalled

Most influential descendants

Showing 3 of 3 · See all
  • K052223Access Epo AssayBeckman Coulter, Inc. · 2006 · cites it directly2descendants
  • K240182Access EPOBeckman Coulter, Inc. · 2024 · 2 generations on0descendants
  • K183088ADVIA Centaur Erythropoietin (EPO) assayAxis-Shield Diagnostics Limited · 2019 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K936016Quantikine Ivd Erythropoietin Enzyme Linked Immunosorbent Assay (Elisa)R&D Systems, Inc.1994—
+1K052223Access Epo AssayBeckman Coulter, Inc.20061
+2K240182Access EPOBeckman Coulter, Inc.2024—
+2K183088ADVIA Centaur Erythropoietin (EPO) assayAxis-Shield Diagnostics Limited20192

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
201910
202410
FIG. 1 — Lineage of K936016, 1994–2024Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GGT? 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 GGT device

  1. #1 K240182 Access EPOscore 7.8 · 3 generations · no Class I recall
Get a 510(k) Report

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? (3)

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

NumberDeviceApplicantDecidedDescendants
K052223Access Epo AssayBeckman Coulter, Inc.20062

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, K052223 (Beckman Coulter, Inc., 2006) has gone furthest, with 2 descendants of its own.

How does its category compare?

All GGT devices

GGT Assay, Erythropoietin: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GGT

1in 2024

2019: 12024: 1
2007high 1 (2019) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GGT

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

Recalls per year · GGT

No recall names GGT since 2007.

Adverse event reports per year · GGT

3in 2012

2012: 3
2007high 3 (2012) · low 0 (2007)2025

MAUDE reports naming product code GGT, 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
20191—00
20200—00
20210—00
20220—00
20230—00
20241—00
20250—00
20260—0—

More from R&D Systems, Inc.

79 FDA decisions under this applicant name. See the company

  • K160606BC-5D Hematology ControlR&D Systems, Inc. · 2016
  • K130962R&D 5D Retic Hematology ControlR&D Systems, Inc. · 2013
  • K101578R&D Systems Body Fluid-I Hematology ControlR&D Systems, Inc. · 2011
  • K100050R & D Systems Xeret Hematology ControlR&D Systems, Inc. · 2010
  • K091433R&D Systems Tetic-I Plus Hemotology ControlR&D Systems, Inc. · 2009

Recent decisions in GGT

The GGT category page

  • K240182Access EPOBeckman Coulter, Inc. · 2024
  • K183088ADVIA Centaur Erythropoietin (EPO) assayAxis-Shield Diagnostics Limited · 20192 recalls
  • K052223Access Epo AssayBeckman Coulter, Inc. · 20061 recall
  • K992799Sangui Biotech, Inc. Epo (Erythropoietin) Elisa KitSangui Biotech, Inc. · 2000
  • K983203Immulite Epo, Model #'S Lkepz & LKEP1Diagnostic Products Corp. · 1999

https://510kreport.com/device/K936016 · printed Nov 6, 2026

Cite this page

510(k) Report. “K936016: Quantikine Ivd Erythropoietin Enzyme Linked Immunosorbent Assay (Elisa).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K936016

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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