510(k) · Cleared

Recalled · Class II · 2021

Quantikine Ivd STFR Enzyme Linked Immunosorbent Assay (Elisa)

K970718510(k) TraditionalCleared May 27, 199790-day reviewClass II21 CFR 866.5880Recalls 3

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. · JNM Immunochemical, Transferrin

Cleared on May 27, 1997 as substantially equivalent to K926221 (Bio-Rad Laboratories, Inc., 1993) after a 90-day review. Its family tree reaches back 1 generation to 1993. 5 later devices descend from it. It has been recalled 3 times.

Decided: May 27, 1997
Review: 90 days
Class: Class II
Product code: JNM
Recalls: 3
Predicates: 1

Its longest line of descent runs back 1 generation to K926221 (1993). 5 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK926221 Access Ferritin AssayBio-Rad Laboratories, Inc. · 1993 · Recalled
This deviceK970718 Quantikine Ivd STFR Enzyme Linked Immunosorbent Assay (Elisa)R&D Systems, Inc. · 1997
Descendant · cites it directly · 1 of its ownK080634 Access STFR, Access STFR Calibrators, and Access STFR QC with…Beckman Coulter, Inc. · 2008
Descendant · 2 generations on · 0 of its ownK240987 Access sTfRBeckman Coulter, Inc. · 2024
Descendant · cites it directly · 0 of its ownK992188 Nichols Advantage Chemiluminescence Soluble Transferrin Receptor…Nichols Institute Diagnostics · 1999
Descendant · cites it directly · 0 of its ownK991157 N Latex STFR ReagentDade Behring, Inc. · 1999
Descendant · cites it directly · 0 of its ownK981208 TFRRamco Laboratories, Inc. · 1998

Most influential descendants

Showing 5 of 5 · See all

K080634Access STFR, Access STFR Calibrators, and Access STFR QC with Models, A32493, A32494…Beckman Coulter, Inc. · 2008 · cites it directly1descendant
K240987Access sTfRBeckman Coulter, Inc. · 2024 · 2 generations on0descendants
K992188Nichols Advantage Chemiluminescence Soluble Transferrin Receptor Immunoassay, Model…Nichols Institute Diagnostics · 1999 · cites it directly0descendants
K991157N Latex STFR ReagentDade Behring, Inc. · 1999 · cites it directly0descendants
K981208TFRRamco Laboratories, Inc. · 1998 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K926221	Access Ferritin Assay	Bio-Rad Laboratories, Inc.	1993	1
0 (this device)	K970718	Quantikine Ivd STFR Enzyme Linked Immunosorbent Assay (Elisa)	R&D Systems, Inc.	1997	—
+1	K080634	Access STFR, Access STFR Calibrators, and Access STFR QC with Models, A32493…	Beckman Coulter, Inc.	2008	—
+2	K240987	Access sTfR	Beckman Coulter, Inc.	2024	—
+1	K992188	Nichols Advantage Chemiluminescence Soluble Transferrin Receptor Immunoassay…	Nichols Institute Diagnostics	1999	—
+1	K991157	N Latex STFR Reagent	Dade Behring, Inc.	1999	—
+1	K981208	TFR	Ramco Laboratories, Inc.	1998	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
1999	2	0
2008	1	0
2024	1	0

FIG. 1 — Lineage of K970718, 1993–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 JNM? 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.

Type	Number	Device	Applicant	Decided	Recalls
*	K926221	Access Ferritin Assay Summary page 1 …Product name: Quantikine IVD sTfR immunoassay Device Class: Class I1 Device to which substantial equivalence is claimed: Sanofi Diagnostics ferritin assay, Chaska, MN, K926221 The product is a microtiter-plate-based sandwich enzyme immunoassay for soluble transferrin receptor. The Quantikine™ IVD™ sTFR…	Bio-Rad Laboratories, Inc.	1993	1

Also cleared against K926221: 4 other devices →

What descends from it? (5)

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K080634	Access STFR, Access STFR Calibrators, and Access STFR QC with Models, A32493, A32494…	Beckman Coulter, Inc.	2008	1
K992188	Nichols Advantage Chemiluminescence Soluble Transferrin Receptor Immunoassay, Model…	Nichols Institute Diagnostics	1999	0
K991157	N Latex STFR Reagent	Dade Behring, Inc.	1999	0
K981208	TFR	Ramco Laboratories, Inc.	1998	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jan 20, 2021	Class II	Z-1255-2021	Under Investigation by firm	R&D Systems, Inc. received two complaints that the standard signal was low and controls were not within the specification range provided with the kit. Investigation confirmed low standard signal and controls running out of specification…
Nov 1, 2018	Class III	Z-0691-2019	Labeling mix-ups	The Human sTfR Quantikine IVD ELISA Kit, catalog # DTFR1, lot P180151 was packed with the incorrect control data card number 750228.4.
Aug 24, 2016	Class II	Z-2887-2016	Nonconforming Material/Component	R&D Systems, Inc. received two customer complaints that results of the Controls provided with the Quantikine¿ IVD¿ Human sTfR Immunoassay kit were out of the range high. Internal testing within R&D Systems confirmed a problem with Control…

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has a recall.
Of its descendants, K080634 (Beckman Coulter, Inc., 2008) has gone furthest, with 1 descendant of its own.
4 other devices also cite its predicate K926221.

How does its category compare?

All JNM devices

JNM Immunochemical, Transferrin: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JNM

FDA has decided no JNM device since 2007.

Median 510(k) review, days · JNM

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

Recalls per year · JNM

1in 2018

2007high 1 (2018) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JNM

1in 2011

2007high 1 (2011) · low 0 (2007)2025

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

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	0
2008	—	0	0
2009	—	0	0
2010	—	0	0
2011	—	0	1
2012	—	0	0
2013	—	0	0
2014	—	0	0
2015	—	0	0
2016	—	0	0
2017	—	0	0
2018	—	1	0
2019	—	0	0
2020	—	0	0
2021	—	0	0
2022	—	0	0
2023	—	0	0
2024	—	0	0
2025	—	0	0
2026	—	0	—

What is it indicated for?

The Quantikine™ IVD™ sTFR Enzyme linked immunosorbent assay is intended for the measurement of sTfR concentration in human serum or plasma as an aid in the diagnosis of iron deficiency anemia, especially the differential diagnosis of iron deficiency anemia and anemia of chronic disease.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K970718 · printed Nov 5, 2026

Cite this page

510(k) Report. “K970718: Quantikine Ivd STFR Enzyme Linked Immunosorbent Assay (Elisa).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K970718

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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