510(k) · Cleared

Cleared

TFR

K981208510(k) TraditionalCleared Oct 21, 1998202-day reviewClass II21 CFR 866.5880

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

Ramco Laboratories, Inc. · JNM Immunochemical, Transferrin

Cleared on Oct 21, 1998 as substantially equivalent to K970718 (R&D Systems, Inc., 1997) after a 202-day review. Its family tree reaches back 2 generations to 1993.

Decided: Oct 21, 1998
Review: 202 days
Class: Class II
Product code: JNM
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K926221 (1993). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK926221 Access Ferritin AssayBio-Rad Laboratories, Inc. · 1993 · Recalled
1 generation backK970718 Quantikine Ivd STFR Enzyme Linked Immunosorbent Assay (Elisa)R&D Systems, Inc. · 1997 · Recalled
This deviceK981208 TFRRamco Laboratories, Inc. · 1998

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K926221	Access Ferritin Assay	Bio-Rad Laboratories, Inc.	1993	1
−1	K970718	Quantikine Ivd STFR Enzyme Linked Immunosorbent Assay (Elisa)	R&D Systems, Inc.	1997	3
0 (this device)	K981208	TFR	Ramco Laboratories, Inc.	1998	—

FIG. 1 — Lineage of K981208, 1993–1998Source: 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

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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
*	K970718	Quantikine Ivd STFR Enzyme Linked Immunosorbent Assay (Elisa) Summary page 1 …ceptor Assay IR TfR Assay sTfR Immunological Test System Quantikine IVD sTfR Immunoassay R&D Systems, Inc. 614 McKinley Place N.E. . Minneapolis, MN 55413 ™ 510(k) #K970718 The TfR assay is an in vitro enzyme immunoassay based upon the double antibody sandwich method. Plasma or serum samples are dilu…	R&D Systems, Inc.	1997	3

Also cleared against K970718: 3 other devices →

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?

The line of descent spans 5 years and passes through 3 companies; a new generation was cleared every 4.4 years on median.
2 of the 2 ancestors have a recall of any class.
3 other devices also cite its predicate K970718.

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 TfR assay is an in vitro enzyme immunoassay for quantifying the concentration of transferrin receptor in human serum or plasma to aid in the diagnosis of iron deficiency anemia, particularly in the presence of other disease states.

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/K981208 · printed Nov 5, 2026

Cite this page

510(k) Report. “K981208: TFR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K981208

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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