510(k) · Cleared

Recalled · Class II · 2019

Rheumatoid Factor Immunological Test System

K102673510(k) TraditionalCleared Sep 30, 2011379-day reviewClass II21 CFR 866.5775Recalls 1

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

Phadia US, Inc. · DHR System, Test, Rheumatoid Factor

Cleared on Sep 30, 2011 as substantially equivalent to K971614 (Inova Diagnostics, Inc., 1997) and 1 other predicate after a 379-day review. Its family tree reaches back 1 generation to 1997. 1 later device descends from it. It has been recalled once.

Decided: Sep 30, 2011
Review: 379 days
Class: Class II
Product code: DHR
Recalls: 1
Predicates: 2

Its longest line of descent runs back 1 generation to K971614 (1997). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK971614 Quanta Lite RF IgmInova Diagnostics, Inc. · 1997
This deviceK102673 Rheumatoid Factor Immunological Test SystemPhadia US, Inc. · 2011
Descendant · cites it directly · 0 of its ownK182747 EliA RF IgM ImmunoassayPhadia AB · 2018 · Recalled

Most influential descendants

Showing 1 of 1 · See all

K182747EliA RF IgM ImmunoassayPhadia AB · 2018 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K971614	Quanta Lite RF Igm	Inova Diagnostics, Inc.	1997	—
0 (this device)	K102673	Rheumatoid Factor Immunological Test System	Phadia US, Inc.	2011	—
+1	K182747	EliA RF IgM Immunoassay	Phadia AB	2018	1

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2018	1	0

FIG. 1 — Lineage of K102673, 1997–2018Source: 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 DHR? 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? (2)

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
*	K971614	Quanta Lite RF Igm Summary page 2 …JJY 1 862.1660 Substantial Equivalence to Quanta Lite Rf 1gM Elisa K97 1614 Quanta Lite Rf IgA Elisa K983084 Intended Use Statements o…	Inova Diagnostics, Inc.	1997	—
*	K983084	Quanta Lite RF Iga Elisa Summary page 2 …stantial Equivalence to Quanta Lite Rf 1gM Elisa K97 1614 Quanta Lite Rf IgA Elisa K983084 Intended Use Statements of the New Devices 1) EHiA RE 1gM is intended for the in vitro quantitative…	Inova Diagnostics, Inc.	1998	—

Also cleared against K971614: 1 other device →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K182747	EliA RF IgM Immunoassay	Phadia AB	2018	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
May 10, 2019	Class II	Z-1907-2019	Nonconforming Material/Component	Potential for reporting low assay results

No ancestor or descendant has a Class I recall.

What does this lineage say?

None of the 2 ancestors has a recall.
Of its descendants, K182747 (Phadia AB, 2018) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K971614.

How does its category compare?

All DHR devices

DHR System, Test, Rheumatoid Factor: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · DHR

1in 2020

2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DHR

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

Recalls per year · DHR

1in 2019

2007high 3 (2011) · low 0 (2007)2026

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

Adverse event reports per year · DHR

2in 2025

2007high 400 (2011) · low 0 (2007)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	1	—	0	0
2008	0	—	0	0
2009	1	—	0	0
2010	1	—	1	19
2011	1	—	3	400
2012	0	—	2	91
2013	0	—	0	0
2014	0	—	0	0
2015	1	—	0	0
2016	1	—	0	0
2017	1	—	0	0
2018	1	—	2	1
2019	1	—	1	0
2020	1	—	0	0
2021	0	—	0	0
2022	0	—	0	0
2023	0	—	0	0
2024	0	—	0	3
2025	0	—	0	2
2026	0	—	0	—

What is it indicated for?

EliA RF 1gM is intended for the in vitro semni-quantitative measurement of 1gM class rheumatoid factor antibodies in human serum and plasma (Li-heparin, EDTA, citrate) to aid in the diagnosis of rheumatoid arthritis in conjunction with other laboratory and clinical findings. EliA RF 1gM uses the EliA 1gM method on the instruments Phadia 100 and Phadia 250. EliA RF IgA is intended for the in vitro semni-quantitative measurement of IgA class rheumatoid…

Read the full statement (178 words)

EliA RF IgA is intended for the in vitro semni-quantitative measurement of IgA class rheumatoid factor antibodies in human serum and plasma (Li-heparin, EDTA, citrate) to aid in the diagnosis of rheumatoid arthritis in conjunction with other laboratory and clinical findings. EliA RF IgA uses the EliA IgA method on the instruments Phadia 100 and Phadia 250.

EliA RE Positive Control 100 is intended for laboratory use in monitoring the Performance of in vitro measurement of rheumatoid factor (RE) with Phadia 100 using the EliA 1gM or IgA method.

EliA RE Positive Control 250 is intended for laboratory use in monitoring the performance of in vitro measurement of rheumatoid factor (RF) with Phadia 250 using the EliA 1gM or IgA method.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K102673 · printed Nov 5, 2026

Cite this page

510(k) Report. “K102673: Rheumatoid Factor Immunological Test System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K102673

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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