510(k) · Cleared
ClearedQuanta Lite RF Igm
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inova Diagnostics, Inc. · DHR System, Test, Rheumatoid Factor
Cleared on Jun 20, 1997 after a 49-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.
- Decided
- Jun 20, 1997
- Review
- 49 days
- Class
- Class II
- Product code
- DHR
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK971614 Quanta Lite RF IgmInova Diagnostics, Inc. · 1997
- Descendant · cites it directly · 1 of its ownK102673 Rheumatoid Factor Immunological Test SystemPhadia US, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 0 of its ownK182747 EliA RF IgM ImmunoassayPhadia AB · 2018 · Recalled
- Descendant · cites it directly · 0 of its ownK083080 Igx Plex Rheumatoid Arthritis (RA) Assay and Sqidworks Diagnostics…Sqi Diagnostics Systems · 2009
Most influential descendants
Showing 3 of 3 · See all- K102673Rheumatoid Factor Immunological Test SystemPhadia US, Inc. · 2011 · cites it directly1descendant
- K182747EliA RF IgM ImmunoassayPhadia AB · 2018 · 2 generations on0descendants
- K083080Igx Plex Rheumatoid Arthritis (RA) Assay and Sqidworks Diagnostics PlatformSqi Diagnostics Systems · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K971614 | Quanta Lite RF Igm | Inova Diagnostics, Inc. | 1997 | — |
| +1 | K102673 | Rheumatoid Factor Immunological Test System | Phadia US, Inc. | 2011 | 1 |
| +2 | K182747 | EliA RF IgM Immunoassay | Phadia AB | 2018 | 1 |
| +1 | K083080 | Igx Plex Rheumatoid Arthritis (RA) Assay and Sqidworks Diagnostics Platform | Sqi Diagnostics Systems | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2018 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K102673 (Phadia US, Inc., 2011) has gone furthest, with 1 descendant of its own.
How does its category compare?
All DHR devicesDHR System, Test, Rheumatoid Factor: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DHR
1in 2020
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
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DHR
2in 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?
A semiquantitative enzyme linked immunocassay for use in screening patients for IgM rheumatoid factor (RF) antibodies. Detection of these IgM antibodies is an aid in the diagnosis of rheumatoid arthritis (RA).
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971614 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971614: Quanta Lite RF Igm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971614
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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