510(k) · Cleared
ClearedIgx Plex Rheumatoid Arthritis (RA) Assay and Sqidworks Diagnostics Platform
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sqi Diagnostics Systems · DHR System, Test, Rheumatoid Factor
Cleared on Oct 29, 2009 as substantially equivalent to K983084 (Inova Diagnostics, Inc., 1998) and 3 other predicates after a 378-day review. Its family tree reaches back 2 generations to 1992.
- Decided
- Oct 29, 2009
- Review
- 378 days
- Class
- Class II
- Product code
- DHR
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K922830 (1992). 18 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK922830 Quanta Lite SS-a ElisaInova Diagnostics, Inc. · 1992
- 1 generation backK041658 Bioplex 200 Ana Screen on the Bioplex 2200 Multi-Analyte Detection…Bio-Rad Laboratories, Inc. · 2004 · Recalled
- This deviceK083080 Igx Plex Rheumatoid Arthritis (RA) Assay and Sqidworks Diagnostics…Sqi Diagnostics Systems · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K922830 | Quanta Lite SS-a Elisa | Inova Diagnostics, Inc. | 1992 | — |
| −1 | K041658 | Bioplex 200 Ana Screen on the Bioplex 2200 Multi-Analyte Detection System… | Bio-Rad Laboratories, Inc. | 2004 | 1 |
| 0 (this device) | K083080 | Igx Plex Rheumatoid Arthritis (RA) Assay and Sqidworks Diagnostics Platform | Sqi Diagnostics Systems | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1995 | 4 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
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
What was it cleared against? (4)
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 | Decided |
|---|---|---|---|
| * | K983084 | Quanta Lite RF Iga ElisaSummary page 5…stic IgX PLEX RF IgA QUANTA LiteTM RIF IgA K983084 Intended Use As aid in diagnosis of rheumatoid Same… | 1998 |
| * | K971614 | Quanta Lite RF IgmSummary page 5…teristic IgX PLEX RV IgM QUANTA Lite RFIgM K971614 Intended Use As aid in diagnosis of rheumatoid Same… | 1997 |
| * | K052264 | Quanta Lite CCP3 Igg ElisaSummary page 5…istic IgX PLEX Anti-CCP IgG QUANTA Lite CCP3 IgG K052264 Intended Use As aid in diagnosis of rheumatoid Same… | 2005 |
| * | K041658 | Bioplex 200 Ana Screen on the Bioplex 2200 Multi-Analyte Detection System, Model Bioplex…Summary page 6…Diagnostic Platform Detection System K041658 Multi-analyte Yes Same Multiplexing Method… | 2004 |
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 17 years and passes through 3 companies; a new generation was cleared every 12.3 years on median.
- 3 of the 18 ancestors have a recall of any class.
- 1 other device also cites its predicate K983084.
How does its category compare?
All DHR devicesDHR System, Test, Rheumatoid Factor: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
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?
The IgX PLEXTM Rheumatoid Arthritis Qualitative Assay and SQiDworksTM Diagnostics Platform is an in vitro diagnostic test system for the qualitative detection of the IgA and IgM classes of Rheumatoid Factors, and the IgG class of anti-cyclic citrullinated peptide antibodies (CCP-proprietary third generation equivalent formulation) in human serum specimens.
The IgX PLEXTM Rheumatoid Arthritis Qualitative Assay is intended for use in clinical laboratories as an aid in the diagnosis of Rheumatoid Arthritis in conjunction with other laboratory and clinical findings, and requires the SQiDworksTM Diagnostics Platform.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083080 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083080: Igx Plex Rheumatoid Arthritis (RA) Assay and Sqidworks Diagnostics Platform.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083080
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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