510(k) · Cleared
Recalled · Class II · 2019Optilite Rheumatoid Factor Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Binding Site Group, Ltd. · DHR System, Test, Rheumatoid Factor
Cleared on May 3, 2017 as substantially equivalent to K160070 (The Binding Site Group, Ltd., 2016) after a 265-day review. Its family tree reaches back 1 generation to 2016. It has been recalled once.
- Decided
- May 3, 2017
- Review
- 265 days
- Class
- Class II
- Product code
- DHR
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K160070 (2016). No later device cites it as a predicate yet.
- Root · 1 generation backK160070 Rheumatoid Factor (RF) Kit for use on SPAPLUSThe Binding Site Group, Ltd. · 2016 · Recalled
- This deviceK162263 Optilite Rheumatoid Factor KitThe Binding Site Group, Ltd. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K160070 | Rheumatoid Factor (RF) Kit for use on SPAPLUS | The Binding Site Group, Ltd. | 2016 | 2 |
| 0 (this device) | K162263 | Optilite Rheumatoid Factor Kit | The Binding Site Group, Ltd. | 2017 | — |
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? (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 | Decided |
|---|---|---|---|
| * | K160070 | Rheumatoid Factor (RF) Kit for use on SPAPLUS Cleared while this submission was under review Summary page 5…ied ready for use. J. Substantial equivalence information: 1. Predicate device name(s) and 510(k) number(s): Rheumatoid Factor (RF) Kit for use on SPAPLUS; K160070 Optilite Rheumatoid Factor Kit… | 2016 |
| † | K972220 | Rheumatoid Factor Latex-Enhanced Immunoturbidimetric Test Kit | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 7, 2019 | Class II | Z-2110-2020 | Process control | Assigned Rheumatoid Factor (RF) calibrator value for calibrator component included in kit used to aid in the diagnosis of rheumatoid arthritis over recovers by 7% in comparison to the reference material RF serum. This could result in… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
How does its category compare?
All DHR devicesDHR System, Test, Rheumatoid Factor: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Optilite Rheumatoid Factor (RF) Kit is intended for the quantitative in vitro measurement of rheumatoid factor in serum using the Binding Site Optilite analyser. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis. This test should be used in conjunction with other laboratory and clinical findings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162263 · printed Nov 4, 2026
Cite this page
510(k) Report. “K162263: Optilite Rheumatoid Factor Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K162263
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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