510(k) · Cleared
ClearedRubascan Card Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bd Becton Dickinson Vacutainer Systems Preanalytic · LFX Enzyme Linked Immunoabsorbent Assay, Rubella
Cleared on Dec 20, 1996 as substantially equivalent to K832228 (Bd Becton Dickinson Vacutainer Systems Preanalytic, 1983) after a 554-day review. Its family tree reaches back 1 generation to 1983.
- Decided
- Dec 20, 1996
- Review
- 554 days
- Class
- Class II
- Product code
- LFX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K832228 (1983). No later device cites it as a predicate yet.
- Root · 1 generation backK832228 Rubascan Latex Card TestBd Becton Dickinson Vacutainer Systems Preanalytic · 1983
- This deviceK952721 Rubascan Card TestBd Becton Dickinson Vacutainer Systems Preanalytic · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K832228 | Rubascan Latex Card Test | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1983 | — |
| 0 (this device) | K952721 | Rubascan Card Test | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1996 | — |
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 LFX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LFX device
- #1 K250588 Access Rubella IgGscore 10.4 · 1 generation · no Class I recall
- #2 Held for the reportin 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 |
|---|---|---|---|
| * | K832228 | Rubascan Latex Card TestSummary page 1…e Name: RUBAscan® Card Test Common Name/Description: Latex agglutination for Rubella antibodies Classification Name: Latex agglutination assay, Rubella PREDICATE DEVICE: K832228; RUBAscan® Card Test DEVICE DESCRIPTION: INTENDED USE: The RUBAscan ® Card Test is a passive latex agglutination test for the d… | 1983 |
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?
- Its one ancestor has no recall.
How does its category compare?
All LFX devicesLFX Enzyme Linked Immunoabsorbent Assay, Rubella: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LFX
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LFX
354in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LFX
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LFX
12in 2025
MAUDE reports naming product code LFX, 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 | — | 2 | 5 |
| 2008 | 3 | 354 | 2 | 367 |
| 2009 | 0 | — | 3 | 19 |
| 2010 | 2 | — | 2 | 18 |
| 2011 | 1 | — | 1 | 89 |
| 2012 | 1 | — | 0 | 37 |
| 2013 | 0 | — | 0 | 15 |
| 2014 | 0 | — | 0 | 13 |
| 2015 | 0 | — | 0 | 15 |
| 2016 | 0 | — | 2 | 47 |
| 2017 | 0 | — | 0 | 10 |
| 2018 | 0 | — | 0 | 24 |
| 2019 | 0 | — | 0 | 16 |
| 2020 | 0 | — | 0 | 21 |
| 2021 | 0 | — | 1 | 13 |
| 2022 | 0 | — | 0 | 13 |
| 2023 | 0 | — | 0 | 7 |
| 2024 | 0 | — | 0 | 13 |
| 2025 | 2 | — | 0 | 12 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The RUBAscan ® Card Test is a passive latex agglutination test for the detection and/or quantitation of rubella antibodies in human serum. The test is configured to give qualitative results by testing specimens either undiluted or diluted 1:10 to yield two sensitivity levels for detecting rubella antibodies. The choice of protocol used may be based upon judgments concerning the significance of immune status given by antibody levels in protecting the…
Read the full statement (110 words)
The RUBAscan ® Card Test is a passive latex agglutination test for the detection and/or quantitation of rubella antibodies in human serum. The test is configured to give qualitative results by testing specimens either undiluted or diluted 1:10 to yield two sensitivity levels for detecting rubella antibodies. The choice of protocol used may be based upon judgments concerning the significance of immune status given by antibody levels in protecting the individual from primary rubella infection.
The RUBAscan ® Card Test can also be used to give quantitative results when used to test serial dilutions of the specimen. With properly selected paired specimens, the test can determine recent or active infection.
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/K952721 · printed Nov 6, 2026
Cite this page
510(k) Report. “K952721: Rubascan Card Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K952721
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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