510(k) · Cleared
ClearedAnti Rna Polymerase Iii Elisa Kit, Model 7805
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mbl International Corporation · NYO Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody
Cleared on Jun 19, 2006 as substantially equivalent to K040200 (Rhigene, Inc., 2004) and 1 other predicate after a 118-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- Jun 19, 2006
- Review
- 118 days
- Class
- Class II
- Product code
- NYO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K935129 (1994). 5 ancestors in all, the oldest K926562 (1993). No later device cites it as a predicate yet.
- Root · 3 generations backK935129 Relisa Ena Antibody Screening Test SystemImmuno Concepts, Inc. · 1994 · Recalled
- 2 generations backK955603 Relsia SS-a/RO & SS/B LA Antibody Test SystemImmuno Concepts, Inc. · 1996
- 1 generation backK972145 Hep-2000 Fluorescent Ana-RO Test SystemImmuno Concepts, Inc. · 1998
- This deviceK060431 Anti Rna Polymerase Iii Elisa Kit, Model 7805Mbl International Corporation · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K935129 | Relisa Ena Antibody Screening Test System | Immuno Concepts, Inc. | 1994 | 1 |
| −2 | K955603 | Relsia SS-a/RO & SS/B LA Antibody Test System | Immuno Concepts, Inc. | 1996 | — |
| −1 | K972145 | Hep-2000 Fluorescent Ana-RO Test System | Immuno Concepts, Inc. | 1998 | — |
| 0 (this device) | K060431 | Anti Rna Polymerase Iii Elisa Kit, Model 7805 | Mbl International Corporation | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2004 | 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 NYO? 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 NYO device
- #1 K202541 EliA RNA Pol IIIscore 5.0 · 1 generation · no Class I recall
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 | Decided |
|---|---|---|---|
| * | K040200 | Mesacup-2 Test Cenp-BSummary page 1…Anti RNA Polymerase III ELISA Kit Classification Name/Product Codes: LJM Common/Usual Name: ELISA In-Vitro Diagnostic Kit 2. Equivalent legally marketed devices: K040200 MESACUP-2 TEST CENP-B, MBL International (formerly Rhigene), and K972145, HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM, Immuno C… | 2004 |
| * | K972145 | Hep-2000 Fluorescent Ana-RO Test SystemSummary page 1…Common/Usual Name: ELISA In-Vitro Diagnostic Kit 2. Equivalent legally marketed devices: K040200 MESACUP-2 TEST CENP-B, MBL International (formerly Rhigene), and K972145, HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM, Immuno Concepts. 3. Indications for Use (intended use): The anti-RNA Polymerase III… | 1998 |
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 12 years and passes through 2 companies; a new generation was cleared every 2.2 years on median.
- 1 of the 5 ancestors has a recall of any class.
How does its category compare?
All NYO devicesNYO Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NYO
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · NYO
Too few NYO 510(k)s in any year since 2007 to give a median.
Recalls per year · NYO
No recall names NYO since 2007.
Adverse event reports per year · NYO
2in 2014
MAUDE reports naming product code NYO, 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 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 3 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The anti-RNA Polymerase III ELISA Kit is a semi-quantitative, enzyme-linked immunosorbent assay (ELISA) for the detection of anti-RNA Polymerase III antibodies in human serum. The test result is used as an aid in the diagnosis of Systemic Sclerosis (SSc) in conjunction with the clinical and other laboratory findings. The anti-RNA Polymerase III ELISA Kit is intended for in-vitro diagnostic use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060431 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060431: Anti Rna Polymerase Iii Elisa Kit, Model 7805.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060431
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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