510(k) · Cleared
ClearedModification to Fidis Connective 10*, Model MX006
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomedical Diagnostics (Bmd) SA · LKO Anti-Rnp Antibody, Antigen And Control
Cleared on Dec 19, 2007 as substantially equivalent to K053653 (Biomedical Diagnostics (Bmd) SA, 2006) after a 232-day review. Its family tree reaches back 3 generations to 2000. 1 later device descends from it.
- Decided
- Dec 19, 2007
- Review
- 232 days
- Class
- Class II
- Product code
- LKO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K000312 (2000). 11 ancestors in all, the oldest K944169 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK000312 Varelisa SM AntibodiesPharmacia & Upjohn Co. · 2000
- 2 generations backK042629 Varelisa SM Antibodies, Model 18296Sweden Diagnostics (Germany) GmbH · 2004
- 1 generation backK053653 Fidis Connective 10, Model MX006Biomedical Diagnostics (Bmd) SA · 2006
- This deviceK071210 Modification to Fidis Connective 10*, Model MX006Biomedical Diagnostics (Bmd) SA · 2007
- Descendant · cites it directly · 0 of its ownK102607 Fidistm Connective 10, Fidistm Analyzer, CarisBiomedical Diagnostics (Bmd) SA · 2010
Most influential descendants
Showing 1 of 1 · See all- K102607Fidistm Connective 10, Fidistm Analyzer, CarisBiomedical Diagnostics (Bmd) SA · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K000312 | Varelisa SM Antibodies | Pharmacia & Upjohn Co. | 2000 | — |
| −2 | K042629 | Varelisa SM Antibodies, Model 18296 | Sweden Diagnostics (Germany) GmbH | 2004 | — |
| −1 | K053653 | Fidis Connective 10, Model MX006 | Biomedical Diagnostics (Bmd) SA | 2006 | — |
| 0 (this device) | K071210 | Modification to Fidis Connective 10*, Model MX006 | Biomedical Diagnostics (Bmd) SA | 2007 | — |
| +1 | K102607 | Fidistm Connective 10, Fidistm Analyzer, Caris | Biomedical Diagnostics (Bmd) SA | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 5 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 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 LKO? 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 |
|---|---|---|---|
| * | K053653 | Fidis Connective 10, Model MX006Summary page 3…6 5. Predicate Device 510K Number Device Classification Name Manufacturer Name K053653 FIDISTM CONNECTIVE 10* bmd 6. Comparison with the predicate… | 2006 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102607 | Fidistm Connective 10, Fidistm Analyzer, Caris | 2010 | 0 |
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 7 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K102607 (Biomedical Diagnostics (Bmd) SA, 2010) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K053653.
How does its category compare?
All LKO devicesLKO Anti-Rnp Antibody, Antigen And Control: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · LKO
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · LKO
Too few LKO 510(k)s in any year since 2007 to give a median.
Recalls per year · LKO
No recall names LKO since 2007.
Adverse event reports per year · LKO
No MAUDE report names LKO since 2007.
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 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 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 FIDISTM CONNECTIVE 10* kit is a semi-quantitative homogeneous fluorescent-based microparticles immunoassay using flow cytometry. The test system is used to simultaneously detect the presence of 10 autoantibody specificities: double stranded DNA (dsDNA), SSA (60 kDa and 52 kDa), SSB, Sm, SmnRNP, Scl7O, Jol, ribosome and centromere. (*Antibodies to dsDNA, Sm, Sm/RNJ'P, SSA, SSB, Scl-70, Jo-], ribosome and centromere can be reported using this assay).…
Read the full statement (156 words)
The FIDISTM CONNECTIVE 10* kit is a semi-quantitative homogeneous fluorescent-based microparticles immunoassay using flow cytometry. The test system is used to simultaneously detect the presence of 10 autoantibody specificities: double stranded DNA (dsDNA), SSA (60 kDa and 52 kDa), SSB, Sm, SmnRNP, Scl7O, Jol, ribosome and centromere.
(*Antibodies to dsDNA, Sm, Sm/RNJ'P, SSA, SSB, Scl-70, Jo-], ribosome and centromere can be reported using this assay).
Clinical utili
The results of the FIDISTM CONNECTIVE 10* are to be used in conjunction with the clinical findings and the other laboratory tests to aid in the diagnosis of connective diseases (systemic lupus erythematosus (SLE), Sjogren's syndrome, mixed connective tissue disease (MCTD), scleroderma, dermatomyositis and CREST syndrome).
FIDISTM CONNECTIVE 10* kit uses serum only, and is to be run on the FIDISTm Instrument and MLX-BOOSTERTM Software.
FIDIS Tm CONNECTIVE 10* kit may be used with the CARISTh system (diluting and dispensing device).
This test is for in vitro diagnostic use.
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/K071210 · printed Nov 5, 2026
Cite this page
510(k) Report. “K071210: Modification to Fidis Connective 10*, Model MX006.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071210
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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