510(k) · Cleared
ClearedFidis 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 · LLL Extractable Antinuclear Antibody, Antigen And Control
Cleared on Mar 13, 2006 as substantially equivalent to K950031 (Elias U.S.A., Inc., 1995) and 8 other predicates after a 73-day review. Its family tree reaches back 2 generations to 2000. 5 later devices descend from it.
- Decided
- Mar 13, 2006
- Review
- 73 days
- Class
- Class II
- Product code
- LLL
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 2 generations to K000312 (2000). 10 ancestors in all, the oldest K944169 (1994). 5 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK000312 Varelisa SM AntibodiesPharmacia & Upjohn Co. · 2000
- 1 generation backK042629 Varelisa SM Antibodies, Model 18296Sweden Diagnostics (Germany) GmbH · 2004
- This deviceK053653 Fidis Connective 10, Model MX006Biomedical Diagnostics (Bmd) SA · 2006
- Descendant · cites it directly · 2 of its ownK151429 QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash…Inova Diagnostics, Inc. · 2016
- Descendant · cites it directly · 1 of its ownK071210 Modification to Fidis Connective 10*, Model MX006Biomedical Diagnostics (Bmd) SA · 2007
- Descendant · 2 generations on · 0 of its ownK213403 Aptiva CTD Essential ReagentInova Diagnostics, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK180975 QUANTA Flash HMGCR ReagentsInova Diagnostics, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK102607 Fidistm Connective 10, Fidistm Analyzer, CarisBiomedical Diagnostics (Bmd) SA · 2010
Most influential descendants
Showing 5 of 5 · See all- K151429QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 CiontrolsInova Diagnostics, Inc. · 2016 · cites it directly2descendants
- K071210Modification to Fidis Connective 10*, Model MX006Biomedical Diagnostics (Bmd) SA · 2007 · cites it directly1descendant
- K213403Aptiva CTD Essential ReagentInova Diagnostics, Inc. · 2023 · 2 generations on0descendants
- K180975QUANTA Flash HMGCR ReagentsInova Diagnostics, Inc. · 2018 · 2 generations on0descendants
- K102607Fidistm Connective 10, Fidistm Analyzer, CarisBiomedical Diagnostics (Bmd) SA · 2010 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K000312 | Varelisa SM Antibodies | Pharmacia & Upjohn Co. | 2000 | — |
| −1 | K042629 | Varelisa SM Antibodies, Model 18296 | Sweden Diagnostics (Germany) GmbH | 2004 | — |
| 0 (this device) | K053653 | Fidis Connective 10, Model MX006 | Biomedical Diagnostics (Bmd) SA | 2006 | — |
| +1 | K151429 | QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1… | Inova Diagnostics, Inc. | 2016 | — |
| +1 | K071210 | Modification to Fidis Connective 10*, Model MX006 | Biomedical Diagnostics (Bmd) SA | 2007 | — |
| +2 | K213403 | Aptiva CTD Essential Reagent | Inova Diagnostics, Inc. | 2023 | — |
| +2 | K180975 | QUANTA Flash HMGCR Reagents | Inova Diagnostics, Inc. | 2018 | — |
| +2 | 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 |
|---|---|---|
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2023 | 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 LLL? 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 LLL device
- #1 K253817 IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/Lascore 12.2 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (9)
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 |
|---|---|---|---|
| * | K950031 | Varelisa Dsdna Antibodies (Farr Version)Summary page 1…Jo-1, Ribosomes and Centromeres. Classification Name: Immunology and Microbiology Devices 3. Predicate Devices 510K Number Device Classification Name Manufacturer Name K950031 Varelisa dsDNA antibodies Sweden Diagnostics, GBMH K944169 Varelisa RO (SS-A) antibodies Sweden Diagnostics, GBMH K944168 Varelis… | 1995 |
| * | K944169 | Varelisa RO (SS-a) AntibodiesSummary page 1…ology and Microbiology Devices 3. Predicate Devices 510K Number Device Classification Name Manufacturer Name K950031 Varelisa dsDNA antibodies Sweden Diagnostics, GBMH K944169 Varelisa RO (SS-A) antibodies Sweden Diagnostics, GBMH K944168 Varelisa LA (SS-B) antibodies Sweden Diagnostics, GBMH K042629 Var… | 1994 |
| * | K944168 | Varelisa LA (SS-B) AntibodiesSummary page 1…er Device Classification Name Manufacturer Name K950031 Varelisa dsDNA antibodies Sweden Diagnostics, GBMH K944169 Varelisa RO (SS-A) antibodies Sweden Diagnostics, GBMH K944168 Varelisa LA (SS-B) antibodies Sweden Diagnostics, GBMH K042629 Varelisa SM antibodies Sweden Diagnostics, GBMH K993589 Varelisa R… | 1994 |
| * | K042629 | Varelisa SM Antibodies, Model 18296Summary page 1…a dsDNA antibodies Sweden Diagnostics, GBMH K944169 Varelisa RO (SS-A) antibodies Sweden Diagnostics, GBMH K944168 Varelisa LA (SS-B) antibodies Sweden Diagnostics, GBMH K042629 Varelisa SM antibodies Sweden Diagnostics, GBMH K993589 Varelisa RNP antibodies Sweden Diagnostics, GBMH K944173 Varelisa JOI ant… | 2004 |
| * | K993589 | Varelisa RNP AntibodiesSummary page 1…lisa RO (SS-A) antibodies Sweden Diagnostics, GBMH K944168 Varelisa LA (SS-B) antibodies Sweden Diagnostics, GBMH K042629 Varelisa SM antibodies Sweden Diagnostics, GBMH K993589 Varelisa RNP antibodies Sweden Diagnostics, GBMH K944173 Varelisa JOI antibodies Sweden Diagnostics, GBMH K944172 Varelisa SCL-70… | 1999 |
| * | K944173 | Varelisa JO-1 AntibodiesSummary page 1…8 Varelisa LA (SS-B) antibodies Sweden Diagnostics, GBMH K042629 Varelisa SM antibodies Sweden Diagnostics, GBMH K993589 Varelisa RNP antibodies Sweden Diagnostics, GBMH K944173 Varelisa JOI antibodies Sweden Diagnostics, GBMH K944172 Varelisa SCL-70 antibodies Sweden Diagnostics, GBMH K944171 Varelisa CEN… | 1994 |
| * | K944172 | Varelisa SCL-70 AntibodiesSummary page 1…K042629 Varelisa SM antibodies Sweden Diagnostics, GBMH K993589 Varelisa RNP antibodies Sweden Diagnostics, GBMH K944173 Varelisa JOI antibodies Sweden Diagnostics, GBMH K944172 Varelisa SCL-70 antibodies Sweden Diagnostics, GBMH K944171 Varelisa CENTROMERE antibodies Sweden Diagnostics, GBMH K981237 Quant… | 1994 |
| * | K944171 | Varelisa Centromere AntibodiesSummary page 1…589 Varelisa RNP antibodies Sweden Diagnostics, GBMH K944173 Varelisa JOI antibodies Sweden Diagnostics, GBMH K944172 Varelisa SCL-70 antibodies Sweden Diagnostics, GBMH K944171 Varelisa CENTROMERE antibodies Sweden Diagnostics, GBMH K981237 QuantaLite RIBOSOME P ELISA INOVA Diagnostics, Inc Page 1 of 3 S.… | 1994 |
| * | K981237 | Quanta Lite Ribosome P ElisaSummary page 1…elisa JOI antibodies Sweden Diagnostics, GBMH K944172 Varelisa SCL-70 antibodies Sweden Diagnostics, GBMH K944171 Varelisa CENTROMERE antibodies Sweden Diagnostics, GBMH K981237 QuantaLite RIBOSOME P ELISA INOVA Diagnostics, Inc Page 1 of 3 S.A au Capital de 2 755.46 Euros Registered Office : Tel: 33 (0)1… | 1998 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 6 years and passes through 3 companies; a new generation was cleared every 4.7 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K151429 (Inova Diagnostics, Inc., 2016) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K950031.
How does its category compare?
All LLL devicesLLL Extractable Antinuclear Antibody, Antigen And Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LLL
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLL
265in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLL
1in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLL
1in 2011
MAUDE reports naming product code LLL, 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 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 1 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 1 | 1 |
| 2012 | 0 | — | 1 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 3 | 265 | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The FIDISTM CONNECTIVE 10* kit is a semi-quantitative homogeneous fluorescent based microparticles immunoassay using flow cytometry readings. It is designed for the simultaneous detection of autoantibody specificities: double stranded DNA (dsDNA), SSA (60 kDA and 52 kDA), SSB, Sm, Sm/RNP, Scl-70, Jo-I ribosome and centromere in human serum. (*Antibodies to dsDNA, SSA, SSB, Sm, Sm/RNP, Scl-70, Jo-1, ribosome and centromere can be reported using this…
Read the full statement (111 words)
The FIDISTM CONNECTIVE 10* kit is a semi-quantitative homogeneous fluorescent based microparticles immunoassay using flow cytometry readings. It is designed for the simultaneous detection of autoantibody specificities: double stranded DNA (dsDNA), SSA (60 kDA and 52 kDA), SSB, Sm, Sm/RNP, Scl-70, Jo-I ribosome and centromere in human serum. (*Antibodies to dsDNA, SSA, SSB, Sm, Sm/RNP, Scl-70, Jo-1, ribosome and centromere can be reported using this assay).
The test system is used to screen serum samples and detect the presence of antinuclear antibodies associated with connective diseases systemic lupus erythematosus (SLE), Sjcgren's syndrome, mixed connective tissue disease (MCTD), scleroderma, dermatomyositis, and CREST syndrome, in conjunction with clinical findings and other laboratory tests.
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/K053653 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053653: Fidis Connective 10, Model MX006.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053653
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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