510(k) · Cleared
ClearedFidistm Connective 10, Fidistm Analyzer, Caris
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 Dec 3, 2010 as substantially equivalent to K071210 (Biomedical Diagnostics (Bmd) SA, 2007) after an 84-day review. Its family tree reaches back 4 generations to 2000.
- Decided
- Dec 3, 2010
- Review
- 84 days
- Class
- Class II
- Product code
- LLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K000312 (2000). 12 ancestors in all, the oldest K944169 (1994). No later device cites it as a predicate yet.
- Root · 4 generations backK000312 Varelisa SM AntibodiesPharmacia & Upjohn Co. · 2000
- 3 generations backK042629 Varelisa SM Antibodies, Model 18296Sweden Diagnostics (Germany) GmbH · 2004
- 2 generations backK053653 Fidis Connective 10, Model MX006Biomedical Diagnostics (Bmd) SA · 2006
- 1 generation backK071210 Modification to Fidis Connective 10*, Model MX006Biomedical Diagnostics (Bmd) SA · 2007
- This deviceK102607 Fidistm Connective 10, Fidistm Analyzer, CarisBiomedical Diagnostics (Bmd) SA · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K000312 | Varelisa SM Antibodies | Pharmacia & Upjohn Co. | 2000 | — |
| −3 | K042629 | Varelisa SM Antibodies, Model 18296 | Sweden Diagnostics (Germany) GmbH | 2004 | — |
| −2 | K053653 | Fidis Connective 10, Model MX006 | Biomedical Diagnostics (Bmd) SA | 2006 | — |
| −1 | K071210 | Modification to Fidis Connective 10*, Model MX006 | Biomedical Diagnostics (Bmd) SA | 2007 | — |
| 0 (this device) | 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 |
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? (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 |
|---|---|---|---|
| * | K071210 | Modification to Fidis Connective 10*, Model MX006Summary page 5…racteristics* The following table summarizes similarities and differences between the modified FIDISTNI CONNECTIVE 10 and the predicate device FIDISTM CONNECTIVE 10 (K071210). Comparison with the predicate… | 2007 |
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 10 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
- None of the 12 ancestors has a recall.
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. 2010, this device’s year, is highlighted.
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 FIDIS TM 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), SS-A (60kDa and TRIM 21 (SS-A 52kDa)), SS-B3, Sm, Sm/RNP, Scl-70, Jo-i, ribosomes and centromere (CENP-B3). (*Antibodies to dsDNA, Sin, Sm/RNg, SS-A, SS-B, Scl-70, Jo-], ribosomes and CENP-B can be…
Read the full statement (164 words)
The FIDIS TM 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), SS-A (60kDa and TRIM 21 (SS-A 52kDa)), SS-B3, Sm, Sm/RNP, Scl-70, Jo-i, ribosomes and centromere (CENP-B3).
(*Antibodies to dsDNA, Sin, Sm/RNg, SS-A, SS-B, Scl-70, Jo-], ribosomes and CENP-B can be reported using this assay).
Clinical utility.
The results of the FIDIS TM 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).
FIDIS TM CONNECTIVE 10 kit uses serum only, and is to be run on the FIDIS TM Instrument and MLX-BOOSTER TM Software.
FIDIS TM CONNECTIVE 10 kit may be used with the CARIS TM system (diluting and dispensing device).
This kit is for In vitro Diagnostic Use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102607 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102607: Fidistm Connective 10, Fidistm Analyzer, Caris.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102607
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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