510(k) · Cleared
ClearedAeskulisa Ana 8PRO
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesku, Inc. · LLL Extractable Antinuclear Antibody, Antigen And Control
Cleared on Dec 16, 2003 after a 127-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Dec 16, 2003
- Review
- 127 days
- Class
- Class II
- Product code
- LLL
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
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?
AESKULISA ANA-8Pro is a solid phase enzyme immunoassay for the separate qualitative detection of IgG antibodies against eight cellular and nuclear antigens in human serum. The wells are separately coated with recombinant 70 kDa Ul snRNP, SS-B, SS-A 52 kDa, Scl 70, centromere protein B (CenpB), Jo-1 and highly purified native human snRNP/Sm, Sm and SS-A 60 kDa. The assay is an aid in the differential diagnosis of systemic rheumatic diseases and should be…
Read the full statement (705 words)
AESKULISA ANA-8Pro is a solid phase enzyme immunoassay for the separate qualitative detection of IgG antibodies against eight cellular and nuclear antigens in human serum. The wells are separately coated with recombinant 70 kDa Ul snRNP, SS-B, SS-A 52 kDa, Scl 70, centromere protein B (CenpB), Jo-1 and highly purified native human snRNP/Sm, Sm and SS-A 60 kDa. The assay is an aid in the differential diagnosis of systemic rheumatic diseases and should be used in conjunction with other serological tests and clinical findings.
AESKULISA ENA-6Pro is a solid phase enzyme immunoassay for the separate semi-quantitative detection of IgG antibodies against six cellular and nuclear antigens in human serum. The wells are coated with recombinant SS-B, SS-A 52 kDa, Scl 70, Jo-1 and highly purified native human snRNP/Sm, Sm and SS-A 60 kDa. The assay is an aid in the differential diagnosis of systemic rheumatic diseases and should be used in conjunction with other serological tests and clinical findings.
AESKULISA Ul-70 is a solid phase enzyme immunoassay employing recombinant human 70 kDa protein of the U 1-snRNP complex for the semi-quantitative and qualitative detection of antibodies against the 70 kDa Ul-RNP in human serum. The assay is an aid in the diagnosis of mixed connective tissue diseases (MCTD) and systemic lupus erythematosus (SLE) and should be used in conjunction with other serological tests and clinical findings.
AESKULISA snRNP-C is a solid phase enzyme immunoassay for the qualitative and semi-quantitative detection of antibodies against the snRNP complex in human serum. The assay employs native human U1-snRNP complex purified from the cell-line HeLa. The U1-snRNP complex comprises of the Smith antigen (Sm) and RNPs, the 7OkDa Ul-specific protein plus protein A and C. The assay is an aid for the diagnosis of mixed connective tissue diseases (MCTD) and systemic lupus erythematosus (SLE) and should be used in conjunction with other serological tests and clinical findings.
AESKULISA Sm is a solid phase enzyme immunoassay with purified native Smith antigen (Sm) from human eukaryotic cells (HeLa) for the qualitative and semiquantitative detection of antibodies against Sm in human serum. Anti-Sm antibodies recognize specific conformational epitopes only accessible on native human Sm. The assay is an aid in the differential diagnosis of systemic lupus erythematosus (SLE) and should be used in conjunction with other serological tests and clinical findings.
AESKULISA SS-A is a solid phase enzyme immunoassay for the semi-quantitative and qualitative detection of antibodies against Ro/ SS-A in human serum. The assay employs human Ro/SS-A antigen composed of purified native 6OkDa and recombinant human 52 kDa Ro/SS-A protein. Anti-SS-A antibodies preferentially react with the native 6OkDa molecule where as most antibodies to the 52 kDa protein prefer the denatured molecule. The assay is an aid in the diagnosis of Sj6gren's syndrome (SS) and systemic lupus erythematosus (SLE) and should be used in conjunction with other serological tests and clinical findings.
AESKULISA SS-B is a solid phase enzyme immunoassay employing human recombinant La-antigen! SS-B3 for the qualitative and semi-quantitative detection of antibodies against La-antigen / SS-B in human serum. The assay is an aid in the diagnosis of Sj~5gren's syndrome (SS) and systemic lupus erythematosus (SLE) and should be used in conjunction with other serological tests and clinical findings.
AESKULISA ScI-70 is a solid phase enzyme immunoassay with human recombinant 70 kDa fragment of DNA topoisomerase I for the qualitative and semi-quantitative detection of antibodies against ScI-70 (70 kDa scieroderma antigen) in human serum. The assay is an aid in the differential diagnosis of systemic sclerosis and should be used in conjunction with other serological tests and clinical findings.
AESKULISA CENP-B is a solid phase enzyme immunoassay employing purified recombinant human 80 kDa centromere protein B (Cenp-B) for the qualitative and semi-quantitative detection of IgG antibodies against Cenp-B in human serum. The assay serves as an aid in the diagnosis of systemic sclerosis and CREST syndrome and should be used in conjunction with other serological tests and clinical findings.
AESKULISA Jo-1 is a solid phase enzyme immunoassay with recombinant human histidyl-tRNA-synthetase (HRS) for the semi-quantitative and qualitative detection of antibodies against Jo-1 in human serum. The assay is an aid in the diagnosis of polymyositis and dermatomyositis and should be used in conjunction with other serological tests and clinical findings.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K032469 · printed Nov 5, 2026
Cite this page
510(k) Report. “K032469: Aeskulisa Ana 8PRO.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K032469
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026