510(k) · Cleared
ClearedAna Line Blot, Catalog Number: Kalabi (20 Tests)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnostic Products Corp. · LKJ Antinuclear Antibody, Antigen, Control
Cleared on Jun 3, 2002 as substantially equivalent to K954723 (Helix Diagnostics, Inc., 1995) after a 45-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Jun 3, 2002
- Review
- 45 days
- Class
- Class II
- Product code
- LKJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K954723 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK954723 Enzyme Immunoassay Ana Screening Test KitHelix Diagnostics, Inc. · 1995 · Recalled
- This deviceK021257 Ana Line Blot, Catalog Number: Kalabi (20 Tests)Diagnostic Products Corp. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K954723 | Enzyme Immunoassay Ana Screening Test Kit | Helix Diagnostics, Inc. | 1995 | 6 |
| 0 (this device) | K021257 | Ana Line Blot, Catalog Number: Kalabi (20 Tests) | Diagnostic Products Corp. | 2002 | — |
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 LKJ? 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 LKJ device
- #1 K210902 EliA Ro52, EliA Ro60score 4.0 · 2 generations · no Class I recall
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 |
|---|---|---|---|
| * | K954723 | Enzyme Immunoassay Ana Screening Test KitSummary page 3…tially equivalent results to other commercially marketed autoimmune disease assays, such as the Helix Diagnostics Enzyme Immunoassay Antinuclear Antibody Screening Test (K954723). Both are designed to identifi antibodies in human serum, against various cytoplasmic and nuclear antigens. Each product is inte… | 1995 |
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?
- Its one ancestor has a recall.
- 10 other devices also cite its predicate K954723.
How does its category compare?
All LKJ devicesLKJ Antinuclear Antibody, Antigen, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LKJ
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · LKJ
Too few LKJ 510(k)s in any year since 2007 to give a median.
Recalls per year · LKJ
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LKJ
2in 2018
MAUDE reports naming product code LKJ, 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 | — | 1 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 7 | 2 |
| 2011 | 0 | — | 0 | 17 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 1 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 1 | 2 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 1 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
ANA line Blot is an antinuclear antibody screening test designed to identify IgG antibodies in human serum, against the following cytoplasmic and nuclear antigens, collectively in one strip: centromere, dsDNA, histones, Jo-1,Sci70, SSA (SSA Ro52, SSA R060), SSB, Sm (SmB and SmD), RNP (RNP-70, RNP-A and RNP-C), and Ribosomal RNP ("0). The test is intended as an aid in the diagnosis of autoimmune diseases such as systemic lupus erythematosus (SLE), multiple connective tissue disorders, Sjogren's syndrome, CREST syndrome, scleroderma (progressive systemic sclerosis, PSS), and myositis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021257 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021257: Ana Line Blot, Catalog Number: Kalabi (20 Tests).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021257
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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