510(k) · Cleared

Recalled · Class II · 2020

Elia Dsdna Immunoassay, Model 14-5500-01, Elia Ana Control, Model 83-1004-01

K072393510(k) TraditionalCleared Dec 7, 2007102-day reviewClass II21 CFR 866.5100Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Phadia US, Inc. · LSW Anti-Dna Antibody, Antigen And Control

Cleared on Dec 7, 2007 as substantially equivalent to K874873 (Diagnostic Products Corp., 1988) after a 102-day review. Its family tree reaches back 1 generation to 1988. 1 later device descends from it. It has been recalled once.

Decided: Dec 7, 2007
Review: 102 days
Class: Class II
Product code: LSW
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K874873 (1988). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK874873 Combigene (TM) Anti-Dna #Kaddz, KADD1Diagnostic Products Corp. · 1988
This deviceK072393 Elia Dsdna Immunoassay, Model 14-5500-01, Elia Ana Control, Model…Phadia US, Inc. · 2007
Descendant · cites it directly · 0 of its ownK253367 EliA CTD 13 ScreenPhadia AB · 2026

Most influential descendants

Showing 1 of 1 · See all

K253367EliA CTD 13 ScreenPhadia AB · 2026 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K874873	Combigene (TM) Anti-Dna #Kaddz, KADD1	Diagnostic Products Corp.	1988	—
0 (this device)	K072393	Elia Dsdna Immunoassay, Model 14-5500-01, Elia Ana Control, Model 83-1004-01	Phadia US, Inc.	2007	—
+1	K253367	EliA CTD 13 Screen	Phadia AB	2026	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2026	1	0

FIG. 1 — Lineage of K072393, 1988–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 LSW? 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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K874873	Combigene (TM) Anti-Dna #Kaddz, KADD1 Summary page 1 …Control JJY 1 862.1660 Substantial Equivalence to DPC anti-DNA 5 10(k) number: K874873 EliA T M dsDNA - New Device 510(k) Submission Section 9: Summary of Safety and Effectiveness Intended U…	Diagnostic Products Corp.	1988	—

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K253367	EliA CTD 13 Screen	Phadia AB	2026	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Dec 14, 2020	Class II	Z-1107-2021	Under Investigation by firm	Decreased values for EliA ANA Positive Control when using the EliA dsDNA Well lot BFA37/0142 may potentially cause false positive results (increase in patient test results).

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K253367 (Phadia AB, 2026) has gone furthest, with 0 descendants of its own.

How does its category compare?

All LSW devices

LSW Anti-Dna 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 · LSW

1in 2018

2007high 1 (2007) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LSW

Too few LSW 510(k)s in any year since 2007 to give a median.

Recalls per year · LSW

No recall names LSW since 2007.

Adverse event reports per year · LSW

1in 2019

2007high 1 (2013) · low 0 (2007)2025

MAUDE reports naming product code LSW, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	1	—	0
2008	1	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	1
2014	0	—	0
2015	0	—	0
2016	1	—	0
2017	0	—	0
2018	1	—	0
2019	0	—	1
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	0	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

EliA dsDNA is intended for the in vitro quantitative measurement of lgG antibodies directed to dsDNA in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EllA dsDNA uses the EliA IgG method on the instrument ImmunoCAP 100 and ImmunoCAP 250.

EliA ANA Control is intended for laboratory use in monitoring the performance of in vitro measurement of antinuclear antibodies (ANA) with ImmunoCAP 100 or ImmunoCAP 250 using the EliA IgG method.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K072393 · printed Nov 4, 2026

Cite this page

510(k) Report. “K072393: Elia Dsdna Immunoassay, Model 14-5500-01, Elia Ana Control, Model 83-1004-01.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072393

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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