510(k) · Cleared

Cleared

Varelisa SM Antibodies, Model 18296

K042629510(k) TraditionalCleared Dec 8, 200472-day reviewClass II21 CFR 866.5100

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

Sweden Diagnostics (Germany) GmbH · LKP Anti-Sm Antibody, Antigen And Control

Cleared on Dec 8, 2004 as substantially equivalent to K000312 (Pharmacia & Upjohn Co., 2000) after a 72-day review. Its family tree reaches back 1 generation to 2000. 7 later devices descend from it.

Decided: Dec 8, 2004
Review: 72 days
Class: Class II
Product code: LKP
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K000312 (2000). 7 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK000312 Varelisa SM AntibodiesPharmacia & Upjohn Co. · 2000
This deviceK042629 Varelisa SM Antibodies, Model 18296Sweden Diagnostics (Germany) GmbH · 2004
Descendant · cites it directly · 5 of its ownK053653 Fidis Connective 10, Model MX006Biomedical Diagnostics (Bmd) SA · 2006
Descendant · 2 generations on · 2 of its ownK151429 QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash…Inova Diagnostics, Inc. · 2016
Descendant · 2 generations on · 1 of its ownK071210 Modification to Fidis Connective 10*, Model MX006Biomedical Diagnostics (Bmd) SA · 2007
Descendant · 3 generations on · 0 of its ownK213403 Aptiva CTD Essential ReagentInova Diagnostics, Inc. · 2023
Descendant · 3 generations on · 0 of its ownK180975 QUANTA Flash HMGCR ReagentsInova Diagnostics, Inc. · 2018

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2005high 1 (2005) · low 0 (2008)2026

Most influential descendants

Showing 5 of 7 · See all

K053653Fidis Connective 10, Model MX006Biomedical Diagnostics (Bmd) SA · 2006 · cites it directly5descendants
K151429QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 CiontrolsInova Diagnostics, Inc. · 2016 · 2 generations on2descendants
K071210Modification to Fidis Connective 10*, Model MX006Biomedical Diagnostics (Bmd) SA · 2007 · 2 generations on1descendant
K213403Aptiva CTD Essential ReagentInova Diagnostics, Inc. · 2023 · 3 generations on0descendants
K180975QUANTA Flash HMGCR ReagentsInova Diagnostics, Inc. · 2018 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K000312	Varelisa SM Antibodies	Pharmacia & Upjohn Co.	2000	—
0 (this device)	K042629	Varelisa SM Antibodies, Model 18296	Sweden Diagnostics (Germany) GmbH	2004	—
+1	K053653	Fidis Connective 10, Model MX006	Biomedical Diagnostics (Bmd) SA	2006	—
+2	K151429	QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1…	Inova Diagnostics, Inc.	2016	—
+2	K071210	Modification to Fidis Connective 10*, Model MX006	Biomedical Diagnostics (Bmd) SA	2007	—
+3	K213403	Aptiva CTD Essential Reagent	Inova Diagnostics, Inc.	2023	—
+3	K180975	QUANTA Flash HMGCR Reagents	Inova Diagnostics, Inc.	2018	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2006	1	0
2007	1	0
2010	1	0
2016	1	0
2018	1	0
2023	1	0

FIG. 1 — Lineage of K042629, 2000–2023Source: 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 LKP? 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 LKP device

#1 K202067 EliA SmDP-Sscore 1.7 · 1 generation · no Class I recall

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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
*	K000312	Varelisa SM Antibodies Summary page 1 …CFR Varelisa® Sm Antibodies LKP II 866.5100 Substantial Equivalence to Varelisa® Sm Antibodies (510(k) number: K000312) Page 48 Varelisa® Sm Antibodies - New Device 510(k) Submission Section…	Pharmacia & Upjohn Co.	2000	—

Also cleared against K000312: 1 other device →

What descends from it? (7)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K053653	Fidis Connective 10, Model MX006	Biomedical Diagnostics (Bmd) SA	2006	5
K050625	Varelisa Recombi Ana Profile, Model 18496	Sweden Diagnostics (Germany) GmbH	2005	0

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 no recall.
Of its descendants, K053653 (Biomedical Diagnostics (Bmd) SA, 2006) has gone furthest, with 5 descendants of its own.
1 other device also cites its predicate K000312.

How does its category compare?

All LKP devices

LKP Anti-Sm Antibody, Antigen And Control: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LKP

1in 2021

2007high 1 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LKP

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

Recalls per year · LKP

1in 2015

2007high 1 (2015) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LKP

No MAUDE report names LKP since 2007.

View these four charts as a table

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

What is it indicated for?

The Varelisa Sm Antibodies EIA kit is designed for the semiquantitative and qualitative determination of SmD antibodies in serum or plasma to aid in the diagnosis of systemic lupus erythematosus (SLE).

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K042629 · printed Nov 6, 2026

Cite this page

510(k) Report. “K042629: Varelisa SM Antibodies, Model 18296.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042629

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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