510(k) · Cleared

Cleared

Liquichek Anti-SS-B Control, Eia, Model 210

K984478510(k) TraditionalCleared Dec 22, 19986-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

Bio-Rad · LKJ Antinuclear Antibody, Antigen, Control

Cleared on Dec 22, 1998 as substantially equivalent to K954723 (Helix Diagnostics, Inc., 1995) after a 6-day review. Its family tree reaches back 1 generation to 1995. 1 later device descends from it.

Decided: Dec 22, 1998
Review: 6 days
Class: Class II
Product code: LKJ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K954723 (1995). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK954723 Enzyme Immunoassay Ana Screening Test KitHelix Diagnostics, Inc. · 1995 · Recalled
This deviceK984478 Liquichek Anti-SS-B Control, Eia, Model 210Bio-Rad · 1998
Descendant · cites it directly · 0 of its ownK024232 Liquichek Anti-SS-B Control, Positive, Catalog #113Bio-Rad · 2003

Most influential descendants

Showing 1 of 1 · See all

K024232Liquichek Anti-SS-B Control, Positive, Catalog #113Bio-Rad · 2003 · cites it directly0descendants

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)	K984478	Liquichek Anti-SS-B Control, Eia, Model 210	Bio-Rad	1998	—
+1	K024232	Liquichek Anti-SS-B Control, Positive, Catalog #113	Bio-Rad	2003	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0

FIG. 1 — Lineage of K984478, 1995–2003Source: 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 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

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
*	K954723	Enzyme Immunoassay Ana Screening Test Kit Summary page 1 …rol. Devices to Which Substantial Equivalence is Claimed Helix Enzyme Immunoassay Antinuclear Antibody Screening Test Kit Helix Diagnostics West Sacrament, California K954723 Statement of Intended Use Liquichek Anti-SS-B Control, EIA is intended for use as an unassayed quality control to monitor enzy…	Helix Diagnostics, Inc.	1995	6

Also cleared against K954723: 10 other devices →

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
K024232	Liquichek Anti-SS-B Control, Positive, Catalog #113	Bio-Rad	2003	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 a recall.
Of its descendants, K024232 (Bio-Rad, 2003) has gone furthest, with 0 descendants of its own.
10 other devices also cite its predicate K954723.

How does its category compare?

All LKJ devices

LKJ Antinuclear Antibody, Antigen, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LKJ

1in 2022

2007high 1 (2008) · low 0 (2007)2026

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

2007high 7 (2010) · low 0 (2008)2026

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

Adverse event reports per year · LKJ

2in 2018

2007high 17 (2011) · low 0 (2007)2025

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?

Liquichek Anti-SS-B Control, EIA is intended for use as an unassayed quality control

to monitor enzyme immunoassay procedures for the detection of Anti-SS-B

autoantibodies.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K984478 · printed Nov 4, 2026

Cite this page

510(k) Report. “K984478: Liquichek Anti-SS-B Control, Eia, Model 210.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K984478

Report an extraction error

Are you the manufacturer?

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