510(k) · Cleared

Cleared

Liquichek Ana Control Set, Positive: Homogeneous, Speckled, Centromere and Nucleolar Patterns, Catalog #131

K024230510(k) TraditionalCleared Jan 15, 200323-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 · DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control

Cleared on Jan 15, 2003 as substantially equivalent to K792610 (Kallestad Laboratories, Inc., 1980) and 1 other predicate after a 23-day review. Its family tree reaches back 2 generations to 1982.

Decided: Jan 15, 2003
Review: 23 days
Class: Class II
Product code: DHN
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K813592 (1982). 3 ancestors in all, the oldest K792610 (1980). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK813592 Quantafluor Fluorescent Test ReagentsKallestad Laboratories, Inc. · 1982 · Recalled
1 generation backK984397 Liquichek Ana Control, Centromere Pattern, Model 203Bio-Rad · 1998
This deviceK024230 Liquichek Ana Control Set, Positive: Homogeneous, Speckled…Bio-Rad · 2003

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K813592	Quantafluor Fluorescent Test Reagents	Kallestad Laboratories, Inc.	1982	2
−1	K984397	Liquichek Ana Control, Centromere Pattern, Model 203	Bio-Rad	1998	—
0 (this device)	K024230	Liquichek Ana Control Set, Positive: Homogeneous, Speckled, Centromere and…	Bio-Rad	2003	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1980	1	0

FIG. 1 — Lineage of K024230, 1982–2003Source: 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 DHN? 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

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What was it cleared against? (2)

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
*	K792610	Kallestad Florescent Ana/Ama/Asma Test Summary page 1 …tantial Equivalence is Claimed I. KallestadTM ANA Positive Control Homogeneous Pattern Bio-Rad Laboratories 510 (k) Number: K792610 II. LiquichekTMANA Control, Centromere Pattern Bio-Rad Laboratories 510 (k) Number:…	Kallestad Laboratories, Inc.	1980	1
*	K984397	Liquichek Ana Control, Centromere Pattern, Model 203 Summary page 1 …510 (k) Number: K792610 II. LiquichekTMANA Control, Centromere Pattern Bio-Rad Laboratories 510 (k) Number: K984397 131-51 O(k)-ANA-I 2/02 Bio-Rad Laboratories Page 2 o…	Bio-Rad	1998	—

Also cleared against K792610: 6 other devices →

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?

The line of descent spans 21 years and passes through 2 companies; a new generation was cleared every 16.9 years on median.
2 of the 3 ancestors have a recall of any class.
6 other devices also cite its predicate K792610.

How does its category compare?

All DHN devices

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

FDA decisions per year · DHN

1in 2022

2007high 2 (2015) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DHN

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

Recalls per year · DHN

1in 2011

2007high 2 (2008) · low 0 (2007)2026

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

Adverse event reports per year · DHN

No MAUDE report names DHN since 2007.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	1	—	0	0
2008	0	—	2	0
2009	0	—	0	0
2010	0	—	1	0
2011	0	—	1	0
2012	1	—	0	0
2013	0	—	0	0
2014	1	—	0	0
2015	2	—	0	0
2016	2	—	0	0
2017	0	—	0	0
2018	1	—	0	0
2019	0	—	0	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?

The Liquichek ANA Controls Set, Positive: Homogeneous, Speckled, Centromere, and Nucleolar Patterns, is intended for use as an unassayed quality control set to monitor indirect immunofluorescent testing of antinuclear antibodies (ANA).

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K024230 · printed Nov 3, 2026

Cite this page

510(k) Report. “K024230: Liquichek Ana Control Set, Positive: Homogeneous, Speckled, Centromere and Nucleolar Patterns, Catalog #131.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K024230

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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