510(k) · Cleared

Cleared

Cliniqa Liquid-QC HCG Control Level 1, 2, and 3

K022232510(k) TraditionalCleared Aug 1, 200222-day reviewClass I21 CFR 862.1660

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

Cliniqa Corporation · JJX Single (Specified) Analyte Controls (Assayed And Unassayed)

Cleared on Aug 1, 2002 after a 22-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it.

Decided: Aug 1, 2002
Review: 22 days
Class: Class I
Product code: JJX
Recalls: None
Predicates: 0

2 later devices descend from it, 1 citing it directly.

This deviceK022232 Cliniqa Liquid-QC HCG Control Level 1, 2, and 3Cliniqa Corporation · 2002
Descendant · cites it directly · 1 of its ownK121237 Beta HCG Control Level 1 Beta HCG Control Level 2 Beta HCG Control…Cliniqa Corporation · 2012
Descendant · 2 generations on · 0 of its ownK133002 i-STAT Total beta-hCG Test, i-STAT Total beta-hCG Controls, i-STAT…Abbott Point of Care, Inc. · 2015

Most influential descendants

Showing 2 of 2 · See all

K121237Beta HCG Control Level 1 Beta HCG Control Level 2 Beta HCG Control Level 3 Beta HCG…Cliniqa Corporation · 2012 · cites it directly1descendant
K133002i-STAT Total beta-hCG Test, i-STAT Total beta-hCG Controls, i-STAT Total beta-hCG…Abbott Point of Care, Inc. · 2015 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K022232	Cliniqa Liquid-QC HCG Control Level 1, 2, and 3	Cliniqa Corporation	2002	—
+1	K121237	Beta HCG Control Level 1 Beta HCG Control Level 2 Beta HCG Control Level 3…	Cliniqa Corporation	2012	—
+2	K133002	i-STAT Total beta-hCG Test, i-STAT Total beta-hCG Controls, i-STAT Total…	Abbott Point of Care, Inc.	2015	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	1	0
2015	1	0

FIG. 1 — Lineage of K022232, 2002–2015Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in JJX? 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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K121237	Beta HCG Control Level 1 Beta HCG Control Level 2 Beta HCG Control Level 3 Beta HCG…	Cliniqa Corporation	2012	1

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?

Of its descendants, K121237 (Cliniqa Corporation, 2012) has gone furthest, with 1 descendant of its own.

How does its category compare?

All JJX devices

JJX Single (Specified) Analyte Controls (Assayed And Unassayed): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JJX

2in 2017

2007high 24 (2010) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JJX

31in 2016

2007high 80 (2009) · low 30 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JJX

1in 2021

2007high 3 (2007) · low 0 (2009)2026

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

Adverse event reports per year · JJX

22in 2025

2007high 82 (2019) · low 0 (2008)2025

MAUDE reports naming product code JJX, 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	6	53	3	2
2008	8	52	3	0
2009	17	80	0	1
2010	24	80	3	6
2011	19	62	2	62
2012	15	40	0	32
2013	19	37	0	51
2014	22	30	1	48
2015	11	65	1	67
2016	6	31	2	37
2017	2	—	0	19
2018	0	—	2	35
2019	0	—	0	82
2020	0	—	0	77
2021	0	—	1	43
2022	0	—	0	24
2023	0	—	0	22
2024	0	—	0	30
2025	0	—	0	22
2026	0	—	0	—

What is it indicated for?

CLINIQA Liquid-QCTMhCG Control is intended for use as an assayed quality control material for serum Human Chorionic Gonadotropin protein analysis, which is used to monitor the accuracy and precision of procedures in use in the clinical laboratory.

Indications for use as stated in the FDA 510(k) statement.

https://510kreport.com/device/K022232 · printed Nov 6, 2026

Cite this page

510(k) Report. “K022232: Cliniqa Liquid-QC HCG Control Level 1, 2, and 3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022232

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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