510(k) · Cleared

Cleared

Abbott Lipid Multi Constituent Calibrator

K123372510(k) TraditionalCleared Jan 14, 201374-day reviewClass II21 CFR 862.1150

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

Abbott Laboratories · JIX Calibrator, Multi-Analyte Mixture

Cleared on Jan 14, 2013 as substantially equivalent to K983289 (Abbott Laboratories, 1999) after a 74-day review. Its family tree reaches back 2 generations to 1997.

Decided: Jan 14, 2013
Review: 74 days
Class: Class II
Product code: JIX
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K964292 (1997). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK964292 N-Assay Tia Apo A1 Test KitCrestat Diagnostics, Inc. · 1997
1 generation backK983289 Apolipoprotein A1Abbott Laboratories · 1999 · Recalled
This deviceK123372 Abbott Lipid Multi Constituent CalibratorAbbott Laboratories · 2013

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K964292	N-Assay Tia Apo A1 Test Kit	Crestat Diagnostics, Inc.	1997	—
−1	K983289	Apolipoprotein A1	Abbott Laboratories	1999	2
0 (this device)	K123372	Abbott Lipid Multi Constituent Calibrator	Abbott Laboratories	2013	—

FIG. 1 — Lineage of K123372, 1997–2013Source: 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 JIX? 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? (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
*	K983289	Apolipoprotein A1 Summary page 2 …methods. Substantial Equivalence: LipidMCC is substantially equivalent to the Apolipoprotein AlI/Apolipoprotein B Calibrator (ApoAl/ApoB Calibrator) K983289. These calibrators yield substantially equivalent results on the ARCHITECT c8000 Analyzer. Device similarities and differences ar…	Abbott Laboratories	1999	2

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 16 years and passes through 2 companies; a new generation was cleared every 14.0 years on median.
1 of the 2 ancestors has a recall of any class.

How does its category compare?

All JIX devices

JIX Calibrator, Multi-Analyte Mixture: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · JIX

1in 2016

2007high 7 (2011) · low 0 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JIX

29in 2015

2007high 121 (2009) · low 29 (2015)2026

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

Recalls per year · JIX

7in 2023

2007high 7 (2023) · low 0 (2013)2026

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

Adverse event reports per year · JIX

18in 2025

2007high 173 (2008) · low 0 (2010)2025

MAUDE reports naming product code JIX, 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	2	140
2008	5	69	3	173
2009	4	121	2	39
2010	5	100	1	0
2011	7	77	2	9
2012	2	—	1	3
2013	4	50	0	24
2014	1	—	1	35
2015	3	29	0	4
2016	1	—	1	6
2017	0	—	1	17
2018	0	—	1	16
2019	0	—	1	12
2020	0	—	2	22
2021	0	—	0	9
2022	0	—	0	11
2023	0	—	7	13
2024	0	—	0	15
2025	0	—	0	18
2026	0	—	1	—

What is it indicated for?

Abbott Lipid Multiconstituent Calibrator is an in vitro diagnostic product intended for the

calibration of Abbott Apolipoprotein A1, Apolipoprotein B, HDL-Cholesterol and LDL-Cholesterol assays on the ARCHITECT c8000 clinical chemistry analyzer.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K123372 · printed Nov 4, 2026

Cite this page

510(k) Report. “K123372: Abbott Lipid Multi Constituent Calibrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K123372

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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