510(k) · Cleared

Cleared

Modification to Calibrator for Automatic Systems (Cfas)

K033501510(k) SpecialCleared Nov 20, 200315-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

Roche Diagnostics Corp. · JIX Calibrator, Multi-Analyte Mixture

Cleared on Nov 20, 2003 as substantially equivalent to K990460 (Roche Diagnostics Corp., 1999) after a 15-day review. Its family tree reaches back 1 generation to 1999. 31 later devices descend from it.

Decided: Nov 20, 2003
Review: 15 days
Class: Class II
Product code: JIX
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K990460 (1999). 31 later devices descend from it, 17 citing it directly.

By dateBy generation

Root · 1 generation backK990460 Calibrator for Automated Systems (C.F.a.S.)Roche Diagnostics Corp. · 1999
This deviceK033501 Modification to Calibrator for Automatic Systems (Cfas)Roche Diagnostics Corp. · 2003
Descendant · cites it directly · 15 of its ownK052007 Abx Pentra 400 Clinical Chemistry Analyzer (Option: I.S.E. Module)Horiba Abx · 2005 · Recalled
Descendant · 2 generations on · 3 of its ownK060854 Abx Pentra 400: LipoproteinsHoriba Abx · 2006 · Recalled
Descendant · 2 generations on · 2 of its ownK123171 Abx Pentra Calcium as CP, Abx Pentra Urine Control L/H, Abx Pentra…Horiba Abx Sas · 2013
Descendant · cites it directly · 1 of its ownK122083 Elitech Clinical Systems CK Nac SLElitechgroup · 2012
Descendant · 2 generations on · 1 of its ownK110530 Abx Pentra Creatinine 120 CP; Abx Pentra Multical; Abx Pentra N…Horiba Abx Sas · 2012 · Recalled

Showing 5 of 31 descendants. See all descendants

Descendants cleared per year

2005high 10 (2011) · low 0 (2008)2026

Most influential descendants

Showing 5 of 31 · See all

K052007Abx Pentra 400 Clinical Chemistry Analyzer (Option: I.S.E. Module)Horiba Abx · 2005 · cites it directly15descendants
K060854Abx Pentra 400: LipoproteinsHoriba Abx · 2006 · 2 generations on3descendants
K123171Abx Pentra Calcium as CP, Abx Pentra Urine Control L/H, Abx Pentra Multical, Abx Pentra…Horiba Abx Sas · 2013 · 2 generations on2descendants
K122083Elitech Clinical Systems CK Nac SLElitechgroup · 2012 · cites it directly1descendant
K110530Abx Pentra Creatinine 120 CP; Abx Pentra Multical; Abx Pentra N Control; Abx Pentra P…Horiba Abx Sas · 2012 · 2 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K990460	Calibrator for Automated Systems (C.F.a.S.)	Roche Diagnostics Corp.	1999	—
0 (this device)	K033501	Modification to Calibrator for Automatic Systems (Cfas)	Roche Diagnostics Corp.	2003	—
+1	K052007	Abx Pentra 400 Clinical Chemistry Analyzer (Option: I.S.E. Module)	Horiba Abx	2005	6
+2	K060854	Abx Pentra 400: Lipoproteins	Horiba Abx	2006	2
+2	K123171	Abx Pentra Calcium as CP, Abx Pentra Urine Control L/H, Abx Pentra Multical…	Horiba Abx Sas	2013	—
+1	K122083	Elitech Clinical Systems CK Nac SL	Elitechgroup	2012	—
+2	K110530	Abx Pentra Creatinine 120 CP; Abx Pentra Multical; Abx Pentra N Control; Abx…	Horiba Abx Sas	2012	3

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2006	3	0
2007	2	0
2010	3	0
2011	10	0
2012	3	0
2013	2	0
2014	2	0
2015	2	0
2016	1	0
2019	1	0
2021	1	0

FIG. 1 — Lineage of K033501, 1999–2021Source: 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
*	K990460	Calibrator for Automated Systems (C.F.a.S.) Summary page 2 …the enclosed value sheet. Predicate We claim substantial equivalence to the currently marketed Calibrator for Device Automated Systems (C.f.a.s .)(K990460). I 24 DEPAR…	Roche Diagnostics Corp.	1999	—

Also cleared against K990460: 4 other devices →

What descends from it? (31)

See all 31

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

Number	Device	Applicant	Decided	Descendants
K052007	Abx Pentra 400 Clinical Chemistry Analyzer (Option: I.S.E. Module)	Horiba Abx	2005	15
K122083	Elitech Clinical Systems CK Nac SL	Elitechgroup	2012	1
K062319	Calibrator for Automated Systems (C.F.a.S.), Model 10759350 360	Roche Diagnostics Corp.	2006	1
K153644	ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech…	Elitechgroup	2016	0
K151552	ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical…	Elitechgroup	2015	0
K132399	Elitech Clinical Systems Creatinine Pap SL, Elical 2, Elitrol I and Elitrol II, Urine…	Elitechgroup	2014	0
K130765	Elitech Clinical Systems Elical 2; Elitech Clinical Systems Elitrol I, Elitech Clinical…	Elitechgroup	2013	0
K122858	Eltech Chinical System Amylase SL Elitech Clinical Systems ELICAL2 Eltech Clinical…	Elitechgroup	2012	0
K103376	Elitech Clinical Systems Creatinne Pap SL Model CRSL-0250, Clitech Clinical Systems…	Seppim S.A.S.	2011	0
K110780	Elitech Clinical Systems Bilirubin Total 4+1, Elitech Clinical Systems Elical 2, Elitech…	Elitechgroup	2011	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, K052007 (Horiba Abx, 2005) has gone furthest, with 15 descendants of its own.
4 other devices also cite its predicate K990460.

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.

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?

Calibrator for automated systems (C.f.a.s.) is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the enclosed value sheet.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K033501 · printed Nov 5, 2026

Cite this page

510(k) Report. “K033501: Modification to Calibrator for Automatic Systems (Cfas).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K033501

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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