510(k) · Cleared

Cleared

Elitech Clinical Sysems Ise Control 1 and 2

K111996510(k) AbbreviatedCleared Sep 14, 201163-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

Elitechgroup · JJY Multi-Analyte Controls, All Kinds (Assayed)

Cleared on Sep 14, 2011 as substantially equivalent to K040273 (Bio-Rad Laboratories, Inc., 2004) after a 63-day review. Its family tree reaches back 2 generations to 1988.

Decided: Sep 14, 2011
Review: 63 days
Class: Class I
Product code: JJY
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K874280 (1988). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK874280 Lyphochek Assayed Chemistry Control (Human), I/IIBio-Rad · 1988
1 generation backK040273 Lyphochek Assayed Chemistry ControlBio-Rad Laboratories, Inc. · 2004 · Recalled
This deviceK111996 Elitech Clinical Sysems Ise Control 1 and 2Elitechgroup · 2011

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K874280	Lyphochek Assayed Chemistry Control (Human), I/II	Bio-Rad	1988	—
−1	K040273	Lyphochek Assayed Chemistry Control	Bio-Rad Laboratories, Inc.	2004	2
0 (this device)	K111996	Elitech Clinical Sysems Ise Control 1 and 2	Elitechgroup	2011	—

FIG. 1 — Lineage of K111996, 1988–2011Source: 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 JJY? 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
*	K040273	Lyphochek Assayed Chemistry Control Summary page 1 …ssayed) Product code JJY - multi-analyte controls, all kinds (assayed) Predicate device Biorad-Lyphochek Assayed Chemistry Control Level 1and 2.(K040273) Device description ELiTech Clinical Systems ISE CONTROL I and ISE CONTROL I are two level q…	Bio-Rad Laboratories, Inc.	2004	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 23 years and passes through 3 companies; a new generation was cleared every 16.1 years on median.
1 of the 2 ancestors has a recall of any class.

How does its category compare?

All JJY devices

JJY Multi-Analyte Controls, All Kinds (Assayed): FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · JJY

3in 2017

2007high 16 (2013) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JJY

78in 2017

2007high 153 (2015) · low 40 (2012)2026

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

Recalls per year · JJY

2in 2025

2007high 6 (2010) · low 0 (2008)2026

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

Adverse event reports per year · JJY

13in 2025

2007high 20 (2012) · low 0 (2022)2025

MAUDE reports naming product code JJY, 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	11	49	5	2
2008	7	54	0	1
2009	8	80	2	3
2010	10	109	6	3
2011	14	120	1	6
2012	13	40	3	20
2013	16	82	2	5
2014	10	49	2	4
2015	4	153	1	4
2016	1	—	3	13
2017	3	78	4	12
2018	0	—	3	7
2019	0	—	4	1
2020	0	—	6	7
2021	0	—	0	1
2022	0	—	3	0
2023	0	—	3	4
2024	0	—	0	1
2025	0	—	2	13
2026	0	—	1	—

What is it indicated for?

ELITech Clinical Systems ISE CONTROL I and ISE CONTROL II are control sera for in vitro diagnostic use in quality control of ELITech Clinical Systems ISE Na, K, Cl, Total CO2 on ELITech Clinical Systems Selectra analyzers equipped with ISE Module.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K111996 · printed Nov 6, 2026

Cite this page

510(k) Report. “K111996: Elitech Clinical Sysems Ise Control 1 and 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111996

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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