510(k) · Cleared

Recalled · 2009

Lyphochek Assayed Chemistry Control

K040273510(k) TraditionalCleared Mar 4, 200428-day reviewClass I21 CFR 862.1660Recalls 2

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

Bio-Rad Laboratories, Inc. · JJY Multi-Analyte Controls, All Kinds (Assayed)

Cleared on Mar 4, 2004 as substantially equivalent to K874280 (Bio-Rad, 1988) after a 28-day review. Its family tree reaches back 1 generation to 1988. 1 later device descends from it. It has been recalled 2 times.

Decided: Mar 4, 2004
Review: 28 days
Class: Class I
Product code: JJY
Recalls: 2
Predicates: 1

Its longest line of descent runs back 1 generation to K874280 (1988). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK874280 Lyphochek Assayed Chemistry Control (Human), I/IIBio-Rad · 1988
This deviceK040273 Lyphochek Assayed Chemistry ControlBio-Rad Laboratories, Inc. · 2004
Descendant · cites it directly · 0 of its ownK111996 Elitech Clinical Sysems Ise Control 1 and 2Elitechgroup · 2011

Most influential descendants

Showing 1 of 1 · See all

K111996Elitech Clinical Sysems Ise Control 1 and 2Elitechgroup · 2011 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	0

FIG. 1 — Lineage of K040273, 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
*	K874280	Lyphochek Assayed Chemistry Control (Human), I/II Summary page 1 …bstantial Equivalence is Claimed Lyphochek Assayed Chemistry Control Bio-Rad Laboratories Irvine, California Docket Number: K874280 4.0 Description of Device Lyphochek Assayed Chemistry Control is prepared from human serum with added constit…	Bio-Rad	1988	—

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K111996	Elitech Clinical Sysems Ise Control 1 and 2	Elitechgroup	2011	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Dec 4, 2009	Not classified	Z-1233-2010	Other	Vital Diagnostics observed a bias in the Quality Control Consensus Program between published values for ALP on the ATAC 8000 and reported customer means. The ranges were adjusted to reflect the analyzer population.
Dec 4, 2009	Not classified	Z-1234-2010	Other	Vital Diagnostics observed a bias in the Quality Control Consensus Program between published values for ALP on the ATAC 8000 and reported customer means. The ranges were adjusted to reflect the analyzer population.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K111996 (Elitechgroup, 2011) has gone furthest, with 0 descendants of its own.

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.

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?

For use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K040273 · printed Nov 3, 2026

Cite this page

510(k) Report. “K040273: Lyphochek Assayed Chemistry Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040273

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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