510(k) Report

510(k) · Cleared

Cleared

Lyphochek Tumor Marker Control, Levels 1 and 2, 2ML, Model 580

K011579510(k) TraditionalCleared Jun 26, 200135-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

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

Cleared on Jun 26, 2001 as substantially equivalent to K992172 (Bio-Rad, 1999) after a 35-day review. Its family tree reaches back 3 generations to 1994. 6 later devices descend from it.

Decided
Jun 26, 2001
Review
35 days
Class
Class I
Product code
JJY
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K940433 (1994). 6 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2007: 1 descendant cleared2008: 1 descendant cleared2004: 1 descendant cleared2014: 1 descendant cleared2017: 1 descendant cleared2010: 1 descendant clearedK940433 · Doa Liquid Drugs of Abuse Controls Levls 2,3,& 4,G2,G3,& G4 · Medical Analysis Systems, Inc. · 1994K983807 · Lyphochek Tumor Marker Control, Model #580 · Bio-Rad · 1998K992172 · Lyphochek Tumor Marker Control, Model 580 · Bio-Rad · 19991990200020102020
Descendants, by generation 1 generation forward: 3 descendants2 generations forward: 3 descendants K992172 · Lyphochek Tumor Marker Control, Model 580 · Bio-Rad · 1999K983807 · Lyphochek Tumor Marker Control, Model #580 · Bio-Rad · 1998K940433 · Doa Liquid Drugs of Abuse Controls Levls 2,3,& 4,G2,G3,& G4 · Medical Analysis Systems, Inc. · 19940
  1. Root · 3 generations backK940433 Doa Liquid Drugs of Abuse Controls Levls 2,3,& 4,G2,G3,& G4Medical Analysis Systems, Inc. · 1994
  2. 2 generations backK983807 Lyphochek Tumor Marker Control, Model #580Bio-Rad · 1998
  3. 1 generation backK992172 Lyphochek Tumor Marker Control, Model 580Bio-Rad · 1999
  4. This deviceK011579 Lyphochek Tumor Marker Control, Levels 1 and 2, 2ML, Model 580Bio-Rad · 2001
  5. Descendant · cites it directly · 2 of its ownK071675 Liquichek Tumor Marker ControlBio-Rad Laboratories · 2007
  6. Descendant · cites it directly · 1 of its ownK082036 Lyphochek Tumor Market Plus Control Level 1, 2 and 3 and MinipakBio-Rad Laboratories · 2008
  7. Descendant · 2 generations on · 0 of its ownK163015 Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker…Bio-Rad Laboratories · 2017
  8. Descendant · 2 generations on · 0 of its ownK141073 Liquichek Tumor Marker ControlBio-Rad Laboratories · 2014
  9. Descendant · 2 generations on · 0 of its ownK101809 Fujirebio Diagnostics Tumor Marker Control Model 108-20Fujirebio Diagnostics,Inc. · 2010

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2004: 12007: 12008: 12010: 12014: 12017: 1
2004high 1 (2004) · low 0 (2005)2026

Most influential descendants

Showing 5 of 6 · See all
  • K071675Liquichek Tumor Marker ControlBio-Rad Laboratories · 2007 · cites it directly2descendants
  • K082036Lyphochek Tumor Market Plus Control Level 1, 2 and 3 and MinipakBio-Rad Laboratories · 2008 · cites it directly1descendant
  • K163015Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2…Bio-Rad Laboratories · 2017 · 2 generations on0descendants
  • K141073Liquichek Tumor Marker ControlBio-Rad Laboratories · 2014 · 2 generations on0descendants
  • K101809Fujirebio Diagnostics Tumor Marker Control Model 108-20Fujirebio Diagnostics,Inc. · 2010 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K940433Doa Liquid Drugs of Abuse Controls Levls 2,3,& 4,G2,G3,& G4Medical Analysis Systems, Inc.1994—
−2K983807Lyphochek Tumor Marker Control, Model #580Bio-Rad1998—
−1K992172Lyphochek Tumor Marker Control, Model 580Bio-Rad1999—
0 (this device)K011579Lyphochek Tumor Marker Control, Levels 1 and 2, 2ML, Model 580Bio-Rad2001—
+1K071675Liquichek Tumor Marker ControlBio-Rad Laboratories2007—
+1K082036Lyphochek Tumor Market Plus Control Level 1, 2 and 3 and MinipakBio-Rad Laboratories2008—
+2K163015Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level…Bio-Rad Laboratories2017—
+2K141073Liquichek Tumor Marker ControlBio-Rad Laboratories2014—
+2K101809Fujirebio Diagnostics Tumor Marker Control Model 108-20Fujirebio Diagnostics,Inc.2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200710
200810
201010
201410
201710
FIG. 1 — Lineage of K011579, 1994–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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.

TypeNumberDeviceApplicantDecidedRecalls
*K992172Lyphochek Tumor Marker Control, Model 580
Summary page 1
…ulation Number: CFR 862.1660 Device to Which Substantial Equivalence is Claimed Lyphochek® Tumor Marker Control Bio-Rad Laboratories Irvine, California Docket Number: K992172 Description of Device Lyphochek® Tumor Marker Control is prepared from human serum with added constituents of human origin and…
Bio-Rad1999—

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K071675Liquichek Tumor Marker ControlBio-Rad Laboratories20072
K082036Lyphochek Tumor Market Plus Control Level 1, 2 and 3 and MinipakBio-Rad Laboratories20081
K042815Quest Tumor Marker Control, Model 955Bio-Rad20040

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 7 years and passes through 2 companies; a new generation was cleared every 1.8 years on median.
  • None of the 3 ancestors has a recall.
  • Of its descendants, K071675 (Bio-Rad Laboratories, 2007) has gone furthest, with 2 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

2007: 112008: 72009: 82010: 102011: 142012: 132013: 162014: 102015: 42016: 12017: 3
2007high 16 (2013) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JJY

78in 2017

2007: 49 days median2008: 54 days median2009: 80 days median2010: 109 days median2011: 120 days median2012: 40 days median2013: 82 days median2014: 49 days median2015: 153 days median2017: 78 days median
2007high 153 (2015) · low 40 (2012)2026

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

Recalls per year · JJY

2in 2025

2007: 52009: 22010: 62011: 12012: 32013: 22014: 22015: 12016: 32017: 42018: 32019: 42020: 62022: 32023: 32025: 22026 (partial year): 1
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

2007: 22008: 12009: 32010: 32011: 62012: 202013: 52014: 42015: 42016: 132017: 122018: 72019: 12020: 72021: 12023: 42024: 12025: 13
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007114952
200875401
200988023
20101010963
20111412016
20121340320
2013168225
2014104924
2015415314
20161—313
2017378412
20180—37
20190—41
20200—67
20210—01
20220—30
20230—34
20240—01
20250—213
20260—1—

What is it indicated for?

An assayed quality control serum to monitor the precision of laboratory

testing procedures for analytes listed in the package insert.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Bio-Rad

322 FDA decisions under this applicant name. See the company

  • K171061MRSASelect IIBio-Rad · 20171 recall
  • K122187Vreselect Culture MediumBio-Rad · 2012
  • K103684Vreselect Culture MediumBio-Rad · 2011
  • K093678Platelia Aspergillus Eia Model 62793Bio-Rad · 2011
  • K100589Mrsa Select - Skin and Soft Tissue Wound SpecimensBio-Rad · 2010

Recent decisions in JJY

The JJY category page

  • K162530Multichem IA PlusTechno-Path Manufacturing · 2017
  • K163629Audit MicroControls Linearity FD Tumor Markers IIAalto Scientific, Ltd. · 2017
  • K163015Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker…Bio-Rad Laboratories · 2017
  • K153712VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea…Radiometer America, Inc. · 2016
  • K150300Liquichek Cardiac Markers Plus Control LTBio-Rad Laboratories · 2015

https://510kreport.com/device/K011579 · printed Nov 5, 2026

Cite this page

510(k) Report. “K011579: Lyphochek Tumor Marker Control, Levels 1 and 2, 2ML, Model 580.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K011579

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026