510(k) Report

510(k) · Cleared

Cleared

Lyphochek Tumor Marker Control, Model 580

K992172510(k) TraditionalCleared Sep 2, 199966-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 Sep 2, 1999 as substantially equivalent to K983807 (Bio-Rad, 1998) after a 66-day review. Its family tree reaches back 2 generations to 1994. 7 later devices descend from it.

Decided
Sep 2, 1999
Review
66 days
Class
Class I
Product code
JJY
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K940433 (1994). 7 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2001: 1 descendant cleared2007: 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 · 19981990200020102020
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 3 descendants3 generations forward: 3 descendants K983807 · 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 · 2 generations backK940433 Doa Liquid Drugs of Abuse Controls Levls 2,3,& 4,G2,G3,& G4Medical Analysis Systems, Inc. · 1994
  2. 1 generation backK983807 Lyphochek Tumor Marker Control, Model #580Bio-Rad · 1998
  3. This deviceK992172 Lyphochek Tumor Marker Control, Model 580Bio-Rad · 1999
  4. Descendant · cites it directly · 6 of its ownK011579 Lyphochek Tumor Marker Control, Levels 1 and 2, 2ML, Model 580Bio-Rad · 2001
  5. Descendant · 2 generations on · 2 of its ownK071675 Liquichek Tumor Marker ControlBio-Rad Laboratories · 2007
  6. Descendant · 2 generations on · 1 of its ownK082036 Lyphochek Tumor Market Plus Control Level 1, 2 and 3 and MinipakBio-Rad Laboratories · 2008
  7. Descendant · 3 generations on · 0 of its ownK163015 Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker…Bio-Rad Laboratories · 2017
  8. Descendant · 3 generations on · 0 of its ownK141073 Liquichek Tumor Marker ControlBio-Rad Laboratories · 2014

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2001: 12004: 12007: 12008: 12010: 12014: 12017: 1
2001high 1 (2001) · low 0 (2002)2026

Most influential descendants

Showing 5 of 7 · See all
  • K011579Lyphochek Tumor Marker Control, Levels 1 and 2, 2ML, Model 580Bio-Rad · 2001 · cites it directly6descendants
  • K071675Liquichek Tumor Marker ControlBio-Rad Laboratories · 2007 · 2 generations on2descendants
  • K082036Lyphochek Tumor Market Plus Control Level 1, 2 and 3 and MinipakBio-Rad Laboratories · 2008 · 2 generations on1descendant
  • K163015Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2…Bio-Rad Laboratories · 2017 · 3 generations on0descendants
  • K141073Liquichek Tumor Marker ControlBio-Rad Laboratories · 2014 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

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

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200410
200710
200810
201010
201410
201710
FIG. 1 — Lineage of K992172, 1994–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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
Get a 510(k) Report

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
*K983807Lyphochek Tumor Marker Control, Model #580
Summary page 1
…Control, All Kinds (Assayed and Unassayed) Devices to Which Substantial Equivalence is Claimed Lyphochek Tumor Marker Control Bio-Rad Laboratories Irvine, California K983807 Statement of Intended Use Lyphochek Tumor Marker Control is intended for use as an assayed quality control serum to monitor the…
Bio-Rad1998—

What descends from it? (7)

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

NumberDeviceApplicantDecidedDescendants
K011579Lyphochek Tumor Marker Control, Levels 1 and 2, 2ML, Model 580Bio-Rad20016

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 5 years and passes through 2 companies; a new generation was cleared every 4.4 years on median.
  • None of the 2 ancestors has a recall.
  • Of its descendants, K011579 (Bio-Rad, 2001) has gone furthest, with 6 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?

Lyphochek Tumor Marker Control is intended 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 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/K992172 · printed Nov 6, 2026

Cite this page

510(k) Report. “K992172: Lyphochek Tumor Marker Control, Model 580.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992172

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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