510(k) Report

510(k) · Cleared

Cleared

Liquichek Urine Chemistry Control (Cat.NO. 397,398)

K971954510(k) TraditionalCleared Jun 11, 199714-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 11, 1997 after a 14-day review. The FDA summary names its predicate without a number. 20 later devices descend from it.

Decided
Jun 11, 1997
Review
14 days
Class
Class I
Product code
JJY
Recalls
None
Predicates
0

20 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2002: 1 descendant cleared2013: 3 descendants cleared2007: 4 descendants cleared2014: 2 descendants cleared2012: 3 descendants cleared2011: 2 descendants cleared2008: 1 descendant cleared2021: 1 descendant cleared2019: 2 descendants cleared2015: 1 descendant cleared1995200020052010201520202025
  1. This deviceK971954 Liquichek Urine Chemistry Control (Cat.NO. 397,398)Bio-Rad · 1997
  2. Descendant · cites it directly · 19 of its ownK020817 Liquichek Urine Chemistry ControlBio-Rad Laboratories, Inc. · 2002
  3. Descendant · 2 generations on · 11 of its ownK070249 Abx Pentra 400, Calcium CP, Creatinine CP, Phosphorus CP, Amylase…Horiba Abx · 2007 · Recalled
  4. Descendant · 3 generations on · 3 of its ownK070146 Abx Pentra Glucose HK CP, Urea CP, Uric Acid CPHoriba Abx · 2007
  5. Descendant · 3 generations on · 2 of its ownK123171 Abx Pentra Calcium as CP, Abx Pentra Urine Control L/H, Abx Pentra…Horiba Abx Sas · 2013
  6. Descendant · 4 generations on · 2 of its ownK081276 Abx Pentra Glucose HK CP, Abx Pentra Uric Acid CP, Abx Pentra Urine…Horiba Abx · 2008 · Recalled

Showing 5 of 20 descendants. See all descendants

Descendants cleared per year

2002: 12007: 42008: 12011: 22012: 32013: 32014: 22015: 12019: 22021: 1
2002high 4 (2007) · low 0 (2003)2026

Most influential descendants

Showing 5 of 20 · See all
  • K020817Liquichek Urine Chemistry ControlBio-Rad Laboratories, Inc. · 2002 · cites it directly19descendants
  • K070249Abx Pentra 400, Calcium CP, Creatinine CP, Phosphorus CP, Amylase CP, Urine Control L/HHoriba Abx · 2007 · 2 generations on11descendants
  • K070146Abx Pentra Glucose HK CP, Urea CP, Uric Acid CPHoriba Abx · 2007 · 3 generations on3descendants
  • K123171Abx Pentra Calcium as CP, Abx Pentra Urine Control L/H, Abx Pentra Multical, Abx Pentra…Horiba Abx Sas · 2013 · 3 generations on2descendants
  • K081276Abx Pentra Glucose HK CP, Abx Pentra Uric Acid CP, Abx Pentra Urine Control L/HHoriba Abx · 2008 · 4 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K971954Liquichek Urine Chemistry Control (Cat.NO. 397,398)Bio-Rad1997—
+1K020817Liquichek Urine Chemistry ControlBio-Rad Laboratories, Inc.2002—
+2K070249Abx Pentra 400, Calcium CP, Creatinine CP, Phosphorus CP, Amylase CP, Urine…Horiba Abx20071
+3K070146Abx Pentra Glucose HK CP, Urea CP, Uric Acid CPHoriba Abx2007—
+3K123171Abx Pentra Calcium as CP, Abx Pentra Urine Control L/H, Abx Pentra Multical…Horiba Abx Sas2013—
+4K081276Abx Pentra Glucose HK CP, Abx Pentra Uric Acid CP, Abx Pentra Urine Control L/HHoriba Abx20081

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200740
200810
201120
201230
201330
201420
201510
201920
202110
FIG. 1 — Lineage of K971954, 1997–2021Source: 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
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
*—Human Urine Control
Named without a submission number
—

What descends from it? (20)

See all 20

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

NumberDeviceApplicantDecidedDescendants
K020817Liquichek Urine Chemistry ControlBio-Rad Laboratories, Inc.200219

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?

  • Of its descendants, K020817 (Bio-Rad Laboratories, Inc., 2002) has gone furthest, with 19 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?

Liquichek Urine Chemistry Control is intended for use as an assayed quality control urine 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

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  • 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

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  • 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/K971954 · printed Nov 4, 2026

Cite this page

510(k) Report. “K971954: Liquichek Urine Chemistry Control (Cat.NO. 397,398).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971954

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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