510(k) Report

510(k) · Cleared

Cleared

Liquichek Immunoassay Plus Control, Model 360, 361, 362, 363

K001373510(k) TraditionalCleared May 25, 200024-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 May 25, 2000 after a 24-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.

Decided
May 25, 2000
Review
24 days
Class
Class I
Product code
JJY
Recalls
None
Predicates
0

6 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2013: 2 descendants cleared2005: 1 descendant cleared2012: 1 descendant cleared2003: 1 descendant cleared2017: 1 descendant cleared200020052010201520202025
  1. This deviceK001373 Liquichek Immunoassay Plus Control, Model 360, 361, 362, 363Bio-Rad · 2000
  2. Descendant · cites it directly · 1 of its ownK132091 Multichem IA and IA PlusTechno-Path Manufacturing, Ltd. · 2013
  3. Descendant · cites it directly · 1 of its ownK033366 Liquichek Qualitative Urine Toxicology Control, Negative, Model 454…Bio-Rad · 2003
  4. Descendant · 2 generations on · 0 of its ownK162530 Multichem IA PlusTechno-Path Manufacturing · 2017
  5. Descendant · cites it directly · 0 of its ownK132227 Liquichek Immunoassay Premium Control-Trilevel, Liquichek…Bio-Rad Laboratories · 2013
  6. Descendant · cites it directly · 0 of its ownK122838 Liquickek Immunoassay Plus Control, Level 1 Model 267, Liquichek…Bio-Rad Laboratories · 2012

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2003: 12005: 12012: 12013: 22017: 1
2003high 2 (2013) · low 0 (2004)2026

Most influential descendants

Showing 5 of 6 · See all
  • K132091Multichem IA and IA PlusTechno-Path Manufacturing, Ltd. · 2013 · cites it directly1descendant
  • K033366Liquichek Qualitative Urine Toxicology Control, Negative, Model 454; Positive, Model 455Bio-Rad · 2003 · cites it directly1descendant
  • K162530Multichem IA PlusTechno-Path Manufacturing · 2017 · 2 generations on0descendants
  • K132227Liquichek Immunoassay Premium Control-Trilevel, Liquichek Immunoassay Premium…Bio-Rad Laboratories · 2013 · cites it directly0descendants
  • K122838Liquickek Immunoassay Plus Control, Level 1 Model 267, Liquichek Immunoassay Plus…Bio-Rad Laboratories · 2012 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K001373Liquichek Immunoassay Plus Control, Model 360, 361, 362, 363Bio-Rad2000—
+1K132091Multichem IA and IA PlusTechno-Path Manufacturing, Ltd.2013—
+1K033366Liquichek Qualitative Urine Toxicology Control, Negative, Model 454; Positive…Bio-Rad2003—
+2K162530Multichem IA PlusTechno-Path Manufacturing2017—
+1K132227Liquichek Immunoassay Premium Control-Trilevel, Liquichek Immunoassay Premium…Bio-Rad Laboratories2013—
+1K122838Liquickek Immunoassay Plus Control, Level 1 Model 267, Liquichek Immunoassay…Bio-Rad Laboratories2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200510
201210
201320
201710
FIG. 1 — Lineage of K001373, 2000–2017Source: 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), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K132091Multichem IA and IA PlusTechno-Path Manufacturing, Ltd.20131
K033366Liquichek Qualitative Urine Toxicology Control, Negative, Model 454; Positive, Model 455Bio-Rad20031
K132227Liquichek Immunoassay Premium Control-Trilevel, Liquichek Immunoassay Premium…Bio-Rad Laboratories20130
K122838Liquickek Immunoassay Plus Control, Level 1 Model 267, Liquichek Immunoassay Plus…Bio-Rad Laboratories20120
K052053Liquichek Qualitative Urine Toxicology Control, Negative, Positive, MinipakBio-Rad20050

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, K132091 (Techno-Path Manufacturing, Ltd., 2013) has gone furthest, with 1 descendant 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—

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The JJY category page

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https://510kreport.com/device/K001373 · printed Nov 5, 2026

Cite this page

510(k) Report. “K001373: Liquichek Immunoassay Plus Control, Model 360, 361, 362, 363.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K001373

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026