510(k) Report

510(k) · Cleared

Cleared

Modification to:Roche Diagnostics Precinorm Universal and Precipath Universal Control Sera

K041227510(k) SpecialCleared May 27, 200417-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

Roche Diagnostics Corp. · JJY Multi-Analyte Controls, All Kinds (Assayed)

Cleared on May 27, 2004 as substantially equivalent to K992900 (Roche Diagnostics Corp., 1999) after a 17-day review. Its family tree reaches back 2 generations to 1981. 17 later devices descend from it.

Decided
May 27, 2004
Review
17 days
Class
Class I
Product code
JJY
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K811832 (1981). 17 later devices descend from it, 16 citing it directly.

Descendants, by year cleared 2016: 1 descendant cleared2012: 2 descendants cleared2010: 2 descendants cleared2015: 1 descendant cleared2011: 8 descendants cleared2014: 2 descendants cleared2013: 1 descendant clearedK811832 · Precinorm U & Precipath U Human Serum · Boehringer Mannheim Corp. · 1981K992900 · Precinorm Universal and Precipath Universal Control Sera · Roche Diagnostics Corp. · 199919801990200020102020
Descendants, by generation 1 generation forward: 16 descendants2 generations forward: 1 descendant K992900 · Precinorm Universal and Precipath Universal Control Sera · Roche Diagnostics Corp. · 1999K811832 · Precinorm U & Precipath U Human Serum · Boehringer Mannheim Corp. · 19810
  1. Root · 2 generations backK811832 Precinorm U & Precipath U Human SerumBoehringer Mannheim Corp. · 1981
  2. 1 generation backK992900 Precinorm Universal and Precipath Universal Control SeraRoche Diagnostics Corp. · 1999
  3. This deviceK041227 Modification to:Roche Diagnostics Precinorm Universal and Precipath…Roche Diagnostics Corp. · 2004
  4. Descendant · cites it directly · 1 of its ownK122083 Elitech Clinical Systems CK Nac SLElitechgroup · 2012
  5. Descendant · cites it directly · 0 of its ownK153644 ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems…Elitechgroup · 2016
  6. Descendant · cites it directly · 0 of its ownK151552 ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL…Elitechgroup · 2015
  7. Descendant · 2 generations on · 0 of its ownK141265 Elitech Clinical Systems Envoy 500 CK Reagent KitElitechgroup · 2014
  8. Descendant · cites it directly · 0 of its ownK132399 Elitech Clinical Systems Creatinine Pap SL, Elical 2, Elitrol I and…Elitechgroup · 2014

Showing 5 of 17 descendants. See all descendants

Descendants cleared per year

2010: 22011: 82012: 22013: 12014: 22015: 12016: 1
2010high 8 (2011) · low 0 (2017)2026

Most influential descendants

Showing 5 of 17 · See all
  • K122083Elitech Clinical Systems CK Nac SLElitechgroup · 2012 · cites it directly1descendant
  • K153644ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech…Elitechgroup · 2016 · cites it directly0descendants
  • K151552ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical…Elitechgroup · 2015 · cites it directly0descendants
  • K141265Elitech Clinical Systems Envoy 500 CK Reagent KitElitechgroup · 2014 · 2 generations on0descendants
  • K132399Elitech Clinical Systems Creatinine Pap SL, Elical 2, Elitrol I and Elitrol II, Urine…Elitechgroup · 2014 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K811832Precinorm U & Precipath U Human SerumBoehringer Mannheim Corp.1981—
−1K992900Precinorm Universal and Precipath Universal Control SeraRoche Diagnostics Corp.1999—
0 (this device)K041227Modification to:Roche Diagnostics Precinorm Universal and Precipath Universal…Roche Diagnostics Corp.2004—
+1K122083Elitech Clinical Systems CK Nac SLElitechgroup2012—
+1K153644ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2…Elitechgroup2016—
+1K151552ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech…Elitechgroup2015—
+2K141265Elitech Clinical Systems Envoy 500 CK Reagent KitElitechgroup2014—
+1K132399Elitech Clinical Systems Creatinine Pap SL, Elical 2, Elitrol I and Elitrol…Elitechgroup2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201020
201180
201220
201310
201420
201510
201610
FIG. 1 — Lineage of K041227, 1981–2016Source: 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
*K992900Precinorm Universal and Precipath Universal Control Sera
Summary page 2
…claims substantial equivalence to the currently marketed Roche Equivalence Diagnostics Precinorm ® Universal and Precipath ® Universal Control Sera (K992900). Substantial The table below compares Precinorm U/ Precipath U with the predicate Equivalence - device (currently market…
Roche Diagnostics Corp.1999—

What descends from it? (17)

See all 17

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

NumberDeviceApplicantDecidedDescendants
K122083Elitech Clinical Systems CK Nac SLElitechgroup20121
K153644ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech…Elitechgroup20160
K151552ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical…Elitechgroup20150
K132399Elitech Clinical Systems Creatinine Pap SL, Elical 2, Elitrol I and Elitrol II, Urine…Elitechgroup20140
K130765Elitech Clinical Systems Elical 2; Elitech Clinical Systems Elitrol I, Elitech Clinical…Elitechgroup20130
K122858Eltech Chinical System Amylase SL Elitech Clinical Systems ELICAL2 Eltech Clinical…Elitechgroup20120
K103376Elitech Clinical Systems Creatinne Pap SL Model CRSL-0250, Clitech Clinical Systems…Seppim S.A.S.20110
K110780Elitech Clinical Systems Bilirubin Total 4+1, Elitech Clinical Systems Elical 2, Elitech…Elitechgroup20110
K103747Elitech Clincal Systems Cholesterol HDL SL 2G, HDL 2G Calibrator, LDL SL 2G, LDL 2G…Elitechgroup Seppim S.A.S.20110
K112029Elitech Clinical Systems Elical 2, Elitech Clinical Systems Elitrol I, Elitech Clinical…Elitechgroup20110

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 23 years and passes through 2 companies; a new generation was cleared every 18.4 years on median.
  • None of the 2 ancestors has a recall.
  • Of its descendants, K122083 (Elitechgroup, 2012) 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—

What is it indicated for?

Precinorm U is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet. Precipath U is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet.

Indications for use as stated in the FDA summary.

More from Roche Diagnostics Corp.

621 FDA decisions under this applicant name. See the company

  • P990056/S046Elecsys Total Psa Immunoassay and Total Psa CalsetRoche Diagnostics Corp. · 2026
  • P000027/S045Elecsys Free Psa Immunoassay/Calset/CalcheckRoche Diagnostics Corp. · 2026
  • P000027/S044Elecsys free PSA assayRoche Diagnostics Corp. · 2026
  • P990056/S045Elecsys total PSA assayRoche Diagnostics Corp. · 2026
  • P990056/S044Elecsys Total Psa Immunoassay and Total Psa CalsetRoche Diagnostics Corp. · 2025

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/K041227 · printed Nov 6, 2026

Cite this page

510(k) Report. “K041227: Modification to:Roche Diagnostics Precinorm Universal and Precipath Universal Control Sera.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041227

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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