510(k) · Cleared

Cleared

Precinorm Universal and Precipath Universal Control Sera

K992900510(k) TraditionalCleared Nov 24, 199986-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 Nov 24, 1999 as substantially equivalent to K811832 (Boehringer Mannheim Corp., 1981) after an 86-day review. Its family tree reaches back 1 generation to 1981. 18 later devices descend from it.

Decided: Nov 24, 1999
Review: 86 days
Class: Class I
Product code: JJY
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K811832 (1981). 18 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK811832 Precinorm U & Precipath U Human SerumBoehringer Mannheim Corp. · 1981
This deviceK992900 Precinorm Universal and Precipath Universal Control SeraRoche Diagnostics Corp. · 1999
Descendant · cites it directly · 17 of its ownK041227 Modification to:Roche Diagnostics Precinorm Universal and Precipath…Roche Diagnostics Corp. · 2004
Descendant · 2 generations on · 1 of its ownK122083 Elitech Clinical Systems CK Nac SLElitechgroup · 2012
Descendant · 2 generations on · 0 of its ownK153644 ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems…Elitechgroup · 2016
Descendant · 2 generations on · 0 of its ownK151552 ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL…Elitechgroup · 2015
Descendant · 3 generations on · 0 of its ownK141265 Elitech Clinical Systems Envoy 500 CK Reagent KitElitechgroup · 2014

Showing 5 of 18 descendants. See all descendants

Descendants cleared per year

2004high 8 (2011) · low 0 (2005)2026

Most influential descendants

Showing 5 of 18 · See all

K041227Modification to:Roche Diagnostics Precinorm Universal and Precipath Universal Control SeraRoche Diagnostics Corp. · 2004 · cites it directly17descendants
K122083Elitech Clinical Systems CK Nac SLElitechgroup · 2012 · 2 generations on1descendant
K153644ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech…Elitechgroup · 2016 · 2 generations on0descendants
K151552ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical…Elitechgroup · 2015 · 2 generations on0descendants
K141265Elitech Clinical Systems Envoy 500 CK Reagent KitElitechgroup · 2014 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K811832	Precinorm U & Precipath U Human Serum	Boehringer Mannheim Corp.	1981	—
0 (this device)	K992900	Precinorm Universal and Precipath Universal Control Sera	Roche Diagnostics Corp.	1999	—
+1	K041227	Modification to:Roche Diagnostics Precinorm Universal and Precipath Universal…	Roche Diagnostics Corp.	2004	—
+2	K122083	Elitech Clinical Systems CK Nac SL	Elitechgroup	2012	—
+2	K153644	ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2…	Elitechgroup	2016	—
+2	K151552	ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech…	Elitechgroup	2015	—
+3	K141265	Elitech Clinical Systems Envoy 500 CK Reagent Kit	Elitechgroup	2014	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2010	2	0
2011	8	0
2012	2	0
2013	1	0
2014	2	0
2015	1	0
2016	1	0

FIG. 1 — Lineage of K992900, 1981–2016Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K811832	Precinorm U & Precipath U Human Serum Summary page 1 …ices legally marketed in the United States. We claim equivalence to the currently marketed Roche Diagnostics Precinorm® Universal and Precipath® Universal Contrail Sera (K811832) Roche Diagnostics Precinorm® Universal and Precipath® Universal Control Sera is a two level quality control product prepared fr…	Boehringer Mannheim Corp.	1981	—

Also cleared against K811832: 1 other device →

What descends from it? (18)

See all 18

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

Number	Device	Applicant	Decided	Descendants
K041227	Modification to:Roche Diagnostics Precinorm Universal and Precipath Universal Control Sera	Roche Diagnostics Corp.	2004	17

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?

Its one ancestor has no recall.
Of its descendants, K041227 (Roche Diagnostics Corp., 2004) has gone furthest, with 17 descendants of its own.
1 other device also cites its predicate K811832.

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

2007high 16 (2013) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JJY

78in 2017

2007high 153 (2015) · low 40 (2012)2026

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

Recalls per year · JJY

2in 2025

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	11	49	5	2
2008	7	54	0	1
2009	8	80	2	3
2010	10	109	6	3
2011	14	120	1	6
2012	13	40	3	20
2013	16	82	2	5
2014	10	49	2	4
2015	4	153	1	4
2016	1	—	3	13
2017	3	78	4	12
2018	0	—	3	7
2019	0	—	4	1
2020	0	—	6	7
2021	0	—	0	1
2022	0	—	3	0
2023	0	—	3	4
2024	0	—	0	1
2025	0	—	2	13
2026	0	—	1	—

What is it indicated for?

For quality control in the quantitative determination of substrates, electrolytes, lipids, enzymes, proteins, and drugs. The control is used for monitoring accuracy or precision both for manual techniques and assays from Roche on automated clinical chemistry analyzers.

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

https://510kreport.com/device/K992900 · printed Nov 4, 2026

Cite this page

510(k) Report. “K992900: Precinorm Universal and Precipath Universal Control Sera.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992900

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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