510(k) · Cleared
ClearedModification to Precinorm Universal Plus and Precipath Universal Plus Control Sera
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · JJY Multi-Analyte Controls, All Kinds (Assayed)
Cleared on Sep 14, 2004 as substantially equivalent to K993360 (Roche Diagnostics Corp., 1999) after a 12-day review. Its family tree reaches back 2 generations to 1981. 3 later devices descend from it.
- Decided
- Sep 14, 2004
- Review
- 12 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K811832 (1981). 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK811832 Precinorm U & Precipath U Human SerumBoehringer Mannheim Corp. · 1981
- 1 generation backK993360 Precinorm Universal Plus and Precipath Universal Plus Control SeraRoche Diagnostics Corp. · 1999
- This deviceK042389 Modification to Precinorm Universal Plus and Precipath Universal…Roche Diagnostics Corp. · 2004
- Descendant · cites it directly · 1 of its ownK102016 Precicontrol Clinchem Multi 1 and 2Roche Diagnostics · 2010
- Descendant · 2 generations on · 0 of its ownK133330 C.F.a.S. Proteins, C.F.a.S. Pac, Precicontrol Clinchem Multi 1 & 2…Roche Diagnostics · 2013
- Descendant · cites it directly · 0 of its ownK080485 Aspartate Amino Transferase (Ast/Sgot) Test System, Asat (Got) FSDiasys Diagnostics Systems GmbH · 2008
Most influential descendants
Showing 3 of 3 · See all- K102016Precicontrol Clinchem Multi 1 and 2Roche Diagnostics · 2010 · cites it directly1descendant
- K133330C.F.a.S. Proteins, C.F.a.S. Pac, Precicontrol Clinchem Multi 1 & 2, Precinorm Protein &…Roche Diagnostics · 2013 · 2 generations on0descendants
- K080485Aspartate Amino Transferase (Ast/Sgot) Test System, Asat (Got) FSDiasys Diagnostics Systems GmbH · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K811832 | Precinorm U & Precipath U Human Serum | Boehringer Mannheim Corp. | 1981 | — |
| −1 | K993360 | Precinorm Universal Plus and Precipath Universal Plus Control Sera | Roche Diagnostics Corp. | 1999 | — |
| 0 (this device) | K042389 | Modification to Precinorm Universal Plus and Precipath Universal Plus Control… | Roche Diagnostics Corp. | 2004 | — |
| +1 | K102016 | Precicontrol Clinchem Multi 1 and 2 | Roche Diagnostics | 2010 | — |
| +2 | K133330 | C.F.a.S. Proteins, C.F.a.S. Pac, Precicontrol Clinchem Multi 1 & 2, Precinorm… | Roche Diagnostics | 2013 | — |
| +1 | K080485 | Aspartate Amino Transferase (Ast/Sgot) Test System, Asat (Got) FS | Diasys Diagnostics Systems GmbH | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K993360 | Precinorm Universal Plus and Precipath Universal Plus Control SeraSummary page 2…a ,Continued Substantial Roche claims substantial equivalence to the currently marketed Roche Equivalence Diagnostics Precinomi® U Plus/ Precipath ® U Plus (K993360). Submitter Roche Diagnostics name, address, 9115 Hague Road contact Indianapolis, IN 46250… | 1999 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K102016 (Roche Diagnostics, 2010) has gone furthest, with 1 descendant of its own.
How does its category compare?
All JJY devicesJJY 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
2026 to Oct 25, outlined.
Median 510(k) review, days · JJY
78in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JJY
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJY
13in 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?
Precinorm ®U Plus is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet.
Precipath ® U Plus 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.
https://510kreport.com/device/K042389 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042389: Modification to Precinorm Universal Plus and Precipath Universal Plus 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/K042389
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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