510(k) · Cleared
ClearedPrecinorm U & Precipath U Human Serum
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boehringer Mannheim Corp. · JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Cleared on Jul 15, 1981 after a 16-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 24 later devices descend from it.
- Decided
- Jul 15, 1981
- Review
- 16 days
- Class
- Class I
- Product code
- JJX
- Recalls
- None
- Predicates
- 0
24 later devices descend from it, 2 citing it directly.
- This deviceK811832 Precinorm U & Precipath U Human SerumBoehringer Mannheim Corp. · 1981
- Descendant · cites it directly · 18 of its ownK992900 Precinorm Universal and Precipath Universal Control SeraRoche Diagnostics Corp. · 1999
- Descendant · 2 generations on · 17 of its ownK041227 Modification to:Roche Diagnostics Precinorm Universal and Precipath…Roche Diagnostics Corp. · 2004
- Descendant · cites it directly · 4 of its ownK993360 Precinorm Universal Plus and Precipath Universal Plus Control SeraRoche Diagnostics Corp. · 1999
- Descendant · 2 generations on · 3 of its ownK042389 Modification to Precinorm Universal Plus and Precipath Universal…Roche Diagnostics Corp. · 2004
- Descendant · 3 generations on · 1 of its ownK122083 Elitech Clinical Systems CK Nac SLElitechgroup · 2012
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K992900Precinorm Universal and Precipath Universal Control SeraRoche Diagnostics Corp. · 1999 · cites it directly18descendants
- K041227Modification to:Roche Diagnostics Precinorm Universal and Precipath Universal Control SeraRoche Diagnostics Corp. · 2004 · 2 generations on17descendants
- K993360Precinorm Universal Plus and Precipath Universal Plus Control SeraRoche Diagnostics Corp. · 1999 · cites it directly4descendants
- K042389Modification to Precinorm Universal Plus and Precipath Universal Plus Control SeraRoche Diagnostics Corp. · 2004 · 2 generations on3descendants
- K122083Elitech Clinical Systems CK Nac SLElitechgroup · 2012 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K811832 | Precinorm U & Precipath U Human Serum | Boehringer Mannheim Corp. | 1981 | — |
| +1 | K992900 | Precinorm Universal and Precipath Universal Control Sera | Roche Diagnostics Corp. | 1999 | — |
| +2 | K041227 | Modification to:Roche Diagnostics Precinorm Universal and Precipath Universal… | Roche Diagnostics Corp. | 2004 | — |
| +1 | K993360 | Precinorm Universal Plus and Precipath Universal Plus Control Sera | Roche Diagnostics Corp. | 1999 | — |
| +2 | K042389 | Modification to Precinorm Universal Plus and Precipath Universal Plus Control… | Roche Diagnostics Corp. | 2004 | — |
| +3 | K122083 | Elitech Clinical Systems CK Nac SL | Elitechgroup | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2004 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 8 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
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 JJX? 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (24)
See all 242 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?
- Of its descendants, K992900 (Roche Diagnostics Corp., 1999) has gone furthest, with 18 descendants of its own.
How does its category compare?
All JJX devicesJJX Single (Specified) Analyte Controls (Assayed And Unassayed): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JJX
2in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JJX
31in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JJX
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJX
22in 2025
MAUDE reports naming product code JJX, 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 | 6 | 53 | 3 | 2 |
| 2008 | 8 | 52 | 3 | 0 |
| 2009 | 17 | 80 | 0 | 1 |
| 2010 | 24 | 80 | 3 | 6 |
| 2011 | 19 | 62 | 2 | 62 |
| 2012 | 15 | 40 | 0 | 32 |
| 2013 | 19 | 37 | 0 | 51 |
| 2014 | 22 | 30 | 1 | 48 |
| 2015 | 11 | 65 | 1 | 67 |
| 2016 | 6 | 31 | 2 | 37 |
| 2017 | 2 | — | 0 | 19 |
| 2018 | 0 | — | 2 | 35 |
| 2019 | 0 | — | 0 | 82 |
| 2020 | 0 | — | 0 | 77 |
| 2021 | 0 | — | 1 | 43 |
| 2022 | 0 | — | 0 | 24 |
| 2023 | 0 | — | 0 | 22 |
| 2024 | 0 | — | 0 | 30 |
| 2025 | 0 | — | 0 | 22 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K811832 · printed Nov 6, 2026
Cite this page
510(k) Report. “K811832: Precinorm U & Precipath U Human Serum.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K811832
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026