510(k) · Cleared
ClearedBoehringer Mannheim Precinorm Precipath Protein Controls
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boehringer Mannheim Corp. · JJY Multi-Analyte Controls, All Kinds (Assayed)
Cleared on May 18, 1998 as substantially equivalent to K871027 (Boehringer Mannheim Corp., 1987) and 1 other predicate after a 31-day review. Its family tree reaches back 1 generation to 1987. 7 later devices descend from it.
- Decided
- May 18, 1998
- Review
- 31 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K871027 (1987). 2 ancestors in all. 7 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK871027 Precinorm (R) ProteinBoehringer Mannheim Corp. · 1987
- This deviceK981401 Boehringer Mannheim Precinorm Precipath Protein ControlsBoehringer Mannheim Corp. · 1998
- Descendant · cites it directly · 5 of its ownK040280 Precinorm Proteins in Urine/CSF Precipath Proteins in Urine/CSR…Roche Diagnostics Corp. · 2004
- Descendant · 2 generations on · 2 of its ownK041812 Modification to Roche Diagnostics Precinorm Proteins in Urine/CSF…Roche Diagnostics Corp. · 2004
- Descendant · 3 generations on · 1 of its ownK050026 Precinorm Proteins in Urine/CSF (Puc) and Precipath PucRoche Diagnostics · 2005
- Descendant · cites it directly · 0 of its ownK133330 C.F.a.S. Proteins, C.F.a.S. Pac, Precicontrol Clinchem Multi 1 & 2…Roche Diagnostics · 2013
- Descendant · 2 generations on · 0 of its ownK132156 Randox CSF Controls Levels 2 and 3Randox Laboratories, Ltd. · 2013
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K040280Precinorm Proteins in Urine/CSF Precipath Proteins in Urine/CSR ControlsRoche Diagnostics Corp. · 2004 · cites it directly5descendants
- K041812Modification to Roche Diagnostics Precinorm Proteins in Urine/CSF (Puc) and Precipath…Roche Diagnostics Corp. · 2004 · 2 generations on2descendants
- K050026Precinorm Proteins in Urine/CSF (Puc) and Precipath PucRoche Diagnostics · 2005 · 3 generations on1descendant
- K133330C.F.a.S. Proteins, C.F.a.S. Pac, Precicontrol Clinchem Multi 1 & 2, Precinorm Protein &…Roche Diagnostics · 2013 · cites it directly0descendants
- K132156Randox CSF Controls Levels 2 and 3Randox Laboratories, Ltd. · 2013 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K871027 | Precinorm (R) Protein | Boehringer Mannheim Corp. | 1987 | — |
| 0 (this device) | K981401 | Boehringer Mannheim Precinorm Precipath Protein Controls | Boehringer Mannheim Corp. | 1998 | — |
| +1 | K040280 | Precinorm Proteins in Urine/CSF Precipath Proteins in Urine/CSR Controls | Roche Diagnostics Corp. | 2004 | — |
| +2 | K041812 | Modification to Roche Diagnostics Precinorm Proteins in Urine/CSF (Puc) and… | Roche Diagnostics Corp. | 2004 | — |
| +3 | K050026 | Precinorm Proteins in Urine/CSF (Puc) and Precipath Puc | Roche Diagnostics | 2005 | — |
| +1 | K133330 | C.F.a.S. Proteins, C.F.a.S. Pac, Precicontrol Clinchem Multi 1 & 2, Precinorm… | Roche Diagnostics | 2013 | — |
| +2 | K132156 | Randox CSF Controls Levels 2 and 3 | Randox Laboratories, Ltd. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2013 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | K871027 | Precinorm (R) ProteinSummary page 1…path ® Protein Controls Classification name: Multi-analyte Controls, All Kinds (assayed and unassayed) We claim substantial equivalence to Precinorm ® Protein control (K871027) and Precipath ® Protein (K933589) control Boehringer Mannheim Precinorm ® Protein Precipath ® Protein Controls are a two-level… | 1987 |
| * | K933589 | Boehringer Mannheim Tina-Quant Transferrin AssaySummary page 1…ation name: Multi-analyte Controls, All Kinds (assayed and unassayed) We claim substantial equivalence to Precinorm ® Protein control (K871027) and Precipath ® Protein (K933589) control Boehringer Mannheim Precinorm ® Protein Precipath ® Protein Controls are a two-level liquid preparation of pooled human… | 1993 |
What descends from it? (7)
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?
- None of the 2 ancestors has a recall.
- Of its descendants, K040280 (Roche Diagnostics Corp., 2004) has gone furthest, with 5 descendants 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?
For use as a control in the immunoturbidimetric assay of serum proteins. It is well suited for automated analytical procedures. The assigned values for each constituent are obtained on Boehringer Mannheim/Hitachi systems.
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/K981401 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981401: Boehringer Mannheim Precinorm Precipath Protein Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981401
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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