510(k) · Cleared
ClearedN/T Protein Control
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Behring, Inc. · JJY Multi-Analyte Controls, All Kinds (Assayed)
Cleared on Sep 5, 2003 as substantially equivalent to K991704 (Dade Behring, Inc., 1999) after a 46-day review. Its family tree reaches back 2 generations to 1996. 1 later device descends from it.
- Decided
- Sep 5, 2003
- Review
- 46 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K955858 (1996). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK955858 N/T Protein Control SY/L, M and HBehring Diagnostics, Inc. · 1996
- 1 generation backK991704 N/T Protein Control LCDade Behring, Inc. · 1999
- This deviceK032237 N/T Protein ControlDade Behring, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK081299 Dimension Vista System TRF Flex Reagent Cartridge, Dimension Vista…Siemens Healthcare Diagnostics, Inc. · 2008
Most influential descendants
Showing 1 of 1 · See all- K081299Dimension Vista System TRF Flex Reagent Cartridge, Dimension Vista System Protein 1…Siemens Healthcare Diagnostics, Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K955858 | N/T Protein Control SY/L, M and H | Behring Diagnostics, Inc. | 1996 | — |
| −1 | K991704 | N/T Protein Control LC | Dade Behring, Inc. | 1999 | — |
| 0 (this device) | K032237 | N/T Protein Control | Dade Behring, Inc. | 2003 | — |
| +1 | K081299 | Dimension Vista System TRF Flex Reagent Cartridge, Dimension Vista System… | Siemens Healthcare Diagnostics, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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 |
|---|---|---|---|
| * | K991704 | N/T Protein Control LCSummary page 1…ssayed) Classification Number: Class I(862.1660) 3. Identification of the Legally Marketed Device: N/T Protein Control LC (K991704) 4. Device Description: N i l Protein Control LC is a lyophilized control prepared from human urine and serum… | 1999 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081299 | Dimension Vista System TRF Flex Reagent Cartridge, Dimension Vista System Protein 1… | 2008 | 0 |
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 7 years and passes through 2 companies; a new generation was cleared every 4.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K081299 (Siemens Healthcare Diagnostics, Inc., 2008) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K991704.
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?
N/T Protein Control LC is intended for use as an assayed accuracy and precision
control for immunochemical determination of IgA, IgG and IgM in CSF, transferrin and
a,-microglobulin in urine, albumin and total protein in urine and CSF using the BNTM
Systems and also for IgG in CSF and albumin in urine and CSF, using the TurbiTime
System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032237 · printed Nov 5, 2026
Cite this page
510(k) Report. “K032237: N/T Protein Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K032237
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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