510(k) Report

510(k) · Cleared

Cleared

N/T Protein Control LC

K991704510(k) TraditionalCleared Jun 25, 199937-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

Dade Behring, Inc. · JJY Multi-Analyte Controls, All Kinds (Assayed)

Cleared on Jun 25, 1999 as substantially equivalent to K955858 (Behring Diagnostics, Inc., 1996) after a 37-day review. Its family tree reaches back 1 generation to 1996. 9 later devices descend from it.

Decided
Jun 25, 1999
Review
37 days
Class
Class I
Product code
JJY
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K955858 (1996). 9 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2006: 1 descendant cleared2003: 1 descendant cleared2008: 3 descendants cleared2007: 2 descendants cleared2009: 1 descendant cleared2023: 1 descendant clearedK955858 · N/T Protein Control SY/L, M and H · Behring Diagnostics, Inc. · 19961995200020052010201520202025
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 2 descendants3 generations forward: 1 descendant4 generations forward: 2 descendants5 generations forward: 2 descendants K955858 · N/T Protein Control SY/L, M and H · Behring Diagnostics, Inc. · 19960+5
  1. Root · 1 generation backK955858 N/T Protein Control SY/L, M and HBehring Diagnostics, Inc. · 1996
  2. This deviceK991704 N/T Protein Control LCDade Behring, Inc. · 1999
  3. Descendant · cites it directly · 6 of its ownK061990 Dimension Vista Microalbumin Flex Reagent Cartridge; Protein 3…Dade Behring, Inc. · 2006
  4. Descendant · 2 generations on · 5 of its ownK063508 Dimension Vista Protein 1 Calibrator and Control L, M, H; Protein 2…Dade Behring, Inc. · 2007
  5. Descendant · 3 generations on · 4 of its ownK072435 Dimension Vista Protein 3 Calibrator, 3 Control,1 Control L, 1…Dade Behring, Inc. · 2007
  6. Descendant · 4 generations on · 1 of its ownK083445 N Antisera to Human Immunoglobulins (Igg, Iga and Igm) and N/T…Siemens Healthcare Diagnostics · 2009 · Recalled
  7. Descendant · 4 generations on · 1 of its ownK073561 Dimension Vista System Immunoglobulin G Flex Reagent Cartridge…Dade Behring, Inc. · 2008

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2003: 12006: 12007: 22008: 32009: 12023: 1
2003high 3 (2008) · low 0 (2004)2026

Most influential descendants

Showing 5 of 9 · See all
  • K061990Dimension Vista Microalbumin Flex Reagent Cartridge; Protein 3 Calibrator; Protein 3…Dade Behring, Inc. · 2006 · cites it directly6descendants
  • K063508Dimension Vista Protein 1 Calibrator and Control L, M, H; Protein 2 Calibrator and…Dade Behring, Inc. · 2007 · 2 generations on5descendants
  • K072435Dimension Vista Protein 3 Calibrator, 3 Control,1 Control L, 1 Control M, 1 Control HDade Behring, Inc. · 2007 · 3 generations on4descendants
  • K083445N Antisera to Human Immunoglobulins (Igg, Iga and Igm) and N/T Protein Control LCSiemens Healthcare Diagnostics · 2009 · 4 generations on1descendant
  • K073561Dimension Vista System Immunoglobulin G Flex Reagent Cartridge, Dimension Vista System…Dade Behring, Inc. · 2008 · 4 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K955858N/T Protein Control SY/L, M and HBehring Diagnostics, Inc.1996—
0 (this device)K991704N/T Protein Control LCDade Behring, Inc.1999—
+1K061990Dimension Vista Microalbumin Flex Reagent Cartridge; Protein 3 Calibrator…Dade Behring, Inc.2006—
+2K063508Dimension Vista Protein 1 Calibrator and Control L, M, H; Protein 2 Calibrator…Dade Behring, Inc.2007—
+3K072435Dimension Vista Protein 3 Calibrator, 3 Control,1 Control L, 1 Control M, 1…Dade Behring, Inc.2007—
+4K083445N Antisera to Human Immunoglobulins (Igg, Iga and Igm) and N/T Protein Control…Siemens Healthcare Diagnostics20092
+4K073561Dimension Vista System Immunoglobulin G Flex Reagent Cartridge, Dimension…Dade Behring, Inc.2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200610
200720
200830
200910
202310
FIG. 1 — Lineage of K991704, 1996–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K955858N/T Protein Control SY/L, M and H
Summary page 1
…tein Control LC: Quality Control Material (assayed) Classification Number: Class | (862.1660) 3. Identification of the Legally Marketed Device: N/T Protein Control UY (K955858) 4. Device Description: N/T Protein Control LC is a lyophilized control prepared from human urine and serum proteins with polyge…
Behring Diagnostics, Inc.1996—

What descends from it? (9)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K061990Dimension Vista Microalbumin Flex Reagent Cartridge; Protein 3 Calibrator; Protein 3…Dade Behring, Inc.20066
K032237N/T Protein ControlDade Behring, Inc.20031

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, K061990 (Dade Behring, Inc., 2006) has gone furthest, with 6 descendants of its own.

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

2007: 112008: 72009: 82010: 102011: 142012: 132013: 162014: 102015: 42016: 12017: 3
2007high 16 (2013) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JJY

78in 2017

2007: 49 days median2008: 54 days median2009: 80 days median2010: 109 days median2011: 120 days median2012: 40 days median2013: 82 days median2014: 49 days median2015: 153 days median2017: 78 days median
2007high 153 (2015) · low 40 (2012)2026

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

Recalls per year · JJY

2in 2025

2007: 52009: 22010: 62011: 12012: 32013: 22014: 22015: 12016: 32017: 42018: 32019: 42020: 62022: 32023: 32025: 22026 (partial year): 1
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

2007: 22008: 12009: 32010: 32011: 62012: 202013: 52014: 42015: 42016: 132017: 122018: 72019: 12020: 72021: 12023: 42024: 12025: 13
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007114952
200875401
200988023
20101010963
20111412016
20121340320
2013168225
2014104924
2015415314
20161—313
2017378412
20180—37
20190—41
20200—67
20210—01
20220—30
20230—34
20240—01
20250—213
20260—1—

What is it indicated for?

N/T Protein Control LC is intended for use as an assayed accuracy control for immunonephelometric determination of the proteins a4-microglobulin in urine, IgA in CSF, 1gG in CSF, transferrin in urine, albumin in urine and CSF, and total protein in urine and CSF using the Behring Nephelometer Systems and also for IgG in CSF and albumin in urine and CSF, using the TurbiTimeSystem.

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

More from Dade Behring, Inc.

347 FDA decisions under this applicant name. See the company

  • K093848PT-Multi-Calibrator, Model OPAT07Dade Behring, Inc. · 2010
  • K081161Dimension Vista System Igg Flex Reagent Cartridge, Dimension Vista System Protein 1 Calibrator, and…Dade Behring, Inc. · 2008
  • K081249Dimension Vista System A2MAC Flex Reagent Cartridge, Dimension Vista System Protein 1 Calibrator, Dimension…Dade Behring, Inc. · 2008
  • K071603Dimension Vista Carcinoembryonic Antigen Flex Reagent Cartridge (Cea)Dade Behring, Inc. · 2008
  • K071597Dimension Vista (R) Afp Flex (R) Reagent Cartridge, Model K6454, Dimension Vista (R) Loci 5 Calibrator…Dade Behring, Inc. · 2008

Recent decisions in JJY

The JJY category page

  • K162530Multichem IA PlusTechno-Path Manufacturing · 2017
  • K163629Audit MicroControls Linearity FD Tumor Markers IIAalto Scientific, Ltd. · 2017
  • K163015Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker…Bio-Rad Laboratories · 2017
  • K153712VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea…Radiometer America, Inc. · 2016
  • K150300Liquichek Cardiac Markers Plus Control LTBio-Rad Laboratories · 2015

https://510kreport.com/device/K991704 · printed Nov 6, 2026

Cite this page

510(k) Report. “K991704: N/T Protein Control LC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991704

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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