510(k) Report

510(k) · Cleared

Recalled · Class II · 2017

Modification to N Protein Standard SL

K012470510(k) TraditionalCleared Sep 28, 200157-day reviewClass II21 CFR 862.1150Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Dade Behring, Inc. · JIX Calibrator, Multi-Analyte Mixture

Cleared on Sep 28, 2001 as substantially equivalent to K002804 (Dade Behring, Inc., 2000) after a 57-day review. Its family tree reaches back 1 generation to 2000. 28 later devices descend from it. It has been recalled once.

Decided
Sep 28, 2001
Review
57 days
Class
Class II
Product code
JIX
Recalls
1
Predicates
1

Its longest line of descent runs back 1 generation to K002804 (2000). 28 later devices descend from it, 16 citing it directly.

Descendants, by year cleared 2007: 10 descendants cleared2008: 5 descendants cleared2005: 1 descendant cleared2006: 7 descendants cleared2004: 1 descendant cleared2015: 2 descendants cleared2009: 1 descendant cleared2023: 1 descendant clearedK002804 · N Protein Standard SL · Dade Behring, Inc. · 2000200020052010201520202025
Descendants, by generation 1 generation forward: 16 descendants2 generations forward: 8 descendants3 generations forward: 3 descendants4 generations forward: 1 descendant K002804 · N Protein Standard SL · Dade Behring, Inc. · 20000
  1. Root · 1 generation backK002804 N Protein Standard SLDade Behring, Inc. · 2000
  2. This deviceK012470 Modification to N Protein Standard SLDade Behring, Inc. · 2001
  3. Descendant · cites it directly · 7 of its ownK061338 Dimension Vista Iga Flex Reagent Cartridge AssayDade Behring, Inc. · 2006
  4. Descendant · cites it directly · 6 of its ownK063663 Dimension Vista STFR Flex Reagent Cartridge and Protein 1 Calibrator…Dade Behring, Inc. · 2007
  5. Descendant · cites it directly · 6 of its ownK061990 Dimension Vista Microalbumin Flex Reagent Cartridge; Protein 3…Dade Behring, Inc. · 2006
  6. Descendant · 2 generations on · 6 of its ownK062055 Dimension Vista Protein 1 Calibrator, Control Low, Control Medium…Dade Behring, Inc. · 2006
  7. Descendant · 2 generations on · 5 of its ownK063508 Dimension Vista Protein 1 Calibrator and Control L, M, H; Protein 2…Dade Behring, Inc. · 2007

Showing 5 of 28 descendants. See all descendants

Descendants cleared per year

2004: 12005: 12006: 72007: 102008: 52009: 12015: 22023: 1
2004high 10 (2007) · low 0 (2010)2026

Most influential descendants

Showing 5 of 28 · See all
  • K061338Dimension Vista Iga Flex Reagent Cartridge AssayDade Behring, Inc. · 2006 · cites it directly7descendants
  • K063663Dimension Vista STFR Flex Reagent Cartridge and Protein 1 Calibrator and Control L, M…Dade Behring, Inc. · 2007 · cites it directly6descendants
  • K061990Dimension Vista Microalbumin Flex Reagent Cartridge; Protein 3 Calibrator; Protein 3…Dade Behring, Inc. · 2006 · cites it directly6descendants
  • K062055Dimension Vista Protein 1 Calibrator, Control Low, Control Medium, Control HighDade Behring, Inc. · 2006 · 2 generations on6descendants
  • K063508Dimension Vista Protein 1 Calibrator and Control L, M, H; Protein 2 Calibrator and…Dade Behring, Inc. · 2007 · 2 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K002804N Protein Standard SLDade Behring, Inc.2000—
0 (this device)K012470Modification to N Protein Standard SLDade Behring, Inc.2001—
+1K061338Dimension Vista Iga Flex Reagent Cartridge AssayDade Behring, Inc.2006—
+1K063663Dimension Vista STFR Flex Reagent Cartridge and Protein 1 Calibrator and…Dade Behring, Inc.2007—
+1K061990Dimension Vista Microalbumin Flex Reagent Cartridge; Protein 3 Calibrator…Dade Behring, Inc.2006—
+2K062055Dimension Vista Protein 1 Calibrator, Control Low, Control Medium, Control HighDade Behring, Inc.2006—
+2K063508Dimension Vista Protein 1 Calibrator and Control L, M, H; Protein 2 Calibrator…Dade Behring, Inc.2007—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200510
200670
2007100
200850
200910
201520
202310
FIG. 1 — Lineage of K012470, 2000–2023Source: 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 JIX? 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
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K002804N Protein Standard SL
Summary page 1
…n: N Protein Standard SL: Calibrator, Multi-Analyte Classification Number: Class Il (862.1150) 3. Identification of the Legally Marketed Device: N Protein Standard SL (K002804) 4, Device Description: N Protein Standard SL is a liquid standard prepared from human serum with stabilizers and preservative.…
Dade Behring, Inc.2000—

What descends from it? (28)

See all 28

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

NumberDeviceApplicantDecidedDescendants
K061338Dimension Vista Iga Flex Reagent Cartridge AssayDade Behring, Inc.20067
K063663Dimension Vista STFR Flex Reagent Cartridge and Protein 1 Calibrator and Control L, M…Dade Behring, Inc.20076
K061990Dimension Vista Microalbumin Flex Reagent Cartridge; Protein 3 Calibrator; Protein 3…Dade Behring, Inc.20066
K051087Dimension Vista Integrated SystemDade Behring, Inc.20055
K063206Dimension Vista Hcys Flex Reagent Cartridge; Protein 1 Calibrator; Protein 1 Control…Dade Behring, Inc.20061
K082503Dimension Vista LG Light Chains, Type Kappa, Dimension Vista LG Light Chains, Type…Siemens Healthcare Diagnostics20080
K081299Dimension Vista System TRF Flex Reagent Cartridge, Dimension Vista System Protein 1…Siemens Healthcare Diagnostics, Inc.20080
K081249Dimension Vista System A2MAC Flex Reagent Cartridge, Dimension Vista System Protein 1…Dade Behring, Inc.20080
K063655Dimension Vista; Cer Flex Reagent Cartridge, Protein 1 Calibrator, Protein 1 Control…Dade Behring, Inc.20070
K063425Dimension Vista Ige Flex Reagent Cartridge, Protein 1 Calibrator, Protein 1 Control…Dade Behring, Inc.20070

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jun 5, 2017Class IIZ-0190-2018Nonconforming Material/ComponentSiemens Healthcare Diagnostics has confirmed a negative bias of approximately -20% for results obtained with N Antiserum to Human Ceruloplasmin when calibrating Ceruloplasmin with various lots of N Protein Standard SL. N/T Protein…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.
  • Of its descendants, K061338 (Dade Behring, Inc., 2006) has gone furthest, with 7 descendants of its own.

How does its category compare?

All JIX devices

JIX Calibrator, Multi-Analyte Mixture: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JIX

1in 2016

2007: 62008: 52009: 42010: 52011: 72012: 22013: 42014: 12015: 32016: 1
2007high 7 (2011) · low 0 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JIX

29in 2015

2007: 53 days median2008: 69 days median2009: 121 days median2010: 100 days median2011: 77 days median2013: 50 days median2015: 29 days median
2007high 121 (2009) · low 29 (2015)2026

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

Recalls per year · JIX

7in 2023

2007: 22008: 32009: 22010: 12011: 22012: 12014: 12016: 12017: 12018: 12019: 12020: 22023: 72026 (partial year): 1
2007high 7 (2023) · low 0 (2013)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JIX

18in 2025

2007: 1402008: 1732009: 392011: 92012: 32013: 242014: 352015: 42016: 62017: 172018: 162019: 122020: 222021: 92022: 112023: 132024: 152025: 18
2007high 173 (2008) · low 0 (2010)2025

MAUDE reports naming product code JIX, 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
20076532140
20085693173
20094121239
2010510010
201177729
20122—13
2013450024
20141—135
201532904
20161—16
20170—117
20180—116
20190—112
20200—222
20210—09
20220—011
20230—713
20240—015
20250—018
20260—1—

What is it indicated for?

Establishment of reference curves for the determination of IgG, 1gG14, IgA, IgM, IgE,

C3c, C4, Transferrin, Albumin, a4-antitrypsin, az-macroglobulin, Haptoglobin, o4-acid

glycoprotein, Prealbumin, Hemopexin, Ceruloplasmin, RbP, Ig/L-chain lambda &

kappa, soluble Transferrin Receptor (sTfR), Ferritin, Bz-microglobulin, and Total protein

by immunonephelometry with BN™ Systems.

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 JIX

The JIX category page

  • K161140VITROS Chemistry Products Calibrator Kit 3Ortho-Clinical Diagnostics, Inc. · 2016
  • K153365ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 CalibratorSiemens Healthcare Diagnostics, Inc. · 2015
  • K151552ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical Systems ELITROL IIElitechgroup · 2015
  • K140790Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG)Siemens Healthcare Diagnostics · 20152 recalls
  • K141388System CalibraterBeckman Coulter Ireland, Inc. · 2014

https://510kreport.com/device/K012470 · printed Nov 5, 2026

Cite this page

510(k) Report. “K012470: Modification to N Protein Standard SL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K012470

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026