510(k) Report

510(k) · Cleared

Cleared

N Antisera to Human Immunoglobulins (Igg, Iga and Igm)

K042735510(k) TraditionalCleared Feb 15, 2005137-day reviewClass II21 CFR 866.5510

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

Dade Behring, Inc. · CFN Method, Nephelometric, Immunoglobulins (G, A, M)

Cleared on Feb 15, 2005 as substantially equivalent to K860894 (Behring Diagnostics, Inc., 1986) after a 137-day review. Its family tree reaches back 1 generation to 1986. 10 later devices descend from it.

Decided
Feb 15, 2005
Review
137 days
Class
Class II
Product code
CFN
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K860894 (1986). 10 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 2008: 2 descendants cleared2009: 2 descendants cleared2006: 3 descendants cleared2023: 1 descendant cleared2007: 2 descendants clearedK860894 · Behring Nephelometer System · Behring Diagnostics, Inc. · 19861990200020102020
Descendants, by generation 1 generation forward: 6 descendants2 generations forward: 2 descendants3 generations forward: 1 descendant4 generations forward: 1 descendant K860894 · Behring Nephelometer System · Behring Diagnostics, Inc. · 19860
  1. Root · 1 generation backK860894 Behring Nephelometer SystemBehring Diagnostics, Inc. · 1986
  2. This deviceK042735 N Antisera to Human Immunoglobulins (Igg, Iga and Igm)Dade Behring, Inc. · 2005
  3. Descendant · cites it directly · 7 of its ownK061338 Dimension Vista Iga Flex Reagent Cartridge AssayDade Behring, Inc. · 2006
  4. Descendant · 2 generations on · 6 of its ownK062055 Dimension Vista Protein 1 Calibrator, Control Low, Control Medium…Dade Behring, Inc. · 2006
  5. Descendant · 3 generations on · 5 of its ownK063508 Dimension Vista Protein 1 Calibrator and Control L, M, H; Protein 2…Dade Behring, Inc. · 2007
  6. Descendant · 4 generations on · 4 of its ownK072435 Dimension Vista Protein 3 Calibrator, 3 Control,1 Control L, 1…Dade Behring, Inc. · 2007
  7. Descendant · cites it directly · 1 of its ownK083445 N Antisera to Human Immunoglobulins (Igg, Iga and Igm) and N/T…Siemens Healthcare Diagnostics · 2009 · Recalled

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2006: 32007: 22008: 22009: 22023: 1
2006high 3 (2006) · low 0 (2010)2026

Most influential descendants

Showing 5 of 10 · See all
  • K061338Dimension Vista Iga Flex Reagent Cartridge AssayDade Behring, Inc. · 2006 · cites it directly7descendants
  • 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 · 3 generations on5descendants
  • K072435Dimension Vista Protein 3 Calibrator, 3 Control,1 Control L, 1 Control M, 1 Control HDade Behring, Inc. · 2007 · 4 generations on4descendants
  • K083445N Antisera to Human Immunoglobulins (Igg, Iga and Igm) and N/T Protein Control LCSiemens Healthcare Diagnostics · 2009 · cites it directly1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K860894Behring Nephelometer SystemBehring Diagnostics, Inc.1986—
0 (this device)K042735N Antisera to Human Immunoglobulins (Igg, Iga and Igm)Dade Behring, Inc.2005—
+1K061338Dimension Vista Iga Flex Reagent Cartridge AssayDade Behring, Inc.2006—
+2K062055Dimension Vista Protein 1 Calibrator, Control Low, Control Medium, Control HighDade Behring, Inc.2006—
+3K063508Dimension Vista Protein 1 Calibrator and Control L, M, H; Protein 2 Calibrator…Dade Behring, Inc.2007—
+4K072435Dimension Vista Protein 3 Calibrator, 3 Control,1 Control L, 1 Control M, 1…Dade Behring, Inc.2007—
+1K083445N Antisera to Human Immunoglobulins (Igg, Iga and Igm) and N/T Protein Control…Siemens Healthcare Diagnostics20092

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200630
200720
200820
200920
202310
FIG. 1 — Lineage of K042735, 1986–2023Source: 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 CFN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new CFN device

  1. #1 K233663 N Antisera to Human Immunoglobulins (IgG, IgA…score 8.3 · 7 generations · no Class I recall
  2. #2 Held for the reportin 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
*K860894Behring Nephelometer System
Summary page 1
…Product Code: CFN 3. Identification of the Legally Marketed Device: N Antisera to Human Immunoglobulins (IgG, IgA and IgM) - K860894 4. Device Description: Proteins contained in human body fluids form immune complexes in an immunochemnical…
Behring Diagnostics, Inc.1986—

Also cleared against K860894: 16 other devices →

What descends from it? (10)

6 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
K083445N Antisera to Human Immunoglobulins (Igg, Iga and Igm) and N/T Protein Control LCSiemens Healthcare Diagnostics20091
K073561Dimension Vista System Immunoglobulin G Flex Reagent Cartridge, Dimension Vista System…Dade Behring, Inc.20081
K090594Dimension Vista Immunoglobulin a Flex Reagent Cartridge (Iga), and Dimension Vista…Siemens Healthcare Diagnostics20090
K081161Dimension Vista System Igg Flex Reagent Cartridge, Dimension Vista System Protein 1…Dade Behring, Inc.20080
K061845Dimension Vista Igm Flex Reagent Cartridge and Protein 1 Calibrator and Control L, M and HDade Behring, Inc.20060

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, K061338 (Dade Behring, Inc., 2006) has gone furthest, with 7 descendants of its own.
  • 16 other devices also cite its predicate K860894.

How does its category compare?

All CFN devices

CFN Method, Nephelometric, Immunoglobulins (G, A, M): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CFN

2in 2023

2008: 72009: 42010: 22012: 12013: 42014: 22015: 12017: 12019: 62023: 2
2007high 7 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CFN

28in 2019

2008: 69 days median2009: 160 days median2013: 431 days median2019: 28 days median
2007high 431 (2013) · low 28 (2019)2026

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

Recalls per year · CFN

1in 2023

2014: 52018: 22022: 22023: 1
2007high 5 (2014) · low 0 (2007)2026

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

Adverse event reports per year · CFN

1in 2024

2010: 32012: 32016: 22017: 42018: 22019: 82022: 12024: 1
2007high 8 (2019) · low 0 (2007)2025

MAUDE reports naming product code CFN, 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
20070—00
200876900
2009416000
20102—03
20110—00
20121—03
2013443100
20142—50
20151—00
20160—02
20171—04
20180—22
201962808
20200—00
20210—00
20220—21
20232—10
20240—01
20250—00
20260—0—

What is it indicated for?

In vitro diagnostic reagents for the quantitative determination of immunoglobulins (IgG, IgA and IgM) in human serum, heparinized and EDTA plasma as well as IgG in human cerebrospinal fluid (CSF) using the BN™ Systems. Measurements of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

Indications for use as stated in the FDA summary.

Also cleared against K860894

16 other devices cite the same predicate.

  • K082503Dimension Vista LG Light Chains, Type Kappa, Dimension Vista LG Light Chains, Type Lambda, Dimension Vista…Siemens Healthcare Diagnostics · 20081 recall
  • K063608Dimension Vista APOA1 and Apob Flex Reagent Cartridges and Protein 1 Calibrator and Control Medium and HighDade Behring, Inc. · 2007
  • K061990Dimension Vista Microalbumin Flex Reagent Cartridge; Protein 3 Calibrator; Protein 3 ControlDade Behring, Inc. · 2006
  • K053072N Antisera to Human ALPHA1-AntitrypsinDade Behring, Inc. · 2006
  • K053073N Antisera to Human ALPHA2-MacroglobulinDade Behring, Inc. · 2006
  • K053074N Antisera to Human CeruloplasminDade Behring, Inc. · 2006

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 CFN

The CFN category page

  • K233663N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)Siemens Healthcare Diagnostics Products GmbH · 2023
  • K221114Immunoglobulin G (IgG)Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. · 2023
  • K192116Human IgA liquid reagent kit for Use on SPAPlusThe Binding Site Group, Ltd. · 2019
  • K191985Optilite IgA KitThe Binding Site Group, Ltd. · 2019
  • K191635Optilite IgM KitThe Binding Site Group, Ltd. · 20191 recall

https://510kreport.com/device/K042735 · printed Nov 5, 2026

Cite this page

510(k) Report. “K042735: N Antisera to Human Immunoglobulins (Igg, Iga and Igm).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042735

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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