510(k) Report

510(k) · Cleared

Cleared

Vitros Chemistry Products Igg, Iga and Igm Reagents; Vitros Chemistry Product Calibrator Kit 20; Vitros Chemistry Produc

K042475510(k) TraditionalCleared Nov 10, 200458-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

Ortho-Clinical Diagnostics, Inc. · CFN Method, Nephelometric, Immunoglobulins (G, A, M)

Cleared on Nov 10, 2004 as substantially equivalent to K860894 (Behring Diagnostics, Inc., 1986) and 2 other predicates after a 58-day review. Its family tree reaches back 2 generations to 2000.

Decided
Nov 10, 2004
Review
58 days
Class
Class II
Product code
CFN
Recalls
None
Predicates
3

Its longest line of descent runs back 2 generations to K002852 (2000). 5 ancestors in all, the oldest K860894 (1986). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2001: 1 other ancestor1986: 1 other ancestor2000: 1 other ancestorK002852 · N/T Protein Control SL · Dade Behring, Inc. · 2000K012468 · Modification to N/T Protein Control SL · Dade Behring, Inc. · 200119851990199520002005
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 1 other ancestor K012468 · Modification to N/T Protein Control SL · Dade Behring, Inc. · 2001K002852 · N/T Protein Control SL · Dade Behring, Inc. · 20000
  1. Root · 2 generations backK002852 N/T Protein Control SLDade Behring, Inc. · 2000
  2. 1 generation backK012468 Modification to N/T Protein Control SLDade Behring, Inc. · 2001
  3. This deviceK042475 Vitros Chemistry Products Igg, Iga and Igm Reagents; Vitros…Ortho-Clinical Diagnostics, Inc. · 2004
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K002852N/T Protein Control SLDade Behring, Inc.2000—
−1K012468Modification to N/T Protein Control SLDade Behring, Inc.2001—
0 (this device)K042475Vitros Chemistry Products Igg, Iga and Igm Reagents; Vitros Chemistry Product…Ortho-Clinical Diagnostics, Inc.2004—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198610
200010
200110
FIG. 1 — Lineage of K042475, 2000–2004Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (3)

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 3
…The VITROS Chemistry Products IgG, IgA, and IgM Reagents and VITROS Chemistry Products Calibrator Kit 20 are substantially equivalent to K860894, the Dade Behring N Antisera to Human Immunoglobulins (IgG, IgA, and IgM), and K012470, Dade Behr…
Behring Diagnostics, Inc.1986—
*K012470Modification to N Protein Standard SL
Summary page 3
…Calibrator Kit 20 are substantially equivalent to K860894, the Dade Behring N Antisera to Human Immunoglobulins (IgG, IgA, and IgM), and K012470, Dade Behring N Protein Standard SL (predicate devices) which were cleared by the FDA for IVD use.…
Dade Behring, Inc.20011
*K012468Modification to N/T Protein Control SLDade Behring, Inc.2001—

Also cleared against K860894: 16 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 4 years and passes through 2 companies; a new generation was cleared every 3.2 years on median.
  • 1 of the 5 ancestors has a recall of any class.
  • 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?

For in vitro diagnostic use only. VITROS Chemistry Products IgG Reagent is used to quantitatively measure immunoglobulin G (IgG) concentration in human serum and plasma. For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 20 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of transferrin, C3, C4, IgG, IgA and IgM. For in vitro diagnostic use only. VITROS Chemistry Products Protein Performance…

Read the full statement (291 words)

For in vitro diagnostic use only. VITROS Chemistry Products IgG Reagent is used to quantitatively measure immunoglobulin G (IgG) concentration in human serum and plasma.

For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 20 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of transferrin, C3, C4, IgG, IgA and IgM.

For in vitro diagnostic use only. VITROS Chemistry Products Protein Performance Verifiers I, II, and III are assayed controls used to monitor the performance of TRFRN, C3, C4, IgG, IgA and IgM Reagents on VITROS 5,1 FS Chemistry Systems.

For in vitro diagnostic use only. VITROS Chemistry Products IgA Reagent is used to quantitatively measure immunoglobulin A (IgA) concentration in human serum and plasma.

For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 20 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of transferrin, C3, C4, IgG, IgA and IgM.

For in vitro diagnostic use only. VITROS Chemistry Products Protein Performance Verifiers I, II, and III are assayed controls used to monitor the performance of TRFRN, C3, C4, IgG, IgA and IgM Reagents on VITROS 5,1 FS Chemistry Systems.

For in vitro diagnostic use only. VITROS Chemistry Products IgM Reagent is used to quantitatively measure immunoglobulin M (1gM) concentration in human serum and plasma.

For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 20 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of transferrin, C3, C4, IgG, IgA and IgM.

For in vitro diagnostic use only. VITROS Chemistry Products Protein Performance Verifiers I, II, and III are assayed controls used to monitor the performance of TRFRN, C3, C4, IgG, IgA and 1gM Reagents on VITROS 5,1 FS Chemistry Systems.

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 Ortho-Clinical Diagnostics, Inc.

273 FDA decisions under this applicant name. See the company

  • K252393VITROS Immunodiagnostic Products hs Troponin I Reagent PackOrtho-Clinical Diagnostics, Inc. · 2025
  • DEN210040VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS Immunodiagnostic Products…Ortho-Clinical Diagnostics, Inc. · 2023
  • DEN210038VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, VITROS Immunodiagnostic Products…Ortho-Clinical Diagnostics, Inc. · 2023
  • P090028/S018VITROS Immunodiagnostic Products HBeAg Reagent Pack and CalibratorOrtho-Clinical Diagnostics, Inc. · 2023
  • P030026/S037VITROS Anti-HBc IgMOrtho-Clinical Diagnostics, Inc. · 2023

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/K042475 · printed Nov 6, 2026

Cite this page

510(k) Report. “K042475: Vitros Chemistry Products Igg, Iga and Igm Reagents; Vitros Chemistry Product Calibrator Kit 20; Vitros Chemistry Produc.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042475

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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