# K042475: Vitros Chemistry Products Igg, Iga and Igm Reagents; Vitros Chemistry Product Calibrator Kit 20; Vitros Chemistry Produc

- Pathway: 510(k) (Traditional)
- Applicant: Ortho-Clinical Diagnostics, Inc.
- Decided: Nov 10, 2004 after 58 days
- Product code: CFN (Method, Nephelometric, Immunoglobulins (G, A, M))
- Device class: 2
- Regulation: 21 CFR 866.5510
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K002852 (2000). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K860894: Behring Nephelometer System, Behring Diagnostics, Inc. (1986) Summary page 3.
- K012470: Modification to N Protein Standard SL, Dade Behring, Inc. (2001) Summary page 3.
- K012468: Modification to N/T Protein Control SL, Dade Behring, Inc. (2001)

## Indications for use
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.

Source page: https://510kreport.com/device/K042475
Methodology: https://510kreport.com/methodology