# K042494: Vitros Chemistry Products C3 and CR Reagent, Calibrator Kit 20, Protein Performance Verifiers I, II, and Iii

- Pathway: 510(k) (Traditional)
- Applicant: Ortho-Clinical Diagnostics
- Decided: Oct 19, 2004 after 35 days
- Product code: CZW (Complement C3, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5240
- 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 K771603 (1977). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964842: Immage Immunochemistry System COMPLEMENTC3 (C3) and COMPLEMENTC4 (C4) Reagent, Beckman Instruments, Inc. (1997) Summary page 7.
- K860894: Behring Nephelometer System, Behring Diagnostics, Inc. (1986) Summary page 8.
- K041720: Vitros Chemistry Products DLDL Reagent, Calibrator Kit 19, FS Calibrator 1 and Performance Verifiers I and II, Ortho-Clinical Diagnostics, Inc. (2004) Summary page 10.

## Indications for use
For in vitro diagnostic use only. VITROS Chemistry Products C3 Reagent is used to quantitatively measure complement C3 (C3) concentration in human serum and plasma. Measurements of these proteins aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components. For in vitro diagnostic use. VITROS Chemistry Products Calibrator Kit 20 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of transferrin, C3, C4, IgA, IgG and IgM. For in vitro diagnostic use only. VITROS Chemistry Products Protein Performance Verifiers are assayed controls used to monitor the performance of TRFRN, C3, C4, IgA, IgG and IgM Reagents on VITROS 5,1 FS Chemistry Systems. For in vitro diagnostic use only. VITROS Chemistry Products C4 Reagent is used to quantitatively measure complement C4 (C4) concentration in human serum and plasma. Measurements of these proteins aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components. For in vitro diagnostic use. VITROS Chemistry Products Calibrator Kit 20 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of transferrin, C3, C4, IgA, IgG and IgM. For in vitro diagnostic use only. VITROS Chemistry Products Protein Performance Verifiers are assayed controls used to monitor the performance of TRFRN, C3, C4, IgA, IgG and IgM Reagents on VITROS 5,1 FS Chemistry Systems.

Source page: https://510kreport.com/device/K042494
Methodology: https://510kreport.com/methodology