# K042521: Vitros Chemistry Products APOA1 and Apob Reagents, Calibrator Kits 21 and 22 and APOA1 and Apob Performance Verifiers

- Pathway: 510(k) (Traditional)
- Applicant: Ortho-Clinical Diagnostics, Inc.
- Decided: Nov 18, 2004 after 63 days
- Product code: JIT (Calibrator, Secondary)
- Device class: 2
- Regulation: 21 CFR 862.1150
- 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 K023158 (2002). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 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.
- K041870: N Apolipoprotein Standard Serum, Dade Behring, Inc. (2004) Summary page 3.
- K993310: Apolipoprotein Control Serum CHD, Model Ouph, Dade Behring, Inc. (1999) Summary page 6.

## Indications for use
For in vitro diagnostic use only. VITROS Chemistry Products ApoAl Reagent is used to quantitatively measure apolipoprotein AI (ApoA1) concentration in human serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 21 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of apolipoprotein Al (ApoA l). For in vitro diagnostic use only. VITROS Chemistry Products ApoA I Performance Verifier I is an assayed controls used to monitor the performance of ApoAl Reagent on VITROS 5,1 FS Chemistry Systems. For in vitro diagnostic use only. VITROS Chemistry Products ApoB Reagent is used to quantitatively measure apolipoprotein B (ApoB3) concentration in human serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 22 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of apolipoprotein B (ApoB). For in vitro diagnostic use only. VITROS Chemistry Products ApoB Performance Verifier I is an assayed controls used to monitor the performance of ApoB Reagent on VITROS 5,1 FS Chemistry Systems.

Source page: https://510kreport.com/device/K042521
Methodology: https://510kreport.com/methodology