# K041870: N Apolipoprotein Standard Serum

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Jul 27, 2004 after 18 days
- Product code: JIX (Calibrator, Multi-Analyte Mixture)
- 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: 1 generation back to K023158 (2002). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023158: Randox Apolipoprotein Calibrator, Randox Laboratories, Ltd. (2002) Summary page 1.

## Most influential descendants
- K063608: Dimension Vista APOA1 and Apob Flex Reagent Cartridges and Protein 1 Calibrator and Control Medium and High (2007), 1 descendant of its own
- K181373: Extended Lipid Panel Assay (2018), 0 descendants of its own
- K042521: Vitros Chemistry Products APOA1 and Apob Reagents, Calibrator Kits 21 and 22 and APOA1 and Apob Performance Verifiers (2004), 0 descendants of its own

## Indications for use
For calibration of the Apolipoprotein A-I and Apolipoprotein B assays on BN™ Systems.

Source page: https://510kreport.com/device/K041870
Methodology: https://510kreport.com/methodology