# K993310: Apolipoprotein Control Serum CHD, Model Ouph

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Nov 30, 1999 after 57 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K903687: Turbiquant Myoglobin, Behring Diagnostics, Inc. (1990). Our OCR of the scanned summary read K903687, FDA’s number for Turbiquant Myoglobin (Behring Diagnostics, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Apolipoprotein Control Serum”. Kept off the family tree. 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
Apolipoprotein Control Serum CHD is used as an assayed control for accuracy and precision in the quantitative immunochemical determination of Apolipoprotein A-l and B by radial immunodiffusion; Apolipoprotein A-l, All*, B, E* and CRP with the Behring Nephelometer Systems; and Apolipoprotein A-l, B and Myoglobin with the TurbiTime System™ * Reagents for these determinations are not available in USA

Source page: https://510kreport.com/device/K993310
Methodology: https://510kreport.com/methodology