# K003696: Stratus CS Stat Fluorometric Analyzer BHCG Testpak,Test System, Model Cbhcg, BHCG Calpak,Model Cbhcg-C, BHCG Dilpak, Mod

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Jan 25, 2001 after 56 days
- Product code: DHA (System, Test, Human Chorionic Gonadotropin)
- Device class: 2
- Regulation: 21 CFR 862.1155
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K060548: Stratus CS Acute Care Betahcg and NT-Probnp Testpak and Testpak Assay, Calpak and Dilpak (2006), 1 descendant of its own
- K071834: Stratus CS Acute Care NT-Probnp Testpak, Model Cpbnpm (2007), 0 descendants of its own

## Recalls of this device
- Apr 3, 2006 · Not classified · Z-0874-06: Foil sealing of theTestPak may occlude the pipet tip resulting in insufficient aspiration of fluids. Erroneous test results may be generated without an associated error code. Test results may be false
- Apr 3, 2006 · Not classified · Z-0880-06: Foil sealing of the DilPak may occlude the pipet tip resulting in insufficient aspiration of fluids. Erroneous test results may be generated without an associated error code. Test results may be false

Source page: https://510kreport.com/device/K003696
Methodology: https://510kreport.com/methodology