# K060548: Stratus CS Acute Care Betahcg and NT-Probnp Testpak and Testpak Assay, Calpak and Dilpak

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Apr 6, 2006 after 36 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
Longest line of descent: 4 generations back to DEN000010 (2000). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003696: Stratus CS Stat Fluorometric Analyzer BHCG Testpak,Test System, Model Cbhcg, BHCG Calpak,Model Cbhcg-C, BHCG Dilpak, Mod, Dade Behring, Inc. (2001) Summary page 1.
- K043476: Stratus CS Acute Care NT-Probnp Testpak, PBNP Calpak Calibrator, PBNP Dilpak Diluent, Dade Behring, Inc. (2005) Summary page 1.

## Most influential descendants
- K071834: Stratus CS Acute Care NT-Probnp Testpak, Model Cpbnpm (2007), 0 descendants of its own

## Recalls of this device
- Nov 11, 2015 · Class II · Z-0615-2016: Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems
- Nov 11, 2015 · Class II · Z-0617-2016: Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems

## Indications for use
The Stratus® CS Acute Care™ βhCG method is an in vitro diagnostic test for the quantitative measurement of the total beta subunit, vis, both the intact hCG dimer and the free β subunit, of the human chorionic gonadotropin hormone in heparinized plasma. βhCG is used for the early detection of pregnancy. This method is for use by trained health care professionals in the clinical laboratory and point of care (POC) settings. The Stratus® CS Acute Care™ βhCG Calibrator (βhCG CalPak) is an in vitro diagnostic product intended to be used for calibration of the Stratus® CS Acute Care™ βhCG method. The Stratus® CS Acute Care™ βhCG Dilution Pak (βhCG DilPak) is an in vitro diagnostic product intended to be used in conjunction with the Acute Care™ hCG TestPak for the measurement of samples with elevated levels of βhCG. The Stratus® CS Acute Care™ NT-proBNP method is an in vitro diagnostic test for the quantitative measurement of N-terminal pro-brain natriuretic peptide (NT-proBNP) in heparinized plasma. In individuals suspected of having congestive heart failure (CHF), measurements of NT-proBNP are used as an aid in the diagnosis and assessment of severity. The test is further indicated for the risk stratification of patients with acute coronary syndrome and heart failure. This method is for use by trained health care professionals in the clinical laboratory and point of care (POC) settings. The Stratus® CS Acute Care™ NT-proBNP Calibrator (pBNP CalPak) is an in vitro diagnostic product intended to be used for calibration of the Stratus® CS Acute Care™ NT-proBNP (pBNP) method. The Stratus® CS Acute Care™ NT-proBNP Dilution Pak (pBNP DilPak) is an in vitro diagnostic product intended to be used in conjunction with the Acute Care™ pBNP TestPak for the measurement of samples with elevated levels of NT-proBNP.

Source page: https://510kreport.com/device/K060548
Methodology: https://510kreport.com/methodology