510(k) · Cleared
Recalled · Class II · 2015Stratus CS Acute Care Betahcg and NT-Probnp Testpak and Testpak Assay, Calpak and Dilpak
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Behring, Inc. · DHA System, Test, Human Chorionic Gonadotropin
Cleared on Apr 6, 2006 as substantially equivalent to K003696 (Dade Behring, Inc., 2001) and 1 other predicate after a 36-day review. Its family tree reaches back 4 generations to 2000. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Apr 6, 2006
- Review
- 36 days
- Class
- Class II
- Product code
- DHA
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 4 generations to DEN000010 (2000). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backDEN000010 Triage B-Type Natriuretic Peptide (BNP) TestBiosite Incorporated · 2000
- 3 generations backK022516 Elecsys Probnp ImmunoassayRoche Diagnostics Corp. · 2002
- 2 generations backK032646 Elecsys Probnp ImmunoassayRoche Diagnostics Corp. · 2003
- 1 generation backK043476 Stratus CS Acute Care NT-Probnp Testpak, PBNP Calpak Calibrator…Dade Behring, Inc. · 2005 · Recalled
- This deviceK060548 Stratus CS Acute Care Betahcg and NT-Probnp Testpak and Testpak…Dade Behring, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK071834 Stratus CS Acute Care NT-Probnp Testpak, Model CpbnpmDade Behring, Inc. · 2007 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K071834Stratus CS Acute Care NT-Probnp Testpak, Model CpbnpmDade Behring, Inc. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | DEN000010 | Triage B-Type Natriuretic Peptide (BNP) Test | Biosite Incorporated | 2000 | — |
| −3 | K022516 | Elecsys Probnp Immunoassay | Roche Diagnostics Corp. | 2002 | — |
| −2 | K032646 | Elecsys Probnp Immunoassay | Roche Diagnostics Corp. | 2003 | — |
| −1 | K043476 | Stratus CS Acute Care NT-Probnp Testpak, PBNP Calpak Calibrator, PBNP Dilpak… | Dade Behring, Inc. | 2005 | 2 |
| 0 (this device) | K060548 | Stratus CS Acute Care Betahcg and NT-Probnp Testpak and Testpak Assay, Calpak… | Dade Behring, Inc. | 2006 | — |
| +1 | K071834 | Stratus CS Acute Care NT-Probnp Testpak, Model Cpbnpm | Dade Behring, Inc. | 2007 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DHA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DHA device
- #1 K233581 VITROS Immunodiagnostic Products Total ß-hCG…score 7.6 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K003696 | Stratus CS Stat Fluorometric Analyzer BHCG Testpak,Test System, Model Cbhcg, BHCG…Summary page 1…Acute Care™ NT-proBNP (pBNP) DilPak (the assay diluent) / Class 11 3. ldentification of the Predicate Device * Dade Behring Stratus® CS BhCG TestPak, CalPak and DilPak K003696 ' » Dade Behring Stratus@® CS pBNP Acute Care™ TestPak, CalPak and DilPak K043476 Dade Bchring Inc.… | 2001 |
| * | K043476 | Stratus CS Acute Care NT-Probnp Testpak, PBNP Calpak Calibrator, PBNP Dilpak DiluentSummary page 1…on of the Predicate Device * Dade Behring Stratus® CS BhCG TestPak, CalPak and DilPak K003696 ' » Dade Behring Stratus@® CS pBNP Acute Care™ TestPak, CalPak and DilPak K043476 Dade Bchring Inc. 510(k) Prnmarket Notification Str… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071834 | Stratus CS Acute Care NT-Probnp Testpak, Model Cpbnpm | 2007 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 11, 2015 | Class II | Z-0615-2016 | Labeling design | Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems |
| Nov 11, 2015 | Class II | Z-0617-2016 | Labeling design | Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K071834 (Dade Behring, Inc., 2007) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DHA devicesDHA System, Test, Human Chorionic Gonadotropin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DHA
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DHA
63in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DHA
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DHA
234in 2025
MAUDE reports naming product code DHA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 64 |
| 2008 | 1 | — | 0 | 99 |
| 2009 | 1 | — | 0 | 196 |
| 2010 | 0 | — | 2 | 179 |
| 2011 | 0 | — | 0 | 478 |
| 2012 | 0 | — | 0 | 277 |
| 2013 | 2 | — | 0 | 244 |
| 2014 | 0 | — | 0 | 119 |
| 2015 | 1 | — | 2 | 52 |
| 2016 | 0 | — | 0 | 55 |
| 2017 | 2 | — | 0 | 101 |
| 2018 | 0 | — | 1 | 103 |
| 2019 | 1 | — | 0 | 152 |
| 2020 | 1 | — | 0 | 115 |
| 2021 | 3 | 289 | 0 | 210 |
| 2022 | 1 | — | 2 | 185 |
| 2023 | 3 | 63 | 0 | 194 |
| 2024 | 1 | — | 0 | 261 |
| 2025 | 0 | — | 0 | 234 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (294 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K060548 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060548: Stratus CS Acute Care Betahcg and NT-Probnp Testpak and Testpak Assay, Calpak and Dilpak.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060548
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026