510(k) · Cleared
Recalled · 2006Stratus CS Stat Fluorometric Analyzer BHCG Testpak,Test System, Model Cbhcg, BHCG Calpak,Model Cbhcg-C, BHCG Dilpak, Mod
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 Jan 25, 2001 after a 56-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it. It has been recalled 2 times.
- Decided
- Jan 25, 2001
- Review
- 56 days
- Class
- Class II
- Product code
- DHA
- Recalls
- 2
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK003696 Stratus CS Stat Fluorometric Analyzer BHCG Testpak,Test System…Dade Behring, Inc. · 2001
- Descendant · cites it directly · 1 of its ownK060548 Stratus CS Acute Care Betahcg and NT-Probnp Testpak and Testpak…Dade Behring, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 0 of its ownK071834 Stratus CS Acute Care NT-Probnp Testpak, Model CpbnpmDade Behring, Inc. · 2007 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003696 | Stratus CS Stat Fluorometric Analyzer BHCG Testpak,Test System, Model Cbhcg… | Dade Behring, Inc. | 2001 | — |
| +1 | K060548 | Stratus CS Acute Care Betahcg and NT-Probnp Testpak and Testpak Assay, Calpak… | Dade Behring, Inc. | 2006 | 2 |
| +2 | K071834 | Stratus CS Acute Care NT-Probnp Testpak, Model Cpbnpm | Dade Behring, Inc. | 2007 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060548 | Stratus CS Acute Care Betahcg and NT-Probnp Testpak and Testpak Assay, Calpak and Dilpak | 2006 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 3, 2006 | Not classified | Z-0874-06 | Other | 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 falsely elevated or depressed, and the… |
| Apr 3, 2006 | Not classified | Z-0880-06 | Other | 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 falsely elevated or depressed, and the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K060548 (Dade Behring, Inc., 2006) has gone furthest, with 1 descendant 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 | — |
https://510kreport.com/device/K003696 · printed Nov 5, 2026
Cite this page
510(k) Report. “K003696: Stratus CS Stat Fluorometric Analyzer BHCG Testpak,Test System, Model Cbhcg, BHCG Calpak,Model Cbhcg-C, BHCG Dilpak, Mod.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K003696
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026