510(k) · Cleared
Recalled · Class II · 2016BCS System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Behring, Inc. · JPA System, Multipurpose For In Vitro Coagulation Studies
Cleared on Nov 9, 2001 as substantially equivalent to K001145 (Dade Behring, Inc., 2000) after a 52-day review. Its family tree reaches back 1 generation to 2000. It has been recalled 2 times.
- Decided
- Nov 9, 2001
- Review
- 52 days
- Class
- Class II
- Product code
- JPA
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K001145 (2000). No later device cites it as a predicate yet.
- Root · 1 generation backK001145 Sysmex Automated Coagulation Analyzer, Model CA-6000Dade Behring, Inc. · 2000
- This deviceK013114 BCS SystemDade Behring, Inc. · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K001145 | Sysmex Automated Coagulation Analyzer, Model CA-6000 | Dade Behring, Inc. | 2000 | — |
| 0 (this device) | K013114 | BCS System | Dade Behring, Inc. | 2001 | — |
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 JPA? 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 JPA device
- #1 K243858 TEG 6s Hemostasis System Citrated: K, KH, RT…score 12.0 · 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? (1)
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 |
|---|---|---|---|
| * | K001145 | Sysmex Automated Coagulation Analyzer, Model CA-6000Summary page 1…: Multipurpose system for in vitro Coagulation studies Classification Number: Class Il (864.5425) Identification of the Legally Marketed Device: Sysmex® CA-6000 System (K001145) Device Description: B The current BCS™ System was originally determined to be substantially equivalent as a fully automated ph… | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 14, 2016 | Class II | Z-0824-2016 | Software design | False short clotting times for PT on BCS and BCS XP with Dade Innovin can occur. This has also an effect for false low PT INR values. These false short clotting times were observed only with turbid, hemolytic and/or icteric samples from… |
| Dec 1, 2010 | Class II | Z-1867-2012 | Device Design | Firm has confirmed that if the Cleaner SCS vial becomes empty after processing a test for Antithrombin assay using the INNOVANCE(R) Antithrombin kit, and the test immediately following is an APTT based clotting assay several results may… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K001145.
How does its category compare?
All JPA devicesJPA System, Multipurpose For In Vitro Coagulation Studies: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JPA
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JPA
30in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JPA
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JPA
11in 2025
MAUDE reports naming product code JPA, 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 | 1 | — | 1 | 1,744 |
| 2008 | 2 | — | 0 | 918 |
| 2009 | 6 | 91 | 0 | 1,363 |
| 2010 | 1 | — | 6 | 727 |
| 2011 | 1 | — | 4 | 161 |
| 2012 | 0 | — | 1 | 52 |
| 2013 | 1 | — | 0 | 43 |
| 2014 | 0 | — | 0 | 48 |
| 2015 | 2 | — | 0 | 45 |
| 2016 | 6 | 114 | 3 | 6 |
| 2017 | 4 | 117 | 0 | 15 |
| 2018 | 1 | — | 0 | 39 |
| 2019 | 3 | 175 | 0 | 27 |
| 2020 | 0 | — | 1 | 18 |
| 2021 | 1 | — | 0 | 7 |
| 2022 | 1 | — | 0 | 9 |
| 2023 | 3 | 506 | 0 | 11 |
| 2024 | 1 | — | 0 | 8 |
| 2025 | 3 | 30 | 0 | 11 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The BCS™ System is an automated coagulation analyzer for in vitro diagnostic
use in clinical laboratories. The instrument performs the following parameters:
o Activated Partial Thromboplastin Time (APTT) e Heparin
e Antithrombin lila ¢ Lupus Anticoagulants
¢ Batroxobin ¢ Prothrombin Time (PT)
¢ D-dimer ¢ Plasminogen
¢ Deficient Plasmas e Protein C-clotting
e Derived Fibrinogen ¢ Protein C-chromogenic
¢ Factor V Leiden e Thrombin Time
¢ Fibrinogen ¢ von Willebrand factor
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/K013114 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013114: BCS System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013114
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026