510(k) · Cleared

Recalled · 2004

BCT System

K011665510(k) TraditionalCleared Aug 9, 200171-day reviewClass II21 CFR 864.5425Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Dade Behring, Inc. · JPA System, Multipurpose For In Vitro Coagulation Studies

Cleared on Aug 9, 2001 as substantially equivalent to K964139 (Dade Intl., Inc., 1997) after a 71-day review. Its family tree reaches back 2 generations to 1989. It has been recalled once.

Decided: Aug 9, 2001
Review: 71 days
Class: Class II
Product code: JPA
Recalls: 1
Predicates: 1

Its longest line of descent runs back 2 generations to K894052 (1989). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK894052 Electra 1000C Automatic Coagulation TimerMedical Laboratory Automation Systems, Inc. · 1989
1 generation backK964139 Sysmex CA-6000Dade Intl., Inc. · 1997
This deviceK011665 BCT SystemDade Behring, Inc. · 2001

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K894052	Electra 1000C Automatic Coagulation Timer	Medical Laboratory Automation Systems, Inc.	1989	—
−1	K964139	Sysmex CA-6000	Dade Intl., Inc.	1997	—
0 (this device)	K011665	BCT System	Dade Behring, Inc.	2001	—

FIG. 1 — Lineage of K011665, 1989–2001Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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#2 Held for the reportin the report
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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	Applicant	Decided	Recalls
*	K964139	Sysmex CA-6000 Summary page 2 …d comparison information: The BCT™ System is substantially equivalent in intended use and results obtained to the Sysmex® CA-6000 System, which was the subject of 510(k) K964139. Both instruments use light at various wavelengths for the measurement of several coagulation assays. 7. Device Performance Char…	Dade Intl., Inc.	1997	—

Also cleared against K964139: 5 other devices →

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
Aug 27, 2004	Not classified	Z-0042-05	Other	APTT determinations when using affected rotors may lead to incorrectly shortened times

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 7.5 years on median.
None of the 2 ancestors has a recall.
5 other devices also cite its predicate K964139.

How does its category compare?

All JPA devices

JPA 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

2007high 6 (2009) · low 0 (2012)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JPA

30in 2025

2007high 506 (2023) · low 30 (2025)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JPA

1in 2020

2007high 6 (2010) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JPA

11in 2025

2007high 1,744 (2007) · low 6 (2016)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 BCT™ System is an automated coagulation analyzer for in vitro diagnostic use in clinical laboratories. The instrument performs the following parameters:

Activated Partial Thromboplastin Time (APTT)

Lupus Anticoagulants

Antithrombin llla

Prothrombin Time (PT)

Batroxobin

Plasminogen

D-dimer

Protein C-clotting

Deficient Plasmas

Protein C-chromogenic

Derived Fibrinogen

Thrombin Time

Fibrinogen

von Willebrand factor

Heparin

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/K011665 · printed Nov 4, 2026

Cite this page

510(k) Report. “K011665: BCT System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011665

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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