510(k) · Cleared
Recalled · Class II · 2017BC Thrombin Reagent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Behring Diagnostics, Inc. · GJA Test, Thrombin Time
Cleared on May 19, 1997 after an 88-day review. The FDA summary names its predicate without a number. 1 later device descends from it. It has been recalled 2 times.
- Decided
- May 19, 1997
- Review
- 88 days
- Class
- Class II
- Product code
- GJA
- Recalls
- 2
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK970645 BC Thrombin ReagentBehring Diagnostics, Inc. · 1997
- Descendant · cites it directly · 0 of its ownK060968 Stasis - I, II and Iii; Serathan - a, B; Intrin - EA, SI Calcium…Wortham Laboratories, Inc. · 2007
Most influential descendants
Showing 1 of 1 · See all- K060968Stasis - I, II and Iii; Serathan - a, B; Intrin - EA, SI Calcium Chloride 0.02M…Wortham Laboratories, Inc. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K970645 | BC Thrombin Reagent | Behring Diagnostics, Inc. | 1997 | — |
| +1 | K060968 | Stasis - I, II and Iii; Serathan - a, B; Intrin - EA, SI Calcium Chloride… | Wortham Laboratories, Inc. | 2007 | — |
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 GJA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | — | Behring Test Thrombin Reagent Named without a submission number |
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 |
|---|---|---|---|
| K060968 | Stasis - I, II and Iii; Serathan - a, B; Intrin - EA, SI Calcium Chloride 0.02M… | 2007 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 17, 2017 | Class II | Z-0827-2018 | Nonconforming Material/Component | The BC Thrombin Reagent kit lot 46751 (contains Thrombin Reagent lot 517468) and kit lot 47184 (contains Thrombin Reagent lot 517469) produce unexpected prolonged Thrombin Time (TT) results for expected normal samples, and may recover… |
| Jul 21, 2004 | Not classified | Z-0007-05 | Other | The product does not demonstrate the expected prolonged thrombin times for specimens obtained from patients recieving heparin |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K060968 (Wortham Laboratories, Inc., 2007) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GJA devicesGJA Test, Thrombin Time: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GJA
FDA has decided no GJA device since 2007.
Median 510(k) review, days · GJA
Too few GJA 510(k)s in any year since 2007 to give a median.
Recalls per year · GJA
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GJA
2in 2023
MAUDE reports naming product code GJA, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 1 | 10 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The BC Thrombin Reagent is used for the determination of the thrombin time in human plasma. The determination of thrombin time is important in: - The monitoring of heparin therapy. - The monitoring of fibrinolysis therapy. The screening of disorders of fibrin formation. The differentiating between a heparin-induced prolongation of the thrombin time and fibrin formation disorders. The BC Thrombin Reagent is used for the determination of the thrombin time…
Read the full statement (112 words)
The BC Thrombin Reagent is used for the determination of the thrombin time in human plasma. The determination of thrombin time is important in:
- The monitoring of heparin therapy.
- The monitoring of fibrinolysis therapy.
The screening of disorders of fibrin formation.
The differentiating between a heparin-induced prolongation of the thrombin time and fibrin formation disorders.
The BC Thrombin Reagent is used for the determination of the thrombin time in human plasma. The determination of thrombin time is important in:
The monitoring of heparin therapy.
The monitoring of fibrinolysis therapy.
The screening of disorders of fibrin formation.
The differentiating between a heparin-induced prolongation of the thrombin time and fibrin formation disorders.
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/K970645 · printed Nov 6, 2026
Cite this page
510(k) Report. “K970645: BC Thrombin Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970645
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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