510(k) · Cleared
ClearedCoatest Apc (TM) Resistance V/Coatest Apc (TM) Resistance V S
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chromogenix AB · GGW Test, Time, Partial Thromboplastin
Cleared on Dec 23, 1996 as substantially equivalent to K945940 (Axis-Shield Doc AS, 1995) after a 133-day review. Its family tree reaches back 1 generation to 1995. 5 later devices descend from it.
- Decided
- Dec 23, 1996
- Review
- 133 days
- Class
- Class II
- Product code
- GGW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K945940 (1995). 5 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK945940 Coatest (R) Apc (TM) ResistanceAxis-Shield Doc AS · 1995
- This deviceK963111 Coatest Apc (TM) Resistance V/Coatest Apc (TM) Resistance V SChromogenix AB · 1996
- Descendant · cites it directly · 0 of its ownK260551 HemosIL Factor V Leiden (APC Resistance V)Instrumentation Laboratory (IL) Co. · 2026
- Descendant · cites it directly · 0 of its ownK083729 Hemoclot Quanti- V-L, Factor V-L Calibrator, Biophen V-L Cal…Aniara Diagnostica, LLC · 2009
- Descendant · cites it directly · 0 of its ownK042760 Pefakit Apc-R Factor V Leiden ControlsPentapharm, Ltd. · 2004
- Descendant · cites it directly · 0 of its ownK042762 Pefakit Apc-R Factor V LeidenPentapharm, Ltd. · 2004
- Descendant · cites it directly · 0 of its ownK042333 Control Plasma N, Proc Control PlasmaDade Behring, Inc. · 2004
Most influential descendants
Showing 5 of 5 · See all- K260551HemosIL Factor V Leiden (APC Resistance V)Instrumentation Laboratory (IL) Co. · 2026 · cites it directly0descendants
- K083729Hemoclot Quanti- V-L, Factor V-L Calibrator, Biophen V-L Cal (Undiluted), Biophen Act.…Aniara Diagnostica, LLC · 2009 · cites it directly0descendants
- K042760Pefakit Apc-R Factor V Leiden ControlsPentapharm, Ltd. · 2004 · cites it directly0descendants
- K042762Pefakit Apc-R Factor V LeidenPentapharm, Ltd. · 2004 · cites it directly0descendants
- K042333Control Plasma N, Proc Control PlasmaDade Behring, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K945940 | Coatest (R) Apc (TM) Resistance | Axis-Shield Doc AS | 1995 | — |
| 0 (this device) | K963111 | Coatest Apc (TM) Resistance V/Coatest Apc (TM) Resistance V S | Chromogenix AB | 1996 | — |
| +1 | K260551 | HemosIL Factor V Leiden (APC Resistance V) | Instrumentation Laboratory (IL) Co. | 2026 | — |
| +1 | K083729 | Hemoclot Quanti- V-L, Factor V-L Calibrator, Biophen V-L Cal (Undiluted)… | Aniara Diagnostica, LLC | 2009 | — |
| +1 | K042760 | Pefakit Apc-R Factor V Leiden Controls | Pentapharm, Ltd. | 2004 | — |
| +1 | K042762 | Pefakit Apc-R Factor V Leiden | Pentapharm, Ltd. | 2004 | — |
| +1 | K042333 | Control Plasma N, Proc Control Plasma | Dade Behring, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 3 | 0 |
| 2009 | 1 | 0 |
| 2026 | 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 GGW? 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 GGW device
- #1 K260551 HemosIL Factor V Leiden (APC Resistance V)score 11.3 · 2 generations · no Class I recall
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 |
|---|---|---|---|
| * | K945940 | Coatest (R) Apc (TM) ResistanceSummary page 1…The original device COATEST® APC™ RESISTANCE C / COATEST® APC™ RESISTANCE SC received 510 (K) clearance for diagnosis of the APC resistance phenotype on August 8, 1995 (K945940). The new device COATEST® APC™ ~ RESISTANCE V / COATEST® APC™ RESISTANCE V S contains a supplementary , component, (factor) V-DEF… | 1995 |
What descends from it? (5)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K260551 | HemosIL Factor V Leiden (APC Resistance V) | 2026 | 0 |
| K083729 | Hemoclot Quanti- V-L, Factor V-L Calibrator, Biophen V-L Cal (Undiluted), Biophen Act.… | 2009 | 0 |
| K042760 | Pefakit Apc-R Factor V Leiden Controls | 2004 | 0 |
| K042762 | Pefakit Apc-R Factor V Leiden | 2004 | 0 |
| K042333 | Control Plasma N, Proc Control Plasma | 2004 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K260551 (Instrumentation Laboratory (IL) Co., 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GGW devicesGGW Test, Time, Partial Thromboplastin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GGW
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · GGW
Too few GGW 510(k)s in any year since 2007 to give a median.
Recalls per year · GGW
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GGW
11in 2025
MAUDE reports naming product code GGW, 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 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 1 | 0 |
| 2012 | 0 | — | 0 | 4 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 7 |
| 2017 | 0 | — | 0 | 15 |
| 2018 | 0 | — | 0 | 18 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 4 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 11 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/K963111 · printed Nov 4, 2026
Cite this page
510(k) Report. “K963111: Coatest Apc (TM) Resistance V/Coatest Apc (TM) Resistance V S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963111
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