510(k) · Cleared
ClearedHemoclot Quanti- V-L, Factor V-L Calibrator, Biophen V-L Cal (Undiluted), Biophen Act. PC-R Control Plasma and Biophen
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aniara Diagnostica, LLC · GGW Test, Time, Partial Thromboplastin
Cleared on May 8, 2009 as substantially equivalent to K963111 (Chromogenix AB, 1996) after a 143-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- May 8, 2009
- Review
- 143 days
- Class
- Class II
- Product code
- GGW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K945940 (1995). No later device cites it as a predicate yet.
- Root · 2 generations backK945940 Coatest (R) Apc (TM) ResistanceAxis-Shield Doc AS · 1995
- 1 generation backK963111 Coatest Apc (TM) Resistance V/Coatest Apc (TM) Resistance V SChromogenix AB · 1996
- This deviceK083729 Hemoclot Quanti- V-L, Factor V-L Calibrator, Biophen V-L Cal…Aniara Diagnostica, LLC · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K945940 | Coatest (R) Apc (TM) Resistance | Axis-Shield Doc AS | 1995 | — |
| −1 | K963111 | Coatest Apc (TM) Resistance V/Coatest Apc (TM) Resistance V S | Chromogenix AB | 1996 | — |
| 0 (this device) | K083729 | Hemoclot Quanti- V-L, Factor V-L Calibrator, Biophen V-L Cal (Undiluted)… | Aniara Diagnostica, LLC | 2009 | — |
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 |
|---|---|---|---|
| * | K963111 | Coatest Apc (TM) Resistance V/Coatest Apc (TM) Resistance V SSummary page 1…ers: 864.7925 862.1150 864.5425 Identification of the Predicate Device: COATEST APC Resistance V (K963111) (Chromogenix) Aniara Diagnostica, LLC… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 12.4 years on median.
- None of the 2 ancestors has a recall.
- 4 other devices also cite its predicate K963111.
How does its category compare?
All GGW devicesGGW Test, Time, Partial Thromboplastin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
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 | — |
What is it indicated for?
HEMOCLOT Quanti VL is an in vitro diagnostic test for the quantitative determination of Factor V Leiden (FVL) activity in human citrated plasma, using automated or manual methods, by its resistance to the action of Activated Protein C (APC). Patients with the Factor V-L (mutation R5060). are exposed to an increased thrombotic risk. Biophen V-L CAL (undiluted), at defined Factor V-Leiden (FV-L) concentrations, for the calibration of Factor V-Leiden…
Read the full statement (297 words)
HEMOCLOT Quanti VL is an in vitro diagnostic test for the quantitative determination of Factor V Leiden (FVL) activity in human citrated plasma, using automated or manual methods, by its resistance to the action of Activated Protein C (APC).
Patients with the Factor V-L (mutation R5060). are exposed to an increased thrombotic risk.
Biophen V-L CAL (undiluted), at defined Factor V-Leiden (FV-L) concentrations, for the calibration of Factor V-Leiden activity on human plasma, using the Hemoclot Quanti V-L kit.
Factor V-L Calibrator, pre diluted (1:20) human plasmas. at defined Factor V-Leiden (FV-L) concentrations, for the calibration of Factor V-L activity on human plasma using Hemoclot Quanti V-L Kit.
Biophen Act PC-r Control Plasma contains human plasma, presenting an Activated Protein C Resistance (APC-R) is used as quality control plasma for the testing of Activated Protein C resistance (APC-R) on human plasma using Hemoclot Quanti V-L kit.
(Updated) BIOPHEN Normal Control Plasma is a set of 12 vials of normal citrated human plasma for the quality control of some coagulation factors. The following table shows the various parameters, which are measured using assays from HYPHEN BioMed or from other manufacturers, and according to the package inserts:
Assays: ATIII; Protein C; aPC resistance (FV Leiden); Lupus Anticoagulant. Reagents: Biophen ATII; Biophen Protein C; Hemoclot Quanti V-L; DVVtest®/DVVconfirm®. Manufacturers: Hyphen Biomed; Hyphen Biomed; Hyphen Biomed; American Diagnostica. Reference: 221102/221105; 221202/221205; CK065K; 810/815/815L.
DWtest, DVVconfirm are registered trademarks from American Diagnostica, Inc.
The BIOPHEN Normal Control Plasma is tested for the absence of Lupus Anticoagulant and can be used as a negative control for this investigation. This control plasma is also tested for the absence of Activated Protein C resistance (Act PC-r). When the APTT is performed with or without Activated Protein C (APC) the ratio obtained (APTT +APC/AP'T) is >2.00.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083729 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083729: Hemoclot Quanti- V-L, Factor V-L Calibrator, Biophen V-L Cal (Undiluted), Biophen Act. PC-R Control Plasma and Biophen.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083729
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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