(143 days)
No
The document describes an in vitro diagnostic test kit and associated calibrators and controls for measuring Factor V Leiden activity. There is no mention of AI or ML in the intended use, device description, or performance studies. The analysis is based on chemical reactions and clotting times, not algorithmic learning.
No.
The device is an in vitro diagnostic test used for the quantitative determination of Factor V Leiden activity, which is not a therapeutic function.
Yes
The "Intended Use / Indications for Use" section explicitly states that "HEMOCLOT Quanti VL is an in vitro diagnostic test for the quantitative determination of Factor V Leiden (FVL) activity in human citrated plasma." This directly indicates its use for diagnosis.
No
The device is an in vitro diagnostic test kit containing lyophilized reagents, calibrators, and controls, which are physical components. It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "HEMOCLOT Quanti VL is an in vitro diagnostic test for the quantitative determination of Factor V Leiden (FVL) activity in human citrated plasma..."
Furthermore, the description of the components includes calibrators and controls, which are typical components of IVD test kits used for diagnostic purposes. The performance studies also compare the device to a predicate device (K963111; COATEST APC Resistance V), which is also an IVD.
N/A
Intended Use / Indications for Use
-
- HEMOCLOT Quanti V-L is a clotling method for measuring the Factor V Leiden (FVL) activity in human citrated plasma, by its resistance to the action of Activated Protein C (APC). The assay is performed in the presence of Activated Protein S (one single test for each patient). In the presence of APC, the prolongation of clotting time is an inverse relationship of the concentration of Factor V-Leiden (mutation R506Q). Normal Factor V is not measured.
-
- Factor V-L Calibrator is Iyophilized, pre-diluted (1:20) human plasmas, at defined Factor V-Leiden (FV-L) concentrations, for the calibration of Factor V-L activity quantitative clotting assay on human citrated plasma, using the HEMOCLOT Quanti. V-L Kit (ref CK065K).
- BIOPHEN V-L CAL (Undiluted) is Iyophilized, undiluted human plasmas, at defined Factor V-3. Leiden (FV-L) concentrations for the calibration curve of Factor V-L activity quantitative clotting assay on human citrated plasma, using HEMOCLOT Quanti V-L Kit (ref CK065K).
-
- BIOPHEN Act PC-r Control Plasma kit contains human plasma, presenting an Activated Protein C Resistance (APC-R), usually correlated with the genetic mutation of Factor V R506Q. This plasma is used as quality control plasma for the testing of Activated Protein C Resistance (APC-R).
-
- (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 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/APTT) is ≥ 2.00.
- 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 (mutalion R506Q), are exposed to an increased thrombotic risk.
- Biophen V-L CAL (undiluted), at defined Factor V-Leiden (FV-L) concentrations, for the callibration of Factor V-Leiden aclivity on human plasma, using the Hemoclot Quanti V-L kit.
- Factor V-L Cafibrator, 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 Quarti 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.
Product codes (comma separated list FDA assigned to the subject device)
GGW, JIT, GGN
Device Description
-
- HEMOCLOT Quanti V-L is an in vitro diagnostic test kit containing 3 vials of each of the following 2 lyophilized reagents: R1: Reagent 1: Clotting mixture containing human Fibrinogen, human prothrombin, Protein S at a constant concentration, optimized for the assay, and human Activated Protein C, lyophilized. It also contains a heparin neutralizing substance. Each vial is to be reconstituted with exactly 2 ml of distilled water. R2: Reagent 2: Purified Human Factor Xa, containing rabbit brain phospholipds (cephalin), lyophilized. Each vial is to be reconstituted with exactly 1 ml of distilled water. Calibrators and controls to be used with the test kit are supplied separately. The following calibrators and control are included in this submission:
-
- Factor V-L Calibrator is a calibrator kit containing 3 vials each of 1.0 ml prediluted human plasma (1:20), freeze dried, at 4 different concentrations of FV-L, to cover the assay range, from 10% to 100%. Each vial is restored with 1.0 ml Owren Koller type buffer.
-
- BIOPHEN V-L CAL (Undiluted) is a calibrator kit containing 3 vials each of 0.5 ml undiluted human plasma, freeze dried, at 3 different concentrations of FV-L, to cover the assay range, from about 10% to 100%. Each vial is restored with 0.5 ml distilled water.
- BIOPHEN Act PC-r Control Plasma is a controls kit containing 12 vials of 0.5 ml human 4. plasma, presenting an Activated Protein C Resistance (APC-R), citrated and Iyophilized. Each vial is to be reconstituted with exactly 0.5 ml of distilled water.
- BIOPHEN Normal Control Plasma manufactured by Hyphen-Biomed, is also used with the test kit and is currently marketed in the US under 510(k) # K043451, It is a controls kit containing 12 vials of 1.0 ml of normal citrated human plasma, lyophilized. Each vial is to be reconstituted with exactly 1.0 ml of distilled water.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The HEMOCLOT Quanti V-L (Hyphen-Biomed) assay shows good consistency with Coatest APCr kit (Chromogenix), as shown from data combined from 4 studies (2 in US, 2 in Europe).
Agreement: 94.18%
Co-positivity: 97.30%
Co-negativity: 89.74%
Sample Size: 189
The Hemoclot Quanti VL Assay shows good consistency with Molecular Biology results.
Agreement: 100.00%
Co-positivity: 100.00%
Co-negativity: 100.00%
Sample Size: 21
Reproducibility of the Hemoclot Quanti V-L assay was tested for 2 plasmas at different FVL concentrations, using the KC10, STAR or Water Bath instrument.
Sample 1 (100% FVL) Intra Assay CV% CT (sec) 4.4%, %FVL 5.9%, N 10. Inter Assay CV% CT (sec) 2.2%, %FVL 3.3%, N 10.
Sample 2 (50% FVL) Intra Assay CV% CT (sec) 4.2%, %FVL 8.2%, N 10. Inter Assay CV% CT (sec) 2.3%, %FVL 4.7%, N 10.
KC10 Instrument Sample 1 (25% FVL) Inter Assay CV% On CT (sec) 7.3%, On %FVL 17.4%, N 5.
KC10 Instrument Sample 2 (10% FVL) Inter Assay CV% On CT (sec) 6%, On %FVL 29.1%, N 5.
STAR Instrument Sample 1 (25% FVL) Inter Assay CV% On CT (sec) 5.2%, On %FVL 13.1%, N 10.
STAR Instrument Sample 2 (10% FVL) Inter Assay CV% On CT (sec) 5.6%, On %FVL 23.7%, N 10.
WATER BATH Instrument Sample 1 (25% FVL) Inter Assay CV% On CT (sec) 2.7%, On %FVL 10.0%, N 5.
WATER BATH Instrument Sample 2 (10% FVL) Inter Assay CV% On CT (sec) 5.6%, On %FVL 15.2%, N 5.
The performance studies demonstrate that the device is substantially equivalent to the predicate device in safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Agreement, Co-positivity, Co-negativity, CV%.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
COATEST APC Resistance V (K963111) (Chromogenix)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 864.7925 Partial thromboplastin time tests.
(a)
Identification. A partial thromboplastin time test is a device used for primary screening for coagulation abnormalities, for evaluation of the effect of therapy on procoagulant disorders, and as an assay for coagulation factor deficiencies of the intrinsic coagulation pathway.(b)
Classification. Class II (performance standards).
0
— 8 2009
Premarket Notification 510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| The assigned 510(k) number is: | K08 3729 |
|---|---|
| Submitted by: | Aniara Diagnostica, LLC |
| 6560 Gove Ct | |
| Mason, Ohio 45040 | |
| Contact Person: | Mr. Ola Andersson |
| Phone Number: | (513) 770-1979 |
| Fax Number: | (513) 573-9241 |
| Email address: | Ola@aniara.com |
| Date of 510(k) Preparation: | December, 2008 |
| Name of the Devices: | 1. HEMOCLOT Quanti V-L |
- Factor V-L Calibrator
- BIOPHEN V-L CAL (Undiluted)
- BIOPHEN Act PC-r Control Plasma |
| Classification Name: | Test, Partial Thrombin Time
Secondary Calibrator
Coagulation Control Plasma |
| Class: | II |
| Classification Panels: | Hematology (81) |
| Product Code: | GGW, Test, Partial Thrombin Time
JIT, Calibrator, Secondary
GGN, Plasma, Coagulation Control |
| Regulation numbers: | 864.7925
862.1150
864.5425 |
| Identification of the Predicate Device: | |
COATEST APC Resistance V (K963111) (Chromogenix)
1
Description of the Device:
[All devices are manufactured by Hyphen-Biomed]
-
- HEMOCLOT Quanti V-L is an in vitro diagnostic test kit containing 3 vials of each of the following 2 lyophilized reagents:
R1: Reagent 1: Clotting mixture containing human Fibrinogen, human prothrombin, Protein S at a constant concentration, optimized for the assay, and human Activated Protein C, lyophilized. It also contains a heparin neutralizing substance. Each vial is to be reconstituted with exactly 2 ml of distilled water.
- HEMOCLOT Quanti V-L is an in vitro diagnostic test kit containing 3 vials of each of the following 2 lyophilized reagents:
R2: Reagent 2: Purified Human Factor Xa, containing rabbit brain phospholipds (cephalin), lyophilized. Each vial is to be reconstituted with exactly 1 ml of distilled water.
Calibrators and controls to be used with the test kit are supplied separately. The following calibrators and control are included in this submission:
-
- Factor V-L Calibrator is a calibrator kit containing 3 vials each of 1.0 ml prediluted human plasma (1:20), freeze dried, at 4 different concentrations of FV-L, to cover the assay range, from 10% to 100%. Each vial is restored with 1.0 ml Owren Koller type buffer.
-
- BIOPHEN V-L CAL (Undiluted) is a calibrator kit containing 3 vials each of 0.5 ml undiluted human plasma, freeze dried, at 3 different concentrations of FV-L, to cover the assay range, from about 10% to 100%. Each vial is restored with 0.5 ml distilled water.
- BIOPHEN Act PC-r Control Plasma is a controls kit containing 12 vials of 0.5 ml human 4. plasma, presenting an Activated Protein C Resistance (APC-R), citrated and Iyophilized. Each vial is to be reconstituted with exactly 0.5 ml of distilled water.
- BIOPHEN Normal Control Plasma manufactured by Hyphen-Biomed, is also used with the ട് test kit and is currently marketed in the US under 510(k) # K043451, It is a controls kit containing 12 vials of 1.0 ml of normal citrated human plasma, lyophilized. Each vial is to be reconstituted with exactly 1.0 ml of distilled water.
Intended Use:
-
- HEMOCLOT Quanti V-L is a clotling method for measuring the Factor V Leiden (FVL) activity in human citrated plasma, by its resistance to the action of Activated Protein C (APC). The assay is performed in the presence of Activated Protein S (one single test for each patient). In the presence of APC, the prolongation of clotting time is an inverse relationship of the concentration of Factor V-Leiden (mutation R506Q). Normal Factor V is not measured.
-
- Factor V-L Calibrator is Iyophilized, pre-diluted (1:20) human plasmas, at defined Factor V-Leiden (FV-L) concentrations, for the calibration of Factor V-L activity quantitative clotting assay on human citrated plasma, using the HEMOCLOT Quanti. V-L Kit (ref CK065K).
- BIOPHEN V-L CAL (Undiluted) is Iyophilized, undiluted human plasmas, at defined Factor V-3. Leiden (FV-L) concentrations for the calibration curve of Factor V-L activity quantitative clotting assay on human citrated plasma, using HEMOCLOT Quanti V-L Kit (ref CK065K).
-
- BIOPHEN Act PC-r Control Plasma kit contains human plasma, presenting an activated Protein C Resistance (APC-R), usually correlated with the genetic mutation of Factor V
2
R506Q. This plasma is used as quality control plasma for the testing of Activated Protein C Resistance (APC-R).
-
- (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 | Reagents | Manufacturers | Reference |
|---|---|---|---|
| ATIII | Biophen ATIII | Hyphen Biomed | 221102/221105 |
| Protein C | Biophen Protein C | Hyphen Biomed | 221202/221205 |
| aPC resistance (FV Leiden) | Hemoclot Quanti V-L | Hyphen Biomed | CK065K |
| Lupus | |||
| Anticoagulant | DVVtest®/DVVconfirm® | American | |
| Diagnostica | 810/815/815L |
DVVtest, DVVconfirm are registered trade marks 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/APTT) is ≥ 2.00.
3
Statement of Technological Characteristics of the Device Compared to Predicate Device:
HEMOCLOT Quanti V-L, BIOPHEN V-L CAL (Undiluted), Factor V-L Calibrator, BIOPHEN Act PC-r Control Plasma, and BIOPHEN Normal Control Plasma are substantially equivalent in performance, intended use and safety and effectiveness to COATEST APC Resistance V (K963111).
| Characteristics | HEMOCLOT Quanti V-L, Factor
V-L Calibrator, Biophen V-L
CAL (undiluted), Biophen Act
PC-r Control Plasma, Biophen
Normal Control Plasma | COATEST APC Resistance V
(K963111). Control Plasmas Level 1
and Level 2 are included in this
device. |
|------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | Measurement of Factor V Leiden
activity in human citrated plasma
by its resistance to the action of
Activated Protein C. | Same |
| Assay Type | Clotting Method | Same |
| Test Sample | Human Citrated Plasma | Same |
| Assay Principle | Measurement of Factor V Leiden
coagulation activity based on
insensitivity of Factor V Leiden to
the action of Activated Protein C. | Same |
| Stability of
Unopened
Reagents | Stable at 2-8°C until expiry date | Same |
| Controls,
Normal | Citrated human plasma,
lyophilized, to provide quality
control in the normal range. APC V
Ratio > 2 | Same |
| Controls,
Abnormal (APC
Resistant) | Citrated human plasma,
lyophilized, to provide quality
control for APC resistant range of
the assay. APC V Ratio 25% FVL. | Normal cut-off value (ratio) determined
by assay of normal patient plasmas
and statistical analysis of the results. |
| Test Sample
Dilution | Test sample diluted in Owren
Koller type buffer (not included in
kit). | Test sample diluted with V-Def Plasma
(included in kit). |
| Controls,
Normal | Biophen Normal Control Plasma
sold separately from kit. | Control Plasma Level 1 included in kit. |
| Controls,
Abnormal (APC
Resistant) | Biophen Act. PC-r Control Plasma
sold separately from kit. | Control Plasma Level 2 included in kit. |
| Controls,
Normal &
Abnormal (APC
Resistant) | %FVL