(78 days)
Not Found
No
The summary describes a traditional in vitro diagnostic test kit with lyophilized reagents and controls. There is no mention of AI, ML, image processing, or any computational analysis beyond standard laboratory calculations.
No
The device is an in vitro diagnostic assay used for determining resistance to activated protein C, not for treating a disease or condition.
Yes
The device is described as an "in vitro diagnostic (IVD) assay" for the determination of resistance to activated protein C, which is a diagnostic purpose. The performance studies also refer to "diagnostic sensitivity and specificity."
No
The device description clearly states it is an in vitro diagnostic test kit containing lyophilized reagents, which are physical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states the device is a "plasma based functional IVD assay". It is intended for the "decemination of resistance to activated protein C caused by the factor V Leiden mulation". This clearly indicates it is used to test a sample (plasma) in vitro to diagnose or assess a specific condition (resistance to activated protein C due to the Factor V Leiden mutation).
- Device Description: The description details a "test kit containing 3 vials each of the following 4 lyophilized reagents". These reagents are designed to be used in a laboratory setting to perform a diagnostic test on a biological sample.
- Quality Assurance/Quality Control: The mention of a corresponding control kit ("Pefakit® APC-R Factor V Leiden Controls") further supports its use as a diagnostic tool, as controls are essential for ensuring the accuracy and reliability of IVD tests.
- Performance Studies: The document describes non-clinical and clinical studies conducted to evaluate the device's performance, including precision, diagnostic sensitivity, and specificity. These types of studies are standard for demonstrating the effectiveness of IVD devices.
- Predicate Device(s): The identification of predicate devices (K963111; COATEST® APC™ RESISTANCE V / COATEST® APC™ RESISTANCE VS) which are also IVDs, indicates that this device is intended for a similar diagnostic purpose and regulatory pathway.
All of these elements strongly indicate that the device is an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The device is a plasma based functional IVD assay for the decemination of resistance to activated protein C caused by the factor V Leiden mulation (EV-QEAC) vated protein C castin bascu for the december (FV: CS00) on automation of resistance to activated protein C caused by the factor V Leiden mulation (FV: (SOO) on automated a the super of of C backed by the factor v Leiden mulation (FV:Q506) on automated and
Product codes (comma separated list FDA assigned to the subject device)
GGW
Device Description
Pefakit® APC-R Factor V Leiden is an in vitro diagnostic test kit containing 3 vials each of the following 4 lyophilized reagents:
R1: APC / RVV-V (+APC) Reagent (APC, RVV-V, Polybrene, Hepes, BSA)
R2: APC / RVV-V (-APC) Reagent (RVV-V, Polybrene, Hepes, BSA)
R3: PTA Reagent (Prothrombin Activator, EDTA, Hepes, BSA)
R4: Dilution Plasma (Human Plasma, processed)
For Quality Assurance/Quality Control the corresponding control kit 'Pefakit® APC-R Factor V Leiden Controls' has to be used. It contains 3 vials each of the following 2 lyophilized control plasmas:
C1: pooled human plasma from donors confirmed to be normal wild-type by FV Leiden PCR testing
C2: pooled human plasma from donors confirmed to be heterozygous by FV Leiden PCR testing
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)
Non-clinical tests were done in-house to determine precision, diagnostic sensitivity and specificity, interferences, stability, and batch-to-batch variability.
The device was shown to have a high precision within the series (20 tests) and from day to day (10 days) on all instruments tested so far, with an overall coefficient of variation (CV)
§ 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
DEC 22 2004
510(k) SUMMARY
Pefakit® APC-R Factor V Leiden
In accordance with the requirements of Safe Medical Devices Act (SMDA) of 1990, a 510(k) summary is provided as outlined in 21 CFR 807.92.
Part A
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- Submitter's name, address, telephone number, contact person, and the date the summary was prepared
| Submitter's Name: | Pentapharm Ltd. |
|---|---|
| Submitter's Address: | Engelgasse 109 |
| CH-4002 Basel/Switzerland | |
| Submitter's Telephone Number: | ++41 61 706 48 48 |
| Submitter's Contact: | Reto Schöni, PhD |
| Regulatory Affairs Specialist Diagnostics, | |
| R&D Hemostasis and Test Kit Development | |
| Date of 510(k) Preparation: | September 30, 2004 |
-
- Name of the device, including the trade or proprietary name, the common or usual name and the classification name
| Trade or Proprietary Name: | Pefakit® APC-R Factor V Leiden |
|---|---|
| Common or Usual Name: | APC Resistance Test |
| Classification Name: | Hematology, Factor Deficiency Test |
3. Identification of the legally marketed device to which the submitter claims substantial equivalence
| Predicate Device Name: | COATEST® APC™ RESISTANCE V /
COATEST® APC™ RESISTANCE VS |
|------------------------|-------------------------------------------------------------|
| 510(k) Number: | K963111 |
| Regulation Number: | 864.7925 |
| Regulatory Class: | II |
1
4. Description of the device
Pefakit® APC-R Factor V Leiden is an in vitro diagnostic test kit containing 3 vials each of the following 4 lyophilized reagents:
R1: APC / RVV-V (+APC) Reagent (APC, RVV-V, Polybrene, Hepes, BSA)
R2: APC / RVV-V (-APC) Reagent (RVV-V, Polybrene, Hepes, BSA)
R3: PTA Reagent (Prothrombin Activator, EDTA, Hepes, BSA)
R4: Dilution Plasma (Human Plasma, processed)
For Quality Assurance/Quality Control the corresponding control kit 'Pefakit® APC-R Factor V Leiden Controls' has to be used. It contains 3 vials each of the following 2 lyophilized control plasmas:
C1: pooled human plasma from donors confirmed to be normal wild-type by FV Leiden PCR testing
C2: pooled human plasma from donors confirmed to be heterozygous by FV Leiden PCR testing
5. Statement on the intended use of the device
Pefakit® APC-R Factor V Leiden is a plasma based functional assay for the determination of resistance to activated protein C caused by the factor V Leiden mutation (FV:Q506).
6. Summary of the technological characteristics of the new device in comparison to those of the predicate device
The predicate device COATEST® APC™ RESISTANCE V / COATEST® APC™ RESISTANCE VS is an aPTT-based test which contains purified phospholipids and colloidal silica as contact activator. It makes use of excess FV deficient plasma to enhance the sensitivity of the test. It also contains polybrene to antagonize heparin eventually present in the patient's blood.
The new device Pefakit® APC-R Factor V Leiden also uses FV deficient plasma and polybrene with the same goal. It was shown that not only heparin is antagonized, but also the more and more frequently used heparinoids like low molecular weight heparins (LMWH) or pentasaccharide (PES). In contrast to the predicate device it is prothrombin based. It means that it is not aPTT based and contains no phosphorlipids. This feature makes it insensitive to even high titres of lupus anticoagulants present in the blood of LAC patients. The formation/activation of thrombin from prothrombin present in the patients blood is induced by a specific FVa-dependent and Ca2+ -independent prothrombin activator (Noscarin) purified from the venom of the tiger snake Notechis scutatus. Thus the test is also independent from all other factors influencing the thrombin formation based on the prothrombinase complex.
Discrimination of different patients with different factor V Leiden genotypes is based on a ratio. As for the predicate device this ratio is calculated from the clotting times measured using a reagent containing activated protein C (+APC reagent) and a reagent containing no activated Protein C (-APC reagent). Both reagents are added to
2 ·
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the patient's plasma sample previously diluted with FV deficient plasma. In contrast to the predicate device in the proposed device a specific FV activator (RVV-V) purified from the venom of Russel's Viper (Daboia russelli) activates the FV present in the patients blood, which makes the test also independent from all other factors present in the patients blood influencing FV activation by other means.
Part B
1. Brief discussion of the non-clinical tests submitted, referenced , or relied on in the premarket notification submission for a determination of substantial equivalence
Non-clinical tests were done in-house to determine precision, diagnostic sensitivity and specificity, interferences, stability, and batch-to-batch variability.
The device was shown to have a high precision within the series (20 tests) and from day to day (10 days) on all instruments tested so far, with an overall coefficient of variation (CV)