(133 days)
No
The description focuses on a traditional clotting assay and does not mention AI or ML terms or concepts.
No.
The device is intended for the diagnosis of APC resistance phenotype, which is a diagnostic purpose, not a therapeutic one.
Yes
The 'Intended Use / Indications for Use' explicitly states "diagnosis of the APC resistance phenotype," which directly indicates it is a diagnostic device.
No
The device description clearly states it is a "test kit" based on an "APTT clotting assay," which are laboratory-based methods involving physical reagents and equipment, not software alone.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is explicitly stated as "diagnosis of the APC resistance phenotype". This is a diagnostic purpose.
- Device Description: The device is a "test" based on a "clotting assay" using "activated protein C". This describes a laboratory test performed on a biological sample (plasma).
- Performance Studies: The performance studies describe analyzing "plasma" samples to assess the device's ability to discriminate for specific genetic variations related to APC resistance. This further confirms it's a test performed on a biological sample.
These characteristics align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
N/A
Intended Use / Indications for Use
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Product codes
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Device Description
The new device COATEST APC™ RESISTANCE V / COATEST APC™ RESISTANCE V S contains a supplementary component, (factor) V-DEF Plasma.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
The first study shows a correlation (R= 0.74) between the two methods and their discrimination for FV:Q666 on analysis of plasma from 218 acutely ill patients with suspected venous thrombosis or pulmonary emboli and from family members. The second study showed a similar correlation and discrimination for FV:Q56, noted above, between the two methods on analysis of plasma from 399 plasmapheresis donors.
Thrombolyzer and MLA/Electra 900C, were utilized for samples of plasma from patients with myocardial infarction (97) and from healthy controls (132) in the former instrument; and on plasma from thrombotic patients or family members (50), in the latter instrument.
COATEST® APC® RESISTANCE V or V S was used for analysis of plasma from 147 patients on OAC therapy and 61 healthy controls by the ACL 300 and of plasma from 129 patients on OAC therapy and 62 healthy controls by the ST-4 instrument.
Key Metrics
Evaluation of the 50 family members by the MLA/Blectra 900C showed that for normal Factor V genotype an APC ratio of 2.4 - 3.4 was obtained, for the Heterozygous genotype 1.6 - 1.9 and for the Homozygous 1.2 to 1.3.
The results support the fact that the COATEST APC RESISTANCE V or V S has a greater than 99 % sensitivity for FV:Q06.
Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
CHROMOGENIX AB
510(k) Application COATEST APC™ RESISTANCE
DEC 23 1996
510(k) SUMMARY
This summary of 510(k) safety and effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
APC resistance is a newly detected abnormality in hemostasis, which appears to be prevalent in 20 % to 50 % of patients with deep venous thrombosis. This abnormality appears to be at least 10 times more common than inherited deficiencies of any of the other anticoagulant proteins.
APC resistance reflects an impairment of the expression of activated protein C (APC) activity in an individual's plasma and will result in a reduced ability to stop thrombin formation. 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 Plasma. The present documentation intends to show the applicability of V-DEF Plasma in a modification of the original COATEST® APC™ Resistance kit and the sensitivity for the mutation in coagulation factor V is considerably increased. 90 to 95% of all cases with APC resistance are explained by a mutation in the factor V protein rendering the activated form of factor V less susceptible to degradation by APC. The documentation shows the applicability of V-DEF Plasma in a modification of the original COATEST APC® RESISTANCE kit with a considerably increased sensitivity for the mutation in factor V.
COATEST APC RESISTANCE V or V S test is based on the use of activated protein C in an APTT clotting assay, as was the original test kit. Two studies support the substantially equivalency of COATEST APC™ RESISTANCE V or V S (modified method) with COATEST APC® RESISTANCE (original method, K945940).
The first study shows a correlation (R= 0.74) between the two methods and their discrimination for FV:Q666 on analysis of plasma from 218 acutely ill patients with suspected venous thrombosis or pulmonary emboli and from family members. The second study showed a similar correlation and discrimination for FV:Q56, noted above, between the two methods on analysis of plasma from 399 plasmapheresis donors. Thus, the data supports COATEST" APC" RESISTANCE V or V S Substantial Equivalency to the predicated device COATEST® APC RESISTANCE C (K945940) and there is a high discrimination for FV:Q506.
The new method, CQATEST APC RESISTANCE V or V S, correlated well with regard to cases with thrombosis and with homo- or heterozygous factor V mutation. All showed pronounced APC resistance. The homozygous cases were properly discriminated from the heterozygous cases which were separated from the rest.
The safety and efficacy of CONTEST APC® RESISTANCE V or V S is further supported by studies which show that this kit can be utilized on instruments with different clot detection principles and that appropriate results are obtained on analysis of plasmas from patients receiving oral anticoagulants, normal or low molecular weight (LMW) heparin or patients with the phospholipid antibody syndrome.
Thrombolyzer and MLA/Electra 900C, were utilized for samples of plasma from patients with myocardial infarction (97) and from healthy controls (132) in the former instrument; and on plasma from thrombotic patients or family members (50), in the latter instrument. The factor V gene nucleotide at
1
CHROMOGENIX AB
510(k) Application COATEST APC™ RESISTANCE
position 1691 was determined in almost all individuals. A clear and complete discrimination is obtained for FV:Q566 by both instruments and an improvement is obtained as compared to the original kit method. This is illustrated for the patient group. Evaluation of the 50 family members by the MLA/Blectra 900C showed that for normal Factor V genotype an APC ratio of 2.4 - 3.4 was obtained, for the Heterozygous genotype 1.6 - 1.9 and for the Homozygous 1.2 to 1.3.
COATEST® APC® RESISTANCE V or V S was used for analysis of plasma from 147 patients on OAC therapy and 61 healthy controls by the ACL 300 and of plasma from 129 patients on OAC therapy and 62 healthy controls by the ST-4 instrument. The factor V gene nucleotide at position 1691 was determined in all.
Results show a clear discrimination obtained for the FV:Q46 mutation on both ACL and ST-4. Similar ranges of APC ratios are obtained for healthy controls vs patients on OAC, for individuals with a normal factor V genotype, and with heterozygosity and homozygosity for FV:Q566, respectively. Results from the ACL and ST-4 instruments for plasmas from patients on unfractionated and low molecular weight (IMW) heparin at concentrations