(48 days)
ACL 300, ACL 6000, ACL 9000, ACL TOP, E1600C, ACL Futura
No
The summary describes a laboratory diagnostic reagent and its use in a standard coagulation assay (PT). There is no mention of AI/ML in the device description, intended use, or performance studies. The method relies on a calibration curve and interpolation, which is a traditional analytical technique, not AI/ML.
No
The device is an in vitro diagnostic intended for the quantitative determination of factor II activity in plasma and does not provide therapeutic benefit or treatment to a patient.
Yes
The 'Intended Use / Indications for Use' section explicitly states that the device is "intended for the in vitro diagnostic quantitative determination of factor II activity".
No
The device is a reagent (human plasma) used in an in vitro diagnostic test, not a software-only medical device.
Yes, this device is an IVD (In Vitro Diagnostic).
The Intended Use and Device Description explicitly state that it is "intended for the in vitro diagnostic quantitative determination of factor II activity in citrated plasma". This clearly indicates its use in a laboratory setting to diagnose or monitor a condition by testing a sample (plasma) taken from the human body.
N/A
Intended Use / Indications for Use
HemosIL Factor II Deficient Plasma is human plasma immunodepleted of factor II and intended for the in vitro diagnostic quantitative determination of factor II activity in citrated plasma, based on the prothrombin time (PT) assay, on IL Coagulation and ELECTRA Systems.
Product codes
GJT
Device Description
HemosIL Factor II Deficient Plasma is human plasma immunodepleted of factor II and intended for the in vitro diagnostic quantitative determination of factor II activity in citrated plasma, based on the prothrombin time (PT) assay, on IL Coagulation and ELECTRA Systems.
Abnormalities of the extrinsic pathway factors are determined by performing a modified prothrombin time (PT) test. Patient plasma is diluted and added to a plasma deficient in factor II. Correction of the clotting time of the deficient plasma is proportional to the concentration (% activity) of the factor II in the patient plasma, interpolated from a calibration curve.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Method Comparison:
In an in-house method comparison study evaluating approximately 60 citrated plasma samples, the correlation statistics for HemosIL Factor II Deficient Plasma versus the predicate devices are shown below:
| System | slope | intercept | r | Reference method |
|---|---|---|---|---|
| ACL 300 | 1.0357 | 1.0196 | 0.9921 | HemosIL Factor II Deficient Plasma |
| ACL 6000 | 1.0464 | -2.1396 | 0.9954 | HemosIL Factor II Deficient Plasma |
| ACL 9000 | 1.0458 | -1.6123 | 0.9953 | HemosIL Factor II Deficient Plasma |
| ACL TOP | 1.0582 | -4.6831 | 0.9855 | HemosIL Factor II Deficient Plasma |
| E1600C | 1.0603 | -0.2821 | 0.9917 | Hemoliance Factor II Deficient Plasma |
NOTE: HemosIL RecombiPlasTin was used as the PT reagent in testing.
In a separate clinical study (n=61), the following correlation statistics were obtained on an ACL Futura using a specific lot of PT reagent (RecombiPlasTin):
| System | slope | intercept | r | Reference method |
|---|---|---|---|---|
| ACL Futura | 1.0602 | -3.6113 | 0.9946 | HemosIL Factor II Deficient Plasma |
Within Run Precision:
Within run and between run precision was assessed over multiple runs (n=80) on different instruments using a specific lot of PT reagent (RecombiPlasTin) and both normal and abnormal controls.
| Instrument | Control | Mean % Factor II | Within run %CV | Between Run %CV |
|---|---|---|---|---|
| ACL 9000 | Normal Control | 99.2 | 2.5 | 2.0 |
| Special Test Control Level 2 | 33.8 | 2.5 | 4.5 | |
| ACL Futura | Normal Control | 86.8 | 3.9 | 4.7 |
| Special Test Control Level 2 | 25.9 | 6.2 | 3.1 | |
| ACL TOP | Normal Control | 130.6 | 2.8 | 4.3 |
| Special Test Control Level 2 | 28.6 | 3.3 | 4.8 | |
| ELECTRA 1600C | Normal Control | 99.4 | 2.3 | 5.1 |
| Special Test Control Level 2 | 33.3 | 2.8 | 6.4 |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 864.7290 Factor deficiency test.
(a)
Identification. A factor deficiency test is a device used to diagnose specific coagulation defects, to monitor certain types of therapy, to detect coagulation inhibitors, and to detect a carrier state (a person carrying both a recessive gene for a coagulation factor deficiency such as hemophilia and the corresponding normal gene).(b)
Classification. Class II (performance standards).
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