(142 days)
Dade® Actin® FS Activated PTT Reagent
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No
The device description and performance studies focus on a chemical reagent for a laboratory test, with no mention of AI/ML terms or functionalities.
No
The device is described as a reagent for the determination of activated partial thromboplastin time in human plasma, making it a diagnostic tool, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" states that Pathromtin SL is "a reagent for the determination of the activated partial thromboplastin time in human plasma," which is a diagnostic measurement.
No
The device description clearly states it is a reagent consisting of physical components (phospholipid and silicon dioxide particles), which are not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is a "reagent for the determination of the activated partial thromboplastin time in human plasma." This is a test performed on a biological sample (human plasma) outside of the body to provide information about a physiological state (blood coagulation).
- Device Description: The description details a reagent used to activate factors in the intrinsic coagulation system, which is a key component of a laboratory test for blood clotting.
- Performance Studies: The performance studies describe analytical performance characteristics (correlation and precision) relevant to a diagnostic test.
These characteristics align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Pathromtin SL is a reagent for the determination of the activated partial thromboplastin time in human plasma.
Product codes
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Device Description
Pathromtin SL is a reagent consisting of a phospholipid (vegetable) and a surface activator (silicon dioxide particles) used to activate the factors of the intrinsic coagulation system.
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
Results of comparative studies using the Pathromtin SL reagent and the Actin® FS aPTT reagent with 212 plasma samples gave a correlation coefficient of 0.96 and a y-intercept of 2.1, and a slope of 0.99.
Precision studies were run over a 5 day period, twice per day, to total n=40. Intra-assay precision was calculated from the n=4 precision values over the 5 days. Intra-assay precision ranges from 0.3-2.5 %CV, while the inter-assay precision ranged from 0.7-3.3 %CV.
Key Metrics
Correlation coefficient: 0.96
y-intercept: 2.1
slope: 0.99
Intra-assay precision: 0.3-2.5 %CV
Inter-assay precision: 0.7-3.3 %CV
Predicate Device(s)
Dade® Actin® FS Activated PTT Reagent
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).
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attachment 1
K95540
510(k) Summary of Safety and Effectiveness for Pathromtin SL
Manufacturer Name, Address, phone number, contact name and date of 1. preparation:
- Behringwerke AG Manufacturer Postfach 1140 35001 Marburg Germany
APR 1 9 1996
000008
Distributor: Behring Diagnostics Inc., 151 University Avenue Westwood, MA 02090 617-320-3153 Contact name: Nancy M Johansen
date of preparation: November 27, 1995
Device Name/Classification: 2.
Reagents for use in the determination of activated partial thromboplastin time/Class II (864 -7925)
3. Identification of the legally marketed device to which the submitter claims equivalence.
Dade® Actin® FS Activated PTT Reagent
Proposed Device Description: 4.
Pathromtin SL is a reagent consisting of a phospholipid (vegetable) and a surface activator (silicon dioxide particles) used to activate the factors of the intrinsic coagulation system.
5. Proposed Device Intended Use:
Pathromtin SL is a reagent for the determination of the activated partial thromboplastin time in human plasma.
6. Medical device to which equivalence is claimed and comparison information:
Pathromtin SL is substantially equivalent in intended use and results obtained to the Actin® FS aPTT reagent. Both assays contain phospholipids (phosphatides) and an activator to initiate the intrinsic coagulation system. Both depend on the addition of calcium chloride to complete the coagulation process.
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Proposed Device Performance characteristics: 7.
Correlation:
をするという
Results of comparative studies using the Pathromtin SL reagent and the Actin® FS aPTT reagent with 212 plasma samples gave a correlation coefficient of 0.96 and a y-intercept of 2.1, and a slope of 0.99.
Precision:
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Precision studies were run over a 5 day period, twice per day, to total n=40. Intra-assay precision was calculated from the n=4 precision values over the 5 days. Intra-assay precision ranges from 0.3-2.5 %CV, while the inter-assay precision ranged from 0.7-3.3 %CV.
Council