K Number
K954625
Device Name
PROTHROMBIN TIME TEST CARD
Date Cleared
1996-03-11

(166 days)

Product Code
Regulation Number
864.7750
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The new TAS PT test card, as the existing marketed TAS PT test card made with rabbit brain thromboplastin, is intended to be used with the TAS Analyzer to determine the prothrombin time in citrated whole blood or plasma.
Device Description
The TAS Prothrombin Time test card provides a one stage method which measures the clotting time of a sample after combining it with activator. This test consists of a single card that contains calcium chloride to initiate clotting in citrated blood samples, tissue thromboplastin as an activator, buffer, and stabilizers. Samples are tested by drawing venous or arterial blood into a sodium citrate tube and briefly mixing by gentle inversion. This allows the operator to control the start of the clotting reaction which requires recalcification. Because the sample is citrated, additional tests such as aPTT can be performed with the same sample. The test card has a magnetic stripe on the back which encodes lot specific information such as number, expiration date, and calibration factors specific to that lot. A room temperature test card is removed from the pouch and the card is passed through the instrument's stripe reader to program the instrument to run a PT. The instrument then requests patient and sample information and instructs the operator to insert a PT test card. The card is quickly warmed and the operator is prompted to add a sample drop of blood to the card sample well. The sample is drawn into the card and rehydrates the PT reagent which recalcifies the sample and begins the clotting reaction. As the reaction proceeds and clotting begins, the movement of the particles decreases, and the instrument signals the clotting time. Low levels of extrinsic clotting factors will cause prolongation of clotting time.
More Information

Not Found

No
The description focuses on a chemical reaction and physical measurement of clotting time, with no mention of AI/ML algorithms for analysis or interpretation.

No.
The device is an in vitro diagnostic test card used to determine prothrombin time, which is a diagnostic measurement, not a therapeutic intervention.

Yes

The intended use explicitly states that the device is used "to determine the prothrombin time in citrated whole blood or plasma," which is a measurement used for diagnostic purposes.

No

The device description clearly describes a physical test card containing reagents and a magnetic stripe, which is a hardware component. The device interacts with an "instrument" (TAS Analyzer) which is also a hardware component.

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use explicitly states it is used "to determine the prothrombin time in citrated whole blood or plasma." This is a diagnostic measurement performed on a biological sample (blood or plasma) outside of the body.
  • Device Description: The description details how the device interacts with a biological sample (blood or plasma) to perform a test (measure clotting time) using reagents contained within the device. This is the core function of an in vitro diagnostic device.
  • Sample Type: The device uses "citrated whole blood or plasma," which are biological samples.
  • Measurement: It measures "prothrombin time," which is a diagnostic parameter related to blood clotting.

The definition of an In Vitro Diagnostic (IVD) device is a medical device that is intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.

This device clearly fits this definition.

N/A

Intended Use / Indications for Use

The new TAS PT test card, as the existing marketed TAS PT test card made with rabbit brain thromboplastin, is intended to be used with the TAS Analyzer to determine the prothrombin time in citrated whole blood or plasma.

Product codes

Not Found

Device Description

The TAS Prothrombin Time test card provides a one stage method which measures the clotting time of a sample after combining it with activator. This test consists of a single card that contains calcium chloride to initiate clotting in citrated blood samples, tissue thromboplastin as an activator, buffer, and stabilizers. Samples are tested by drawing venous or arterial blood into a sodium citrate tube and briefly mixing by gentle inversion. This allows the operator to control the start of the clotting reaction which requires recalcification. Because the sample is citrated, additional tests such as aPTT can be performed with the same sample. The test card has a magnetic stripe on the back which encodes lot specific information such as number, expiration date, and calibration factors specific to that lot. A room temperature test card is removed from the pouch and the card is passed through the instrument's stripe reader to program the instrument to run a PT. The instrument then requests patient and sample information and instructs the operator to insert a PT test card. The card is quickly warmed and the operator is prompted to add a sample drop of blood to the card sample well. The sample is drawn into the card and rehydrates the PT reagent which recalcifies the sample and begins the clotting reaction. As the reaction proceeds and clotting begins, the movement of the particles decreases, and the instrument signals the clotting time. Low levels of extrinsic clotting factors will cause prolongation of clotting time.

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)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K882456

Reference Device(s)

Not Found

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

§ 864.7750 Prothrombin time test.

(a)
Identification. A prothrombin time test is a device used as a general screening procedure for the detection of possible clotting factor deficiencies in the extrinsic coagulation pathway, which involves the reaction between coagulation factors III and VII, and to monitor patients receiving coumarin therapy (the administration of one of the coumarin anticoagulants in the treatment of venous thrombosis or pulmonary embolism).(b)
Classification. Class II (performance standards).

0

K. C. K. A. C. -

MAR 1

Summary of Safety and Effectiveness Information VI.

Trade name: Thrombolytic Assessment System Prothrombin Time Test Card (TAS PT Test Card)

Common Name: PT Test

Classification Name: systems for in vitro coagulation studies, automated or semiautomated instruments and associated reagents and controls used to perform a series of coagulation studies and coagulation factor assays (Class II. 21 C.F.R. 864.5425)

Predicate Device: The proposed TAS PT test card made with thromboplastin from human placenta is substantially equivalent to the marketed TAS PT test card made with rabbit brain thromboplastin (K882456).

Description of the Device: The TAS Prothrombin Time test card provides a one stage method which measures the clotting time of a sample after combining it with activator. This test consists of a single card that contains calcium chloride to initiate clotting in citrated blood samples, tissue thromboplastin as an activator, buffer, and stabilizers. Samples are tested by drawing venous or arterial blood into a sodium citrate tube and briefly mixing by gentle inversion. This allows the operator to control the start of the clotting reaction which requires recalcification. Because the sample is citrated, additional tests such as aPTT can be performed with the same sample. The test card has a magnetic stripe on the back which encodes lot specific information such as number, expiration date, and calibration factors specific to that lot. A room temperature test card is removed from the pouch and the card is passed through the instrument's stripe reader to program the instrument to run a PT. The instrument then requests patient and sample information and instructs the operator to insert a PT test card. The card is quickly warmed and the operator is prompted to add a sample drop of blood to the card sample well. The sample is drawn into the card and rehydrates the PT reagent which recalcifies the sample and begins the clotting reaction. As the reaction proceeds and clotting begins, the movement of the particles decreases, and the instrument signals the clotting time. Low levels of extrinsic clotting factors will cause prolongation of clotting time.

Intended Use. The new TAS PT test card, as the existing marketed TAS PT test card made with rabbit brain thromboplastin, is intended to be used with the TAS Analyzer to determine the prothrombin time in citrated whole blood or plasma.

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