(71 days)
No Reference Device(s) K/DEN numbers were found in the text.
No
The summary describes a quality control material for a coagulation assay, not a device that processes data or makes decisions using AI/ML.
No
The device is a quality control product for an aPTT testing system, used to ensure the accuracy of test results, not to directly treat a patient.
No
This device is described as "controls" to "provide a method for quality control of the system." It is used to ensure the proper functioning of the analyzer and test cards, not to diagnose a patient's condition.
No
The device description clearly describes physical components (vials, ampules, plastic sleeves, diluent, lyophilized plasma) and a physical process (crushing ampules, mixing, adding drops to a test card). This is a physical control material, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the controls are used "to provide a method for quality control of the system" (TAS Analyzer and aPTT cards) and "to indicate that the analyzer and test cards are functioning properly and thereby help assure the accuracy of aPTT test results." This aligns with the definition of an IVD, which is used to examine specimens derived from the human body to provide information for diagnostic purposes. While the controls themselves aren't directly diagnosing a patient, they are essential for ensuring the accuracy of a diagnostic test (aPTT).
- Device Description: The description details the composition of the controls (human plasma) and how they are used with the TAS Analyzer and aPTT cards, which are cleared by the FDA for diagnostic testing.
- Predicate Device: The mention of a predicate device (Ci-trol; Dade; Baxter Diagnostics, Inc.) which is a legally marketed control for the aPTT test, further supports its classification as an IVD. Controls for diagnostic tests are considered IVDs.
Therefore, based on the provided information, the TAS aPTT Controls are intended to be used in vitro (outside the body) to assess the performance of a diagnostic system, making them an IVD.
N/A
Intended Use / Indications for Use
The new TAS aPTT Controls are intended to be used with the TAS Analyzer and aPTT cards, cleared by the FDA, to provide a method for quality control of the system. The controls produce clotting times which must be within accepted, standard ranges, to indicate that the analyzer and test cards are functioning properly and thereby help assure the accuracy of aPTT test results. The controls are substantially equivalent in intended use to other controls used in coagulation assays.
Product codes
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Device Description
The controls for TAS aPTT cards consists of two separate vials. One was designed to mimic a sample from a normal individual, and the second to mimic a sample from a patient with a clotting factor deficiency of the intrinsic or common coagulation pathway. These controls are made with human plasma screened for antibodies to and antigens of human immunodeficiency and hepatitis viruses. To make the controls as easy to use as possible for point-of-care testing, we chose the patented packaging system of EDItek. This consists of a closed, crushable glass ampule containing lyophilized plasma which is inside a plastic sleeve. The sleeve contains water for diluent and has a capped dropper top with a filter tip. The entire assembly is shrink wrapped with a label and plastic seal. To use, the ampule is crushed inside the plastic sleeve, which allows the diluent to mix with the lyophilized plasma. The mixture is reconstituted by shaking or vortexing the capped vial. The plastic seal and cap are removed, two drops of plasma are discarded into a biohazard waste container, and a drop of the plasma suspension is added to a TAS aPTT test card in an analyzer. The rest of the test procedure and the manner of signal production is identical to that for a patient sample.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 864.5425 Multipurpose system for in vitro coagulation studies.
(a)
Identification. A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.(b)
Classification. Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
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Image /page/0/Picture/0 description: The image shows a sequence of handwritten digits and a letter. The sequence starts with the letter 'K', followed by the numbers '961189'. The numbers are written in a bold, slightly irregular style, giving them a distinct, handwritten appearance. The image has a clear contrast between the dark characters and the white background, making the sequence easily readable.
JUN - 5 1996
Summary of Safety and Effectiveness Information TAS aPTT Controls VI.
Trade name: Thrombolytic Assessment System activated Partial Thromboplastin Test Controls (TAS aPTT Controls)
Common Name: in vitro coagulation controls
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: In clinical comparison studies the TAS aPTT Controls provided results that compared well with other legally marketed controls for the aPTT test (Ci-trol; Dade; Baxter Diagnostics, Inc.) when used to test the operation of the TAS Analyzer and test cards. The TAS aPTT Controls are substantially equivalent to the Dade controls, in performance and in intended use, but are specifically to be used with the TAS Analyzer and aPTT test cards. The Dade controls are used with instruments from many different manufacturers, including the TAS Analyzer, to determine the aPTT, a test which is used to screen for factor deficiencies and inhibitors in the intrinsic and common pathways, and to monitor anticoagulant therapy.
Description of the Device: The controls for TAS aPTT cards consists of two separate vials. One was designed to mimic a sample from a normal individual, and the second to mimic a sample from a patient with a clotting factor deficiency of the intrinsic or common coagulation pathway. These controls are made with human plasma screened for antibodies to and antigens of human immunodeficiency and hepatitis viruses. To make the controls as easy to use as possible for point-of-care testing, we chose the patented packaging system of EDItek. This consists of a closed, crushable glass ampule containing lyophilized plasma which is inside a plastic sleeve. The sleeve contains water for diluent and has a capped dropper top with a filter tip. The entire assembly is shrink wrapped with a label and plastic seal. To use, the ampule is crushed inside the plastic sleeve, which allows the diluent to mix with the lyophilized plasma. The mixture is reconstituted by shaking or vortexing the capped vial. The plastic seal and cap are removed, two drops of plasma are discarded into a biohazard waste container, and a drop of the plasma suspension is added to a TAS aPTT test card in an analyzer. The rest of the test procedure and the manner of signal production is identical to that for a patient sample.
Intended Use:The new TAS aPTT Controls are intended to be used with the TAS Analyzer and aPTT cards, cleared by the FDA, to provide a method for quality control of the system. The controls produce clotting times which must be within accepted, standard ranges, to indicate that the analyzer and test cards are functioning properly and thereby help assure the accuracy of aPTT test results. The controls are substantially equivalent in intended use to other controls used in coagulation assays.
1
Summary of Safety and Effectiveness Information
TAS aPTT Controls
Comparison of the TAS aPTT Controls to the Marketed Controls:
| Characteristic | TAS aPTT Controls | Dade Controls |
|---|---|---|
| Intended use | assure performance of system | |
| by functional testing | same | |
| For use with | TAS aPTT test cards | coagulation systems that |
| measure the PT and aPTT | ||
| Format | citrated coagulation test system | same |
| Format | glass ampule in plastic sleeve | capped glass bottle |
| Reagent | lyophilized plasma | same |
| Diluent | water | same |
| Source | human | same |
| Reaction | formation of a fibrin clot | same |
| Results | clotting time (seconds) | same |
| Interpretation of results | system OK if clotting times | |
| are within set limits | same |
There were no significant differences in the performance of the TAS aPTT Controls and the control from another manufacturer used as predicate device. The normal control produces a clotting time like that of a normal individual (but have different times for different reagent/instrument combinations). Like other control manufacturers, we chose to make an abnormal control that responds like a patient that has a severe factor deficiency of the intrinsic coagulation pathway. The method of packaging TAS controls is different, to make them more "user-friendly" for point-of-care testing. With this system, an operator does not have to search for a pipetting device and reagent-grade water for reconstitution, and does not have to wait for the reagent to reconstitute.