TAS A PTT TEST CONTROLS

K961189 · Cardiovascular Diagnostics, Inc. · GGN · Jun 5, 1996 · Hematology

Device Facts

• Record ID: K961189
• Device Name: TAS A PTT TEST CONTROLS
• Applicant: Cardiovascular Diagnostics, Inc.
• Product Code: GGN · Hematology
• Decision Date: Jun 5, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

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.

Device Story

TAS aPTT Controls consist of two vials of lyophilized human plasma: one normal, one abnormal (mimicking intrinsic/common pathway factor deficiency). Designed for point-of-care use with TAS Analyzer and aPTT test cards. Packaging features a crushable glass ampule containing lyophilized plasma inside a plastic sleeve containing diluent. Operator crushes ampule to reconstitute plasma; dispenses drops onto test card. Device functions as a quality control check; clotting times must fall within established ranges to validate analyzer and test card performance. Benefits include simplified, self-contained reconstitution process, eliminating need for external pipettes or water, facilitating rapid system verification by clinicians.

Clinical Evidence

Clinical comparison studies performed comparing TAS aPTT Controls against Dade controls. Results showed no significant differences in performance; TAS aPTT Controls produced clotting times consistent with normal and factor-deficient patient samples, confirming system functionality.

Technological Characteristics

Lyophilized human plasma controls; packaged in crushable glass ampule within plastic sleeve containing diluent. Reconstitution via mechanical crushing. Used for functional testing of coagulation analyzer and test cards. No electronic components or software.

Indications for Use

Indicated for quality control of the TAS Analyzer and aPTT test cards to verify proper system function and ensure accuracy of aPTT test results in clinical settings.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Ci-trol (Dade; Baxter Diagnostics, Inc.)

Submission Summary (Full Text)

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K961189
JUN - 5 1996

# VI. Summary of Safety and Effectiveness Information

## TAS aPTT Controls

**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.

5301 DEPARTURE DRIVE, RALEIGH, NORTH CAROLINA 27604, [phone]
FAX NUMBER [phone]

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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 |
| | 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.

5301 DEPARTURE DRIVE, RALFIGH, NORTH CAROLINA 27604, [phone]
FAX NUMBER [phone]