TAS HMT CONTROLS

K960234 · Cardiovascular Diagnostics, Inc. · GGN · May 30, 1996 · Hematology

Device Facts

• Record ID: K960234
• Device Name: TAS HMT CONTROLS
• Applicant: Cardiovascular Diagnostics, Inc.
• Product Code: GGN · Hematology
• Decision Date: May 30, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

Intended Use

The new TAS HMT controls are intended to be used with the TAS Analyzer and HMT cards, previously cleared to market 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 the HMT test results. The controls are substantially equivalent in intended use to other controls used in coagulation assays.

Device Story

TAS HMT controls consist of two vials of lyophilized human plasma (normal and heparin-treated) packaged in a crushable glass ampule within a plastic sleeve containing diluent. Used at point-of-care by clinicians to verify TAS Analyzer and HMT test card performance. Operator crushes ampule to reconstitute plasma, then dispenses drops onto test card. Analyzer measures clotting time; results compared against established ranges to confirm system accuracy. Ensures reliable monitoring of patient heparin response; reduces risk of inaccurate coagulation assessment.

Clinical Evidence

Bench testing and multi-site clinical evaluation. Studies conducted at two clinical sites and CDI over 20 days (duplicate testing). Evaluated within-day, day-to-day, operator-to-operator, lot-to-lot, and vial-to-vial variation. Normal control mean clotting times ranged 133-150s (CV 7.9-9.8%); heparin control mean clotting times ranged 245-259s (CV 3.2-6.4%). Stability testing confirmed 15-week room temperature stability.

Technological Characteristics

Lyophilized human plasma reagent; water diluent. Packaging: crushable glass ampule in plastic sleeve with dropper tip. Principle: in vitro coagulation (fibrin clot formation). Connectivity: none (standalone reagent). Sterilization: not specified. Software: none.

Indications for Use

Indicated for quality control of the TAS Analyzer and HMT cards used to monitor patient response to high doses of heparin. No specific patient population age or gender restrictions apply as this is an in vitro diagnostic control product.

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

• ACT-trol controls for the Activated Clotting Time Test (Analytical Control Systems, ACS)

Reference Devices

• TAS Analyzer (K933092)
• TAS HMT cards (K943283)
• Hemochron device
• Hemotec device

Submission Summary (Full Text)

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CARDIOVASCULAR DIAGNOSTICS INC.
K 960234
MAY 30 1995

# 510(k) Summary

Submitted by: Cynthia Pritchard, Ph.D.
Director of Test Development

Address: Cardiovascular Diagnostic, Inc.
5301 Departure Drive
Raleigh, NC 27604

Phone: [phone], ext. 248

Fax: [phone]

Contact: Cynthia Pritchard, Ph.D.
Director of Test Development

Date of Summary: January 10, 1995

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

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VI. Summary of Safety and Effectiveness Information HMT Controls

**Trade name**: Thrombolytic Assessment System Heparin Management Test Controls (TAS HMT 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 HMT controls provided results that compared well with legally marketed controls, the ACT-trol controls for the Activated Clotting Time Test (Analytical Control Systems, ACS) when used to test the operation of the instrument and test cards. The TAS HMT controls are substantially equivalent to the ACS controls. These latter controls are used in conjunction with disposable tubes for the Hemochron or Hemotec devices, which are used to determine a patient's response to high doses of heparin, which also is the intended use of the TAS Analyzer and HMT cards (see K943283).

**Description of the Device**: The controls for TAS HMT 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 on a high dose of heparin. 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 waste container, and a drop of the plasma suspension is added to a TAS HMT 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 HMT controls are intended to be used with the TAS Analyzer and HMT cards, previously cleared to market 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 the HMT 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
HMT Controls

Comparison of the TAS HMT Controls to the Marketed Controls:

| Characteristic | HMT Controls | ACT Controls |
| --- | --- | --- |
| Intended use | assure performance of system by functional testing | same |
| For use with | HMT cards that measure response to heparin | tests that measure response to heparin |
| Format | glass ampule in plastic sleeve | capped glass bottle |
| Reagent | lyophilized plasma | same |
| Diluent | water | same |
| Source | human | same or animal |
| Reaction | formation of a fibrin clot | same |
| Results | clotting time | same |
| Interpretation of results | system OK if clotting times are within set limits | same |

There were no significant differences in the performance of the HMT controls and the controls from other manufacturers used as predicate device. The normal controls produce a clotting time like that of a normal individual (but have different times for different reagent/instrument combinations). As other control manufacturers, we chose to make an abnormal control that responded as a patient would that is near the mid-range in heparin response. 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 30 minutes for the reagent to reconstitute.

## Nonclinical Performance Data:

HMT controls are stable for at least 15 weeks of storage at room temperature, indicating a probable refrigerator stability of at least one year. Controls produced acceptable results for about 30 minutes after reconstitution, but we recommend that they be run as soon as possible after reconstitution, preferably within five minutes.

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

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Summary of Safety and Effectiveness Information
HMT Controls

Within day, day to day, operator to operator, lot to lot, vial to vial, drop to drop variation studies all produced mean ranges of 133 - 153 and 235 - 260 for the normal and heparin controls, respectively, with CV ranging from 5 to 9%.

Freezing or warming of the intact vials to incubator temperatures for short periods of time has little, if any, effect on the performance of these controls - there was no significant difference in mean or CV for any of the samples tested compared to vials stored in the refrigerator. Temperature of the vials or sample temperature has little, if any effect on the HMT cards results produced with these controls. The angle at which drops from the control vials are dispensed has no significant effect on the mean clotting times or the CV of the results.

## Clinical Performance Data:

Studies were performed at two clinical study sites and at CDI to establish the performance of the TAS HMT controls in the field. At each of the clinical study sites, the TAS HMT normal and heparin controls were tested in duplicate each day for 20 days with the TAS Analyzer and HMT test cards to determine variation.

| | Normal | | Heparin | |
| --- | --- | --- | --- | --- |
| | Mean | CV | Mean | CV |
| Site A | 135 | 9.8 | 245 | 4.2 |
| Site B | 133 | 8.3 | 245 | 3.2 |
| CDI | 150 | 7.9 | 259 | 6.4 |

Conclusions: TAS HMT controls are substantially equivalent to the predicate device because they have the same intended use and the similar technological characteristics. This application includes sufficient information to demonstrate that the TAS HMT controls, to be used with the TAS Analyzer (K933092) and TAS HMT cards (K943283), are safe and effective as a legally marketed device, and that they do not raise different questions of safety and efficacy.

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