THROMBOLYTIC ASSESSMENT SYSTEM LOW RANGE HEPARIN MANAGEMENT TEST CONTROLS

K981178 · Cardiovascular Diagnostics, Inc. · GGN · Apr 27, 1998 · Hematology

Device Facts

• Record ID: K981178
• Device Name: THROMBOLYTIC ASSESSMENT SYSTEM LOW RANGE HEPARIN MANAGEMENT TEST CONTROLS
• Applicant: Cardiovascular Diagnostics, Inc.
• Product Code: GGN · Hematology
• Decision Date: Apr 27, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

Intended Use

The new TAS LHMT Controls are intended to be used with the TAS Analyzer and the TAS LHMT card 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 TAS LHMT results.

Device Story

TAS LHMT Controls are in vitro coagulation controls used to verify performance of TAS Analyzer and TAS LHMT cards; system used for point-of-care testing. Controls consist of two vials: one mimicking normal plasma, one mimicking plasma with prolonged clotting time due to heparin. Controls utilize pig plasma packaged in crushable glass ampoules within plastic sleeves containing diluent. Operator crushes ampoule to reconstitute plasma; dispenses drops onto TAS LHMT card. Analyzer measures clotting time; results compared against established ranges to confirm system integrity. Benefits include user-friendly, rapid quality control without need for external pipetting or water. Output is clotting time in seconds; healthcare providers use output to validate system accuracy before patient testing.

Clinical Evidence

Bench testing only. Precision studies performed: within-day precision (n=not specified) showed CVs of 1.1% (normal) and 3.3% (heparin). Lot-to-lot precision (n=30 per lot) showed CVs ranging from 1.0% to 5.7%. Stability testing confirmed 6-week room temperature stability. Effects of freezing and dispensing angle were evaluated; no significant impact on clotting time performance observed.

Technological Characteristics

Lyophilized pig plasma reagent; diluent contains water and antifoam. Packaging: crushable glass ampoule inside plastic sleeve with dropper tip and filter. Sensing principle: fibrin clot formation measured by TAS Analyzer. Connectivity: standalone. Sterilization: not specified.

Indications for Use

Indicated for quality control of the TAS Analyzer and TAS LHMT card system to verify proper functioning and accuracy of coagulation test results.

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

• TAS HMT controls (CVDI)

Submission Summary (Full Text)

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K 981178

APR 2 7 1998

# וחוקים חיים חיים ו

# 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92.

The assigned 510(k) number is __

Submitted by:

Cynthia Pritchard, Ph.D. Director of Test Development

Address:

Cardiovascular Diagnostic, Inc. 5301 Departure Drive Raleigh, NC 27616

1-800-247-4234 Phone:

1-919-954-9932 Fax:

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

or

Peter Scott VP of Quality Assurance and Regulatory Affairs

Date of Summary: March, 1998

PA
class II

SK-36

5301 Departure Drive, Raleigh, North Carolina 27616, [phone] FAX NUMBER [phone]

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Summary of Safety and Effectiveness Information TAS LHMT Controls

Trade name: Thrombolytic Assessment System Low Range heparin Management Test Controls (TAS LHMT 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 CFR864.5425)

Predicate Device: TAS LHMT Controls provided results that compared well with other legally marketed controls when used to test the operation of the TAS Analyzer and test cards. TAS LHMT Controls are substantially equivalent to TAS HMT controls (CVDI), in performance and in intended use, but are specifically to be used with the TAS Analyzer and TAS LHMT cards. The TAS HMT controls are used with the TAS instrument and TAS HMT cards, which are to be used with noncitrated blood and citrated blood and plasma samples, to determine the integrity of the reagent/instrument system.

Description of the Device: The controls for TAS LHMT cards consist 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 prolonged clotting time due to administration of heparin. These controls are made with pig plasma. To make the controls as easy to use as possible for point-of-care testing, we chose the patented packaging system of Medtox, (Burlington, NC). This consists of a closed, crushable glass ampoule containing lyophilized plasma which is inside a plastic sleeve. The sleeve contains water for diluent and has a capped dropper top with a filter in the tip (to remove glass shards from the sample). The entire assembly is shrink wrapped with a label and plastic seal. To use, the ampoule is crushed inside the plastic sleeve, which allows the diluent to mix with the Ivophilized plasma. The mixture is reconstituted by shaking or vortexing the capped vial. The plastic seal and cap are removed and three drops of plasma suspension are discarded into a biohazard waste container (to eliminate the dilution effect of the diluent that is contained in the filter). A drop of the plasma suspension is added to a TAS LHMT 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 LHMT Controls are intended to be used with the TAS Analyzer and the TAS LHMT card to provide a method for quality control of the system. The controls produce clotting times which must be within accepted.

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#### Summary of Safety and Effectiveness Information TAS LHMT Controls

standard ranges, to indicate that the analyzer and test cards are functioning properly and thereby help assure the accuracy of TAS LHMT results. The controls are substantially equivalent in intended use to other controls used in coaqulation assays.

| Characteristic | TAS LHMT Control | TAS HMT Control |
|---------------------------|-------------------------------------------------------|-----------------|
| Intended use | assure performance of system<br>by functional testing | same |
| For use with | TAS LHMT cards | TAS HMT cards |
| coaqulation test system | citrated | citrated |
| Format | glass ampoule in plastic sleeve | same |
| Reagent | lyophilized plasma | same |
| Diluent | water plus antifoam | same |
| Source | pig | human |
| Reaction | formation of a fibrin clot | same |
| Results | clotting time (seconds) | same |
| Interpretation of results | system OK if clotting times<br>are within set limits | same |

## Comparison of the TAS LHMT Controls to the Marketed Controls

There were no significant differences in the performance of the TAS LHMT Controls and the TAS HMT controls used as the predicate device. The normal control produces a clotting time like that of a normal individual; the heparin control mimics the response of a patient given a moderate level of heparin. The method of packaging the TAS controls for HMT and LHMT are the same, 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.

TAS LHMT Controls are stable for at least 6 weeks of storage at room temperature (20-25°C) indicating a probable refrigerator stability of at least six months. Reconstituted vials are stable for five minutes.

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# Summary of Safety and Effectiveness Information

### TAS LHMT Controls

| Within day precision | LHMT cards | | |
|----------------------|------------|-----|--------|
| | mean (sec) | SD | CV (%) |
| Normal | 151 | 1.7 | 1.1 |
| Heparin | 296 | 9.8 | 3.3 |

# Lot to lot precision (n = 30 each)

| | LHMT cards | | | |
|---------|------------|-----|--------|-----|
| | mean (sec) | SD | CV (%) | |
| Normal | 1 | 152 | 3.5 | 2.3 |
| | 2 | 153 | 1.9 | 1.3 |
| | 3 | 153 | 1.5 | 1.0 |
| Heparin | 1 | 293 | 10.8 | 3.7 |
| | 2 | 296 | 13.0 | 4.4 |
| | 3 | 293 | 16.7 | 5.7 |

### Nonclinical Performance Data:

Freezing the intact vials has little effect on the performance of these controls; there was no significant difference in mean or CV produced by any of the controls stored at -80°C compared to vials stored in the refrigerator. Heating intact vials to 37°C for several days however, will cause an increase in the mean clotting time on LHMT cards. The angle at which drops from the control vials are dispensed has little effect on the mean clotting times or the CV of the results.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three heads facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

APR 27 1998

Cynthia Pritchard, Ph.D. Executive Director of Development Cardiovascular Diagnostics Inc. 5301 Departure Drive Raleigh, North Carolina 27616

K981178 Re : TAS LHMT Controls Requlatory Class: II Product Code: GGN Dated: April 1, 1998 Received: April 1, 1998

Dear Dr. Pritchard:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval); it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice reguirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. this response to your premarket notification submission does not affect any obliqation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

sincerely yours,
Steven Litman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page **_ of _**

510(k) Number (if known): 4 MT contro Device Name:

Indications For Use:

Iatrided for use with the TAS analyzer
and TAB LHMT cards to provide a
method for quality control of the
- oyoted!

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K981178

Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)