TAS PT-NCTEST CONTROLS

K971748 · Cardiovascular Diagnostics, Inc. · GGN · May 29, 1997 · Hematology

Device Facts

• Record ID: K971748
• Device Name: TAS PT-NCTEST CONTROLS
• Applicant: Cardiovascular Diagnostics, Inc.
• Product Code: GGN · Hematology
• Decision Date: May 29, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

Intended Use

The new TAS PT-NC Controls are intended to be used with the TAS Analyzer and the TAS PT-NC test 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 PT-NC test results. The controls are substantially equivalent in intended use to other controls used in coaqulation assays.

Device Story

TAS PT-NC Controls are in vitro coagulation controls used to verify the performance of the TAS Analyzer and TAS PT-NC test cards. The device consists of two vials of lyophilized human plasma: one normal and one mimicking extrinsic coagulation factor deficiency. Packaging utilizes a crushable glass ampoule within a plastic sleeve containing diluent; crushing the ampoule reconstitutes the plasma. The operator dispenses the reconstituted plasma onto a TAS PT-NC test card inserted into the TAS Analyzer. The analyzer processes the sample to produce a clotting time (seconds). Healthcare providers compare the resulting clotting time against established ranges to confirm system integrity. This quality control process ensures the accuracy of patient coagulation testing, benefiting patients by reducing the risk of erroneous clinical decisions based on faulty analyzer performance.

Clinical Evidence

Bench testing and field studies were conducted. Precision studies (within-day and lot-to-lot) showed CVs ranging from 4.1% to 9.1%. Field studies at two sites evaluated normal and abnormal controls over 20 days; normal control means were 10.5-10.7s (CV 6.3-9.9%) and abnormal control means were 45.2-49.7s (CV 8.0-13.6%). Stability testing confirmed at least 13 weeks of room temperature storage. No clinical patient data was required as this is a quality control reagent.

Technological Characteristics

Lyophilized human plasma controls in crushable glass ampoules within plastic sleeves containing water/calcium diluent. Sensing principle: formation of a fibrin clot measured by the TAS Analyzer. Connectivity: standalone. Sterilization: not applicable (in vitro diagnostic reagent).

Indications for Use

Indicated for quality control of the TAS Analyzer and TAS PT-NC test cards to verify system performance and accuracy of coagulation test results. Intended for use by healthcare professionals in point-of-care 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

• TAS PT controls (CVDI)

Reference Devices

• TAS Analyzer (K933092)
• PT-NC test cards (K904325)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Cardiovascular Diagnostics Inc. The logo features the text "CARDIOVASCULAR DIAGNOSTICS INC." in a stacked format at the top. Below the text is a large triangle shape, within which the letters "CD" are prominently displayed in a bold, stylized font. There is also a dark circular stain on the bottom left of the image.

K971748

MAY 2 9 1997

# 510(k) Summary

- Cynthia Pritchard, Ph.D. Submitted by: Director of Test Development
- Cardiovascular Diagnostic, Inc. Address: 5301 Departure Drive Raleigh, NC 27616
- 1-800-247-4234 Phone:
- Fax:

1-919-954-9932

- Cynthia Pritchard, Ph.D. Contact: Director of Test Development ext. 6114
or

James M. Clinton Director of Quality Assurance and Regulatory Affairs ext. 6131

May 5, 1997 Date of Summary:

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#### Summary of Safety and Effectiveness Information TAS PT-NC Controls

Trade name: Thrombolytic Assessment Svstem Prothrombin Time - Noncitrated Test Controls (TAS PT-NC test 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 PT-NC 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 PT-NC Controls are substantially equivalent to TAS PT controls (CVDI), in performance and in intended use, but are specifically to be used with the TAS Analyzer and TAS PT-NC test cards. The TAS PT controls are used with the TAS instrument and TAS PT and PT ONE test cards, which are to be used with citrated blood and plasma samples, to determine the integrity of the reagent/instrument system.

Description of the Device: The controls for TAS PT-NC test 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 an abnormally prolonged clotting time due to a deficiency of extrinsic coagulation factors. These controls are made with human plasma screened for antibodies to and antigens of hepatitis and Human Immunodeficiency viruses. To make the controls as easy to use as possible for point-of-care testing, we chose the patented packaging system of EDITek (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 lyophilized 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 PT-NC 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.

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#### Summary of Safety and Effectiveness Information TAS PT-NC Controls

Intended Use: The new TAS PT-NC Controls are intended to be used with the TAS Analyzer and the TAS PT-NC test 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 PT-NC test results. The controls are substantially equivalent in intended use to other controls used in coaqulation assays.

| Characteristic<br>Controls | TAS PT-NC Controls | TAS PT |
|----------------------------|-------------------------------------------------------|-------------------|
| Intended use | assure performance of system<br>by functional testing | same |
| For use with<br>cards | TAS PT-NC test cards | TAS PT test cards |
| coagulation test system | noncitrated | citrated |
| Format | glass ampoule in plastic sleeve | same |
| Reagent | lyophilized plasma | same |
| Diluent | water plus calcium | water |
| Source | human | same |
| 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 PT-NC Controls to the Marketed Controls

There were no significant differences in the performance of the TAS PT-NC Controls and the TAS PT controls used as the predicate device. The normal control produces a clotting time like that of a normal individual. Like other control manufacturers, we chose to make an abnormal control that responds like a patient with an extrinsic coagulation factor deficiency. The method of packaging the TAS controls for PT and PT-NC 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.

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#### Summary of Safety and Effectiveness Information TAS PT-NC Controls

TAS PT-NC Controls are stable for at least 13 weeks of storage at room temperature (20-25°C) indicating a probable refrigerator stability of at least one year. Controls must be used immediately upon reconstitution to minimize changes in clotting time.

| Within day precision | PT-NC test cards | | | |
|----------------------|------------------|-----|--------|----------------|
| | mean (sec) | SD | CV (%) | mean<br>ranges |
| PT-NC Normal | 10.1 | 1.4 | 4.1 | 9.3 - 11.0 |
| PT-NC Abnormal | 43.3 | 2.9 | 6.6 | 40.4 - 55.6 |

| PT-NC test cards | | | |
|------------------|------------|-----|--------|
| PT-NC Normal | mean (sec) | SD | CV (%) |
| 1 | 10.1 | 1.4 | 4.2 |
| 2 | 11.9 | 1.7 | 5.8 |
| 3 | 12.2 | 0.7 | 6.1 |
| PT-NC Abnormal | | | |
| 1 | 43.5 | 3.0 | 6.9 |
| 2 | 41.4 | 3.4 | 8.3 |
| 3 | 41.8 | 3.8 | 9.1 |

I ot to lot precision (n = 40 each

## Specific Performance Characteristics

The wide range of CV for the abnormal control is due to coagulation changes in the control as time progress. Most of these studies were done with five to ten drops from the same vial. If "first drop" analysis of the clinical and performance data is done, the overall CV for this control (for all days and all experiments) was 7%, which should be more representative of the values expected for QA testing of the TAS Analyzer in the field.

## 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℃ for several days however, will cause an increase in the mean clotting time on PT-NC test 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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Summary of Safety and Effectiveness Information

Clinical Performance Data:

Studies were performed at one clinical study site and at CVDI to establish the performance of the TAS PT-NC Controls in the field. At each of the sites, the TAS PT-NC normal and abnormal controls were tested at least in duplicate each day for 20 days with TAS PT-NC test cards on TAS Analyzers to determine variation.

Field study of TAS PT-NC Controls on TAS PT-NC test cards

| | Normal | | Abnormal | |
|--------|--------|-----|----------|------|
| | Mean | CV | Mean | CV |
| Site A | 10.7 | 9.9 | 45.2 | 13.6 |
| Site B | 10.5 | 6.3 | 49.7 | 8.0 |

Conclusions: TAS PT-NC Controls are substantially equivalent to the predicate device because they have the same intended use and similar technological characteristics. This application includes sufficient information to demonstrate that the TAS PT-NC Controls, to be used with the TAS Analyzer (K933092) and PT-NC test cards (K904325), are as safe and effective as a legally marketed device, and that they do not raise different questions of safety and efficacy.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The text is in all capital letters and is in a sans-serif font.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 2 9 1997

James M. Clinton Director of QA, and Regulatory Affairs Cardiovascular Diaqnostics, Inc. -5301 Departure Drive Raleigh, North Carolina 27616

K971748 Re : TAS PT-NCtest Controls II Requlatory Class: GGN, GJS Product Code: May 7, 1997 Dated: Received: May 12, 1997

Dear Mr. Clinton:

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 Medical Device Amendments, or to devices that have been 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਰ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: -General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation 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 requlations.

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Paqe 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 requlation (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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510(k) Number (if known):

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Indications For Use:

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Concurrence of CDRH, Office of Device Evaluation (20E) (Division Sign-Off) Division of Clinical Kabgrator 510(k) Number Over-The-Counter Use_ ાર Prescription Use (Per 21 CFR 801.109) (Optional Format 1-2-96)