COAGULATION CONTROL LEVEL 2 (ABNORMAL)

K984130 · Pacific Hemostasis · GGC · Dec 1, 1998 · Hematology

Device Facts

• Record ID: K984130
• Device Name: COAGULATION CONTROL LEVEL 2 (ABNORMAL)
• Applicant: Pacific Hemostasis
• Product Code: GGC · Hematology
• Decision Date: Dec 1, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

Intended Use

Pacific Hemostasis Coagulation Control Level 2 is intended for use as a control to monitor the performance of Prothrombin Time (PT) and Activated Partial Time (APTT) testing. It will yield PT and APTT values in the moderately abnormal range.

Device Story

Device is a lyophilized preparation of citrated human plasma from healthy donors; adjusted to yield prolonged PT and APTT values; includes added stabilizers and buffers. Used in clinical laboratory settings by laboratory personnel to monitor the performance of coagulation assays. Provides a reference point for moderately abnormal clotting times; ensures accuracy and reliability of patient test results. Benefits patient by verifying that coagulation testing equipment and reagents are functioning correctly, reducing risk of erroneous clinical decisions regarding anticoagulant therapy or bleeding disorders.

Clinical Evidence

Bench testing only. Precision studies compared Pacific Hemostasis Coagulation Control Level 2 to Dade Ci-Trol Coagulation Control Level II. Between-run precision (20 duplicate measurements over 10 days) showed CVs < 5% for PT and APTT. Within-run precision (3 runs of 20 duplicates) showed average CVs < 7% for PT and < 1% for APTT. Data confirms performance equivalence.

Technological Characteristics

Lyophilized preparation of citrated human plasma; contains added stabilizers and buffers. Form factor is a lyophilized powder for reconstitution. No electronic, software, or mechanical components. Sterility is not applicable as this is an in vitro diagnostic control.

Indications for Use

Indicated for use as a quality control material to monitor the performance of Prothrombin Time (PT) and Activated Partial Thromboplastin Time (APTT) coagulation assays in the moderately abnormal range.

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

• Dade Ci-Trol Coagulation Control Level II (K771346)

Submission Summary (Full Text)

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#### DEC 1998 -

# 84130

510(K) Summarv Coagulation Control Level 2 (Abnormal)

### PREMARKET NOTIFICATION 510(K) SUMM 7.0

Applicant:

Laura A. Worfolk, Ph.D. Pacific Hemostasis 11515 Vanstory Drive Huntersville, NC 28078 [phone]

Contact Person:

| Fax # [phone] | |
|----------------------|-----------------------------------------------------------|
| Date: | November 12, 1998 |
| Trade Name: | Coagulation Control Level 2 (Abnormal) |
| Common Name: | Abnormal Coagulation Control |
| Classification Name: | Plasma, Coagulation Control (per 21 CFR section 864.5425) |
| Equivalent Device: | Dade Ci-Trol Coagulation Control Level II, K771346 |

Mark Ellis, Regulatory Affairs Manager, phone #[phone]

## Description of Coagulation Control Level 2 (Abnormal)

Pacific Hemostasis Coagulation Control Level 2 (Abnormal) is a lyophilized preparation of citrated plasma obtained from healthy donors, which has been adjusted to yield prolonged Prothrombin Time and Activated Partial Time values. Stabilizers and buffers have been added to the plasma prior to lyophilization. Each unit of source material used in the preparation of the reagent has been tested by an FDA approved method and found non-reactive for HBsAG and negative for antibodies to HIV and HCV.

### Intended Use of Coagulation Control Level 2 (Abnormal)

Pacific Hemostasis Coagulation Control Level 2 is intended for use as a control to monitor the performance of Prothrombin Time (PT) and Activated Partial Time (APTT) testing. It will yield PT and APTT values in the moderately abnormal range.

## Summary of Performance Data for Substantial Equivalence Comparisons

Between-run and within-run precision studies yielded substantially equivalent data for Pacific Hemostasis and Dade Brand Coagulation Controls Level 2 (II) (Table 1). For both controls a CV of less than 5% was obtained for PT and APTT between-run testing. The average CV's obtained for within-run precision were less than 7% for PT testing, and less than 1% for APTT testing of both products.

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| | 510(K) Summary Table 1. Data Summary | | | |
|-----------------------------------------------------------------------------------------|----------------------------------------|----------------------------------------|-----------------------------------------------|----------------------------------------|
| | Prothrombin Time Testing | | Activated Partial Thromboplastin Time Testing | |
| | PH | Dade | PH | Dade |
| Between-run Precision<br>(20 duplicate<br>measurements over a 10<br>day period) | mean = 41.0<br>SD = 1.76<br>CV% = 4.29 | mean = 37.3<br>SD = 1.86<br>CV% = 4.97 | mean = 45.4<br>SD = 1.10<br>CV% = 2.42 | mean = 39.0<br>SD = 0.59<br>CV% = 1.52 |
| Within-run Precision<br>(3 runs of 20 duplicate<br>measurements, average<br>%CV shown.) | 5.31 | 6.12 | 0.73 | 0.71 |

## Conclusion

Pacific Hemostasis and Dade brand Coagulation Control Level 2(II) have the same intended use, to monitor coagulation assays in the moderately abnormal range. Both are preparations of normal donor citrated plasma with added stabilizers and buffers, that have been adjusted to yield prolonged clotting The performance data presented here, as well as the indistinguishable intended use and times. technological characteristics support the substantial equivalence claim for Pacific Hemostasis Coagulation Control Level 2 to Dade Ci-Trol Coagulation Control Level II. Based on the data provided, it is our conclusion that these two products are substantially equivalent.

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# MARKET NOTIFICATION

TRUTHFUL AND ACCURATE STATEMENT [As required by 21 CFR 807.87(j)]

I certify that in my capacity as a Research Scientist at Pacific Hemostasis, a Fisher Scientific Company, I believe to the best of my knowledge, that all data and information submitted in the premarket notification are truthful and accurate and that no material fact has been omitted.

Laura A. Worfolk

Laura A. Worfolk, Ph.D.

11/12/98

K984130

(Premarket Notification [510(k)] Number)

(Premarket Notification [510(k)] Number)

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Image /page/3/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image that resembles an eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 1 1998

Mark Ellis Regulatory Manager Pacific Hemostasis 11515 Vanstory Drive Huntersville, NC 28078

K984130 Re: Trade Name: Coagulation Control Level 2 (Abnormal) Requlatory Class: II Product Code: GGC Dated: November 16, 1998 Received: November 18, 1998

Dear Mr. Ellis:

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 legally marketed predicate 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 of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 regulation 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 regulations.

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Paqe 2

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/dsma/dsmamain.html".

Sincerely yours,

Steven Routman

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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# Statement of Indications for Use

Pacific Hemostasis Coagulation Control, Abnormal, Level 2, is intended for use as a control to Pacific Hemostasis Coagulation Gontine coagulation assays: Prothrombin Time (PT) and montor the performance of two froutine obagalaton Google in Cooryer of Courter of Concernal range.
Activated Partial Thromboplastin Time (APTT), in the moderately abnormal ra

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Peter E. Malin
Division Sign-Off

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number 198413d