COAGULATION CONTROL LEVEL 1 (NORMAL)

K984129 · Pacific Hemostasis · GIZ · Dec 1, 1998 · Hematology

Device Facts

• Record ID: K984129
• Device Name: COAGULATION CONTROL LEVEL 1 (NORMAL)
• Applicant: Pacific Hemostasis
• Product Code: GIZ · 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 1 is intended for use as a control to monitor the performance of routine coagulation assays, i.e. Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT) and Fibrinogen assays. It will yield PT, APTT and Fibrinogen values in the normal range.

Device Story

Lyophilized citrated plasma preparation derived from healthy human donors; includes added stabilizers and buffers. Used in clinical laboratories to monitor performance of routine coagulation assays (PT, APTT, fibrinogen). Healthcare providers reconstitute and run the control alongside patient samples; results verify assay accuracy within the normal range. Benefits include ensuring reliable diagnostic testing for coagulation disorders.

Clinical Evidence

Bench testing only. Precision studies compared Pacific Hemostasis control to Dade Ci-Trol. Between-run precision (20 duplicate measurements over 10 days) showed CV < 2.0% for PT and APTT. Within-run precision showed average CV < 1.5% for PT and < 1.0% for APTT. Fibrinogen values were 287 mg/dL (subject) vs 268 mg/dL (predicate).

Technological Characteristics

Lyophilized citrated human plasma; contains stabilizers and buffers. Form factor is a reagent vial. No electronic components, software, or energy sources. Sterilization not specified, but source material tested for HBsAG, HIV, and HCV.

Indications for Use

Indicated for use as a quality control material to monitor the performance of routine coagulation assays (PT, APTT, and fibrinogen) in clinical laboratory settings. Intended for use with human plasma samples to ensure results fall within the normal 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 1

Submission Summary (Full Text)

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DEC 1 1998

510(K) Summarv Coagulation Control Level 1 (Normal)

#### PREMARKET NOTIFICATION 510(K) SUMMARY 7.0

Applicant: ·

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

Contact Person:

Trade Name:

Common Name:

Classification Name:

Equivalent Device:

Date:

Mark Ellis, Regulatory Manager, phone #[phone] Fax # [phone] November 12, 1998 Coagulation Control Level 1 (Normal) Normal Coagulation Control Plasma, Coagulation Control (per 21 CFR section 864.5425) Dade Ci-Trol Coagulation Control Level 1, a pre-amendment device

#### Description of Coagulation Control Level 1 (Normal)

Pacific Hemostasis Coagulation Control Level 1 (Normal) is a lyophilized preparation of citrated plasma obtained from healthy donors. 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 1 (Normal)

Pacific Hemostasis Coagulation Control Level 1 is intended for use as a control to monitor the performance of routine coagulation assays, i.e. Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT) and Fibrinogen assays. It will yield PT, APTT and Fibrinogen values in the normal 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 1(I) (Table 1). For both controls a CV of less than 2.0% was obtained for PT and APTT between-run testing. The average CV's obtained for within-run precision were less than 1.5% for PT testing, and less than 1.0% for APTT testing of both products. Fibrinogen testing yielded values of 287 and 268 mg/dL for Pacific Hemostasis and Dade brands, respectively, which are both in the normal range for fibrinogen.

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| | Prothrombin Time Testing | | Activated Partial<br>Thromboplastin Time Testing | |
|-----------------------------------------------------------------------------------------|----------------------------------------|----------------------------------------|--------------------------------------------------|----------------------------------------|
| | PH | Dade | PH | Dade |
| Between-run Precision<br>(20 duplicate<br>measurements over a 10<br>day period) | mean = 12.9<br>SD = 0.16<br>CV% = 1.22 | mean = 14.1<br>SD = 0.20<br>CV% = 1.39 | mean = 25.7<br>SD = 0.20<br>CV% = 0.79 | mean = 26.7<br>SD = 0.40<br>CV% = 1.52 |
| Within-run Precision<br>(3 runs of 20 duplicate<br>measurements, average<br>%CV shown.) | 1.39 | 1.20 | 0.70 | 0.70 |

## Conclusion

Pacific Hemostasis and Dade brand Coagulation Control Level I(I) have the same intended use, as normal controls for routine coagulation assays. Both are preparations of citrated plasma obtained from normal donors with added stabilizers and buffers. The performance data presented here, as well as the indistinguishable intended use and technological characteristics support the substantial equivalence claim for Pacific Hemostasis Coagulation Control Level 1 to Dade Ci-Trol Coagulation Control Level I. Based on the data provided, it is our conclusion that these two products are substantially equivalent.

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## PREMARKET 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.

Saura A. Worfolk

Laura A. Worfolk, Ph.D.

11/12/98

K984129

(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 of 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

Re: K984129 Trade Name: Coagulation Control Level 1 (Normal) Regulatory Class: II Product Code: GIZ Dated: November 16, 1998 November 18, 1998 Received:

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 reqistration, listing of devices, qood 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 A substantially Requlations, Title 21, Parts 800 to 895. 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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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 Butman

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

_ 澳门

2. 44

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Pacific Hemostasis Coagulation Control Normal, Level 1, is intended for use as a control to monitor the performance of three routine coagulation assays: Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT), and fibrinogen concentration in the normal range.

Cure E. Main

Prescription.