Pacific Hemostasis Heparin Control Plasma Level 2, an unassayed control plasma, is intended for use in heparin assay procedures. In addition, it can be used for quality control in monitoring heparin therapy with Activated Partial Thromboplastin Time (APTT) testing. It will yield APTT values in the moderately high abnormal range.

Device Description

Pacific Hemostasis Heparin Control Level 2 is a lyophilized preparation of citrated plasma obtained from healthy donors, which contains sodium heparin, stabilizers and buffers. Each unit of source material used in the preparation of the reagent has been tested by an FDA approved method and found nonreactive for HBsAG and negative for antibodies to HIV and HCV.

AI/ML Overview

The provided K992279 510(k) Summary describes the "Heparin Control Plasma, Level 2" device. This is an in vitro diagnostic device, specifically a control plasma used for heparin assay procedures and monitoring heparin therapy with Activated Partial Thromboplastin Time (APTT) testing.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Precision:
Between-run CV < 3.0% (for APTT)	< 3.0% for both Pacific Hemostasis and Dade Brand controls
Within-run CV < 2.0% (for APTT)	< 2.0% for both Pacific Hemostasis and Dade Brand controls

2. Sample Size Used for the Test Set and Data Provenance

The summary does not explicitly state the specific "sample size" in terms of number of patient samples or test runs for the precision studies. It mentions "Between-run and within-run precision studies" were performed.

Test Set Description: The test set for the precision study involved running both the Pacific Hemostasis Heparin Control Level 2 and the predicate device (Dade Ci-Trol Heparin Control High) to compare their precision.
Data Provenance: The document does not specify the country of origin. Given the applicant's address in North Carolina, USA, it's highly probable the data was generated in the USA. The study appears to be prospective as it involves direct testing of the device performance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable to this type of device and study. For in vitro diagnostic controls, the "ground truth" is often an established reference method or the expected performance characteristics based on the control's formulation and intended use, rather than expert consensus on a clinical diagnosis. The precision study assesses the device's consistency, not its diagnostic accuracy against a clinical "ground truth."

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in studies involving subjective interpretation of data (e.g., medical imaging) where multiple readers might disagree, and a consensus ground truth needs to be established. For objective measurements like APTT from a control plasma, such adjudication is not performed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation (e.g., radiology AI). The Heparin Control Plasma is a laboratory reagent; its performance is measured objectively rather than by human readers' interpretations.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This concept is not applicable in the context of this device. The device itself is a control plasma, not an algorithm. Its "standalone performance" is its performance in a laboratory setting when analyzed by an APTT instrument. The precision studies are essentially evaluating the "standalone" performance of the control when used as intended.

7. The Type of Ground Truth Used

The "ground truth" for this precision study is the analytical precision itself, measured by statistical metrics like Coefficient of Variation (CV). There isn't a "ground truth" in the sense of a clinical outcome, pathology, or expert consensus that the device is trying to predict. Instead, the study aims to demonstrate that the device performs consistently and within acceptable analytical limits, similar to a legally marketed predicate device.

8. The Sample Size for the Training Set

There is no training set for this device. This device is a control plasma, not an AI/ML algorithm that requires training data.

9. How the Ground Truth for the Training Set Was Established

As there is no training set, this question is not applicable.

Summary

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K992279

510(k) Summar Heparin Control Plasma, Level 2

PREMARKET NOTIFICATION 510(k) SUMMARY 7.0

Applicant:	Laura A. Worfolk, Ph.D.
Address:	Pacific Hemostasis11515 Vanstory DriveHuntersville, NC 28078
Phone:	(800) 528-0494 or (704) 875-0494
Fax:	(704) 875-2092
Contact Person:	Same as above.
Date:	July 6, 1999
Trade Name:	Heparin Control Plasma Level 2
Common Name:	Heparin Control Plasma Level 2
Classification Name:	Plasma, Coagulation Control
Equivalent Device:	Dade Ci-Trol Heparin Control High, K771346

Description of Heparin Control Level 2

Intended Use of Heparin Control Level 2

Pacific Hemostasis Heparin Control Level 2, an unassayed control plasma, is intended for use in heparin assay procedures. In addition, it can be used for quality control in monitoring heparin therapy with Activated Partial Thromboplastin Time (APTT) testing. It will yield APTT values in the moderately high abnormal range.

Summary of Performance Data for Substantial Equivalence Comparisons

Between-run and within-run precision studies yielded equivalent data for Pacific Hemostasis and Dade Brand Coagulation Heparin control plasmas. For both controls a CV of less than 3.0% was obtained for APTT between-run testing, and less than 2.0% for within-run testing.

Based on the data provided, the similar composition and intended use, it is our conclusion that these two products are substantially equivalent.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a series of flowing lines, possibly representing the interconnectedness of health and human services.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG 26 1990

Laura A. Worfolk, Ph.D. Research Scientist Pacific Hemostasis 11515 Vanstory Drive Suite 125 Huntersville, North Carolina 28078-8144

K992279 Re: Trade Name: Heparin Control Plasma Level 2 Regulatory Class: II Product Code: GGN Dated: August 9, 1999 Received: August 11, 1999

Dear Dr. Worfolk:

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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 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 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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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 (770) 488-7655.

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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, 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

Pacific Hemostasis Heparin Control Plasma Level 2, an unassayed control plasma, is intended for use as a control in heparin assay procedures.

Peter E. Madsen

Prescription
Use

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Regulation Number and Section

§ 864.5425 Multipurpose system for in vitro coagulation studies.

(a)
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.(b)
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.