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 Description

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.

AI/ML Overview

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Acceptance Criteria and Study for Coagulation Control Level 2 (Abnormal)

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the "Pacific Hemostasis Coagulation Control Level 2 (Abnormal)" device were implicitly established through comparison to a legally marketed predicate device, the "Dade Ci-Trol Coagulation Control Level II" (K771346). The primary metric for substantial equivalence was precision (both between-run and within-run), as measured by the Coefficient of Variation (CV%) and standard deviation (SD) of Prothrombin Time (PT) and Activated Partial Thromboplastin Time (APTT) values.

Metric (Acceptance Criteria)	Predicate Device Performance (Dade Ci-Trol Level II)	Proposed Device Performance (Pacific Hemostasis Level 2)	Substantial Equivalence Evaluation
Between-run Precision (PT)	CV% = 4.97, SD = 1.86, Mean = 37.3	CV% = 4.29, SD = 1.76, Mean = 41.0	Proposed device's CV% (4.29) is lower than predicate's (4.97), indicating comparable or better precision.
Between-run Precision (APTT)	CV% = 1.52, SD = 0.59, Mean = 39.0	CV% = 2.42, SD = 1.10, Mean = 45.4	Proposed device's CV% (2.42) is slightly higher than predicate's (1.52), but still within generally accepted clinical ranges for control materials (typically <5% or <10% for clotting assays, though no explicit threshold is given here beyond comparison). The summary states "substantially equivalent data."
Within-run Precision (PT)	Average CV% = 6.12	Average CV% = 5.31	Proposed device's CV% (5.31) is lower than predicate's (6.12), indicating comparable or better precision.
Within-run Precision (APTT)	Average CV% = 0.71	Average CV% = 0.73	Proposed device's CV% (0.73) is very close to predicate's (0.71), indicating comparable precision.
General Acceptance Principle			Data should be "substantially equivalent" to the predicate. Specifically, for both controls, a CV of less than 5% was obtained for PT and APTT between-run testing (stated for both devices collectively). For within-run, average CVs were less than 7% for PT and less than 1% for APTT.

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

Sample Size:
- Between-run Precision: 20 duplicate measurements over a 10-day period. This implies 20 data points per day for 10 days, for a total of 200 measurements per device, per test (PT or APTT).
- Within-run Precision: 3 runs of 20 duplicate measurements. This means 60 measurements per device, per test (PT or APTT) for the "average %CV shown."
Data Provenance: Not explicitly stated, but typically such studies for regulatory submissions are conducted in a controlled laboratory environment by the manufacturer or a contracted lab. There is no information about the country of origin of the data, nor whether it was retrospective or prospective. Given the nature of a device submission, it would almost certainly be prospective data collection specifically for this study.

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

This type of device (a coagulation control) does not typically involve human expert interpretation for "ground truth" in the way a diagnostic imaging AI might. The "ground truth" for its performance is derived from analytical measurements obtained from laboratory instruments (for PT and APTT). Therefore, the concept of "experts establishing ground truth" with their qualifications is not applicable here. The accuracy of the "ground truth" (the measured PT/APTT values) relies on the proper calibration and operation of the coagulation analyzers used in the study.

4. Adjudication Method for the Test Set

Not applicable. As explained in point 3, the ground truth is based on quantitative laboratory measurements, not expert consensus requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If so, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This is an in vitro diagnostic (IVD) control device, not an AI-powered diagnostic tool for human interpretation. Therefore, no MRMC study or assessment of human reader improvement with/without AI assistance was conducted or would be relevant.

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

Yes, in a sense. The "device" in this context is the coagulation control solution itself. The performance study measures the intrinsic analytical characteristics (precision) of this solution when run on standard laboratory equipment, without any human interpretive component being evaluated or an AI algorithm involved. The focus is on the performance of the control material, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for evaluating the performance of the Coagulation Control Level 2 (Abnormal) involved analytical measurements of Prothrombin Time (PT) and Activated Partial Thromboplastin Time (APTT) values from a coagulation analyzer. These are objective, quantitative measurements that define the expected performance characteristics of the control material.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a "training set." The device is a lyophilized plasma preparation, and its performance is evaluated directly through laboratory testing.

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

Not applicable. As this is not an AI/ML device, there is no training set or associated ground truth establishment process in the context of machine learning. The "ground truth" for the device's characteristics is established through its formulation (adulteration to achieve abnormal PT/APTT values) and verified through direct analytical measurement.

Summary

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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 (704) 948-3276

Contact Person:

Fax # (704) 875-2092
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 #(704) 948-3279

Description of Coagulation Control Level 2 (Abnormal)

Intended Use of Coagulation Control Level 2 (Abnormal)

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(20 duplicatemeasurements over a 10day period)	mean = 41.0SD = 1.76CV% = 4.29	mean = 37.3SD = 1.86CV% = 4.97	mean = 45.4SD = 1.10CV% = 2.42	mean = 39.0SD = 0.59CV% = 1.52
Within-run Precision(3 runs of 20 duplicatemeasurements, average%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)

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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 (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 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

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.