Pacific Hemostasis Coagulation Control Level 3 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 markedly abnormal range.

Device Description

Pacific Hemostasis Coagulation Control Level 3 (Abnormal) is a lyophilized preparation of citrated plasma obtained from healthy donors, which has been adjusted to yield prolonged Prothrombin Time and Activated Partial Thromboplastin 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

Here's an analysis of the provided text regarding the acceptance criteria and study for the Coagulation Control Level 3 (Abnormal) device:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a separate section with pass/fail thresholds. Instead, it compares the performance of the new device (Pacific Hemostasis Coagulation Control Level 3) directly against a legally marketed predicate device (Dade Ci-Trol Coagulation Control Level III) to establish substantial equivalence. The implication is that if the new device performs similarly to the predicate device within reasonable bounds, it meets the "acceptance criteria" for substantial equivalence.

Based on the "Summary of Performance Data for Substantial Equivalence Comparisons," the implicit acceptance criteria are that the new device should demonstrate comparable precision (CV%) to the predicate device for both Prothrombin Time (PT) and Activated Partial Thromboplastin Time (APTT) measurements.

Performance Metric	Acceptance Criteria (Implicit, based on predicate)	Reported Device Performance (Pacific Hemostasis)	Predicate Device Performance (Dade)
Between-run Precision (PT)	CV% < 6% (similar to predicate)	mean = 91.8, SD = 4.23, CV% = 4.61	mean = 80.2, SD = 4.38, CV% = 5.46
Between-run Precision (APTT)	CV% < 6% (similar to predicate)	mean = 52.1, SD = 0.86, CV% = 1.65	mean = 51.7, SD = 1.05, CV% = 2.02
Within-run Precision (PT)	CV% < 4% (similar to predicate)	3.09	2.72
Within-run Precision (APTT)	CV% ≤ 2% (similar to predicate)	1.55	1.35

Conclusion: The reported device performance meets the implicit acceptance criteria, as the CV% values for Pacific Hemostasis are either comparable to or lower than the predicate device, and all are within the stated thresholds (less than 6% for between-run, less than 4% for within-run PT, and less than or equal to 2% for within-run APTT).

2. Sample Sizes Used for the Test Set and Data Provenance:

Test Set Sample Size:
- Between-run Precision: 20 duplicate measurements over a 10-day period. This means 20 individual samples were tested in duplicate (40 total measurements) over 10 days for each control (new and predicate).
- Within-run Precision: 3 runs of 20 duplicate measurements. This means 3 runs, each consisting of 20 individual samples tested in duplicate (40 total measurements per run), for each control (new and predicate).
Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given the context of a 510(k) summary for a new product, it is most likely a prospective study conducted by the manufacturer, Pacific Hemostasis, but this is not explicitly stated.

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. The ground truth for a coagulation control is established by its performance characteristics (precision, accuracy, etc.) when measured against standard laboratory tests, not by expert interpretation. The performance itself is the "truth" being assessed in comparison to a predicate device.

4. Adjudication Method for the Test Set:

This information is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where multiple experts interpret data (e.g., medical images) and their disagreements need to be resolved to establish ground truth. For a laboratory control device like this, the measurements are quantitative, and there's no subjective interpretation requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. MRMC studies are relevant for devices that involve human interpretation of results, such as diagnostic imaging aids. This device is a quality control material for automated laboratory assays, not a device interpreted by human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This concept is not applicable in the traditional sense of an "algorithm only" study. The device itself is a material – a lyophilized plasma preparation. Its "performance" is its behavior when used in conjunction with a coagulation analyzer. The study presented is the standalone performance of the control material when measured by laboratory instruments. There is no "human-in-the-loop" interaction in the sense of a user interpreting the control's output that needs to be quantified or assisted. The human interaction is in the laboratory technician performing the test.

7. The Type of Ground Truth Used:

The "ground truth" for this study is the measured performance characteristics (mean, standard deviation, and CV%) of an established, legally marketed predicate device (Dade Ci-Trol Coagulation Control Level III). The new device's performance is compared against the predicate's performance to establish substantial equivalence.

8. The Sample Size for the Training Set:

This document describes a performance validation study for a medical device substance (coagulation control), not a machine learning or AI algorithm. Therefore, there is no "training set" in the context of AI. The product itself is the "device," and its performance is being evaluated, not an algorithm being trained.

9. How the Ground Truth for the Training Set was Established:

As there is no "training set" for an AI algorithm in this context, this question is not applicable.

Summary

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K98413

510(K) Summary Coaqulation Control Level 3 (Abnormal)

PREMARKET NOTIFICATION 510(K) SUMMARY

Applicant:

1 1998

DEC ..

Laura A. Worfolk, Ph.D. Pacific Hemostasis 1515 Vanstory Drive Huntersville, NC 28078 (704) 948-3276

Contact Person:

Mark Ellis, Regulatory Affairs Manager, phone #(704) 948-3279 Fax # (704) 875-2092

Date:	November 12, 1998
Trade Name:	Coagulation Control Level 3 (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 III, K771346

Description of Coagulation Control Level 3 (Abnormal)

Intended Use of Coagulation Control Level 3 (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 3 (III) (Table 1). For both controls, a CV of less than 6% was obtained for PT and APTT between-run testing. The average CV's obtained for within-run precision were less than 4% for PT testing, and less than or equal to 2% for APTT testing of both products.

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	Prothrombin Time Testing		Activated PartialThromboplastin Time Testing
	PH	Dade	PH	Dade
Between-run Precision(20 duplicatemeasurements over a 10day period)	mean = 91.8SD = 4.23CV% = 4.61	mean = 80.2SD = 4.38CV% = 5.46	mean = 52.1SD = 0.86CV% = 1.65	mean = 51.7SD = 1.05CV% = 2.02
Within-run Precision(3 runs of 20 duplicatemeasurements, average%CV shown.)	3.09	2.72	1.55	1.35

Conclusion

Pacific Hemostasis and Dade brand Coagulation Control Level 3(III) have the same intended use, to monitor coagulation assays in the markedly abnormal range. Both are preparations of normal donor citrated plasma with added stabilizers and buffers, that have been adjusted to yield prolonged clotting times. 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 3 to Dade Ci-Trol Coagulation Control Level III. 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.

Laura A. Worfolk

Laura A. Worfolk, Ph.D.

11/12/98
K 984131

(Premarket Notification [510(k)] Number)

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Image /page/3/Picture/2 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" around the perimeter. Inside the circle is a stylized image of three abstract human figures, represented by flowing lines, suggesting movement and connection.

DEC 11 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re: K984131 Trade Name: Coagulation Control Level 3 (Abnormal) Requlatory Class: II Product Code: GGC 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 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. this response to your premarket notification Please note: 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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Page 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 leqally 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, "Misbrandinq 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 Coagulation Control, Abnormal, Level 3, is intended for use as a control to Pacific Hemostasis Coagulation Annonia, Aonomia, Ecover, Resthrombin Time (PT) and monitor the performance or two Youthe "cought": "We markedly abnormal range.

Prescription ✓

Aster E. Madsen

Division of Clinical Laboratory Devices
510(k) Number K984131

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.