The Coagulation Controls Levels 1, 2, and 3 are in-vitro diagnostic reagents intended for clinical use as a control to monitor the performance of coagulation testing of Prothrombin Time (PT) and activated Partial Thromboplastin time (APTT). Level 1 yields result in the normal range. Level 2 yields results in the moderately abnormal range. Level 3 is intended to yield results in the extremely abnormal range.

Device Description

The Coagulation Control Levels 1, 2 and 3 are lyophilized preparations of citrated plasma obtained from healthy donors, which are adjusted to yield prolonged PT and APTT values. Prior to lyophilization buffer and a stabilizer are added. The bulk plasma is tested using an FDA approved method for HBsAG, HIV antibodies and HCV antibodies and is certified for negativity for each batch.

AI/ML Overview

The provided document describes a 510(k) summary for "Coagulation Control Level 1, 2, 3" by Vital Scientific NV. The document focuses on demonstrating substantial equivalence to predicate devices through precision studies rather than establishing acceptance criteria against a predefined performance target for a novel device. The study design is a comparison to legally marketed predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense of a predefined target that the device must meet for approval. Instead, it demonstrates performance by comparing its precision data to that of existing, legally marketed predicate devices. The implicit acceptance criterion is that the new device's precision (measured by Average and %CV) should be "substantially equivalent" to that of the predicate devices.

Control Level	Parameter	Vital Controls Performance (Average ± %CV, n=20)	Reference Controls Performance (Average ± %CV, n=20)	Implicit Acceptance Criteria (Substantial Equivalence)
Within-run Precision
Level 1 (Normal)	PT	12.0 ± 1.1%	11.6 ± 0.7%	Vital Control's precision should be comparable to the reference.
Level 2 (Low abnormal)	PT	18.8 ± 1.4%	18.7 ± 1.2%	Vital Control's precision should be comparable to the reference.
Level 3 (High abnormal)	PT	32.6 ± 3.5%	32.6 ± 2.7%	Vital Control's precision should be comparable to the reference.
Level 1 (Normal)	APTT	28.5 ± 2.3%	24.9 ± 2.3%	Vital Control's precision should be comparable to the reference.
Level 2 (Low abnormal)	APTT	47.0 ± 1.7%	54.8 ± 2.2%	Vital Control's precision should be comparable to the reference.
Level 3 (High abnormal)	APTT	61.2 ± 1.9%	95.7 ± 2.3%	Vital Control's precision should be comparable to the reference.
Between-run Precision
Level 1	PT %CV	1.5%	1.2%	Vital Control's %CV should be comparable to the reference.
Level 2	PT %CV	3.5%	2.0%	Vital Control's %CV should be comparable to the reference.
Level 3	PT %CV	4.5%	3.3%	Vital Control's %CV should be comparable to the reference.
Level 1	APTT %CV	1.8%	0.5%	Vital Control's %CV should be comparable to the reference.
Level 2	APTT %CV	0.7%	2.0%	Vital Control's %CV should be comparable to the reference.
Level 3	APTT %CV	3.9%	2.7%	Vital Control's %CV should be comparable to the reference.

Note: The document states "substantially equivalent data" were yielded, implying the reported performance met this implicit criterion.

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

Test Set Sample Size: For within-run precision studies, n = 20 for both Vital Controls and Reference Controls for each level (1, 2, 3) and for both PT and APTT. ("Average ± %CV, n = 20"). For between-run precision, the sample size is not explicitly stated as 'n' but implies multiple measurements over several days ("Day to Day Precision Results").
Data Provenance: Not explicitly stated. The study was conducted for a US 510(k) submission, but the location of the actual testing is not specified. It is a prospective study as it involves specific experiments for the submission. The plasma itself is obtained from healthy donors, but the origin of these donors (country) is not mentioned.

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

Not applicable. This study is a precision study comparing a control device to predicate control devices, not a diagnostic device where "ground truth" on patient samples would be established by experts. The "truth" here is the performance of the predicate devices.

4. Adjudication Method for the Test Set

Not applicable. There is no adjudication method described as it's a quantitative measurement of precision rather than a qualitative diagnostic outcome requiring expert consensus.

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 not a study involving human readers or AI assistance. It's a laboratory precision and substantial equivalence study for a diagnostic control.

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

Not applicable. This is not an algorithm; it is a physical control plasma. The comparison is between the new control plasma and existing control plasmas run on a coagulometer (MLA-900C Coagulometer). The performance described is "standalone" in the sense that the control itself is being evaluated for its inherent precision characteristics.

7. The Type of Ground Truth Used

The "ground truth" in this context is the established performance characteristics (precision, i.e., average and %CV) of the legally marketed predicate devices. The goal is to show the new device's performance is substantially equivalent to these established benchmarks.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of this device. This is not a machine learning model.

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

Not applicable, as there is no training set mentioned.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for Vital Scientific. The logo consists of a stylized graphic to the left of the company name. The company name, "vital scientific", is written in a sans-serif font, with the word "vital" in a slightly larger font size than "scientific".

USA: One Gateway Center, Suite 415 New 1-617-527-9933. Ext. 22 Fax: 1-617-5

L: van Rensselaerweg 4. Spankeren 6 Fax:31-313-42780

510(k) Summary

Coaqulation Control Level 1, 2, 3

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510K number is: _ h022040

Vital Scientific NV Applicant: One Gateway Center, Suite 415 Newton, MA 02158 Phone: 1-617-527-9933 x41 Fax: 1-617-527-8230
Israel M. Stein MD Contact:

Date: June 18, 2002

Device Name:

Coagulation Control Level 1, 2, 3 (Coaqulation Control Plasma). The Coagulation Control is also tradenamed the Vital Scientific Coagulation Control, and Quikcoag Coagulation Control. References in this document submission may use any of these names interchangeably.

Common Name:

Coagulation Control Plasma

Classification Name:

Coagulation Control Plasma has been classified as Class II device, 21 CFR 864.5425 (Product Code GGN). This device is intended for clinical use as a

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control to monitor coagulation testing of Prothrombin Time (PT) and activated Partial Thromboplastin time (APTT).

Description of the Coagulation Control

Intended Use

The Coagulation Controls Levels 1, 2, and 3 are intended for clinical use as a control to monitor the performance of coagulation testing of Prothrombin Time (PT) and activated Partial Thromboplastin time (APTT). Level 1 yields result in the normal range. Level 2 vields results in the moderately abnormal range. Level 3 is intended to vield results in the extremely abnormal range.

Labeling:

This device is labeled in accordance with 21 CFR 801.

Substantial Equivalence:

The Coagulation Control Level 1 was compared to Precision Biologic Pooled Normal Plasma (K952662). The Coagulation Control 2 was compared with the Assess Low Abnormal Control from Instrumentation laboratory (K931117). The Coagulation Control 3 was compared with the Assess High Abnormal Control from Instrumentation Laboratory (K931118) on the MLA-900C Coagulometer (K884863).

Within-run precision studies were performed and yielded substantially equivalent data as summarized in Tables 1 and 2 below.

Control Level	PT Vital ControlsAverage ± %CV, n = 20	PT Reference ControlsAverage ± %CV, n = 20
Level 1 (Normal)	12.0 ± 1.1%	11.6 ± 0.7%
Level 2 (Low abnormal)	18.8 ± 1.4%	18.7 ± 1.2%
Level 3 (High abnormal)	32.6 ± 3.5%	32.6 ± 2.7%

Table 1: Within-run Precision Results using PT Reagents

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Table 2: Within-run Precision Results using APTT Reagents

Control Level	APTT values of Vital ControlsAverage ± %CV, n = 20	APTT values of Reference ControlsAverage ± %CV, n = 20
Level 1 (Normal)	28.5 ± 2.3%	24.9 ± 2.3%
Level 2 (Low abnormal)	47.0 ± 1.7%	54.8 ± 2.2%
Level 3 (High abnormal)	61.2 ± 1.9%	95.7 ± 2.3%

Between-run precision studies were performed and yielded substantially equivalent data as summarized in Tables 3 and 4.

Table 3: Day to Day Precision Results using PT Reagent

Day	PT values of Vital ControlsAverage ± %CV			PT values of Reference ControlsAverage ± %CV
	Level 1	Level 2	Level 3	Normal	Low Abnormal	HighAbnormal
Average(all days)	11.9	18.3	31.8	11.5	18.3	31.6
%CV(betweendays)	1.5%	3.5%	4.5%	1.2%	2.0%	3.3%

Table 4: Day to Day Precision Results using APTT Reagent

Day	APTT values of Vital ControlsAverage ± %CV			APTT values of Reference ControlsAverage ± %CV
	Level 1	Level 2	Level 3	Normal	Low Abnormal	HighAbnormal
Average(all days)	28.5	46.7	61.8	25.0	54.5	94.1
%CV(betweendays)	1.8%	0.7%	3.9%	0.5%	2.0%	2.7%

Vital Scientific concludes that the Coagulation Controls Levels 1,2, and 3 have a similar intended use, technological characteristics and performance data which

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support the statement that the Coagulation Controls Levels 1,2, and 3 are substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Public Health Service

JUL 2 3 2002

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Israel M. Stein, MD Managing Director US Branch OfficeVital Scientific One Gateway Center Suite 415

K022046 Re:

Newton, MA 02158

Trade/Device Name: Coagulation Control Levels 1, 2, and 3 Regulation Number: 21 CFR 864.5425 Regulation Name: Multipurpose system for in vitro coagulation studies Regulatory Class: Class II Product Code: GGN Dated: June 21, 2002 Received: June 24, 2002

Dear Dr. Stein:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA), 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrb/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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INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K O2 30 40 40 ______________________________________________________________________________________________________________________________________

Device Name: Coagulation Control Levels 1, 2, and 3

Indications For Use:

(Per 21-CFR-801.109)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign (Off) 02204 Division of Clinical Laboratory Devices 510(k) Number -Prescription Use Over-The-Counter Use

(Optional Format 1-2-96)

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.