The Vital Scientific APTT is an in-vitro diagnostic reagent intended for use in a manual method in a clinical laboratory for the performance of Activated Partial Thromboplastin Time (APTT) testing for the detection of coagulation abnormalities in the intrinsic pathway.

Device Description

The APTT reagent is intended for use in determining activated partial thromboplastin time (APTT) and coagulation factor assays that are based on a modified APTT. The capacity of blood to form a fibrin clot by way of the intrinsic homeostatic pathway requires coagulation factors XII, XI, IX, VIII, platelet lipids and calcium. The assay is performed by the addition of a suspension of rabbit brain cephalin with a surface activator.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Vital Scientific APTT device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria (Implied)	Reported Vital Scientific APTT Performance
Correlation with Predicate Device (APTT-LS on MLA 900C)	"acceptable correlation" (implied by K891337)	Correlation coefficient = 0.938, Slope = 0.727, Intercept = 6.96. The document states this indicates "acceptable correlation."
Correlation with Predicate Device (APTT-LS on ACL-100)	"acceptable correlation" (implied by K881367)	Correlation coefficient = 0.930, Slope = 0.952, Intercept = 3.76. The document states this indicates "acceptable correlation."
Within-run Precision (%CV)	"< 5 %"	Normal: 1.1 % < 5% Low Abnormal: 4.3 % < 5% High Abnormal: 4.3 % < 5% Average Precision: 3.2% < 5%
Day to Day Precision (%CV)	"< 5 %"	Normal: 3.6 % < 5% Low Abnormal: 2.5 % < 5% High Abnormal: 4.0 % < 5%
Overall Comparison to Predicate	"clinically acceptable performance comparable" to similar devices	Vital Scientific APTT has "similar intended use, a similar technological principle, and clinically acceptable performance comparable to similar devices currently in commercial distribution and is substantially equivalent to the predicate device." Precision results were stated to be "equivalent" to the predicate for day-to-day and within-run.

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

Sample Size: 107 patient plasmas for each correlation study (30 normal APTT, 77 undergoing heparin therapy).
Data Provenance: Not explicitly stated, but the studies were performed using patient plasmas, suggesting clinical samples. The ACL-100 study was conducted in a "clinical laboratory of a community hospital," implying prospective collection or retrospective use of patient samples from that setting. There is no mention of country of origin of the data.

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

There is no mention of experts being used to establish ground truth for the test set. The study compares the performance of the Vital Scientific APTT reagent to a legally marketed predicate device (Fisher Diagnostics APTT-LS) using measured clotting times. The "ground truth" for the correlation studies is effectively the results obtained by the predicate device, which is an accepted method for determining substantial equivalence of an in-vitro diagnostic.

4. Adjudication Method for the Test Set

Not applicable. This was a direct comparison to a predicate device, not a study involving human 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. This device is an in-vitro diagnostic reagent, not an imaging or interpretive AI device that would typically involve human readers.

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

Yes, the studies presented are standalone performance evaluations of the Vital Scientific APTT reagent when used with an automated coagulometer (MLA 900C and ACL-100). The performance metrics (correlation, precision) describe the behavior of the reagent itself.

7. The Type of Ground Truth Used

The ground truth for the correlation studies was the measured Activated Partial Thromboplastin Time (APTT) values obtained using the predicate device, APTT-LS manufactured by Fisher Diagnostics. For the precision studies, the "ground truth" is inherent within the statistical analysis of repeat measurements (average and %CV).

8. The Sample Size for the Training Set

This information is not provided. The document describes performance studies comparing the new device to a predicate and evaluating its precision. It does not disclose details about any training data that might have been used in the development of the reagent itself (if applicable, as it's a chemical reagent, not a software algorithm).

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

Not applicable, as no training set information is provided.

Summary

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NOV 1 2002

vital scientific

USA: One Gateway Center, Suite 415 Newton, MA 02158
1-617-527-9933, Ext. 22 Fax: 1-617-527-8230

NL: van Rensselaerweg 4, Spankeren 6956AV, NL
-31-313-43500 Fax:31-313-427807

510(k) Summary

Vital Scientific APTT

The assigned 510K number is: K022021

Applicant: Vital Scientific NV One Gateway Center, Suite 415 Newton, MA 02158 Phone: 1-617-527-9933 x41 Fax: 1-617-527-8230

Contact: Israel M. Stein MD

October 30, 2002 Date:

Device Name:

Vital Scientific APTT (In-vitro diagnostic reagent). The Vital Scientific APTT is also tradenamed the QuikCoag APTT, and APTT. References in this document submission may use these names interchangeably.

Common Name:

Activated Partial Thromboplastin Time (APTT)

Classification Name:

Activated Partial Thromboplastin - has been classified as Class II device, as per 21 CFR 864.7925 (Product Code GFO). This device is intended for clinical use in conjunction with an analyzer to measure clot formation.

Description of the APTT

The APTT reagent is intended for use in determining activated partial thromboplastin time (APTT) and coagulation factor assays that are based on a

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modified APTT. The capacity of blood to form a fibrin clot by way of the intrinsic homeostatic pathway requires coagulation factors XII, XI, IX, VIII, platelet lipids and calcium. The assay is performed by the addition of a suspension of rabbit brain cephalin with a surface activator.

Intended Use

Labeling:

This device is labeled in accordance with 21 CFR 801.

Substantial Equivalence:

The safety and effectiveness of APTT has been demonstrated by showing its substantial equivalence to APTT-LS manufactured by Fisher Diagnostics (formerly Pacific Hemostasis) K891337.

A correlation study was performed using a total of 107 patient plasmas; 30 from patients with normal APTT values and 77 with patients undergoing heparin therapy. The assays were performed on the MLA 900C coagulometer (K884863). The correlation coefficient for all plasmas was 0.938 and the slope is 0.727 and the intercept is 6.96, indicating acceptable correlation between the two reagents. The results are plotted on the following graph.

Image /page/1/Figure/10 description: This image is a scatter plot titled "APTT reagent Correlation on MLA Electra 800C". The x-axis is labeled "Vital APTT clotting time (sec.)" and ranges from 20.0 to 80.0. The y-axis is labeled "Reference APTT-LS clotting time (sec.)" and ranges from 20.0 to 90.0. The data points show a positive correlation between the two APTT clotting times, and a trend line is drawn through the data.

A correlation study of these reagents was also performed on an ACL-100 coagulometer (K881367) in the clinical laboratory of a community hospital using

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October 30, 2002

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a total of 107 patient plasmas; 30 from patients with normal APTT values and 77 with patients undergoing heparin therapy. The correlation coefficient for all plasmas was 0.930, the slope was 0.952 and the intercept was 3.76, indicating acceptable correlation between the two reagents. The results are plotted on the following graph.

Image /page/2/Figure/3 description: The figure is a scatter plot titled "APTT Correlation on ACL 100". The x-axis is labeled "BioMadica APTT" and ranges from 20 to 140. The y-axis is labeled "Pacific Hemostasis APTT-LS" and ranges from 20 to 120. There is a positive correlation between the two variables.

Day to Day and Within-run Precision studies were performed. All within-run %CV values were less than 5 %. The day to day precision is the %CV of the average APTT value obtained over five days. All day to day %CV values were less than 5%. The day to day and within run precision of Vital APTT and the predicate device APTT reagent were equivalent. The results for the within-run precision are shown in Table 1 and for the day to day precision is shown in Table 2 below:

Controls	Vital APTT		Reference APTT-LS
	Average (n=16)	% CV	Average (n=16)	%CV
Normal	24.2	1.1 %	25.0	2.3 %
Low Abnormal	43.3	4.3 %	55.0	2.3 %
High Abnormal	73.8	4.3 %	94.7	2.4 %
Average Precision		3.2 %		2.3 %

Table 1 Within-run Precision

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	Vital APTT		Reference APTT-LS
	Average	%CV	Average	%CV
Normal Control
Average (n=5)	24.2	1.4 %	25.0	2.4 %
Day to Day % CV	3.6 %		0.2 %
Low Abnormal
Average (n=5)	41.9	2.7 %	54.4	2.1 %
Day to Day % CV	2.5 %		1.9 %
High Abnormal
Average (n=5)	70.2	3.3 %	93.8	1.9 %
Day to Day % CV	4.0 %		2.6 %

Table 2: Day to Day Precision

Vital Scientific concludes that the APTT has a similar intended use, a similar technological principle, and clinically acceptable performance comparable to similar devices currently in commercial distribution and is substantially equivalent to the predicate device.

・

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Israel M. Stein, M.D. Managing Director Vital Scientific NV One Gateway Center, Suite 415 Newton, MA 02158

Re: K022021

Trade/Device Name: Vital Scientific APTT Regulation Number: 21 CFR 864.7925 Regulation Name: Partial Thromboplastin Time Tests Regulatory Class: Class II Product Code: GFO Dated: September 30, 2002 Received: October 3, 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 (QS) 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/cdrlvdsma/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): K022021

Device Name: Vital Scientific APTT

Indications For Use:

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

Concurrence of CDRH, Qffice of Device Evaluation (ODE)

Thushine Bautista

(Division Sign-Off)
Division of Clinical Laboratory Devices

510(k) Number K02262

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use (Optional Format 1-2-96)

Regulation Number and Section

§ 864.7925 Partial thromboplastin time tests.

(a)
Identification. A partial thromboplastin time test is a device used for primary screening for coagulation abnormalities, for evaluation of the effect of therapy on procoagulant disorders, and as an assay for coagulation factor deficiencies of the intrinsic coagulation pathway.(b)
Classification. Class II (performance standards).