The Vital Scientific PT with Calcium is an in vitro diagnostic test intended for use for the performance of Prothrombin Time (PT) testing and quantitative PT-based factor assays (for Factors II, V, VII and X). The test is used for the quantitative determination of blood clotting factors in the extrinsic pathway, (VII), and common pathway (II, V and X) of coagulation. The capacity of blood to form a fibrin clot by way of the extrinsic haemostatic pathway requires thromboplastin, calcium, factors VII, V, X, II and I. The Vital Scientific PT with Calcium consists of a lyophilized extract of rabbit brain thromboplastin calcium salt, buffers and stabilizers.

The Vital Scientific PT with Calcium is an in-vitro diagnostic reagent intended for use for the performance of one-stage Prothrombin Time (PT) Testing and assays which are based on a modified prothrombin time.

Device Description

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:

Device: Vital Scientific PT with Calcium (Prothrombin Time Test)
Predicate Device: Instrumentation Laboratory Inc. IL Test PT-Fibrinogen HS (K981479)

The provided text describes a substantial equivalence comparison study, not a study specifically designed to meet pre-defined acceptance criteria with absolute thresholds for performance metrics. Instead, the "acceptance criteria" are implicitly defined by the need to demonstrate performance comparable to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit)	Reported Device Performance (Vital Scientific PT with Calcium)
Correlation with Predicate Device (Overall PT): High correlation coefficient across normal, abnormal, and anti-coagulated patient specimens.	Correlation Coefficient: 0.92 (when tested against the predicate device at a community hospital, using specimens from normal, abnormal, and anti-coagulated patients).
Agreement with Predicate Device (Elevated PT Samples): Average values of elevated PT samples to be within one standard deviation of the predicate device's average.	Elevated PT Sample Agreement: Average values of elevated PT samples were within one standard deviation of the predicate device average.
Agreement with Predicate Device (INR Values): After conversion to INR (which corrects for reagent sensitivity differences), a high correlation with a slope close to 1 and intercept close to 0, indicating equivalent INR values.	INR Correlation: Slope of 1.01 and intercept of 0.01.
Precision (Within-run and Between-run): Low Coefficient of Variation (CV) to demonstrate reproducibility.	CVs: Less than 1% for within-run and between-run precision studies.
Intended Use Equivalence: Same indications for use as the predicate device.	Intended Use: Identical to the predicate device - "for use for the performance of Prothrombin Time (PT) testing and quantitative PT-based factor assays (for Factors II, V, VII and X)... for monitoring oral anticoagulant therapy."
Technological Principle Equivalence: Similar underlying scientific principles.	Technological Principle: Similar principle - both detect deficiencies in factors II, V, VII and X (PT and PT-based factor assays). Both are in vitro tests and consist of lyophilized rabbit brain thromboplastin, calcium salt, buffers, and stabilizers.

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

Test Set Sample Size: Not explicitly stated as a single number. The text mentions "PT testing of specimens from normal and abnormal patients, as well as samples from patients receiving anti-coagulant therapy." The specific number of patients or samples within each category is not provided.
Data Provenance:
- Country of Origin: Not explicitly stated, but the study was conducted "at a community hospital," implying a clinical setting within the country where the submission was made (presumably the USA, given the FDA context).
- Retrospective or Prospective: Not explicitly stated. The phrasing "were tested using both reagent devices" could imply either. However, in substantial equivalence studies, retrospective analysis of banked samples or a prospective collection for comparison is common. It's more likely a prospective collection for the study or a retrospective analysis of samples that fit the criteria.

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

Number of Experts: Not applicable. This study does not involve expert interpretation or ground truth establishment in the way a diagnostic imaging study might. The "ground truth" or reference values are derived from the predicate device's performance on the same patient samples.
Qualifications of Experts: Not applicable. The comparison is against an established, legally marketed diagnostic device.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. No expert adjudication process is described for this type of in-vitro diagnostic device comparison study. The comparison is quantitative based on assay results.

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

MRMC Study Done: No. This is not an AI/imaging device. It's an in-vitro diagnostic reagent.

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

Standalone Performance: Yes, in a sense. The device itself (the reagent system) is a standalone diagnostic tool. Its performance is measured directly by comparing its output (PT results, INR) to the predicate device's output on the same samples. There isn't a human-in-the-loop for interpreting the core result of the PT test itself; it's a quantitative measurement.

7. The Type of Ground Truth Used

Type of Ground Truth: The "ground truth" for this study is the results obtained from the legally marketed predicate device (IL Test PT-Fibrinogen HS (K981479)) when run on the same patient samples. This is a common approach for demonstrating substantial equivalence for in-vitro diagnostics. In essence, the predicate device serves as the reference standard.

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable. This is not a machine learning/AI device, so there is no "training set." The device is a chemical reagent.

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

Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.

Summary

{0}------------------------------------------------

KO20840

MAY 1 5 2002

PREMARKET NOTIFICATION 510(K) SUMMARY

Applicant:	Vital Scientific NVOne Gateway centerSuite 411Newton, MA 024581(617) 527-9933 Ext 42Fax:1 (617) 527-8230
Contact:	Israel M. Stein MD
Date:	March 14, 2002
Device Name:	Vital Scientific PT with CalciumQuik Coag PT with CalciumVital Scientific PTPT with Calcium
Common Name:	Prothrombin Time Test
Classification Name:	Prothrombin Time Test, 21 CFR section 864.7750 (GJS)
Comparison Device:	Instrumentation Laboratory Inc.IL Test PT-Fibrinogen HS (K981479)

Description of the Device and Intended Use

{1}------------------------------------------------

Summary of Substantial Equivalence Comparisons

The Vital Scientific PT with Calcium is substantially equivalent in intended use and performance to Instrumentation Laboratory IL Test PT-Fibrinogen HS (K981479).

Both the predicate device and the proposed product are formulated to detect deficiencies in factors II, V, VII and X (PT and PT-based factor assays). Both are in vitro tests which can be used for monitoring oral anticoagulant therapy.

In correlation studies, PT testing of specimens from normal and abnormal patients, as well as samples from patients receiving anti-coagulant therapy, were tested using both reagent devices at a community hospital and yielded a correlation coefficient 0.92. The average values of the elevated PT samples were within one standard deviation of the predicate device average.

The systematic bias was eliminated when the results were converted to INR. The correlation using INR values, which corrects for differences in reagent sensitivity, shows a slope of 1.01 and the intercept 0.01. This indicates that the PT reagents provide the same INR value as any other calibrated PT reagent.

Within-run and between run precision studies were performed and CV's of less than 1% were obtained for the proposed device.

Vital Scientific NV, submits that the Vital Scientific PT with Calcium has the same intended use, a similar technological principle, and clinically acceptable performance comparable to similar devices currently in commercial distribution.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/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" around the perimeter. Inside the circle is an abstract image of an eagle with three lines representing its wings.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 1 5 2002

Israel M. Stein, M.D. Managing Director Vital Scientific One Gateway Center, Suite 415 Newton, Massachusetts 02458

Re: K020840

Trade/Device Name: Vital Scientific PT with Calcium Regulation Number: 21 CFR § 864.7750 Regulation Name: Prothrombin Time Test Regulatory Class: II Product Code: GJS Dated: March 14, 2002 Received: March 15, 2002

Dear Dr. Stein:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use surved in the encreated of the enactment date of the Medical Device Amendments, or to commerce pror to Hay 2011 11:57 accordance with the provisions of the Federal Food, Drug, de rices unat in re been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may ; alerely mains of the Act include requirements for annual registration, listing of general connolo provisions of the tice, 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 If your device is exasting to words. Existing major regulations affecting your device can may oe subject to back additions, 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 I loast be advised that I Dr i blocative or our device complies with other requirements of the Act that I Dr has made a associations administered by other Federal agencies. You must or any I ecoral statutes and regarients, including, but not limited to: registration and listing (21 comply with an the Fee ore cart 801); good manufacturing practice requirements as set OI A ratt 6077; adoming (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{3}------------------------------------------------

Page 2

This letter will allow you to begin marketing your device as described in your 510(k) premarket This letter will and in you to or substantial equivalence of your device to a legally marketed nonlication. The I Dr I mining of vossification 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 additionally 60911 8 for questions on the promotion and advertising of your device, (2017) 594-4639. I reasonaliance at (301) 594-4639. Also, please note the regulation in 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 mormation on 90ar responser Assistance at its toll-free number (800) 638-2041 or Manufacturers Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Autman

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

{4}------------------------------------------------

INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K_Q 30 8 40

Device Name: Vital Scientific PT

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Josephine-Bautista

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K020 840

Prescription Use (Per 21 CFR 801.109) OR

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

Regulation Number and Section

§ 864.7750 Prothrombin time test.

(a)
Identification. A prothrombin time test is a device used as a general screening procedure for the detection of possible clotting factor deficiencies in the extrinsic coagulation pathway, which involves the reaction between coagulation factors III and VII, and to monitor patients receiving coumarin therapy (the administration of one of the coumarin anticoagulants in the treatment of venous thrombosis or pulmonary embolism).(b)
Classification. Class II (performance standards).