The Hemochron® Jr. Citrated PT is a unitized microcoagulation test intended for in vitro diagnostic use in performing a quantitative, one-stage prothrombin time. The Citrated PT test is performed using a citrated whole blood sample on the Hemochron® Jr. microcoagulation system. The instrument is portable and is intended for point of care testing. The instrument is not intended for home use. For in vitro Diagnostic Use

Device Description

The Hemochron® Jr. Microcoagulation Citrated PT test is a self-contained disposable test cuvette, prefilled with dried reagents required to perform a PT using citrated whole blood with the Hemochron® Jr. Whole Blood Microcoagulation System. The thromboplastin employed in the Hemochron® Jr. Microcoagulation Citrated PT test is identical to that used in the predicate device, the ITC Microcoagulation Prothrombin Time Test. The difference between the current assay and the predicate is a reagent modification to include calcium salt such that citrated whole blood may be used as the test substrate. The predicate device uses only fresh, non-citrated whole blood. In addition to the calcium salt, the preparation contains rabbit brain thromboplastin, stabilizers and buffers, similar to the reagents contained in the predicate device. The Hemochron® Jr. Microcoagulation Citrated PT and the predicate ITC Microcoagulation Prothrombin Time Test are both intended for point-of-care use. Both assays are performed using the ITC Microcoagulation analyzers.

AI/ML Overview

The provided document describes the Hemochron® Jr. Microcoagulation Citrated PT test, a device intended for in-vitro diagnostic use to perform a quantitative, one-stage prothrombin time for monitoring patients receiving oral anticoagulant therapy.

Here's an analysis based on the supplied text:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a table format. However, it indicates that the device's performance was evaluated against laboratory standards and a predicate device.

Performance Characteristic	Acceptance Criteria (Implicit/Inferred)	Reported Device Performance
Sensitivity to Vitamin K dependent coagulation factors	High correlation to laboratory (plasma-based) assay.	Dose-response curves were obtained and highly correlated to the laboratory (plasma-based) assay. As the coagulant factor level decreased below 40%, the Citrated PT result began to prolong above the normal range.
Correlation with laboratory PT-INR results (Clinical Comparison)	High degree of correlation.	Demonstrated a high degree of correlation of the Hemochron Jr. Citrated PT-INR result and laboratory PT-INR results.
Precision	Not explicitly stated.	Between 1% and 7% across different operators and test days (using whole blood controls).
Substantial Equivalence	To the predicate device and standard laboratory plasma PT assay.	The thromboplastin is identical to the predicate. Reagent modification includes calcium salt (for citrated blood). Results are displayed as INR and plasma PT equivalent.

Study Details:

Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not explicitly stated. The document mentions "clinical correlation studies" and "laboratory studies" that were conducted, but does not provide specific numbers for patient samples or controls.
- Data Provenance: The "clinical comparisons to the laboratory assay were conducted at three university medical centers." The country of origin is implicitly the USA, given the FDA submission. The studies were likely prospective clinical comparisons based on the nature of "clinical correlation studies."
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not specified in the provided text. The "ground truth" for correlation studies was the "laboratory (plasma-based) assay" and "laboratory PT-INR results," implying standard clinical laboratory procedures and established reference methods.
Adjudication Method for the Test Set:
- Not applicable as the ground truth appears to be based on established laboratory assays rather than expert consensus on interpretations.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This type of study (comparing human readers with and without AI assistance to improve diagnostic accuracy) is not relevant for this device, which is an in-vitro diagnostic test.
Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Yes, implicitly. The device itself is an automated analyzer that performs the test and displays results (INR and plasma PT equivalent) without human interpretation of raw data. The studies focused on the accuracy and precision of the device's output compared to laboratory standards.
Type of Ground Truth Used:
- Laboratory Assay Results: The primary ground truth was the "laboratory (plasma-based) assay" and "laboratory PT-INR results," which are recognized clinical standards for measuring coagulation.
Sample Size for the Training Set:
- Not applicable. This device is a diagnostic test kit and analyzer, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. The "training" would involve reagent formulation and instrument calibration based on known concentrations/levels, but specific sample sizes for this are not provided.
How the Ground Truth for the Training Set Was Established:
- Not applicable for a training set in the AI sense. For the development and calibration of the assay, the ground truth would have been established through standard biochemical and clinical laboratory methods, using reference materials and established PT/INR measurements.

Summary

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INTERNATIONAL

►ITC

TECHNIDYNE

CORPORATION

SEP 3 0 1998

8 Olsen Avenue▼ Edison, NJ 08820 Toll Free Phone: (800) 631-5945 Phone: (732) 548-5700 FAX: (732) 632-9299

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Kan2864

510(k) SUMMARY

March 26, 1998

Prepared:

March 26, 1998

Submitted by:

Robert Matland International Technidyne Corporation 23 Nevsky Street Edison, NJ 08820 Office: 732-548-5700 x 248 Fax: 732-548-2419

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.

Device Name

PRODUCT NAME:	Hemochron® Jr. Microcoagulation Citrated PT
COMMON/USUAL NAME:	Citrated Whole Blood Prothrombin Time Test

Predicate Device

International Technidyne Corporation Hemochron® Jr. Microcoagulation Prothrombin Time Test, which was approved under 510(k), K940432/S1 dated 5/18/94.

Device Description

The thromboplastin employed in the Hemochron® Jr. Microcoagulation Citrated PT test is identical to that used in the predicate device, the ITC Microcoagulation Prothrombin Time Test. The difference between the current assay and the predicate is a reagent modification to include calcium salt such that citrated whole blood may be used as the test substrate. The predicate device uses only fresh, non-citrated whole blood. In addition to the calcium salt, the preparation contains rabbit brain thromboplastin, stabilizers and buffers, similar to the reagents contained in

SK-49

HE
class

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the predicate device. The Hemochron® Jr. Microcoagulation Citrated PT and the predicate ITC Microcoagulation Prothrombin Time Test are both intended for point-of-care use. Both assays are performed using the ITC Microcoagulation analyzers.

The Hemochron® Jr. Microcoagulation Citrated PT and the predicate ITC Microcoagulation ProTime® test are both also substantially equivalent to the standard laboratory plasma PT assay. The results of the Hemochron® Jr. citrated PT are displayed as INR (International Normalized ration). Based on the clinical correlation studies presented in this submission, a conversion of the whole blood PT to the plasma PT is programmed into the instrument and the plasma PT (in seconds) also displayed at the conclusion of the test. In this way. PT results are available to the clinician in familiar plasma equivalent clotting times. The displayed plasma equivalent is at an assumed plasma PT reagent ISI of 1.0.

Statement of Intended Use

The Hemochron® Jr. Microcoagulation Citrated PT is a unitized microcoagulation test intended for in-vitro diagnostic use in performing a quantitative, one-stage prothrombin time for the monitoring of patient receiving oral anticoagulant therapy. The Citrated PT test is performed using a citrated whole blood sample on the Hemochron® Microcoagulation system. The instrument is portable and is intended for point-of-care testing. The instrument is not intended for home use.

Summary of Performance Characteristics

The Hemochron® Jr. Microcoagulation Citrated PT test was evaluated in laboratory studies to establish sensitivity to vitamin K depending coagulation factors. Dose-response curves were obtained for the factors which were highly correlated to the laboratory (plasma-based) assay. As the coagulant factor level decreased below 40% the Citrated PT result began to prolong above normal range. Clinical comparisons to the laboratory assay were conducted at the three university medical centers. These tests demonstrated a high degree of correlation of the Hemochron Jr. Citrated PT-INR result and laboratory PT-INR results. Precision of the assay measured using whole blood controls was between 1% and 7% across different operators and test days.

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Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of a human figure embracing a bird, which is a common emblem associated with health and human services.

SEP 3 0 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Robert Matland Compliance Officer International Technidyne Corporation 8 Olsen Avenue Edison, New Jersey 08820

Re : K972866/S3 Trade Name: HEMOCHRON® Jr. Microcoagulation Citrated PT Regulatory Class: II Product Code: GJS Dated: Auqust 1, 1998 Received: August 6, 1998

Dear Mr. Matland:

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 against 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 Requlations, 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 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" (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. " in Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K972866 510(k) Number (if known):

Hemochron® Jr. Microcoagulation Citrated PT Device Name:

Indications For Use:

INTENDED USE:

The Hemochron® Jr. Citrated PT is a unitized microcoagulation test intended for in vitto diagnostic use in performing a quantitative, one-stage prothrombin time. The Citrated PT test is performed using a citrated whole blood sample on the Hemochron® Jr. microcoagulation system. The instrument is portable and is intended for point of care testing. The instrument is not intended for home use. For in vitro_Diagnostic Use

(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

of CDRH, Office of Device Evaluation (ODE) oncurrer

(Division Sign-Off) Division of Clinical 510(k) Number

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

(श्रृङ्ग्

ത്രി

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).