The Hemochron Jr. Citrate APTT is a unitized microcoagulation test intended to be used in performing a quantitative one-stage Activated Partial Thromboplastin Time (APTT for monitoring low doses of heparin anticoagulation (up to 1.5 units/ml). The test is performed using a citrated whole blood sample on the Hemochron Jr. microcoagulation instruments. The test is intended for use in point of care settings. For In Vitro Diagnostic Use Only

Device Description

The Hemochron Jr.Citrate APTT test is a self-contained disposable test cuvette, pre-filled with dried reagents required to perform an Activated Partial Thromboplastin Time (APTT) using citrated whole blood in the Hemochron Jr. Whole Blood Microcoagulation Analyzers. The preparation consists of kaolin, phospholipid, stabilizers and buffers. These same components are used in the previous formulation of the citrate APTT. The citrate APTT test can be performed on both the Hemochron Jr. II and Hemochron Jr. Signature Series instruments. The test is intended for point of care use. The instrument draws a precise volume of blood into the test channel of the cuvette. The cuvette contains the APTT reagent formulation. An array of LED's detects the motion of the blood sample/reagent mixtures as it moves through the precision channel. The blood is pumped back and forth until a clot begins to form, obstructing the channel and slowing the flow of the blood sample. The instrument detects a clot when the blood movement decreases below a predetermined rate.

AI/ML Overview

This document describes the Hemochron® Jr. Citrate Activate Partial Thromboplastin Time (APTT) Cuvette, a medical device for monitoring heparin anticoagulation.

Here's the breakdown of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The device is a modification of a predicate device, and the primary acceptance criterion appears to be an improved correlation with laboratory APTT plasma results.

Acceptance Criterion (Implicit)	Reported Device Performance
Improved correlation to laboratory APTT Plasma result	The Hemochron Jr. APTT plasma equivalent values were highly correlated to the laboratory plasma citrate APTT values (R=0.88). The correlation equation was y = 0.77x + 8.57.
Acceptable precision for normal and heparinized samples (Level I and Level II)	Cuvette Lot 1 - Normal: Day 1: Mean 95 sec, SD 6.5 sec, CV 6.9%; Day 2: Mean 92 sec, SD 2.1 sec, CV 2.3%; Day 3: Mean 86 sec, SD 5.0 sec, CV 5.9%. Total: Mean 91 sec, SD 5.9 sec, CV 6.4%. Cuvette Lot 2 - Normal: Day 1: Mean 94 sec, SD 1.0 sec, CV 1.1%; Day 2: Mean 99 sec, SD 5.9 sec, CV 5.9%; Day 3: Mean 90 sec, SD 6.1 sec, CV 6.8%. Total: Mean 95 sec, SD 5.8 sec, CV 6.1%. (Note: The table provided for "PRECISION DATA" in the document only includes data for "Normal" levels, not "Level II" for heparinized samples, despite mentioning Level II in the descriptive text.)
Substantial equivalence to the predicate device	"The technology employed and intended use of the modified Hemochron Jr.Citrate APTT cuvette is substantially equivalent to the Predicate Hemochron Jr. Citrate APTT."

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

Sample Size for Test Set: 210 fresh citrated blood samples.
Data Provenance: The samples were collected from patients undergoing catheterization and angioplasty. While the document doesn't explicitly state the country of origin, the company is based in Edison, NJ, USA, and the FDA review process suggests the data is likely from the United States. The study appears to be prospective in nature, as samples were collected "at the patient bedside" and then analyzed.

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

This information is not provided in the document. The ground truth for the correlation study was established by a laboratory APTT test performed on an Electra 900 MLA instrument using Dade Actin FSL* APTT reagent. This is a reference method, not an expert consensus.

4. Adjudication Method for the Test Set

This information is not applicable/provided. The ground truth was established by a laboratory reference method, not by human experts requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done. The primary study was a correlation study comparing the device's performance to a laboratory reference method. The device is for coagulation testing, which typically does not involve human readers interpreting results in the same way imaging devices might.

6. If a Standalone (Algorithm Only Without Human-in-the Loop Performance) Was Done

Yes, a standalone study was done. The described "Summary of Performance Data and Precision" specifically evaluates the performance of the Hemochron Jr. Citrate APTT device itself, comparing its results to a laboratory standard (correlation) and evaluating its consistency (precision) independently. The device provides a quantitative measurement, so human interpretation after the device provides the result is inherent to its use, but the analytical performance of the device was tested in a standalone manner.

7. The Type of Ground Truth Used

Reference Laboratory Method: The ground truth for the correlation study was established by performing an APTT test on plasma samples using the Dade Actin FSL* APTT reagent on an Electra 900 MLA instrument. This acts as the "gold standard" laboratory method.

8. The Sample Size for the Training Set

This information is not provided. The document describes a "modified" reagent formulation, implying that development and potentially internal "training" or optimization occurred, but details on a specific training set size for the algorithms or formulation are absent.

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

This information is not provided. As the specific training set and its use are not detailed, neither is the method for establishing its ground truth.

Summary

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TECHNIDYN CORPORATION Phone: (732) 548-5700 FAX: (732) 632-9299

510 (k) Summary

Hemochron® Jr. Citrate Activate Partial Thromboplastin Time (APTT) Cuvette

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

The assigned 510(k) number is: _K014 008

November 29, 2001 Prepared:

John Clay Submitted by: International Technidyne Corp. 6 Olsen Ave. Edison, NJ 08820 (732-548-2325) Fax (732-548-5700) Ext. 265

Device Name

Common / Usual Name:	Activated Partial Thromboplastin Time
Product Name:	Hemochron® Jr. Citrate APTT Cuvette

Predicate Device

The "modified" Hemochron Jr. Citrate APTT, which is the subject of this special 510(k) is a modification of the predicate Hemochron Jr. Citrate APTT, which was cleared under K972831.

Device Description and Technological Characteristics

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The instrument draws a precise volume of blood into the test channel of the The mountient contains the APTT reagent formulation. An array of LED's detects the motion of the blood sample/reagent mixtures as it moves through the precision the modon of the orood campler. The blood is pumped back and forth until a clot begins to form, obstructing the channel and slowing the flow of the blood sample. The instrument detects a clot when the blood movement decreases below a predetermined rate.

Modifications to the Predicate Hemochron Jr Citrate APTT Cuvette

Formulation

The only modification to the citrate APTT cuvette is to the reagent formulation, The only invention would the phospholipid concentration and the reduction spoonnoan'y, are open of calcium salts required for re-calcification of the citrated whole blood sample. The modification to the formula improves the correlation to the laboratory APTT Plasma result when either 3.2% or 3.8% sodium citrate tubes are used for the blood sample collection.

The modifications to the Citrate APTT described herein do not change the indications for use or the fundamental technology used in the previously cleared system.

Statement of Intended Use

For In Vitro Diagnostic Use Only

Summary of Performance Data and Precision

The laboratory correlation was generated using fresh citrated blood samples (n=210) from patients undergoing catheterization and angioplasty. Samples were analyzed at the patient bedside using the "modified" Hemochron Jr. Citrate APTT. An aliquot of at the pattern bousine with sodium citrate, centrifuged and plasma was sent to a the sumple was mined will be these a PTT test was performed on each sample collected using Dade Actin FSL* APTT reagent on an Electra 900 MLA instrument.

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Additional clinical studies were conducted to confirm the correlation to the laboratory result. The Hemochron Jr. APTT plasma equivalent values were highly correlated to the laboratory plasma citrate APTT values (R=0.88) with a correlation equation of v=0.77x+8.57.

In House Precision Testing

Precision testing was evaluated by performing multiple citrate APTT tests using two I receision tooning was on on on on on on preparations, which have been selected to represent normal donors (Level I) and patients receiving heparin anticoagulant (Level II). Two different lots of Citrate APTT test cuvettes were used in the precision study and testing was performed on three separate days.

PRECISION DATA

Cuvette Lot 1

Normal
	N	Mean(sec)	SD(sec)	CV(%)	N
Day 1	3	95	6.5	6.9	3
Day 2	3	92	2.1	2.3	3
Day 3	3	86	5.0	5.9	3
Total	9	91	5.9	6.4	9
Cuvette Lot 2
Normal
	N	Mean(sec)	SD(sec)	CV(%)	N
Day 1	3	94	1.0	1.1	3
Day 2	3	99	5.9	5.9	3
Day 3	3	90	6.1	6.8	3
Total	9	95	5.8	6.1	9

Conclusion

The technology employed and intended use of the modified Hemochron Jr.Citrate APTT cuvette is substantially equivalent to the Predicate Hemochron Jr. Citrate APTT. This modification to the formula improves the correlation to the laboratory APTT Plasma result when either 3.2% or 3.8% sodium citrate tubes are used for the blood sample collection.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a bird or abstract human figure, composed of three curved lines.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. John Clay Regulatory Affairs Manager ITC. Inc. 8 Olsen Avenue Edison, NJ 08820

JAN 2 4 2002

Re: K014008

Trade/Device Name: Hemochron® Jr. Citrate APTT cuvette Regulation Number: 21 CFR 864.7925 Regulation Name: Partial thromboplastin time tests Regulatory Class: Class II Product Code: GFO Dated: January 16, 2002 Received: January 17, 2002

Dear Mr. Clay:

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/cdrb/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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510(k) Number (If Known):

K014008

Device Name: Hemochron® Jr. Citrate APTT cuvette Indications for Use:

For In Vitro Diagnostic Use Only

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Jasmine Bautista

(Division Sign-Off)
Clinical Laboratory Devices
510(k) number K0114008

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).