K Number

Device Name

ACTALYKE ACTIVATED CLOTTING TIME TEST SYSTEM/CLOTTING TIME TUBES/WHOLE BLOOD QC KIT/ACTALYKE ELECTRONIC CLOTTING TUBE

Manufacturer

ARRAY MEDICAL, INC.

Date Cleared

1997-03-06

(108 days)

Product Code

JBP

Regulation Number

864.7140

Intended Use

The Actalyke Activated Clotting Time System and Test Tubes are intended for use in the measurement of the activated clotting time test (ACT). Current markets using the ACT include: bypass surgery, vascular surgery, transplant surgery, renal dialysis, ECMO, cardiac catheterization and Percutaneous Transluminal Coronary Angioplasty (PTCA), Critical Care, and other medical therapies requiring heparin anticoagulation.

Device Description

The Actalyke System is a portable, battery operated device designed to perform a range of whole blood coagulation tests at the patient's bedside using Activated Clotting Time (ACT) measurement techniques. Each test well of the Actalyke Instrument incorporates a highly sensitive clot detection mechanism. Operationally, the detection mechanism comprises a magnet located inside a test tube and two solid state magnetic detectors positioned within the test well - one situated at 0° and another situated at 90° with respect to the test tube. When a test tube is inserted into the test well, the detector at 0° senses the presence of the magnet as the tube slowly rotates. As clotting forms, the fibrin strands cause the magnet to rotate within the tube such that its presence is sensed by the detector at 90° (indicating the occurrence of clotting and triggering end-point detection). This two-point detection sensing system is an improvement in ACT detection methods and minimizes the possibility of a missed end-point. Each Actalyke test tube has a barcode label affixed to it, which is read by the Actalyke instrument to determine the test tube type (i.e., celite, kaolin, or glass bead), If the result is printed (optional), the normal range for the identified test tube type will be printed. The lot number and expiration date of each tube are also identified on the barcode label.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

HEMOCHRON Whole Blood Coagulation System and Activated Clotting Time Tests (pre-1976)

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description details a mechanical and magnetic clot detection mechanism, and there is no mention of AI, ML, or related concepts in the summary.

Therapeutic

No.
A therapeutic device is one that performs treatment, prevention, or cures a disease or condition. This device is used for diagnostic purposes by measuring activated clotting time (ACT).

Diagnostic

Yes
The device is intended for use in the measurement of the activated clotting time test (ACT) for various medical therapies requiring heparin anticoagulation, and its description highlights its function in detecting clotting, which is a diagnostic measurement.

SaMD (Software as a Medical Device)

The device description clearly outlines a portable, battery-operated hardware instrument with physical components (magnet, magnetic detectors) designed to perform a physical measurement (clotting time). While it likely includes software for processing and display, it is fundamentally a hardware device.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use explicitly states that the system is for "use in the measurement of the activated clotting time test (ACT)". This is a test performed on a biological sample (whole blood) to provide information about a patient's health status (their clotting time).
Device Description: The device performs a "range of whole blood coagulation tests". Whole blood is a biological specimen.
Performance Studies: The performance studies involve testing "Patient samples", which are biological specimens. The results are measurements of ACT in seconds, which are diagnostic parameters.
Predicate Device: The predicate device is the "HEMOCHRON Whole Blood Coagulation System and Activated Clotting Time Tests", which is also an IVD device used for similar diagnostic testing.

The device analyzes a biological sample (whole blood) in vitro (outside the body) to provide diagnostic information (activated clotting time). This aligns directly with the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

Not Found

Device Description

Actalyke System

ACT Measurement Principles

A step-by-step description of the Actalyke ACT measurement principle is provided below:

Each test well of the Actalyke Instrument incorporates a highly sensitive clot detection mechanism.
Operationally, the detection mechanism comprises a magnet located inside a test tube and two solid state magnetic detectors positioned within the test well - one situated at 0° and another situated at 90° with respect to the test tube.
When a test tube is inserted into the test well, the detector at 0° senses the presence of the magnet as the tube slowly rotates.
As clotting forms, the fibrin strands cause the magnet to rotate within the tube such that its presence is sensed by the detector at 90° (indicating the occurrence of clotting and triggering end-point detection). This two-point detection sensing system is an improvement in ACT detection methods and minimizes the possibility of a missed end-point.

Actalyke Activated Clotting Time Tubes

Each Actalyke test tube has a barcode label affixed to it, which is read by the Actalyke instrument to determine the test tube type (i.e., celite, kaolin, or glass bead), If the result is printed (optional), the normal range for the identified test tube type will be printed. The lot number and expiration date of each tube are also identified on the barcode label.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

patient's bedside

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Normal Range Study:

Celite Normal Range Study: Tested 15 patient samples with both Hemochron and Actalyke instruments and tubes. Data includes individual patient results and statistical summaries (mean, std, %cv, max, min, x-2std, x+2std, x-3std, x+3std).
Kaolin Normal Range Study: Tested 15 patient samples with both Hemochron and Actalyke instruments and tubes. Data includes individual patient results and statistical summaries.
Glass Bead Normal Range Study: Tested 15 patient samples with both Hemochron and Actalyke instruments and tubes. Data includes individual patient results and statistical summaries.

Correlation with predicate device:

Celite tubes: Compared mean ACT data at different heparin concentrations (0, 1, 3, 5 u/ml heparin) for combinations of Hemochron and Actalyke instruments and tubes.
Kaolin tubes: Compared mean ACT data at different heparin concentrations (0, 1, 3, 5 u/ml heparin) for combinations of Hemochron and Actalyke instruments and tubes.
Glass Bead tubes: Compared mean ACT data at different heparin concentrations (0, 0.3, 0.6, 1, 2 u/ml heparin) for combinations of Hemochron and Actalyke instruments and tubes.

Key results:

Actalyke Instrument/Actalyke ACT tubes yielded similar normal ranges when compared to the Hemochron Instrument/Hemochron ACT tubes when utilizing the same normal patient samples.
Actalyke Instrument/Actalyke ACT tubes yielded high correlation with Hemochron Instrument/Hemochron ACT tubes when utilizing the same patient samples.
Hemochron Instruments/Actalyke ACT tubes yielded high correlation with Hemochron Instrument/Hemochron ACT tubes when utilizing the same patient samples.
Actalyke Instruments/Hemochron ACT tubes yielded high correlation with Hemochron Instrument/Hemochron ACT tubes when utilizing the same patient samples.

Key Metrics

Not Found

Predicate Device(s)

HEMOCHRON Whole Blood Coagulation System and Activated Clotting Time Tests (pre-1976)

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 864.7140 Activated whole blood clotting time tests.

(a)
Identification. An activated whole blood clotting time tests is a device, used to monitor heparin therapy for the treatment of venous thrombosis or pulmonary embolism by measuring the coagulation time of whole blood.(b)
Classification. Class II (performance standards).

Summary

K964609

1. 510(k) Summary of Information Respecting Safety and Effectiveness
A. Legally Marketed Device

Array Medical claims substantial equivalence to the HEMOCHRON Whole Blood Coagulation System and Activated Clotting Time Tests (pre-1976), currently in commercial distribution by International Technidyne Corporation.

B. Device Description

Actalyke System

ACT Measurement Principles

A step-by-step description of the Actalyke ACT measurement principle is provided below:

l ) Each test well of the Actalyke Instrument incorporates a highly sensitive clot detection mechanism.
1. Operationally, the detection mechanism comprises a magnet located inside a test tube and two solid state magnetic detectors positioned within the test well - one situated at 0° and another situated at 90° with respect to the test tube. See below:

Image /page/0/Figure/12 description: This image shows a diagram of a test well with a tube inside. There is a detector at 90 degrees and a detector at 0 degrees. A magnet is also present in the diagram, positioned near the tube.

1. When a test tube is inserted into the test well, the detector at 0° senses the presence of the magnet as the tube slowly rotates.
1. As clotting forms, the fibrin strands cause the magnet to rotate within the tube such that its presence is sensed by the detector at 90° (indicating the occurrence of clotting and triggering end-point detection). This two-point detection sensing system is an improvement in ACT detection methods and minimizes the possibility of a missed end-point.

Device Description (continued)

Actalyke Activated Clotting Time Tubes

Cat. No.	Recomm. Use	Activator	Description
C-ACT	Bypass and
Vascular surgery	Celite (14 mg.)	Glass tube with black
flip-top tube
and barcode label.
2.0 ml blood sample
K-ACT	Bypass surgery
in the presence
aprotinin	Kaolin (14 mg.)	Glass tube with gold
flip-top and barcode
label. 2.0 ml blood
sample
G-ACT	Renal Dialysis	Glass beads (50 mg.)	Plastic tube with clea
flip-top and barcode
label. 0.4 ml blood
sample

NOTE: Used Actalyke test tubes should be disposed of in accordance with each institution's policy regarding biohazardous materials.

C. Intended Use

D. Comparison with Predicate Device

(

Feature Comparison of Actalyke and HEMOCHRON Systems

	Actalyke	HEMOCHRON
Intended Use	Activated Clotting Time Test	Activated Clotting Time Test
Method of detection	Magnetic detection	Magnetic Detection
Reactive Ingredients (tubes)	Celite, kaolin, glass-beads	Celite, kaolin, glass-beads
Storage of tubes	Room temperature	Room temperature
Materials provided	Instrument
Test Tubes
Controls	Instrument
Test Tubes
Controls
Instrument Specifications	No. Test Channels: 1 or 2 Timing Range: 0-1500 Operating Time on Battery (hours): 4-6 Test barcode identification Options: Printer	No. Test Channels: 1 or 2 Timing Range: 0-1500 Operating Time on Battery (hours): 4-6
Performance	C-ACT 105-130 sec.
K-ACT 114-130 sec.
G-ACT 165-212 sec.
Normal Range studies	CA510 105-167 sec.
K-ACT 91-151 sec.
P214 145-195 sec.
Normal Range studies

E. Performance Data

Specific Performance Characteristics

Normal Range Study

Celite Normal Range Study

Instrument		Hemochron		Actalyke
Tubes		Hemochron	Actalyke	Hemochron	Actalyke
No	Patient ID
1	S011	129	133	103	117
2	S012	124	126	118	125
3	S013	112	118	106	113
4	S014	110	110	100	109
5	S015	104	112	113	125
6	S016	109	114	108	117
7	S002	108	117	109	112
8	S017	116	119	112	123
9	S018	107	114	112	117
10	S019	101	108	100	110
11	S020	109	115	110	116
12	S021	121	129	120	130
13	S022	104	106	102	112
14	S023	113	124	110	122
15	S024	108	112	110	115
	mean	111.67	117.13	108.87	117.53
	std	7.83	7.83	5.95	6.20
	%cv	7.01	6.68	5.47	5.27
	max	129.00	133.00	120.00	130.00
	min	101.00	108.00	100.00	109.00
	x-2std	96.02	101.48	96.97	105.14
	x+2std	127.32	132.79	120.77	129.93
	x-3std	88.19	93.65	91.01	98.94
	x+3std	135.14	140.62	126.72	136.13

Kaolin Normal Range Study

.. '-

Instrument		Hemochron		Actalyke
Tubes		Hemochron	Actalyke	Hemochron	Actalyke
No	Patient ID
1	S033	118	128	107	117
2	S034	118	119	108	118
3	S035	116	120	105	119
4	S036	122	128	115	125
5	S037	114	122	110	119
6	S004	116	125	118	128
7	11L001	119	130	115	122
8	S005	122	132	119	128
9	S037	108	118	108	121
10	S038	112	121	114	120
11	S009	122	133	122	127
12	S030	119	127	121	126
13	S031	115	121	116	122
14	S039	110	125	106	118
15	S040	109	119	108	119
	mean	116.00	124.53	112.80	121.93
	std	4.66	4.96	5.71	3.88
	%cv	4.02	3.98	5.06	3.18
	max	122.00	133.00	122.00	128.00
	min	108.00	118.00	105.00	117.00
	x-2std	106.68	114.62	101.38	114.17
	x+2std	125.32	134.44	124.22	129.70
	x-3std	102.02	109.67	95.67	110.29
	x+3std	129.98	139.40	129.93	133.58

Glass Bead Normal Range Study

Instrument		Hemochron		Actalyke
Tubes		Hemochron	Actalyke	Hemochron	Actalyke
No	Patient ID
1	S051	188	180	188	203
2	S027	175	168	163	185
3	S025	177	167	177	199
4	S052	178	199	199	198
5	S028	166	169	178	178
6	S019	162	167	163	167
7	S035	168	197	158	199
8	S045	173	172	179	172
9	11L001	171	190	155	189
10	S049	191	186	157	203
11	S048	174	169	181	197
12	S006	169	180	185	185
13	S016	157	176	166	177
14	S030	150	178	167	183
15	S009	145	179	170	188
	mean	169.60	178.47	172.40	188.20
	std	12.55	10.56	12.76	11.45
	%cv	7.40	5.91	7.40	6.08
	max	191.00	199.00	199.00	203.00
	min	145.00	167.00	155.00	167.00
	X-2std	144.50	157.36	146.88	165.31
	x+2std	194.70	199.58	197.92	211.09
	x-3std	131.95	145.80	134.12	153.86
	x+3std	207.25	210.13	210.68	222.54

Correlation with predicate device

Summary Celite tubes
----------------------	--	--

Mean data	u/ml heparin
Instrument	tube	0	1	3	5
Hemochron	Hemochron	120.6	252.4	448.8	782.2
Hemochron	Actalyke	123	264	431.8	709.2
Actalyke	Hemochron	114	214.2	377.4	548
Actalyke	Actalyke	122	235.2	386.8	598.6

Image /page/5/Figure/3 description: This figure is a line graph titled "Mean total data Celite tubes". The x-axis is labeled "u/ml heparin" and ranges from 0 to 5. The y-axis is labeled "ACT (seconds)" and ranges from 0 to 1000. There are 4 lines on the graph, representing Hemochron and Actalyke.

Summary Kaolin tubes

(

Mean data		u/ml heparin
instrument	tube	0	1	3	5
Hemochron	Hemochron	129.6	291	533.4	848.75
Hemochron	Actalyke	137	297.6	511	780.2
Actalyke	Hemochron	124	264.4	497	735.6

Image /page/6/Figure/2 description: The image is a graph titled "Mean total data Kaolin tubes". The x-axis is labeled "u/ml heparin" and ranges from 0 to 5. The y-axis is labeled "ACT (seconds)" and ranges from 0 to 900. There are four lines on the graph, representing Hemochron and Actalyke, showing the relationship between heparin concentration and ACT.

내

Summary Glass Bead tubes

Mean data	u/ml heparin
Instrument	tube	0	0.3	0.6	1	2
Hemochron	Hemochron	179.0	294.4	345.6	451.0	636.2
Hemochron	Actalyke	181.0	270.2	336.0	402.0	584.4
Actalyke	Hemochron	178.4	272.6	337.6	378.4	554.6

Image /page/7/Figure/2 description: The image is a graph titled "Mean total data Glass bead tubes". The x-axis is labeled "u/ml heparin" and ranges from 0 to 2. The y-axis is labeled "ACT (seconds)" and ranges from 0.0 to 800.0. There are multiple lines on the graph, representing Hemochron and Actalyke.

DATA SUMMARY

Actalyke Instrument/Actalyke ACT tubes yielded similar normal ranges when compared . to the Hemochron Instrument/Hemochron ACT tubes when utilizing the same normal patient samples
Actalyke Instrument/Actalyke ACT tubes yielded high correlation with Hemochron . Instrument/Hemochron ACT tubes when utilizing the same patient samples
Hemochron Instruments/Actalyke ACT tubes yielded high correlation with . Hemochron Instrument/Hemochron ACT tubes when utilizing the same patient samples
Actalyke Instruments/Hemochron ACT tubes yielded high correlation with . Hemochron Instrument/Hemochron ACT tubes when utilizing the same patient samples

. . .

ë;