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.

AI/ML Overview

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Actalyke System appear to be based on demonstrating "normal ranges" and "high correlation" with the legally marketed predicate device, the HEMOCHRON Whole Blood Coagulation System, across different test tube types (Celite, Kaolin, Glass Bead). Since specific quantitative acceptance thresholds are not explicitly stated, the reported performance is compared directly to the predicate device's performance in the provided tables.

Test Tube Type	Acceptance Criteria (Implied)	Reported Actalyke Performance (Ranges from studies)	Predicate Device (HEMOCHRON) Performance (Ranges from studies)
Celite	Similar normal range to predicate	108-133 seconds	101-129 seconds
	High correlation with predicate for varying heparin concentrations	See "Correlation with Predicate Device" tables and graphs.	See "Correlation with Predicate Device" tables and graphs.
Kaolin	Similar normal range to predicate	118-133 seconds	108-133 seconds
	High correlation with predicate for varying heparin concentrations	See "Correlation with Predicate Device" tables and graphs.	See "Correlation with Predicate Device" tables and graphs.
Glass Bead	Similar normal range to predicate	167-199 seconds	145-191 seconds
	High correlation with predicate for varying heparin concentrations	See "Correlation with Predicate Device" tables and graphs.	See "Correlation with Predicate Device" tables and graphs.

Summary of Reported Device Performance:

Normal Range Studies: The Actalyke System, using its own tubes, demonstrated normal ranges largely overlapping with or comparable to the Hemochron system using its own tubes, when tested on healthy patient samples (as shown in the detailed tables for Celite, Kaolin, and Glass Bead).
Correlation Studies (with varying heparin): The Actalyke Instrument and Actalyke ACT tubes showed "high correlation" with the Hemochron Instrument and Hemochron ACT tubes across different heparin concentrations for all three tube types (Celite, Kaolin, Glass Bead), indicating similar performance in measuring coagulation time under anticoagulation. This was visually represented and stated generally as "high correlation" in the DATA SUMMARY.

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

Sample Size (Normal Range Studies):
- Celite Normal Range Study: 15 patient samples (S011-S024 excluding some, plus S002).
- Kaolin Normal Range Study: 15 patient samples (S033-S040, S004, S005, S009, S030, S031, S037, plus 11L001).
- Glass Bead Normal Range Study: 15 patient samples (S051, S027, S025, S052, S028, S019, S035, S045, 11L001, S049, S048, S006, S016, S030, S009).
Sample Size (Correlation Studies):
- The sample size for the heparin correlation studies is not explicitly stated as a number of individual patients. However, the data represents "mean data" for varying heparin concentrations (0, 1, 3, 5 u/ml for Celite & Kaolin; 0, 0.3, 0.6, 1, 2 u/ml for Glass Bead), suggesting multiple measurements per heparin concentration. Given the normal range studies used 15 patients, it's plausible similar numbers were used for correlation, but it's not confirmed.
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The patient IDs (e.g., S011, S002) suggest individual patient data was collected, but we cannot deduce if it was prospective or retrospective from the provided text.

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

Not applicable. This device measures a physical property (clotting time) directly, rather than relying on expert interpretation of images or other qualitative data. The "ground truth" is the measured Activated Clotting Time (ACT) itself, or comparison to an established, legally marketed device (HEMOCHRON system).

4. Adjudication Method (for the test set)

Not applicable. As noted above, the device measures a physical property directly. There is no qualitative assessment or interpretation by experts that would require an adjudication method. The study design involves direct comparison of measurements between the Actalyke system and the predicate device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This is not applicable to the Actalyke System. An MRMC study typically involves human readers interpreting cases (e.g., medical images) with and without AI assistance to assess changes in diagnostic performance. The Actalyke System is a point-of-care coagulation analyzer, not an AI-powered diagnostic imaging tool that assists human readers.

6. Standalone Performance Study

Yes, a standalone performance was done in the "Normal Range Study" for each tube type. The Actalyke instrument was used with Actalyke tubes to establish normal ranges, which were then compared to the normal ranges obtained by the Hemochron instrument with Hemochron tubes. Additionally, the correlation studies implicitly demonstrate standalone performance when the Actalyke instrument is used with Actalyke tubes across varying heparin concentrations.

7. Type of Ground Truth Used

The ground truth used is predominantly:

Comparison to a Legally Marketed Predicate Device: The performance of the Actalyke System is evaluated by comparing its results directly to those obtained from the HEMOCHRON Whole Blood Coagulation System, which is the established standard.
Measured Activated Clotting Time (ACT): For the normal range studies, the ACT measurements from healthy individuals define the "normal range." For the correlation studies, the measured ACT values at different heparin concentrations serve as the primary data point for comparison.

8. Sample Size for the Training Set

Not applicable. The Actalyke System does not appear to be an AI/machine learning device that requires a "training set" in the conventional sense. It is a hardware device based on magnetic detection principles. The studies described are performance validation studies, not training of an algorithm.

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

Not applicable, as there is no "training set" for this device.

Summary

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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.

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Device Description (continued)

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.

Cat. No.	Recomm. Use	Activator	Description
C-ACT	Bypass andVascular surgery	Celite (14 mg.)	Glass tube with blackflip-top tubeand barcode label.2.0 ml blood sample
K-ACT	Bypass surgeryin the presenceaprotinin	Kaolin (14 mg.)	Glass tube with goldflip-top and barcodelabel. 2.0 ml bloodsample
G-ACT	Renal Dialysis	Glass beads (50 mg.)	Plastic tube with cleaflip-top and barcodelabel. 0.4 ml bloodsample

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

C. Intended Use

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D. Comparison with Predicate Device

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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	InstrumentTest TubesControls	InstrumentTest TubesControls
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

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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

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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

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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.

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Summary Kaolin tubes

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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.

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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;

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).