ACTALYKE ACTIVATED CLOTTING TIME TEST SYSTEM/CLOTTING TIME TUBES/WHOLE BLOOD QC KIT/ACTALYKE ELECTRONIC CLOTTING TUBE
Device Facts
| Record ID | K964609 |
|---|---|
| Device Name | ACTALYKE ACTIVATED CLOTTING TIME TEST SYSTEM/CLOTTING TIME TUBES/WHOLE BLOOD QC KIT/ACTALYKE ELECTRONIC CLOTTING TUBE |
| Applicant | Array Medical, Inc. |
| Product Code | JBP · Hematology |
| Decision Date | Mar 6, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.7140 |
| Device Class | Class 2 |
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 Story
Portable, battery-operated Actalyke System performs whole blood Activated Clotting Time (ACT) tests at patient bedside. System uses specialized test tubes containing activators (celite, kaolin, or glass beads). Operation involves inserting blood-filled tube into instrument; tube rotates; internal magnet detects fibrin strand formation via two-point magnetic sensing (0° and 90° detectors). This dual-sensor mechanism improves end-point detection and reduces missed clots. Instrument reads tube-specific barcodes to identify activator type and normal ranges. Used by clinicians in OR, dialysis, and critical care settings to monitor heparin anticoagulation levels. Output (ACT time) informs clinical decisions regarding heparin dosing and reversal. Benefits include rapid, accurate bedside coagulation monitoring to guide surgical and therapeutic interventions.
Clinical Evidence
Bench testing only. Normal range studies (n=15 per tube type) compared Actalyke and Hemochron systems, showing similar mean ACT values and standard deviations. Correlation studies across varying heparin concentrations (0-5 u/ml) demonstrated high correlation between Actalyke and Hemochron instruments using both Actalyke and Hemochron test tubes.
Technological Characteristics
Portable, battery-operated (4-6 hours) instrument. Magnetic clot detection principle using two solid-state magnetic detectors at 0° and 90°. Test tubes contain celite, kaolin, or glass bead activators. Barcode-based tube identification. 1 or 2 test channels. Timing range 0-1500 seconds. Optional printer integration.
Indications for Use
Indicated for patients undergoing medical procedures requiring heparin anticoagulation, including bypass, vascular, and transplant surgery, renal dialysis, ECMO, cardiac catheterization, and PTCA.
Regulatory Classification
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.
Predicate Devices
- HEMOCHRON Whole Blood Coagulation System and Activated Clotting Time Tests
Related Devices
- K983649 — MAX-ACT · Array Medical, Inc. · Dec 11, 1998
- K013078 — ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM, MODEL 5750/5752 · Helena Laboratories · Jan 10, 2002
- K971935 — B&D ACTIVATED CLOTTING TIME (ACT) TEST TUBES BD-C101 (DIATOMACEOUS EARTH) AND BD-K101 (KAOLIN) · B & D Corp. · Oct 1, 1997
- K992851 — ACT TEST CATRIDGES FOR COAGUCHEK PRO SYSTEM, ACT CONTROLS FOR COAGUCHEK PRO SYSTEM · Roche Diagnostics Corp. · Jan 14, 2000
Submission Summary (Full Text)
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K964609
MAR - 6 1997
9. 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**
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.
**ACT Measurement Principles**
A step-by-step description of the Actalyke ACT measurement principle is provided below:
1) Each test well of the Actalyke Instrument incorporates a highly sensitive clot detection mechanism.
2) 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 $0^{\circ}$ and another situated at $90^{\circ}$ with respect to the test tube. See below:
3) When a test tube is inserted into the test well, the detector at $0^{\circ}$ senses the presence of the magnet as the tube slowly rotates.
4) As clotting forms, the fibrin strands cause the magnet to rotate within the tube such that its presence is sensed by the detector at $90^{\circ}$ (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 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 clear 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
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.
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# 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 |
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E. Performance Data
Specific Performance Characteristics
Normal Range Study
Celite Normal Range Study
| Instrument Tubes | | Hemochron | | Actalyte | |
| --- | --- | --- | --- | --- | --- |
| No | Patient ID | Hemochron | Actalyte | Hemochron | Actalyte |
| 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 | 106.00 | 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 Tubes | | Hemochron | | Actalyte | |
| --- | --- | --- | --- | --- | --- |
| No | Patient ID | Hemochron | Actalyte | Hemochron | Actalyte |
| 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 | I1L001 | 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 Tubes | Hemochron | | Actalyke | | |
| --- | --- | --- | --- | --- | --- |
| | | 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 | ITL001 | 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 | 146.80 | 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 |
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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 |
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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 |
## 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
