DESTINY MAX COAGULATION ANALYZER
Device Facts
| Record ID | K083896 |
|---|---|
| Device Name | DESTINY MAX COAGULATION ANALYZER |
| Applicant | Trinity Biotech |
| Product Code | JPA · Hematology |
| Decision Date | Jul 2, 2009 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.5425 |
| Device Class | Class 2 |
Intended Use
The Destiny Max Coagulation Analyzer is a multipurpose system for in vitro coagulation studies consisting of one automated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.
Device Story
Destiny Max is an automated high-throughput coagulation analyzer for clinical laboratory use. It processes human plasma samples via cap-piercing or open-tube aspiration. The system utilizes disposable cuvettes, pre-heating them before reagent addition. Measurement modules include electromechanical (clotting times) and electro-optical (transmission monitoring at four wavelengths for clotting, chromogenic, and immuno-turbidimetric assays). A PC-based GUI allows operators to order tests, monitor QC (Levy-Jennings charts), and print results. The device automates sample handling, dilution, and analysis, providing quantitative or qualitative coagulation data. This output assists clinicians in diagnosing and monitoring coagulation disorders and factor deficiencies, facilitating therapeutic decision-making.
Clinical Evidence
Bench testing only. Method comparison studies at 3 sites using clinical samples (N=19-117 per assay) showed high correlation with the predicate (R^2 0.88-1.00). Precision studies (within-run and total) across 3 sites demonstrated %CVs generally ranging from 0.6% to 24.2% depending on the assay and level. Linearity was established for all assays with R values 0.993-1.000.
Technological Characteristics
Multipurpose coagulation analyzer. Detection: optical (340nm, 405nm, 635nm, 705nm) and mechanical. Throughput: ~350 PT tests/hr. Features: cap piercing, barcode ID, QC scheduling, result tracking. Connectivity: external PC. Software: separated instrument drive and user interface.
Indications for Use
Indicated for in vitro coagulation studies and coagulation factor assays in various patient populations to detect clotting deficiencies or disorders and/or monitor anticoagulant therapy.
Regulatory Classification
Identification
A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.
Special Controls
*Classification.* Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
Predicate Devices
- Amax Destiny™ Coagulation Analyzer (k021162)
Related Devices
- K130090 — STA COMPACT MAX · Diagnostica Stago, Incorporated · Feb 12, 2013
- K991101 — COAG-A-MATE MAX · Organon Teknika Corp. · Jun 1, 1999
- K961579 — STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER · American Bioproducts Co. · Jul 10, 1996
Submission Summary (Full Text)
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Trinity Biotech
K083896
JUL - 2 2009
## 510(k) Summary
Destiny MAX
#### A. 510(k) Submitter Information:
| Submitter's name: | Trinity Biotech |
|------------------------------|----------------------------------------------------------------------------------------------|
| Address: | IDA Business Park<br>Bray, Co. Wicklow<br>Ireland |
| Contact Person: | Bonnie DeJoy |
| Phone Number:<br>Fax Number: | (716) 483-3851<br>(716) 488-1990 |
| Date of Preparation: | December, 15 2008 |
| B. Device Information: | |
| Trade Name: | Destiny MAX |
| Device Classification Name: | System, Multipurpose for in vitro<br>coagulation studies, 21CFR864.5425,<br>Product code JPA |
| Common Name: | Destiny MAX |
| C. Predicate Device: | AMAX DestinyTM Coagulation Analyzer<br>(K021162) |
#### Indications for Use
The Destiny Max Coagulation Analyzer is a multipurpose system for in vitro coagulation studies consisting of one automated instrument and its associated maynts and controls. The system is used to perform a scries of coagulation studies and coagulation factor assays.
#### Device Description
The Destiny Max instrument performs coagulation testing (clotting, chromogenic and immuno-turbidimetric) using human samples. The system is comprised of an instrument (Destiny Max Analyzer) that performs the tasks necessary to general an assay result together with a Personal Computer (PC) that reccives the user's secueeds and provides the results. The assays used with the Destiny Max are generally requences detection of clotting deficiencies or disorders and/or monitoring of anticoagalant therapy on various patient populations.
#### Section 3: 510k Summary Page 1 of 10
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#### Destiny Max Trinity Biotech 510(k) Submission Traditional Premarket Notification
#### Predicate Device and Equivalence Information
The Destiny Max employs the same detection technologies previously employed in the predicate device with a new graphic user interface, cap piercing capability and enhanced through put. The Destiny Max system is substantially equivalent to the AMAX Destiny system in intended use and performance.
#### Device Technological Characteristics
Table 1 is a summary of the technological characteristics of the Destiny Max compared to the predicate device.
| Feature | AMAX Destiny | Destiny MAX |
|----------------------------------------------------------|--------------|----------------------------------|
| Integrated PC | Yes | No |
| Integrated Monitor | Yes | No |
| Touch screen | Yes | Yes |
| Instrument Drive and User Interface SW separated | No | Yes |
| Optical clotting | Yes | Yes |
| Minimum test volume in µL optical clotting | 150 | 150 |
| Mechanical clotting | Yes | Yes |
| Minimum test volume in µL mechanical clotting | 75 | 75 |
| Throughput PT | 180 | ≈350 |
| Throughput PT/PTT/FIB | 110 | ≈300 |
| Multishot sample | Yes | Yes |
| Multiple dispense reagent on appropriate reagents | Yes | Yes |
| Optical Wavelengths | 405nm | 340nm, 405nm,<br>635nm and 705nm |
| Cap piercing | No | Yes |
| QC scheduling | No | Yes |
| Result tracking to Lot#, operator, QC, calibration curve | No | Yes |
| Tracking of Operator to editing of assay definitions | Yes | Yes |
| Barcode ID of samples and reagents | Yes | Yes |
Table 1: Comparison of Technological Characteristics
Device Performance Characteristics – Method Comparison
Table 2 describes the performance of the Destiny Max system whon compared to the predicate at 3 sites using a variety of clinical samples.
| Assay | Site | N | Slope | Intercept | R^2 |
|-------------------------------------------------|------|-----|-------|-----------|------|
| TriniCLOT PT HTF Optical Mode Seconds | 1 | 77 | 1.04 | -2.00 | 1.00 |
| TriniCLOT PT HTF Optical Mode Seconds | 2 | 42 | 1.00 | -1.28 | 0.99 |
| TriniCLOT PT HTF Optical Mode Seconds | 3 | 85 | 1.23 | -3.71 | 0.99 |
| TriniCLOT PT HTF Mechanical Mode Seconds | 1 | 80 | 1.02 | -1.37 | 1.00 |
| TriniCLOT PT HTF Mechanical Mode Seconds | 2 | 51 | 1.02 | -1.66 | 1.00 |
| TriniCLOT PT HTF Mechanical Mode Seconds | 3 | 86 | 1.21 | -3.01 | 1.00 |
| Assay | Site | N | Slope | Intercept | R |
| TriniCLOT Excel S Optical Mode Seconds | 1 | 77 | 1.03 | -1.61 | 1.00 |
| TriniCLOT Excel S Optical Mode Seconds | 2 | 43 | 0.99 | -1.36 | 1.00 |
| TriniCLOT Excel S Optical Mode Seconds | 3 | 75 | 1.01 | -0.05 | 1.00 |
| TriniCLOT Excel S Mechanical Mode Seconds | 1 | 78 | 1.09 | -2.08 | 1.00 |
| TriniCLOT Excel S Mechanical Mode Seconds | 2 | 49 | 1.04 | -1.29 | 1.00 |
| TriniCLOT Excel S Mechanical Mode Seconds | 3 | 78 | 1.13 | -1.43 | 1.00 |
| TriniCLOT APTT S Optical Mode Seconds | 1 | 63 | 0.97 | -1.82 | 0.99 |
| TriniCLOT APTT S Optical Mode Seconds | 2 | 49 | 0.87 | 1.57 | 0.93 |
| TriniCLOT APTT S Optical Mode Seconds | 3 | 80 | 1.03 | -3.11 | 0.99 |
| TriniCLOT APTT S Mechanical Mode Seconds | 1 | 67 | 0.91 | 2.65 | 0.99 |
| TriniCLOT APTT S Mechanical Mode Seconds | 2 | 57 | 1.05 | -2.08 | 0.97 |
| TriniCLOT APTT S Mechanical Mode Seconds | 3 | 86 | 1.01 | -0.27 | 0.98 |
| TriniCLOT Thrombin Time Mechanical Mode Seconds | 1 | 50 | 1.21 | -3.35 | 0.97 |
| TriniCLOT Thrombin Time Mechanical Mode Seconds | 2 | 19 | 0.89 | 0.91 | 0.96 |
| TriniCLOT Thrombin Time Mechanical Mode Seconds | 3 | 73 | 1.04 | -0.37 | 0.99 |
| TriniCLOT Fibrinogen Optical Mode mg/dL | 1 | 80 | 0.90 | 15.56 | 1.00 |
| TriniCLOT Fibrinogen Optical Mode mg/dL | 2 | 69 | 1.02 | -5.45 | 0.98 |
| TriniCLOT Fibrinogen Optical Mode mg/dL | 3 | 68 | 0.73 | 71.70 | 0.95 |
| TriniCLOT Fibrinogen Mechanical Mode mg/dL | 1 | 80 | 0.86 | 44.28 | 0.99 |
| TriniCLOT Fibrinogen Mechanical Mode mg/dL | 2 | 65 | 1.10 | -21.04 | 0.97 |
| TriniCLOT Fibrinogen Mechanical Mode mg/dL | 3 | 60 | 0.91 | 49.84 | 0.94 |
| TriniCLOT FVII Optical Mode % | 1 | 77 | 0.94 | 0.30 | 0.98 |
| TriniCLOT FVII Optical Mode % | 2 | 81 | 0.99 | -1.65 | 0.98 |
| TriniCLOT FVII Optical Mode % | 3 | 57 | 0.78 | 8.56 | 0.98 |
| TriniCLOT FVII Mechanical Mode % | 1 | 77 | 0.98 | 3.91 | 0.96 |
| TriniCLOT FVII Mechanical Mode % | 2 | 82 | 0.89 | 10.35 | 0.96 |
| TriniCLOT FVII Mechanical Mode % | 3 | 58 | 0.82 | 6.87 | 0.96 |
| TriniCLOT FIX Optical Mode % | 1 | 117 | 0.84 | 0.92 | 0.88 |
| TriniCLOT FIX Optical Mode % | 2 | 76 | 1.01 | -1.43 | 0.97 |
| TriniCLOT FIX Optical Mode % | 3 | 60 | 1.06 | -6.17 | 0.95 |
| TriniCLOT FIX Mechanical Mode % | 1 | 117 | 0.96 | 3.21 | 0.90 |
| TriniCLOT FIX Mechanical Mode % | 2 | 77 | 0.95 | 1.46 | 0.96 |
| TriniCLOT FIX Mechanical Mode % | 3 | 60 | 0.87 | 2.60 | 0.97 |
| TriniCHROM Antithrombin IIa % | 1 | 80 | 0.98 | 7.87 | 0.99 |
| TriniCHROM Antithrombin IIa % | 2 | 77 | 0.84 | 4.52 | 0.97 |
| TriniCHROM Antithrombin IIa % | 3 | 80 | 0.95 | 13.62 | 0.99 |
| TriniLIA D-Dimer ng/mL | 1 | 76 | 0.88 | 182.84 | 0.99 |
| TriniLIA D-Dimer ng/mL | 2 | 68 | 1.28 | -184.08 | 0.99 |
| TriniLIA D-Dimer ng/mL | 3 | 79 | 1.14 | -435.84 | 0.98 |
#### Section 3: 510k Summary Page 2 of 10
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Image /page/2/Picture/0 description: The image shows the logo for Trinity Biotech. The logo consists of a triangle shape on the left and the text "Trinity Biotech" on the right. The triangle is made up of three lines that form a triangle shape.
Section 3: 510k Summary Page 3 of 10
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# Trinity Biotech
#### Destiny Max 510(k) Submission Traditional Premarket Notification
Device Performance Characteristics - Linearity
Table 3 describes the linearity data generated for calibrated assays on the Destiny Max system.
| Assay | Range% | R |
|-------------------------------------------|------------|-------|
| TriniCLOT Fibrinogen Optical Mode | 64 - 1400 | 0.993 |
| TriniCLOT Fibrinogen Mechanical Mode | 62 - 844 | 1.000 |
| TriniCLOT Factor VII Optical Mode | 1 - 112 | 0.998 |
| TriniCLOT Factor VII Mechanical Mode | 2 - 110 | 0.998 |
| TriniCLOT Factor IX Optical Mode | 0 - 230 | 0.996 |
| TriniCLOT Factor IX Mechanical Mode | 0 - 104 | 0.996 |
| TriniCHROM Antithrombin Chromogenic Mode | 0-150 | 0.998 |
| TriniLIA D-Dimer Immunoturbidometric Mode | 70 - 13911 | 0.996 |
Device Performance Characteristics - Precision Tables 4 to 12 describe the precision data generated at 3 sites
| | | | | | | | Mode: Clotting | | | | | | | |
|------------|---------|------|------|-----|------|------|----------------|------------|------|------|-----|------|------|-----|
| Level<br>1 | Optical | | | | | | | Mechanical | | | | | | |
| | N | Sec | SD | %CV | Sec | SD | %CV | N | Sec | SD | %CV | Sec | SD | %CV |
| Site 1 | 57 | 12.3 | 0.32 | 2.6 | 12.3 | 0.42 | 3.4 | 57 | 12.8 | 0.31 | 2.4 | 12.8 | 0.41 | 3.2 |
| Site 2 | 56 | 12.6 | 0.29 | 2.3 | 12.6 | 0.58 | 4.6 | 60 | 12.8 | 0.28 | 2.2 | 12.8 | 0.5 | 3.9 |
| Site 3 | 60 | 12.5 | 0.26 | 2.1 | 12.5 | 0.28 | 2.3 | 58 | 12.5 | 0.15 | 1.2 | 12.5 | 0.27 | 2.2 |
#### Table 4a: Level 1 Precision Data TriniCl OT PT HTF
### Table 4b: Level 2 Precision Data TriniCLOT PT HTF
| Mode: Clotting | | | | | | | Mechanical | | | | | | | |
|----------------|------------|------|------|-------|------|------|------------|----|------|-------|-----|------|------|-----|
| Level 2 | Optical | | | | | | | | | | | | | |
| | Within Run | | | Total | | | Within Run | | | Total | | | | |
| | N | Sec | SD | %CV | Sec | SD | %CV | N | Sec | SD | %CV | Sec | SD | %CV |
| Site 1 | 56 | 20.7 | 0.46 | 2.2 | 20.7 | 0.55 | 2.6 | 56 | 21.2 | 0.52 | 2.4 | 21.2 | 0.58 | 2.7 |
| Site 2 | 56 | 21.2 | 0.41 | 1.9 | 21.2 | 0.57 | 2.7 | 59 | 21.5 | 0.39 | 1.8 | 21.5 | 0.40 | 1.9 |
| Site 3 | 59 | 21.1 | 0.34 | 1.6 | 21.1 | 0.42 | 2.0 | 57 | 21.0 | 0.2 | 0.9 | 21.0 | 0.38 | 1.8 |
#### Section 3: 510k Summary Page 4 of 10
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Image /page/4/Picture/0 description: The image shows the logo for Trinity Biotech. The logo consists of a triangle on the left and the words "Trinity Biotech" on the right. The triangle is black and has a dotted pattern. The words "Trinity Biotech" are also black and in a sans-serif font.
Table 4c: Level 3 Precision Data TriniCLOT PT HTF
| Level<br>3 | Mode: Clotting | | | | | | | | | | | | | | |
|------------|----------------|------|------|-----|------------|------|-----|----|------------|------|-----|------|-------|-----|--|
| | Optical | | | | Mechanical | | | | | | | | | | |
| | Within Run | | | | Total | | | | Within Run | | | | Total | | |
| | N | Sec | SD | %CV | Sec | SD | %CV | N | Sec | SD | %CV | Sec | SD | %CV | |
| Site 1 | 53 | 34.8 | 0.57 | 1.6 | 34.8 | 0.56 | 1.6 | 55 | 34.7 | 0.51 | 1.5 | 35.7 | 0.68 | 1.9 | |
| Site 2 | 59 | 35.5 | 0.54 | 1.5 | 35.5 | 0.81 | 2.3 | 60 | 36.1 | 0.86 | 2.4 | 36.1 | 1.05 | 2.9 | |
| Site 3 | 60 | 35.1 | 0.47 | 1.3 | 35.1 | 0.7 | 2.0 | 60 | 35.4 | 0.39 | 1.1 | 35.4 | 0.58 | 1.7 | |
### Table 5a: Level 1 Precision Data TriniCLOT PT Excel S
| Level<br>1 | Optical | | | | | | | Mechanical | | | | | | |
|------------|------------|------|------|-----|-------|------|-----|------------|------|------|-----|-------|------|-----|
| | Within Run | | | | Total | | | Within Run | | | | Total | | |
| | N | Sec | SD | %CV | Sec | SD | %CV | N | Sec | SD | %CV | Sec | SD | %CV |
| Site 1 | 54 | 13.6 | 0.24 | 1.7 | 13.6 | 0.25 | 1.8 | 57 | 14.2 | 0.21 | 1.5 | 14.2 | 0.26 | 1.8 |
| Site 2 | 54 | 13.8 | 0.23 | 1.6 | 13.8 | 0.43 | 3.1 | 59 | 14.4 | 0.22 | 1.5 | 14.4 | 0.47 | 3.3 |
| Site 3 | 60 | 13.4 | 0.26 | 1.9 | 13.4 | 0.29 | 2.2 | 59 | 14.0 | 0.24 | 1.7 | 14.0 | 0.28 | 2.0 |
Table 5b: Level 2 Precision Data TriniCLOT PT Excel S
| | | | | | | | Mode: Clotting | | | | | | | | | | | | | | | | |
|--------|----|------|------|-----|------|------|----------------|----|------|------|------------|------------|------|-----|-------|--|--|------------|--|--|-------|--|--|
| Level | | | | | | | Optical | | | | Mechanical | | | | | | | | | | | | |
| 2 | | | | | | | | | | | | Within Run | | | Total | | | Within Run | | | Total | | |
| | N | Sec | SD | %CV | Sec | SD | %CV | N | Sec | SD | %CV | Sec | SD | %CV | | | | | | | | | |
| Site 1 | 56 | 23.9 | 0.36 | 1.5 | 23.9 | 0.61 | 2.6 | 57 | 25.4 | 0.46 | 1.8 | 25.4 | 0.75 | 3.0 | | | | | | | | | |
| Site 2 | 45 | 24.8 | 0.5 | 2.0 | 24.8 | 1.04 | 4.3 | 59 | 26.3 | 0.31 | 1.2 | 26.3 | 1.08 | 4.1 | | | | | | | | | |
| Site 3 | 59 | 23.2 | 0.40 | 1.7 | 23.2 | 0.62 | 2.7 | 58 | 25.1 | 0.52 | 2.1 | 25.1 | 0.76 | 3.0 | | | | | | | | | |
Section 3: 510k Summary Page 5 of 10
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Image /page/5/Picture/0 description: The image shows the logo for Trinity Biotech. The logo consists of a triangle shape on the left and the text "Trinity Biotech" on the right. The triangle is made up of smaller lines, and the text is in a simple, sans-serif font.
| Level | | | | | | | Mode: Clotting | | | | | | | |
|--------|----|------|------------|---------|------|-------|----------------|------------|------|------------|-----|------|-------|-----|
| | | | | Optical | | | | Mechanical | | | | | | |
| 3 | | | Within Run | | | Total | | | | Within Run | | | Total | |
| | N | Sec | SD | %CV | Sec | SD | %CV | N | Sec | SD | %CV | Sec | SD | %CV |
| Site 1 | 57 | 42.8 | 0.68 | 1.6 | 42.8 | 1.60 | 3.8 | 57 | 45.9 | 0.79 | 1.7 | 45.9 | 1.72 | 3.8 |
| Site 2 | 57 | 42.8 | 0.69 | 1.6 | 42.8 | 2.28 | 5.3 | 60 | 47.4 | 0.95 | 2.0 | 47.4 | 2.62 | 5.5 |
| Site 3 | 59 | 39.9 | 0.44 | 1.1 | 39.9 | 1.02 | 2.5 | 60 | 43.5 | 1.04 | 2.4 | 43.5 | 1.76 | 4.1 |
Table 5c: Level 3 Precision Data TriniCLOT PT Excel S
Table 6a: Level 1 Precision Data TriniCLOT APTT S
| | | Optical | | | | | | Mechanical | | | | | | | |
|-------|--------|------------|------|------|-------|------|------|------------|----|------|-------|-----|------|------|-----|
| Level | | Within Run | | | Total | | | Within Run | | | Total | | | | |
| | | N | Sec | SD | %CV | Sec | SD | %CV | N | Sec | SD | %CV | Sec | SD | %CV |
| 1 | Site 1 | 57 | 30.9 | 0.21 | 0.7 | 30.9 | 0.4 | 1.3 | 57 | 32.4 | 0.73 | 2.3 | 32.4 | 0.97 | 3.0 |
| | Site 2 | 59 | 30.7 | 0.29 | 0.9 | 30.6 | 0.59 | 1.9 | 60 | 33.3 | 1.12 | 3.4 | 33.3 | 1.19 | 3.6 |
| | Site 3 | 59 | 30.6 | 0.21 | 0.7 | 30.6 | 0.35 | 1.1 | 58 | 32.4 | 0.66 | 2.0 | 32.4 | 0.82 | 2.5 |
Table 6b: Level 2 Precision Data TriniCLOT APTT S
| Mode: Clotting | | | | | | | | | | | | | | |
|----------------|------------|------|------|-----|-------|------|-----|------------|------|------|-----|-------|------|-----|
| Level 2 | Optical | | | | | | | Mechanical | | | | | | |
| | Within Run | | | | Total | | | Within Run | | | | Total | | |
| | N | Sec | SD | %CV | Sec | SD | %CV | N | Sec | SD | %CV | Sec | SD | %CV |
| Site 1 | 57 | 65.3 | 0.59 | 0.9 | 65.3 | 1.00 | 1.5 | 56 | 69.1 | 1.13 | 1.6 | 69.1 | 1.64 | 2.4 |
| Site 2 | 53 | 63.0 | 0.75 | 1.2 | 63.0 | 1.81 | 2.9 | 52 | 69.0 | 2.24 | 3.2 | 69.0 | 2.56 | 3.7 |
| Site 3 | 57 | 61.1 | 0.37 | 0.6 | 61.1 | 1.81 | 3.0 | 57 | 66.1 | 1.21 | 1.8 | 66.1 | 1.71 | 2.6 |
Section 3: 510k Summary Page 6 of 10
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Image /page/6/Picture/0 description: The image shows the logo for Trinity Biotech. The logo consists of a triangle shape on the left and the words "Trinity Biotech" on the right. The triangle is made up of smaller lines, and the words are in a bold, sans-serif font.
| Table 6c: Level 3 Precision Data TriniCLOT APTT S<br>Mode: Clotting | | | | | | | | | | | | | | |
|---------------------------------------------------------------------|------------|------|------|-------|------------|------|-----|-------|-------|------|-----|-------|------|-----|
| Level<br>3 | Optical | | | | Mechanical | | | | | | | | | |
| | Within Run | | | Total | Within Run | | | Total | | | | | | |
| | N | Sec | SD | %CV | Sec | SD | %CV | N | Sec | SD | %CV | Sec | SD | %CV |
| Site 1 | 57 | 94.8 | 1.08 | 1.1 | 94.8 | 1.63 | 1.7 | 56 | 101.0 | 2.95 | 2.9 | 101.0 | 4.12 | 4.1 |
| Site 2 | 59 | 91.0 | 1.59 | 1.7 | 91.0 | 2.18 | 2.4 | 58 | 96.7 | 3.80 | 3.9 | 96.7 | 9.20 | 9.5 |
| Site 3 | 59 | 87.0 | 0.69 | 0.8 | 87.0 | 2.55 | 2.9 | 58 | 94.7 | 1.92 | 2.0 | 94.7 | 2.89 | 3.1 |
#### Tablo Bo: L מ 3 Procision Date TripiCL OT ADTT S
Table 7a and Table 7b: Level 1 and Level 2 Precision Data TriniCLOT Thrombin Time
| Level<br>1 | Mode: Clotting<br>Optical | | | | Level<br>2 | Mode: Clotting<br>Optical | | | | | | | | | |
|------------|---------------------------|------|------|-----|------------|---------------------------|-----|--------|------------|------|------|-----|-------|------|-----|
| | Within Run | | | | Total | | | | Within Run | | | | Total | | |
| | N | Sec | SD | %CV | Sec | SD | %CV | | N | Sec | SD | %CV | Sec | SD | %CV |
| Site 1 | 59 | 15.8 | 0.41 | 2.6 | 15.8 | 0.49 | 3.1 | Site 1 | 60 | 18.8 | 0.27 | 1.5 | 18.8 | 0.40 | 2.1 |
| Site 2 | 47 | 15.1 | 0.16 | 1.1 | 15.1 | 2.5 | 1.7 | Site 2 | 59 | 18.7 | 0.24 | 1.3 | 18.7 | 0.45 | 2.4 |
| Site 3 | 56 | 15.0 | 0.38 | 2.5 | 15.0 | 0.49 | 3.3 | Site 3 | 54 | 18.4 | 0.30 | 1.6 | 18.4 | 0.32 | 1.8 |
・
#### Table 8a: Level 1 Precision Data TriniCLOT Fibrinogen r
| Mode: Clotting | | | | | | | | | | | | | | |
|----------------|------------|-------|------|-----|-------|-------|------------|----|-------|------|-------|-------|-------|-----|
| Level<br>1 | Optical | | | | | | Mechanical | | | | | | | |
| | Within Run | | | | Total | | Within Run | | | | Total | | | |
| | N | mg/dL | SD | %CV | mg/dL | SD | %CV | N | mg/dL | SD | %CV | mg/dL | SD | %CV |
| Site 1 | 60 | 339.4 | 8.18 | 2.4 | 339.4 | 12.26 | 3.6 | 60 | 295.3 | 5.54 | 1.9 | 295.3 | 6.39 | 2.2 |
| Site 2 | 54 | 311.9 | 5.89 | 1.9 | 311.9 | 11.4 | 3.7 | 47 | 343.0 | 6.77 | 2.0 | 343.0 | 10.14 | 3.0 |
| Site 3 | 60 | 288.1 | 4.63 | 1.6 | 288.1 | 7.14 | 2.5 | 59 | 336.9 | 7.37 | 2.2 | 336.9 | 9.27 | 2.8 |
#### Section 3: 510k Summary Page 7 of 10
{7}------------------------------------------------
# Trinity Biotech
.
#### Destiny Max 510(k) Submission Traditional Premarket Notification
| Level 2 | | | | Optical | | | | | | | Mechanical | | | |
|---------|----|-------|------|------------|-------|------|-------|----|-------|------|------------|-------|------|-------|
| | | | | Within Run | | | Total | | | | Within Run | | | Total |
| | N | mg/dL | SD | %CV | mg/dL | SD | %CV | N | mg/dL | SD | %CV | mg/dL | SD | %CV |
| Site 1 | 60 | 129.1 | 4.35 | 3.5 | 129.1 | 5.34 | 4.4 | 60 | 111.4 | 5.52 | 5.0 | 111.4 | 6.99 | 6.3 |
| Site 2 | 53 | 124.2 | 6.97 | 5.6 | 124.2 | 9.76 | 7.9 | 51 | 132.1 | 2.11 | 1.6 | 132.1 | 6.51 | 4.9 |
| Site 3 | 59 | 110.1 | 3.78 | 3.4 | 110.1 | 4.47 | 4.1 | 59 | 126.3 | 6.25 | 4.9 | 126.3 | 8.76 | 6.9 |
Table 8b: Level 2 Precision Data TriniCLOT Fibrinogen
Table 9a: Level 1 Precision Data TriniCLOT FVII
| | Mode: Clotting | | | | | | | | | | | | | |
|------------|----------------|-------|-------|------|------------|-------|-------|----|-------|-------|------|-------|-------|------|
| Level<br>1 | Optical | | | | Mechanical | | | | | | | | | |
| | Within Run | | Total | | Within Run | | Total | | | | | | | |
| | N | % | SD | %CV | % | SD | %CV | N | % | SD | %CV | % | SD | %CV |
| Site 1 | 60 | 100.8 | 10.31 | 10.2 | 100.8 | 12.93 | 12.8 | 60 | 105.1 | 11.72 | 11.1 | 105.1 | 14.83 | 14.1 |
| Site 2 | 60 | 113.9 | 9.06 | 8.0 | 113.9 | 10.95 | 9.6 | 60 | 128.2 | 10.20 | 8.0 | 128.2 | 10.86 | 8.5 |
| Site 3 | 59 | 115.3 | 10.15 | 8.8 | 115.3 | 10.15 | 8.8 | 60 | 103.8 | 7.05 | 6.8 | 103.8 | 7.45 | 7.2 |
Table 9b: Level 2 Precision Data TriniCLOT FVII
| Level<br>2 | Optical | | | | | | | Mechanical | | | | | | |
|------------|---------|------------|------|------|-------|------|------|------------|------|------|-------|------|------|------|
| | | Within Run | | | Total | | | Within Run | | | Total | | | |
| | | N | % | SD | %CV | % | SD | %CV | N | % | SD | %CV | % | SD |
| | Site 1 | 60 | 20.3 | 1.35 | 6.6 | 20.3 | 1.85 | 9.1 | 60 | 21.4 | 1.56 | 7.3 | 21.4 | 2.52 |
| Site 2 | 60 | 20.6 | 1.36 | 6.6 | 20.6 | 1.62 | 7.9 | 60 | 20.5 | 1.26 | 6.1 | 20.5 | 1.49 | 7.3 |
| Site 3 | 58 | 22.3 | 1.16 | 5.2 | 22.3 | 1.3 | 5.8 | 60 | 22.7 | 1.02 | 4.5 | 22.7 | 1.08 | 4.7 |
Section 3: 510k Summary Page 8 of 10
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Image /page/8/Picture/0 description: The image shows the logo for Trinity Biotech. The logo consists of a geometric shape resembling a triangle on the left, followed by the text "Trinity Biotech" in a sans-serif font. The text is in black, and the geometric shape is also in black.
#### Table 9c: Level 3 Precision Data TriniCLOT FVII
| Level<br>3 | Mode: Clotting | | | | | | | | | | | | | |
|------------|----------------|------------|------|-------|------|------------|------|------------|------|------|------|------|------|------|
| | | | | | | | | | | | | | | |
| | Optical | | | | | | | Mechanical | | | | | | |
| | | Within Run | | Total | | Within Run | | Total | | | | | | |
| | N | % | SD | %CV | % | SD | %CV | N | % | SD | %CV | % | SD | %CV |
| Site 1 | 60 | 10.8 | 0.86 | 8.0 | 10.8 | 1.02 | 9.4 | 60 | 12.2 | 0.64 | 5.3 | 12.2 | 0.78 | 6.4 |
| Site 2 | 60 | 11.5 | 0.68 | 5.9 | 11.5 | 0.92 | 8.1 | 60 | 13.0 | 1.30 | 10.0 | 13.0 | 1.93 | 14.9 |
| Site 3 | 58 | 13.0 | 1.09 | 8.4 | 13.0 | 1.33 | 10.3 | 60 | 12.3 | 0.68 | 5.5 | 12.3 | 0.69 | 5.6 |
#### Table 10a: Level 1 Precision Data TriniCLOT FIX
| Level<br>1 | Mode: Clotting | | | | | | | | | | | | | |
|------------|----------------|-------|------|-----|------------|-------|------|----|-------|------|-----|-------|-------|------|
| | Optical | | | | Mechanical | | | | | | | | | |
| | N | % | SD | %CV | % | SD | %CV | N | % | SD | %CV | % | SD | %CV |
| Site 2 | 60 | 113.1 | 8.41 | 7.4 | 113.1 | 17.43 | 15.4 | 59 | 107.3 | 3.94 | 3.7 | 107.3 | 11.60 | 10.8 |
| Site 3 | 60 | 89.7 | 5.02 | 5.6 | 89.7 | 6.68 | 7.4 | 58 | 91.4 | 7.33 | 8.0 | 91.4 | 7.51 | 8.2 |
#### Table 10b: Level 2 Precision Data TriniCLOT FIX
| Level<br>2 | Mode: Clotting | | | | | | | | | | | | | |
|------------|----------------|------|-------|-----|------------|------|-------|----|------|------|-----|------|------|------|
| | Optical | | | | Mechanical | | | | | | | | | |
| | Within Run | | Total | | Within Run | | Total | | | | | | | |
| | N | % | SD | %CV | % | SD | %CV | N | % | SD | %CV | % | SD | %CV |
| Site 2 | 58 | 16.8 | 1.35 | 8.0 | 16.8 | 2.49 | 14.9 | 60 | 19.0 | 0.75 | 4.0 | 19.0 | 3.97 | 20.9 |
| Site 3 | 58 | 18.6 | 1.11 | 5.9 | 18.6 | 2.47 | 13.2 | 58 | 17.2 | 1.41 | 8.2 | 17.2 | 2.28 | 13.3 |
#### Table 10c: Level 3 Precision Data TriniCLOT FIX
| Level<br>3 | Optical | | | | | | | Mechanical | | | | | | |
|------------|------------|-----|------|------|-------|------|------|------------|-----|------|------|-------|------|------|
| | Within Run | | | | Total | | | Within Run | | | | Total | | |
| | N | % | SD | %CV | % | SD | %CV | N | % | SD | %CV | % | SD | %CV |
| Site 2 | 60 | 8.1 | 0.91 | 11.3 | 8.1 | 1.14 | 14.1 | 60 | 9.5 | 0.81 | 8.5 | 9.5 | 2.18 | 23.0 |
| Site 3 | 57 | 9.9 | 1.64 | 16.6 | 9.9 | 1.99 | 20.2 | 56 | 9.3 | 1.15 | 12.4 | 9.3 | 2.25 | 24.2 |
#### Section 3: 510k Summary Page 9 of 10
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Image /page/9/Picture/0 description: The image shows the logo for Trinity Biotech. The logo consists of a triangle shape on the left and the words "Trinity Biotech" on the right. The triangle is made up of smaller triangles, and the words are in a sans-serif font.
Table 11: Level 1 and Level 2 Precision Data TriniCHROM Antithrombin
| Mode: Chromogenic | | | | | | | | Level<br>1 | Mode: Chromogenic | | | | | | | Level<br>2 |
|-------------------|----|-------|------|-------|-------|------|-----|------------|-------------------|------|------|-------|------|------|------|------------|
| Optical | | | | | | | | | Optical | | | | | | | |
| Within Run | | | | Total | | | | Within Run | | | | Total | | | | |
| | N | % | SD | %CV | Sec | SD | %CV | | N | % | SD | %CV | Sec | SD | %CV | |
| Site 1 | 56 | 129.8 | 6.57 | 5.1 | 129.8 | 6.65 | 5.1 | Site 1 | 60 | 49.9 | 2.36 | 4.7 | 49.9 | 2.66 | 5.3 | |
| Site 2 | 58 | 121.1 | 5.78 | 4.8 | 121.1 | 8.08 | 6.7 | Site 2 | 60 | 44.6 | 1.50 | 3.4 | 44.6 | 2.46 | 5.5 | |
| Site 3 | 48 | 125.0 | 3.38 | 2.7 | 125.0 | 7.95 | 6.4 | Site 3 | 47 | 45.9 | 2.56 | 5.6 | 45.9 | 4.62 | 10.1 | |
Table 12a: Level 1 Precision Data TriniLIA D-Dimer
| | Mode: Immunoturbidometric | | | | | | |
|------------|---------------------------|------------|-------|------|-------|-------|------|
| Level<br>1 | Optical | | | | | | |
| | | Within Run | | | Total | | |
| | N | ng/mL | SD | %CV | Sec | SD | %CV |
| Site 1 | 59 | 310.1 | 37.29 | 12.0 | 310.1 | 55.4 | 17.9 |
| Site 2 | 60 | 348.7 | 49.08 | 14.1 | 348.7 | 71.13 | 20.4 |
| Site 3 | 60 | 333.7 | 33.04 | 9.9 | 333.7 | 45.20 | 13.5 |
Table 12b: Level 1 Precision Data TriniLIA D-Dimer
| Level<br>2 | Mode: Immunoturbidometric | | | | | | |
|------------|---------------------------|--------|-------|-------|--------|--------|-----|
| | Optical | | | | | | |
| | Within Run | | | Total | | | |
| | N | ng/mL | SD | %CV | Sec | SD | %CV |
| Site 1 | 58 | 1657.7 | 93.67 | 5.7 | 1657.7 | 120.08 | 7.2 |
| Site 2 | 59 | 1618.8 | 67.57 | 4.2 | 1618.8 | 67.54 | 4.2 |
| Site 3 | 60 | 1753.1 | 55.1 | 3.1 | 1753.1 | 86.85 | 5.0 |
Section 3: 510k Summary Page 10 of 10
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## DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center-WO66-G609 Silver Spring, MD 20993-0002
JUN 0 2 2010
Trinity Biotech c/o Ms. Bonnie B. DeJov Corporate Vice President Trinity Biotech, USA 2823 Girts Road Jamestown, NY 14701
Re: k083896
Trade/Device Name: Destiny MAX Regulation Number: 21 CFR 864.5425 Regulation Name: Multipurpose System for In Vitro Coagulation Studies Regulatory Class: Class II Product Code: JPA Dated: June 15, 2009 Received: June 17, 2009
Dear Ms. DeJoy ::
This letter corrects our substantially equivalent letter of July 2, 2009.
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 (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 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); medical
{11}------------------------------------------------
Page 2 - Ms. Bonnie B. DeJoy
device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safetv/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mona In Chan
Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
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## Indication for Use
K083896
510(k) Number (if known):
Device Name: Destiny MAX
Indication for Use:
:・
The Destiny Max Coagulation Analyzer is a multipurpose system for in vitro coagulation studies consisting of one automated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.
Prescription Use (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use _ (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Maria M. Clan
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K083896
## 000010
