(185 days)
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.
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 receives 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.
The Trinity Biotech Destiny MAX Coagulation Analyzer is a multipurpose system for in vitro coagulation studies. Its acceptance criteria and performance are detailed through a method comparison study and precision studies.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as numerical targets in the provided document. However, the performance is reported through method comparison against a predicate device (AMAX Destiny) and precision data, implying an expectation of strong correlation (for method comparison) and low variability (for precision).
Method Comparison (Slope, Intercept, R/R² values):
The device performance is reported across various assays (TriniCLOT PT HTF, TriniCLOT Excel S, TriniCLOT APTT S, TriniCLOT Thrombin Time, TriniCLOT Fibrinogen, TriniCLOT FVII, TriniCLOT FIX, TriniCHROM Antithrombin IIa, TriniLIA D-Dimer) in both optical and mechanical modes (where applicable). The reported R or R² values are consistently high, ranging from 0.88 to 1.00. Slopes are generally close to 1 and intercepts close to 0, indicating strong correlation and agreement with the predicate device.
Linearity (R values):
For linearity, the reported R values are all very high, ranging from 0.993 to 1.000.
Precision (%CV values):
Precision is assessed at different levels for each assay and mode, with "Within Run" and "Total" %CVs reported. The %CV values generally range from 0.6% to 24.2%, depending on the assay, level, and mode. For most clotting assays (PT, APTT, Thrombin Time), the %CVs are often below 5%. For Fibrinogen, FVII, FIX, Antithrombin, and D-Dimer, some %CVs are higher, particularly at lower concentrations or for “Total” precision.
Since specific acceptance criteria were not explicitly stated (e.g., "R² must be > 0.95" or "%CV must be < 10%"), the determination of "meeting acceptance criteria" is inferred from the high reported correlation and acceptable precision for in vitro diagnostic devices. The submission implies these results demonstrate substantial equivalence and acceptable performance.
2. Sample Size Used for the Test Set and Data Provenance
- Method Comparison:
- The sample sizes (N) for the method comparison study vary by assay and site, ranging from 19 to 117 clinical samples per assay/site combination.
- The data provenance is described as collected at 3 sites (implying clinical or laboratory settings). The document refers to "a variety of clinical samples," suggesting retrospective or prospectively collected samples from a clinical population. The country of origin is not explicitly stated but implied to be regions where the predicate device (AMAX Destiny) is used.
- Linearity: The sample size for linearity studies is not explicitly stated in terms of number of patient samples, but rather the range of concentrations tested.
- Precision: The sample sizes (N) for precision studies vary by assay, level, and site, with most entries showing N values between 45 and 60 runs. These typically refer to repeated measurements of control materials or pooled patient samples over several days/runs. Data provenance is from 3 sites.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of device (coagulation analyzer) does not typically involve human expert interpretation for "ground truth" establishment in the same way imaging or pathology devices do. The "ground truth" for the test set is established by the predicate device, the AMAX Destiny Coagulation Analyzer. Therefore, no human experts were involved in establishing the ground truth for this comparison study. The performance of the predicate device itself is implicitly considered the reference standard.
4. Adjudication Method for the Test Set
Not applicable. As described above, the "ground truth" or reference method for comparison is the predicate device's measurement. There is no human interpretation or classification that would require an adjudication method.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
Not applicable. This is an in vitro diagnostic (IVD) device for quantitative biochemical measurements, not a diagnostic imaging or interpretive device that would typically involve human readers.
6. Standalone Performance
Yes, a standalone performance assessment was conducted in the form of linearity and precision studies. These studies evaluate the Destiny MAX's inherent measurement capabilities independent of direct comparison to the predicate device for each individual test.
- Linearity data (Table 3) shows the analytical measurement range and correlation (R value) of the Destiny MAX for various assays.
- Precision data (Tables 4-12) reports the within-run and total precision (%CV) of the Destiny MAX for various assays and at different concentration levels, demonstrating its reproducibility and variability.
7. Type of Ground Truth Used
- For the method comparison study, the "ground truth" was the measurements obtained from the predicate device, the AMAX Destiny Coagulation Analyzer. This establishes substantial equivalence by demonstrating comparable performance.
- For linearity and precision studies, the ground truth is analytical standards, control materials, or known concentrations used to characterize the device's inherent performance.
8. Sample Size for the Training Set
The document does not provide details on a "training set" for the Destiny MAX in the context of machine learning or AI. This device is a quantitative analyzer, and its development would typically involve engineering, calibration, and internal validation steps, rather than traditional "training sets" as understood in AI/ML contexts. The focus of the 510(k) submission is on performance verification against a predicate and analytical characteristics.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a "training set" in the context of AI/ML for this device. The device's operational parameters and calibration are established through standard laboratory practices using reference materials and established assay principles.
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Trinity Biotech
JUL - 2 2009
510(k) Summary
Destiny MAX
A. 510(k) Submitter Information:
| Submitter's name: | Trinity Biotech |
|---|---|
| Address: | IDA Business ParkBray, Co. WicklowIreland |
| Contact Person: | Bonnie DeJoy |
| Phone Number:Fax Number: | (716) 483-3851(716) 488-1990 |
| Date of Preparation: | December, 15 2008 |
| B. Device Information: | |
| Trade Name: | Destiny MAX |
| Device Classification Name: | System, Multipurpose for in vitrocoagulation studies, 21CFR864.5425,Product code JPA |
| Common Name: | Destiny MAX |
| C. Predicate Device: | AMAX DestinyTM Coagulation Analyzer(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
{1}------------------------------------------------
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,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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Section 3: 510k Summary Page 3 of 10
{3}------------------------------------------------
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 | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Level1 | 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
| Level3 | 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
| Level1 | 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 SMode: Clotting | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Level3 | 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
| Level1 | Mode: ClottingOptical | Level2 | Mode: ClottingOptical | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Level1 | 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 | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Level1 | 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
| Level2 | 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
| Level3 | 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
| Level1 | 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
| Level2 | 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
| Level3 | 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 | Level1 | Mode: Chromogenic | Level2 | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | |||||||
|---|---|---|---|---|---|---|---|
| Level1 | 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
| Level2 | 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
{12}------------------------------------------------
Indication for Use
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
§ 864.5425 Multipurpose system for in vitro coagulation studies.
(a)
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.(b)
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.