DESTINY MAX COAGULATION ANALYZER

• K Number: K083896
• Device Name: DESTINY MAX COAGULATION ANALYZER
• Manufacturer: TRINITY BIOTECH
• Date Cleared: 2009-07-02 ( 185 days)
• Product Code: JPA
• Regulation Number: 864.5425

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 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 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.

Predicate Devices

K021162

Reference Devices

K021162

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on standard automated coagulation testing methods and does not mention any AI/ML components or capabilities.

Therapeutic

No.
The device is used for in vitro coagulation studies and diagnoses, not for treating any condition.

Diagnostic

Yes
The device is described as performing a series of coagulation studies and coagulation factor assays to detect clotting deficiencies or disorders, and/or monitor anticoagulant therapy, which are diagnostic purposes.

SaMD (Software as a Medical Device)

No

The device description explicitly states the system is comprised of an instrument (Destiny Max Analyzer) and a Personal Computer (PC), indicating it includes hardware components beyond just software.

IVD (In Vitro Diagnostic)

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

Here's why:

• Intended Use/Indications for Use: The description explicitly states the system is used "for in vitro coagulation studies" and to "perform a series of coagulation studies and coagulation factor assays." This clearly indicates testing performed on samples taken from the body, which is the definition of in vitro diagnostics.
• Device Description: The description mentions the instrument performs testing "using human samples" and that the assays are used for "detection of clotting deficiencies or disorders and/or monitoring of anticoagalant therapy on various patient populations." This further reinforces that the testing is done on biological samples outside of the body to provide diagnostic information.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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 reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.

Product codes

JPA

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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

Not Found

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

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.
For TriniCLOT PT HTF Optical Mode Seconds:
Site 1: N=77, Slope=1.04, Intercept=-2.00, R^2=1.00
Site 2: N=42, Slope=1.00, Intercept=-1.28, R^2=0.99
Site 3: N=85, Slope=1.23, Intercept=-3.71, R^2=0.99
For TriniCLOT PT HTF Mechanical Mode Seconds:
Site 1: N=80, Slope=1.02, Intercept=-1.37, R^2=1.00
Site 2: N=51, Slope=1.02, Intercept=-1.66, R^2=1.00
Site 3: N=86, Slope=1.21, Intercept=-3.01, R^2=1.00
For TriniCLOT Excel S Optical Mode Seconds:
Site 1: N=77, Slope=1.03, Intercept=-1.61, R=1.00
Site 2: N=43, Slope=0.99, Intercept=-1.36, R=1.00
Site 3: N=75, Slope=1.01, Intercept=-0.05, R=1.00
For TriniCLOT Excel S Mechanical Mode Seconds:
Site 1: N=78, Slope=1.09, Intercept=-2.08, R=1.00
Site 2: N=49, Slope=1.04, Intercept=-1.29, R=1.00
Site 3: N=78, Slope=1.13, Intercept=-1.43, R=1.00
For TriniCLOT APTT S Optical Mode Seconds:
Site 1: N=63, Slope=0.97, Intercept=-1.82, R=0.99
Site 2: N=49, Slope=0.87, Intercept=1.57, R=0.93
Site 3: N=80, Slope=1.03, Intercept=-3.11, R=0.99
For TriniCLOT APTT S Mechanical Mode Seconds:
Site 1: N=67, Slope=0.91, Intercept=2.65, R=0.99
Site 2: N=57, Slope=1.05, Intercept=-2.08, R=0.97
Site 3: N=86, Slope=1.01, Intercept=-0.27, R=0.98
For TriniCLOT Thrombin Time Mechanical Mode Seconds:
Site 1: N=50, Slope=1.21, Intercept=-3.35, R=0.97
Site 2: N=19, Slope=0.89, Intercept=0.91, R=0.96
Site 3: N=73, Slope=1.04, Intercept=-0.37, R=0.99
For TriniCLOT Fibrinogen Optical Mode mg/dL:
Site 1: N=80, Slope=0.90, Intercept=15.56, R=1.00
Site 2: N=69, Slope=1.02, Intercept=-5.45, R=0.98
Site 3: N=68, Slope=0.73, Intercept=71.70, R=0.95
For TriniCLOT Fibrinogen Mechanical Mode mg/dL:
Site 1: N=80, Slope=0.86, Intercept=44.28, R=0.99
Site 2: N=65, Slope=1.10, Intercept=-21.04, R=0.97
Site 3: N=60, Slope=0.91, Intercept=49.84, R=0.94
For TriniCLOT FVII Optical Mode %:
Site 1: N=77, Slope=0.94, Intercept=0.30, R=0.98
Site 2: N=81, Slope=0.99, Intercept=-1.65, R=0.98
Site 3: N=57, Slope=0.78, Intercept=8.56, R=0.98
For TriniCLOT FVII Mechanical Mode %:
Site 1: N=77, Slope=0.98, Intercept=3.91, R=0.96
Site 2: N=82, Slope=0.89, Intercept=10.35, R=0.96
Site 3: N=58, Slope=0.82, Intercept=6.87, R=0.96
For TriniCLOT FIX Optical Mode %:
Site 1: N=117, Slope=0.84, Intercept=0.92, R=0.88
Site 2: N=76, Slope=1.01, Intercept=-1.43, R=0.97
Site 3: N=60, Slope=1.06, Intercept=-6.17, R=0.95
For TriniCLOT FIX Mechanical Mode %:
Site 1: N=117, Slope=0.96, Intercept=3.21, R=0.90
Site 2: N=77, Slope=0.95, Intercept=1.46, R=0.96
Site 3: N=60, Slope=0.87, Intercept=2.60, R=0.97
For TriniCHROM Antithrombin IIa %:
Site 1: N=80, Slope=0.98, Intercept=7.87, R=0.99
Site 2: N=77, Slope=0.84, Intercept=4.52, R=0.97
Site 3: N=80, Slope=0.95, Intercept=13.62, R=0.99
For TriniLIA D-Dimer ng/mL:
Site 1: N=76, Slope=0.88, Intercept=182.84, R=0.99
Site 2: N=68, Slope=1.28, Intercept=-184.08, R=0.99
Site 3: N=79, Slope=1.14, Intercept=-435.84, R=0.98

Device Performance Characteristics - Linearity
Table 3 describes the linearity data generated for calibrated assays on the Destiny Max system.
TriniCLOT Fibrinogen Optical Mode: Range 64 - 1400, R=0.993
TriniCLOT Fibrinogen Mechanical Mode: Range 62 - 844, R=1.000
TriniCLOT Factor VII Optical Mode: Range 1 - 112, R=0.998
TriniCLOT Factor VII Mechanical Mode: Range 2 - 110, R=0.998
TriniCLOT Factor IX Optical Mode: Range 0 - 230, R=0.996
TriniCLOT Factor IX Mechanical Mode: Range 0 - 104, R=0.996
TriniCHROM Antithrombin Chromogenic Mode: Range 0-150, R=0.998
TriniLIA D-Dimer Immunoturbidometric Mode: Range 70 - 13911, R=0.996

Device Performance Characteristics - Precision
Tables 4 to 12 describe the precision data generated at 3 sites.
Table 4a: Level 1 Precision Data TriniCLOT PT HTF
Optical Mode: Site 1 (N=57, 12.3 Sec, SD=0.32, %CV=2.6); Site 2 (N=56, 12.6 Sec, SD=0.29, %CV=2.3); Site 3 (N=60, 12.5 Sec, SD=0.26, %CV=2.1)
Mechanical Mode: Site 1 (N=57, 12.8 Sec, SD=0.31, %CV=2.4); Site 2 (N=60, 12.8 Sec, SD=0.28, %CV=2.2); Site 3 (N=58, 12.5 Sec, SD=0.15, %CV=1.2)
Table 4b: Level 2 Precision Data TriniCLOT PT HTF
Optical Mode: Site 1 (N=56, 20.7 Sec, SD=0.46, %CV=2.2); Site 2 (N=56, 21.2 Sec, SD=0.41, %CV=1.9); Site 3 (N=59, 21.1 Sec, SD=0.34, %CV=1.6)
Mechanical Mode: Site 1 (N=56, 21.2 Sec, SD=0.52, %CV=2.4); Site 2 (N=59, 21.5 Sec, SD=0.39, %CV=1.8); Site 3 (N=57, 21.0 Sec, SD=0.2, %CV=0.9)
Table 4c: Level 3 Precision Data TriniCLOT PT HTF
Optical Mode: Site 1 (N=53, 34.8 Sec, SD=0.57, %CV=1.6); Site 2 (N=59, 35.5 Sec, SD=0.54, %CV=1.5); Site 3 (N=60, 35.1 Sec, SD=0.47, %CV=1.3)
Mechanical Mode: Site 1 (N=55, 34.7 Sec, SD=0.51, %CV=1.5); Site 2 (N=60, 36.1 Sec, SD=0.86, %CV=2.4); Site 3 (N=60, 35.4 Sec, SD=0.39, %CV=1.1)
Table 5a: Level 1 Precision Data TriniCLOT PT Excel S
Optical Mode: Site 1 (N=54, 13.6 Sec, SD=0.24, %CV=1.7); Site 2 (N=54, 13.8 Sec, SD=0.23, %CV=1.6); Site 3 (N=60, 13.4 Sec, SD=0.26, %CV=1.9)
Mechanical Mode: Site 1 (N=57, 14.2 Sec, SD=0.21, %CV=1.5); Site 2 (N=59, 14.4 Sec, SD=0.22, %CV=1.5); Site 3 (N=59, 14.0 Sec, SD=0.24, %CV=1.7)
Table 5b: Level 2 Precision Data TriniCLOT PT Excel S
Optical Mode: Site 1 (N=56, 23.9 Sec, SD=0.36, %CV=1.5); Site 2 (N=45, 24.8 Sec, SD=0.5, %CV=2.0); Site 3 (N=59, 23.2 Sec, SD=0.40, %CV=1.7)
Mechanical Mode: Site 1 (N=57, 25.4 Sec, SD=0.46, %CV=1.8); Site 2 (N=59, 26.3 Sec, SD=0.31, %CV=1.2); Site 3 (N=58, 25.1 Sec, SD=0.52, %CV=2.1)
Table 5c: Level 3 Precision Data TriniCLOT PT Excel S
Optical Mode: Site 1 (N=57, 42.8 Sec, SD=0.68, %CV=1.6); Site 2 (N=57, 42.8 Sec, SD=0.69, %CV=1.6); Site 3 (N=59, 39.9 Sec, SD=0.44, %CV=1.1)
Mechanical Mode: Site 1 (N=57, 45.9 Sec, SD=0.79, %CV=1.7); Site 2 (N=60, 47.4 Sec, SD=0.95, %CV=2.0); Site 3 (N=60, 43.5 Sec, SD=1.04, %CV=2.4)
Table 6a: Level 1 Precision Data TriniCLOT APTT S
Optical Mode: Site 1 (N=57, 30.9 Sec, SD=0.21, %CV=0.7); Site 2 (N=59, 30.7 Sec, SD=0.29, %CV=0.9); Site 3 (N=59, 30.6 Sec, SD=0.21, %CV=0.7)
Mechanical Mode: Site 1 (N=57, 32.4 Sec, SD=0.73, %CV=2.3); Site 2 (N=60, 33.3 Sec, SD=1.12, %CV=3.4); Site 3 (N=58, 32.4 Sec, SD=0.66, %CV=2.0)
Table 6b: Level 2 Precision Data TriniCLOT APTT S
Optical Mode: Site 1 (N=57, 65.3 Sec, SD=0.59, %CV=0.9); Site 2 (N=53, 63.0 Sec, SD=0.75, %CV=1.2); Site 3 (N=57, 61.1 Sec, SD=0.37, %CV=0.6)
Mechanical Mode: Site 1 (N=56, 69.1 Sec, SD=1.13, %CV=1.6); Site 2 (N=52, 69.0 Sec, SD=2.24, %CV=3.2); Site 3 (N=57, 66.1 Sec, SD=1.21, %CV=1.8)
Table 6c: Level 3 Precision Data TriniCLOT APTT S
Optical Mode: Site 1 (N=57, 94.8 Sec, SD=1.08, %CV=1.1); Site 2 (N=59, 91.0 Sec, SD=1.59, %CV=1.7); Site 3 (N=59, 87.0 Sec, SD=0.69, %CV=0.8)
Mechanical Mode: Site 1 (N=56, 101.0 Sec, SD=2.95, %CV=2.9); Site 2 (N=58, 96.7 Sec, SD=3.80, %CV=3.9); Site 3 (N=58, 94.7 Sec, SD=1.92, %CV=2.0)
Table 7a and Table 7b: Level 1 and Level 2 Precision Data TriniCLOT Thrombin Time
Level 1 Optical Mode: Site 1 (N=59, 15.8 Sec, SD=0.41, %CV=2.6); Site 2 (N=47, 15.1 Sec, SD=0.16, %CV=1.1); Site 3 (N=56, 15.0 Sec, SD=0.38, %CV=2.5)
Level 2 Optical Mode: Site 1 (N=60, 18.8 Sec, SD=0.27, %CV=1.5); Site 2 (N=59, 18.7 Sec, SD=0.24, %CV=1.3); Site 3 (N=54, 18.4 Sec, SD=0.30, %CV=1.6)
Table 8a: Level 1 Precision Data TriniCLOT Fibrinogen
Optical Mode: Site 1 (N=60, 339.4 mg/dL, SD=8.18, %CV=2.4); Site 2 (N=54, 311.9 mg/dL, SD=5.89, %CV=1.9); Site 3 (N=60, 288.1 mg/dL, SD=4.63, %CV=1.6)
Mechanical Mode: Site 1 (N=60, 295.3 mg/dL, SD=5.54, %CV=1.9); Site 2 (N=47, 343.0 mg/dL, SD=6.77, %CV=2.0); Site 3 (N=59, 336.9 mg/dL, SD=7.37, %CV=2.2)
Table 8b: Level 2 Precision Data TriniCLOT Fibrinogen
Optical Mode: Site 1 (N=60, 129.1 mg/dL, SD=4.35, %CV=3.5); Site 2 (N=53, 124.2 mg/dL, SD=6.97, %CV=5.6); Site 3 (N=59, 110.1 mg/dL, SD=3.78, %CV=3.4)
Mechanical Mode: Site 1 (N=60, 111.4 mg/dL, SD=5.52, %CV=5.0); Site 2 (N=51, 132.1 mg/dL, SD=2.11, %CV=1.6); Site 3 (N=59, 126.3 mg/dL, SD=6.25, %CV=4.9)
Table 9a: Level 1 Precision Data TriniCLOT FVII
Optical Mode: Site 1 (N=60, 100.8 %, SD=10.31, %CV=10.2); Site 2 (N=60, 113.9 %, SD=9.06, %CV=8.0); Site 3 (N=59, 115.3 %, SD=10.15, %CV=8.8)
Mechanical Mode: Site 1 (N=60, 105.1 %, SD=11.72, %CV=11.1); Site 2 (N=60, 128.2 %, SD=10.20, %CV=8.0); Site 3 (N=60, 103.8 %, SD=7.05, %CV=6.8)
Table 9b: Level 2 Precision Data TriniCLOT FVII
Optical Mode: Site 1 (N=60, 20.3 %, SD=1.35, %CV=6.6); Site 2 (N=60, 20.6 %, SD=1.36, %CV=6.6); Site 3 (N=58, 22.3 %, SD=1.16, %CV=5.2)
Mechanical Mode: Site 1 (N=60, 21.4 %, SD=1.56, %CV=7.3); Site 2 (N=60, 20.5 %, SD=1.26, %CV=6.1); Site 3 (N=60, 22.7 %, SD=1.02, %CV=4.5)
Table 9c: Level 3 Precision Data TriniCLOT FVII
Optical Mode: Site 1 (N=60, 10.8 %, SD=0.86, %CV=8.0); Site 2 (N=60, 11.5 %, SD=0.68, %CV=5.9); Site 3 (N=58, 13.0 %, SD=1.09, %CV=8.4)
Mechanical Mode: Site 1 (N=60, 12.2 %, SD=0.64, %CV=5.3); Site 2 (N=60, 13.0 %, SD=1.30, %CV=10.0); Site 3 (N=60, 12.3 %, SD=0.68, %CV=5.5)
Table 10a: Level 1 Precision Data TriniCLOT FIX
Optical Mode: Site 2 (N=60, 113.1 %, SD=8.41, %CV=7.4); Site 3 (N=60, 89.7 %, SD=5.02, %CV=5.6)
Mechanical Mode: Site 2 (N=59, 107.3 %, SD=3.94, %CV=3.7); Site 3 (N=58, 91.4 %, SD=7.33, %CV=8.0)
Table 10b: Level 2 Precision Data TriniCLOT FIX
Optical Mode: Site 2 (N=58, 16.8 %, SD=1.35, %CV=8.0); Site 3 (N=58, 18.6 %, SD=1.11, %CV=5.9)
Mechanical Mode: Site 2 (N=60, 19.0 %, SD=0.75, %CV=4.0); Site 3 (N=58, 17.2 %, SD=1.41, %CV=8.2)
Table 10c: Level 3 Precision Data TriniCLOT FIX
Optical Mode: Site 2 (N=60, 8.1 %, SD=0.91, %CV=11.3); Site 3 (N=57, 9.9 %, SD=1.64, %CV=16.6)
Mechanical Mode: Site 2 (N=60, 9.5 %, SD=0.81, %CV=8.5); Site 3 (N=56, 9.3 %, SD=1.15, %CV=12.4)
Table 11: Level 1 and Level 2 Precision Data TriniCHROM Antithrombin
Level 1 Optical Mode: Site 1 (N=56, 129.8 %, SD=6.57, %CV=5.1); Site 2 (N=58, 121.1 %, SD=5.78, %CV=4.8); Site 3 (N=48, 125.0 %, SD=3.38, %CV=2.7)
Level 2 Optical Mode: Site 1 (N=60, 49.9 %, SD=2.36, %CV=4.7); Site 2 (N=60, 44.6 %, SD=1.50, %CV=3.4); Site 3 (N=47, 45.9 %, SD=2.56, %CV=5.6)
Table 12a: Level 1 Precision Data TriniLIA D-Dimer
Optical Mode: Site 1 (N=59, 310.1 ng/mL, SD=37.29, %CV=12.0); Site 2 (N=60, 348.7 ng/mL, SD=49.08, %CV=14.1); Site 3 (N=60, 333.7 ng/mL, SD=33.04, %CV=9.9)
Table 12b: Level 2 Precision Data TriniLIA D-Dimer
Optical Mode: Site 1 (N=58, 1657.7 ng/mL, SD=93.67, %CV=5.7); Site 2 (N=59, 1618.8 ng/mL, SD=67.57, %CV=4.2); Site 3 (N=60, 1753.1 ng/mL, SD=55.1, %CV=3.1)

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K021162

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

0

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
Bray, Co. Wicklow
Ireland
Contact Person:	Bonnie DeJoy
Phone Number:
Fax Number:	[phone]
[phone]
Date of Preparation:	December, 15 2008
B. Device Information:
Trade Name:	Destiny MAX
Device Classification Name:	System, Multipurpose for in vitro
coagulation 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

2

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

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
Level
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

4

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

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

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

5

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

6

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

Mode: Clotting
Level
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
1 | Mode: Clotting
Optical | | | | Level
2 | Mode: Clotting
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
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
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

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

8

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

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

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

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

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

9

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
1 | Mode: Chromogenic | | | | | | | Level
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
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

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

10

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 [phone] or [phone] 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

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