The D-Dimer Assay is for the quantitative determination of fibrin degradation products (D-Dimer) in human plasma. Measurement of D-Dimer is used as an aid in detecting the presence of intravascular coagulation and fibrinolysis. For in vitro diagnostic use only.

The Diazyme D-Dimer Calibrator Set is intended for use of the calibration of the Diazyme D-Dimer Assay only. For in vitro diagnostic use only.

The Diazyme D-Dimer Control Set is intended for use as quantitative quality controls for the Diazyme D-Dimer Assay only. For in vitro diagnostic use only.

Device Description

Diazyme's D-Dimer Assay is based on a latex enhanced immunoturbidimetric assay. D-Dimer proteins in the sample bind to the specific anti-D-Dimer antibody, which is coated on latex particles, and causes agglutination. The degree of the turbidity caused by agglutination can be measured optically and is proportional to the amount of D-Dimer in the sample. The instrument calculates the D-Dimer concentration of a patient specimen by interpolation of the obtained signal of a 6-point calibration curve.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Diazyme D-Dimer Assay Kit, Diazyme D-Dimer Assay Calibrator Set, and Diazyme D-Dimer Assay Control Set, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria (Implicit from Predicate)	Reported Device Performance (Diazyme D-Dimer Assay)
Linear Range	0.15 - 9 µg/mL FEU D-Dimer (Predicate: Roche Tina-Quant D-Dimer K062203)	0.15 - 8 µg/mL FEU D-Dimer
Precision (CV%)	0.8 - 8.3% (Predicate: Roche Tina-Quant D-Dimer K062203)	Internal Study:- Plasma Samples Within Run: 1.4% - 5.0%- Plasma Samples Total: 2.7% - 6.2%- Control Samples Within Run: 1.4% - 2.9%- Control Samples Total: 2.8% - 4.4%External Study:- Total CV%: 3.5% - 11.5%
Correlation Coefficient (Method Comparison)	0.775 (Predicate: vs. Asserachrom D-Dimer K862156)	0.939 (vs. Roche Tina-Quant D-Dimer K062203)
Slope (Method Comparison)	1.03 (Predicate: vs. Asserachrom D-Dimer K862156)	0.979 (vs. Roche Tina-Quant D-Dimer K062203)
Intercept (Method Comparison)	-0.11 (Predicate: vs. Asserachrom D-Dimer K862156)	-0.106 (vs. Roche Tina-Quant D-Dimer K062203)
Bias around medical decision point	Not explicitly stated for predicate in summary, but typical for method comparison studies.	-0.12 µg/mL FEU
Limit of Blank (LOB)	Not explicitly stated for predicate.	0.06 µg/mL FEU
Limit of Detection (LOD)	Not explicitly stated for predicate.	0.09 µg/mL FEU
Limit of Quantitation (LOQ)	Not explicitly stated for predicate.	0.15 µg/mL FEU (target CV < 20%)
Interference (% bias)	Less than 10% bias for specified substances (Implicit).	Less than 10% bias for specified substances.

Note: The acceptance criteria are largely implied by comparing the new device's performance to the predicate device and recognized standards like CLSI guidelines. The predicate's correlation coefficient, slope, and intercept were against a different comparator (Asserachrom D-Dimer), so the Diazyme assay provides new comparison values against its chosen predicate (Roche Tina-Quant D-Dimer).

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

The provided document describes the test set as follows:

Precision (Internal Study):
- Plasma Samples: 3 levels of pooled citrated plasma (0.60 µg/mL, 2.41 µg/mL, 5.88 µg/mL FEU). Each level had 240 data points (duplicates over 20 days, likely 6 runs per day to get 240, though not explicitly stated as 'runs').
- Control Samples: 3 levels of D-Dimer controls (0.97, 2.99, 7.47 µg/mL FEU). Each level had 240 data points.
Precision (External Study):
- Patient Samples: 4 different patient samples of citrated plasma (0.36, 1.06, 3.53, 7.20 µg/mL FEU).
- Total Data Points: Not explicitly stated as a single number, but tested in duplicates with 2 runs per day over 5 nonconsecutive working days at three sites, with three lots of reagent, three lots of calibrators, three different operators, and three different instruments. This implies a significant number of data points per sample.
Method Comparison:
- Samples: A total of 128 citrated plasma samples (88 unique samples).
- Range: D-Dimer ranging from 0.17 to 7.95 µg/mL FEU.
- Provenance: Collected from an "intended target population" (Intensive Care Unit, Obstetrics, Trauma, Post-Operative, and Operating Room). Tested at the manufacturer site and two external clinical laboratories. This suggests a prospective or retrospective collection with prospective testing across multiple sites, with the data coming from diverse patient populations. No specific country of origin is mentioned, but "intended target population" and "external clinical laboratories" suggest it's likely within the US, where the submission is being made.
Linearity: 11 levels of the D-Dimer linearity set.
LOB, LOD, LOQ: Specimens with mean measured concentrations ranging from 0.02 to 0.93 were assayed.

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

For this type of in vitro diagnostic device (IVD) for quantitative determination of a biomarker (D-Dimer), the "ground truth" is typically the quantitative value obtained from testing the samples using a well-established, legally marketed reference or predicate method.

Experts: Not applicable in the traditional sense of clinicians or radiologists reviewing images. The "ground truth" for the method comparison study was established by the Roche Tina-Quant D-Dimer (K062203), which is itself a legally marketed, validated assay.
Qualifications: The "qualification" of the ground truth in this context relies on the regulatory approval and established performance of the predicate device. The analysis was performed by laboratory personnel following standard laboratory practices, as implied by the CLSI (Clinical and Laboratory Standards Institute) guidelines cited.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving interpretation of subjective data (e.g., imaging where multiple readers provide independent assessments).

Adjudication Method: None was explicitly mentioned or implied. For quantitative biomarker assays, adjudication is not typically used. The accuracy of the Diazyme D-Dimer Assay was compared directly to the quantitative results from the predicate device (Roche Tina-Quant D-Dimer K062203) using statistical methods like regression analysis.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC Study: No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done.
Reason: This device is an in vitro diagnostic (IVD) assay that quantitatively measures D-Dimer in human plasma. It does not involve human readers interpreting images or data where AI assistance would be relevant. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply to this device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Standalone Performance: The study inherently demonstrates standalone performance of the Diazyme D-Dimer Assay. The device is an automated, immunoturbidimetric assay for quantitative determination of D-Dimer. Its performance (precision, linearity, method comparison, LOB/LOD/LOQ, interference) was evaluated as a standalone analytical system, with the instrument calculating concentrations based on the optical measurements and its calibration curve. There is no human-in-the-loop performance described in the context of interpretation or output modification for this type of IVD.

7. The Type of Ground Truth Used

Type of Ground Truth: The ground truth for the method comparison study was the quantitative D-Dimer concentration results obtained from the predicate device, Roche Tina-Quant D-Dimer (K062203). This is a common approach for IVD assays, where a new device's performance is gauged against an approved, established method.
- For other performance metrics like LOB/LOD/LOQ and linearity, the ground truth is established by carefully prepared standards and dilutions, and statistical models applied to the measurements.

8. The Sample Size for the Training Set

Training Set: The document does not describe a "training set" in the context of machine learning. This device is a biochemical assay, not an AI/ML-based device that requires a separate training set for algorithm development.
- However, the calibration curves are established using a 6-point calibration curve (stated in Assay Principle). The Diazyme D-Dimer Calibrator Set consists of 5 calibrators plus saline (Cal 0). These calibrators are used to "train" the instrument to accurately translate turbidity measurements into D-Dimer concentrations for each assay run.

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

As explained above, there is no "training set" for an AI/ML algorithm.
For the calibration curve, the "ground truth" concentrations of the calibrator set are established during the manufacturing process of the Diazyme D-Dimer Calibrator Set. This process involves precise formulation and validation of the D-Dimer concentrations in each calibrator level. These assigned values are then used by the instrument to generate the standard curve against which patient samples are measured.

Summary

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K1121205

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92

Submitter's name:

Diazyme Laboratories

JAN 2 4 2013

Submitter's address:

12889 Gregg Court Poway, CA 92064 USA

Name of Contact Person:

Dr. Abhijit Datta Diazyme Laboratories 12889 Gregg Court . Poway, CA 92064 Phone: 858-455-4762 Fax: 858-455-2120

January 24, 2013

Date the Summary was Prepared:

Name of the Device

D-Dimer Assay Kit D-Dimer Assay Calibrator Set D-Dimer Assay Control Set

Diazyme D-Dimer Assay Kit

Diazyme D-Dimer Assay Calibrator Set Diazyme D-Dimer Assay Control Set

Trade Name:

Common/Usual Name

Device Classification Name

Product code:

GHH Fibrin Split Products DAP Fibrinogen and Fibrin Split Products, Antigen, Antiserum, Control JIT Calibrator, Secondary

. Panel:

Submission Type

Regulation Number

Hematology (81)

D-Dimer Assay

D-Dimer Test System

510k

21CFR 866.7320

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Device Class Class II Predicate Device: Roche TINA-QUANT D-DIMER SYSTEM (K062203) Manufacturing Address Diazyme Laboratories 12889 Gregg Court Poway, CA 92064 USA

Establishment Registration 2032900

Description of the Device:

Summarv

Thrombus formation is normally followed by an immediate fibrinolytic response. The resultant generation of plasmin causes the release of fibrin degradation products (predominantly containing D-Dimer) into the circulation.

Assay Principle

Indications for Use:

The Diazyme D-Dimer Calibrator Set is intended for use of the calibration of the Diazyme D-Dimer Assay only. For in vitro diagnostic use only.

The Diazyme D-Dimer Control Set is intended for use as quantitative quality controls for the Diazyme D-Dimer Assay only. For in vitro diagnostic use only.

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Roche Tina-Quant D-Dimer K062203	Diazyme D-Dimer Assay
Reagent 1buffer solution, ready to use	Reagent 1100 mM Tris-buffer solution with 0.09% so-dium azide, ready to use
Reagent 2Anti-D-Dimer latex suspension (0.15%) inpH 7.2 buffer matrix	Reagent 2Suspension of latex particles (<0.2%) coatedwith mouse monoclonal anti-human D-Dimerwith 0.09% sodium azide, ready to use.CalibratorsFive lyophilized calibrators, one saline cali-brator
Calibrator set	Calibrator set
1 x 2.5 mL Diluent, Cal 11 x 0.5 mL Calibrator 6	Saline (as cal 0, not provided)1 x 1.0 mL Calibrator 11 x 1.0 mL Calibrator 21 x 1.0 mL Calibrator 31 x 1.0 mL Calibrator 41 x 1.0 mL Calibrator 5
Control Set serum based	Control Set serum based
1 x 0.5mL Control 1	1 x 1.0mL Control 1
1 x 0.5mL Control 2	1 x 1.0mL Control 2

Table 1 Summary of Assay Kit Components

Comparison of new device to predicate: The charts below identify similarities and differences between the predicate device and the Diazyme D-Dimer Assay.

Indications for Use

Roche Tina-Quant D-Dimer K062203	Diazyme D-Dimer Assay	Equivalency
For the in vitro quantitative determina-tion of fibrin degradation products in-cluding D-Dimer and X-oligomers.	The Diazyme D-Dimer Assay is for thequantitative determination of fibrino-gen/fibrin degradation products (D-Dimer) in human plasma. Measurementof D-Dimer is used as an aid in detectingthe presence of intravascular coagulationand fibrinolysis. For in vitro diagnosticuse only.	Same
Aid in detecting the presence and degreeof intravascular coagulation and fibri-nolysis and in monitoring therapy fordisseminated intra vascular coagulation.
In conjunction with a non-high clinical

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probability assessment, a normal (<0.5 µg FEU/mL) result excludes deep vein thrombosis (DVT) and pulmonary embolism (PE) with high sensitivity.
-------------------------------------------------------------------------------------------------------------------------------------------------	--	--

Principle

Roche Tina-Quant D-Dimer K062203	Diazyme D-Dimer Assay	Equivalency
Latex particles of uniform size arecoated with monoclonal antibodies(F(ab')2 fragments) to the D-Dimer epi-tope. The antigen/antibody complexesproduced by the addition of samplescontaining D-Dimer lead to an increasein the turbidity of the test reactants. Thechange in absorbance with time is de-pendent on the concentration of D-Dimer epitopes in the sample.	Diazyme D-Dimer Assay is based on alatex enhanced immunoturbidimetricassay. D-Dimer proteins in the samplebind to the specific anti-D-Dimer anti-body, which is coated on latex particles,and causes agglutination. The degree ofthe turbidity caused by agglutinationcan be measured optically and is pro-portional to the amount of D-Dimer inthe sample. The instrument calculatesthe D-Dimer concentration of a patientspecimen by interpolation of the ob-tained signal of a 6-point calibrationcurve.	Same

Test Objective

Roche Tina-Quant D-Dimer K062203	Diazyme D-Dimer Assay	Equivalency
For the in vitro quantitative determina-tion of D-Dimer in citrated or li-heparinplasma.	For the in vitro quantitative determina-tion of D-Dimer in citrated plasma.	Same

Type of Test

Roche Tina-Quant D-Dimer K062203	Diazyme D-Dimer Assay	Equivalency
Quantitative	Quantitative	Same

Specimen Type

Roche Tina-Quant D-Dimer K062203	Diazyme D-Dimer Assay	Equivalency
----------------------------------	-----------------------	-------------

. . :

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Human citrated or li-heparin plasma.	Human citrated plasma.	Same
Product Type
Roche Tina-Quant D-Dimer K062203	Diazyme D-Dimer Assay	Equivalency
Assay reagent kit, calibrator kit, qualitycontrol kit.	Assay reagent kit, calibrator kit, qualitycontrol kit.	Same

Performance

Roche Tina-Quant D-Dimer K062203	Diazyme D-Dimer Assay
Working Range: 0.15-9 µg/mL FEU D-Dimer	Linear Range: 0.15-8 µg/mL FEU D-Dimer
Precision: CV% of 0.8 - 8.3%	Precision: CV% of 1.4% - 6.2%
Methods Comparion (vs AsserachromD-Dimer K862156):	Methods Comparion (vs. Roche Tina-Quant D-Dimer K062203):
Correlation Coefficient: 0.775Slope/Intercept: y = 1.03/-0.11	Correlation Coefficient: 0.939Slope/ y Intercept: y = 0.979 /-0.10

Calibrator Comparison

Roche D-Dimer Calibrator	Diazyme D-Dimer Calibrator	Equivalency
Separately packaged lot specificcalibrator kit. Lyophilized.	Separately packaged lot specificcalibrator kit. Lyophilized.	Same

Control Comparison

Roche D-Dimer Control I/II	Diazyme D-Dimer Control	Equivalency
Separately packaged quality control kitdesigned for specific assay.Lyophilized.	Separately packaged quality control setdesigned for specific assay.Lyophilized.	Same

Performance Testing Summaries:

The data (precision, method comparison, linearity, LOB/LOD/LOQ and interference) determined using Roche Modular P is given below.

Precision

Internal Study

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The precision of the Diazyme D-Dimer Assay was evaluated according to Clinical Laboratory Standards Institute EP5-A guideline.

In the study, three levels of pooled citrated plasma specimens containing 0.60 µg/mL, 2.41 ug/mL and 5.88 µg/mL FEU, respectively. The low plasma sample was unaltered. The other two plasma samples were spiked with D-Dimer stock solution to targeted concentrations and assayed. Three levels of D-Dimer controls containing 0.97, 2.99 and 7.47 µg/mL FEU, respectively were also tested with 2 runs per day with duplicates over 20 working days with three lops of reagent and three lots of calibrators. The combined results are shown below:

	Level 1: 0.60 µg/mLFEU	Level 2: 2.41 µg/mLFEU	Level 3: 5.88 µg/mLFEU
Data Points N	240	240	240
Mean (g/mL FEU)	0.60	2.41	5.88
SD (g/mL FEU)	0.03	0.05	0.08
CV%	5.0%	2.0%	1.4%

Plasma Samples Within Run Precision

Plasma Samples Total Precision

	Level 1: 0.60 µg/mLFEU	Level 2: 2.41 µg/mLFEU	Level 3: 5.88 µg/mLFEU
Data Points N	240	240	80
Mean (g/mL FEU)	0.60	2.41	5.88
SD (g/mL FEU)	0.04	0.07	0.19
CV%	6.2%	2.7%	3.2%

Control Samples Within Run Precision

	Level 1: 0.97 µg/mL	Level 2: 2.99 µg/mL	Level 2: 7.47 µg/mL
	FEU	FEU	FEU
Data Points N	240	240	240
Mean (g/mL FEU)	0.97	2.99	7.47
SD (g/mL FEU)	0.03	0.05	0.11
CV%	2.9%	1.6%	1.4%

Control Samples Total Precision

	Level 1: 0.97 µg/mLFEU	Level 2: 2.99 µg/mLFEU	Level 2: 7.47 µg/mLFEU
Data Points N	240	240	240
Mean (g/mL FEU)	0.97	2.99	7.47
SD (g/mL FEU)	0.04	0.08	0.27
CV%	4.4%	2.8%	3.6%

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External Study

The precision of the Diazyme D-Dimer Assay was also evaluated at three external sites by intended users. In the study, four different patient samples of citrated plasma containing 0.36 ug/mL, 1.06 µg/mL, 3.53 µg/mL and 7.20 µg/mL FEU respectively, were tested in duplicates with 2 runs per day over 5 nonconsecutive working days using three lots of reagent, three lots of calibrators, three different clinical testing sites, three different operators and three different instruments. The results are shown below:

Sample	withinrun	between run	between day	between lot	total	Meanµg/mLFEU
1	8.9%	8.3%	7.6%	7.1%	11.5%	0.36
2	3.8%	3.6%	7.4%	8.3%	8.3%	1.06
3	2.9%	3.9%	3.1%	0.7%	4.7%	3.53
4	1.6%	3.1%	2.4%	1.5%	3.5%	7.20

LOB, LOD, and LOO

The LOB, LOD, LOQ of the Diazyme D-Dimer Assay was determined according to CLSI EP17-A. LOB was determined to be 0.06 µg/mL FEU; LOD was determined to be 0.09 µg/mL FEU. To determine LOQ, specimens with mean measured concentrations ranging from 0.02 to 0.93 were assayed. Based on the EP evaluator-8 fitted model, the LOQ (lowest concentration for which CV is less than a target of 20%) is 0.15 µg/mL FEU.

Linearity

Eleven levels of the D-Dimer linearity set were prepared by diluting a specimen containing 8.0 ug/mL FEU with saline according to Clinical and Laboratory Standards Institute EP6-A and tested on Modular P. Diazyme D-Dimer assay is linear from 0.15 to 8.0 µg/mL FEU.

Method Comparison

To demonstrate accuracy, the Diazyme D-Dimer Assay was evaluated by testing individual citrated plasma from the intended target population (Intensive Care Unit, Obstetrics, Trauma, Post-Operative and Operating Room) with comparison to a legally marketed D-Dimer revince it the manufacturer site and two external clinical laboratories. A total of 128 citrated plasma samples (88 unique samples) with D-Dimer ranging from 0.17 to 7.95 µg/mL FEU were compared. Repeat testing was addressed by bootstrapped regression analysis with stratification is shown below:

Parameter	Total of 3 sites
Slope	0.979
95% CI	0.909 to 1.060
Intercept	-0.106
95% CI	-0.260 to 0.026
R2	0.939

The bias around the medical decision point is -0.12 µg/ml FEU

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Interference

The following substances do not interfere with this assay at the levels tested (less than 10% bias):

Hemoglobin: Bilirubin: Bilirubin Conjugated: Triglycerides: Ascorbic acid: Rheumatoid Factor Heparin HAMA

up to 500 mg/dL up to 40 mg/dL up to 40 mg/dL up to 1000 mg/dL up to 176 mg/dL up to 100 IU/mL up to 1.5 IU/mL up to 490 ng/mL

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around the perimeter. In the center of the logo is a stylized graphic of an abstract symbol, consisting of three curved lines that resemble a person embracing another person.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Diazyme Laboratories c/o Dr. Abhijit Datta 12889 Gregg Court Poway, CA 92064

Jan 24, 2013

Re: K112120

Trade/Device Name: Diazyme D-Dimer Assay Kit, Diazyme D-Dimer Assay Control Set and Diazyme D-Dimer Assay Calibrator Set Regulation Number: 21 CFR §864.7320 Regulation Name: Fibrinogen/fibrin degradation products assay Regulatory Class: Class II Product Code: GHH, DAP, JIT Dated: January 17, 2013

Received: January 18, 2013

Dear Dr. Datta:

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 application (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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Dr. Abhijit Datta

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/CDRH0ffices/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/Safety/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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Maria M. Chan -S

Maria M. Chan, Ph.D.

Director

Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological

Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (If Known): K112120

Device Name: Diazyme D-Dimer Assay Kit, Diazyme D-Dimer Assay Calibrator Set, Diazyme D-Dimer Assay Control Set.

Indications for Use:

The Diayzme D-Dimer Assay Calibrator Set is intended for use in the calibration of the D-Dimer assay only. For in vitro diagnostic use only.

The Diazyme D-Dimer Assay Control Set is intended for use as quality controls for the Diazyme D-Dimer assay only. For in vitro diagnostic use only.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/Or

Over-The-Counter Use (21 CFR 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 (OVD)

Lenk L. L.

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

K112120 510(k)

Page 1 of

Regulation Number and Section

§ 864.7320 Fibrinogen/fibrin degradation products assay.

(a)
Identification. A fibrinogen/fibrin degradation products assay is a device used to detect and measure fibrinogen degradation products and fibrin degradation products (protein fragments produced by the enzymatic action of plasmin on fibrinogen and fibrin) as an aid in detecting the presence and degree of intravascular coagulation and fibrinolysis (the dissolution of the fibrin in a blood clot) and in monitoring therapy for disseminated intravascular coagulation (nonlocalized clotting in the blood vessels).(b)
Classification. Class II (performance standards).