(367 days)
Not Found
No
The device description details a turbidimetric immunoassay based on antibody-coated latex particles, which is a standard laboratory technique and does not involve AI/ML. The use of a clinical pretest probability model is mentioned, but this is a separate clinical assessment tool, not part of the device's technology.
No
Explanation: The device is an in vitro diagnostic immunoassay used to determine D-Dimer levels to help exclude venous thromboembolism; it does not provide therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use." and describes its use for the quantitative determination of D-Dimer to help exclude venous thromboembolism. These are characteristics of a diagnostic device.
No
The device description clearly states it is a latex enhanced immunoassay using reagents (Latex Reagent and Reaction Buffer) and controls, which are physical components, not software. It also mentions being performed on ACL TOP® Family Systems, which are hardware analyzers.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "For in vitro diagnostic use." This is the primary indicator that the device is intended for use outside of the body to examine specimens from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or condition.
Furthermore, the description of the device and its intended use aligns with the definition of an IVD: it's an assay for the quantitative determination of D-Dimer in human citrated plasma, used in conjunction with a clinical assessment to help exclude venous thromboembolism. This involves testing a biological sample (plasma) to gain diagnostic information.
N/A
Intended Use / Indications for Use
HemosIL D-Dimer HS 500 is an automated latex enhanced immunoassay for the quantitative determination of D-Dimer in human citrated plasma on the ACL TOP® Family Systems for use, in conjunction with a clinical pretest probability (PTP) assessment model to exclude venous thromboembolism (VTE) in outpatients suspected of deep venous thrombosis (DVT) and pulmonary embolism (PE).
HemosIL D-Dimer HS 500 Controls are intended for the quality control of the D-Dimer HS 500 assay performed on the ACL TOP® Family Systems.
For in vitro diagnostic use.
Product codes
DAP, GGN
Device Description
HemosIL D-Dimer HS 500: The D-Dimer HS 500 Latex Reagent is a suspension of polystyrene latex particles of uniform size coated with the F(ab')2 fragment of a monoclonal antibody highly specific for the D-Dimer domain included in fibrin soluble derivatives. The use of the F(ab'), fragment allows a more specific D-Dimer detection avoiding the interference of some endogenous factors like the Rheumatoid Factor. When a plasma containing D-Dimer is mixed with the Latex Reagent and the Reaction Buffer included in the HemosIL D-Dimer HS 500 kit, the coated latex particles agglutinate. The degree of agglutination is directly proportional to the concentration of D-Dimer in the sample and is determined by measuring the decrease of transmitted light caused by the aggregates (turbidimetric immunoassay).
HemosIL D-Dimer HS 500 Controls: The Low and High D-Dimer HS 500 Controls are prepared by means of a dedicated process and contain different concentrations of partially purified D-Dimer obtained by digestion of Factor XIIIa cross-linked human fibrin with human plasmin.
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
Outpatients suspected of deep venous thrombosis (DVT) and pulmonary embolism (PE).
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
An outcome study was performed on 295 frozen samples from patients admitted consecutively to an emergency unit with suspected PE or DVT (frequency of venous thromboembolic disease: 25.4%). Of the 295 samples, 75 were confirmed as VTE positive (47 PE and 28 DVT) by standard objective tests and the remaining 220 were confirmed as negative.
A multi-center management study was performed at four hospitals on 747 samples from patients admitted consecutively to the emergency unit with suspected DVT or PE . 401 patients were suspected of DVT and 346 patients were suspected of PE.
Summary of Performance Studies
Precision: Within run (repeatability) and total (within device) precision was assessed over multiple runs using the two levels of HemosIL D-Dimer HS 500 Controls and a low D-Dimer plasma pool on an ACL TOP instrument.
Mean (U/mL): D-Dimer Plasma Pool 423, Low D-Dimer HS 500 Control 877, High D-Dimer HS 500 Control 2469.
CV % (Within run): D-Dimer Plasma Pool 7.2, Low D-Dimer HS 500 Control 2.9, High D-Dimer HS 500 Control 2.5.
CV % (Total): D-Dimer Plasma Pool 9.5, Low D-Dimer HS 500 Control 8.9, High D-Dimer HS 500 Control 7.3.
Method Comparison: An in-house method comparison study was performed to compare the performance of HemosIL D-Dimer HS 500 on an ACL TOP instrument versus the VIDAS D-Dimer Exclusion Assay with the following results: n=100, Slope=1.00, r=0.981.
Outcome Study: Study type: outcome study. Sample size: 295 frozen samples. Results: With a cut-off of 500 ng/mL on ACL TOP, 100% Sensitivity (95.2% to 100%), 42.3% Specificity (35.7% - 49.1%), and 100% NPV (96.1% to 100%).
Multi-center management study: Study type: multi-center management study. Sample size: 747 samples (401 for DVT, 346 for PE). The overall prevalence DVT was 22.4% (90/401), and PE was 15.0% (52/346). All patients with a negative D-Dimer test result and low PTP score or physician's decision regarding moderate PTP score did not develop DVT or PE after 3 months follow-up.
DVT Performance: (Cut-off: 500 ng/mL)
All samples (n=401): Sensitivity 100.0% (90/90), Specificity 42.1% (131/311), NPV 100.0% (131/131), PPV 33.3% (90/270), Prevalence 22.4% (90/401).
High PTP (n=79): Sensitivity 100.0% (45/45), Specificity 32.4% (11/34), NPV 100.0% (11/11), PPV 66.2% (45/68), Prevalence 57.0% (45/79).
Low + Moderate PTP (n=322): Sensitivity 100.0% (45/45), Specificity 43.3% (120/277), NPV 100.0% (120/120), PPV 22.3% (45/202), Prevalence 14.0% (45/322).
PE Performance: (Cut-off: 500 ng/mL)
All samples (n=346): Sensitivity 100.0% (52/52), Specificity 48.3% (142/294), NPV 100.0% (142/142), PPV 25.5% (52/204), Prevalence 15.0% (52/346).
High PTP (n=24): Sensitivity 100.0% (9/9), Specificity 33.3% (5/15), NPV 100.0% (5/5), PPV 47.4% (9/19), Prevalence 37.5% (9/24).
Low + Moderate PTP (n=322): Sensitivity 100.0% (43/43), Specificity 49.1% (137/279), NPV 100.0% (137/137), PPV 23.2% (43/185), Prevalence 13.4% (43/322).
Key Metrics
Outcome Study:
% Sensitivity (95% CI): 100% (95.2% to 100%)
% Specificity (95% CI): 42.3% (35.7% - 49.1%)
% NPV (95% CI): 100% (96.1% to 100%)
DVT Performance:
Sensitivity: 100.0% (96.0%-100.0%) for all samples; 100.0% (92.1%-100.0%) for High PTP; 100.0% (92.1%-100.0%) for Low + Moderate PTP.
Specificity: 42.1% (36.6%-47.8%) for all samples; 32.4% (17.4%-50.5%) for High PTP; 43.3% (37.4%-49.4%) for Low + Moderate PTP.
Negative Predictive value: 100.0% (97.2%-100.0%) for all samples; 100.0% (71.5%-100.0%) for High PTP; 100.0% (97.0%-100.0%) for Low + Moderate PTP.
Positive Predictive value: 33.3% (27.7%-39.3%) for all samples; 66.2% (53.7%-77.2%) for High PTP; 22.3% (16.7%-28.6%) for Low + Moderate PTP.
Prevalence: 22.4% (18.5%-26.8%) for all samples; 57.0% (45.3%-68.1%) for High PTP; 14.0% (10.4%-18.2%) for Low + Moderate PTP.
PE Performance:
Sensitivity: 100.0% (93.2%-100.0%) for all samples; 100.0% (66.4%-100.0%) for High PTP; 100.0% (91.8%-100.0%) for Low + Moderate PTP.
Specificity: 48.3% (42.5%-54.2%) for all samples; 33.3% (11.8%-61.6%) for High PTP; 49.1% (43.1%-55.1%) for Low + Moderate PTP.
Negative Predictive value: 100.0% (97.4%-100.0%) for all samples; 100.0% (47.8%-100.0%) for High PTP; 100.0% (97.3%-100.0%) for Low + Moderate PTP.
Positive Predictive value: 25.5% (19.7%-32.0%) for all samples; 47.4% (24.4%-71.1%) for High PTP; 23.2% (17.4%-30.0%) for Low + Moderate PTP.
Prevalence: 15.0% (11.4%-19.2%) for all samples; 37.5% (18.8%-59.4%) for High PTP; 13.4% (9.8%-17.6%) for Low + Moderate PTP.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
510(k) Summary
Applicant Contact Information:
| Applicant: | Instrumentation Laboratory Co. | |
|---|---|---|
| Address: | 113 Hartwell Avenue | |
| Lexington, MA 02421 | FEB - 5 2010 | |
| Contact Person: | Carol Marble, Regulatory Affairs Director | |
| Phone Number: | 781-861-4467 | |
| Fax Number: | 781-861-4207 | |
| Revision Date: | August 12, 2009 |
Device Trade Names:
HemosIL® D-Dimer HS 500 HemosIL® D-Dimer HS 500 Controls
Device Regulatory Information:
| Regulation Nos.: | 21 CFR 864.7320 (Assay); 21 CFR 864.5425 (Controls) |
|---|---|
| Regulation Names: | Fibrinogen and Fibrin Split Products, Antigen, Antiserum, Control (Assay) |
| Plasma, Coagulation Controls (Controls) | |
| Regulatory Class: | Class II |
| Product Codes: | DAP (Assay) and GGN (Controls) |
| Panel: | Hematology |
Predicate Devices:
| K040882 | VIDAS® D-Dimer Exclusion™ Assay |
|---|---|
| K070927 | HemosIL® D-Dimer HS |
| K972696 | HemosIL® D-Dimer Controls |
Device Descriptions:
HemosIL D-Dimer HS 500: The D-Dimer HS 500 Latex Reagent is a suspension of polystyrene latex particles of uniform size coated with the F(ab')2 fragment of a monoclonal antibody highly specific for the D-Dimer domain included in fibrin soluble derivatives. The use of the F(ab'), fragment allows a more specific D-Dimer detection avoiding the interference of some endogenous factors like the Rheumatoid Factor. When a plasma containing D-Dimer is mixed with the Latex Reagent and the Reaction Buffer included in the HemosIL D-Dimer HS 500 kit, the coated latex particles agglutinate. The degree of agglutination is directly proportional to the concentration of D-Dimer in the sample and is determined by measuring the decrease of transmitted light caused by the aggregates (turbidimetric immunoassay).
HemosIL D-Dimer HS 500 Controls: The Low and High D-Dimer HS 500 Controls are prepared by means of a dedicated process and contain different concentrations of partially purified D-Dimer obtained by digestion of Factor XIIIa cross-linked human fibrin with human plasmin.
Device Intended Uses:
HemosIL D-Dimer HS 500: Automated latex enhanced immunoassay for the quantitative determination of D-Dimer in human citrated plasma on the ACL TOP® Family Systems for use, in conjunction with a clinical pretest probability (PTP) assessment model to exclude venous thromboembolism (VTE) in outpatients suspected of deep venous thrombosis (DVT) and pulmonary embolism (PE).
HemosIL D-Dimer HS 500 Controls: For the quality control of the D-Dimer HS 500 assay performed on the ACL TOP® Family Systems.
1
510(k) Summary (Cont.)
Substantial Equivalence
| Differences and
Similarities | New Device:
HemosIL D-Dimer HS 500 | Predicate Device (K070927):
HemosIL D-Dimer HS | Predicate Device (K040882):
VIDAS D-Dimer Exclusion Assay |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | HemosIL D-Dimer HS 500 is an automated
latex enhanced immunoassay for the
quantitative determination of D-Dimer in
human citrated plasma on the ACL TOP
Family Systems for use in conjunction with
a clinical pretest probability (PTP)
assessment model to exclude venous
thromboembolism (VTE) in outpatients
suspected of deep venous thrombosis
(DVT) and pulmonary embolism (PE). | Same | VIDAS D-Dimer Exclusion assay is an
automated quantitative test for use on the
VIDAS analyzers for the immunoenzymatic
determination of fibrin degradation products
(FbDP) in citrated human plasma using the
ELFA techniques (Enzyme Linked
Fluorescent Assay). The VIDAS D-Dimer
Exclusion assay is indicated for use in
conjunction with a clinical pretest probability
(PTP) assessment model to exclude deep
venous thrombosis (DVT) and pulmonary
embolism (PE) in outpatients suspected of
DVT and PE. |
| Physical Format | Liquid Latex Reagent | Lyophilized Latex Reagent | Ready-to-use strips |
| Assay Principle | Latex-enhanced immunoturbidimetric assay | Same | Two-step enzyme immunoassay sandwich
method with a final fluorescent detection |
| Instrument Platforms | ACL TOP family of analyzers | Same | VIDAS instruments |
| Sample Type | Citrated Plasma | Same | Same |
| Calibrator | Same as K070927 (included in kit) | D-Dimer Calibrator (included in kit) | D-Dimer Calibrator (included in kit) |
| Quality Controls | HemosIL D-Dimer HS 500 Controls
(sold separately) | HemosIL D-Dimer Controls
(sold separately) | Vidas D-Dimer Controls C1 and C2
(included in kit) |
| Detection Limit | 203 ng/mL | 21 ng/mL | 45 ng/mL (FEU) |
| Linear Range | 215-128000 ng/mL with Auto Rerun | 150 - 69000 ng/mL with Auto Rerun | 45-10000 ng/mL (FEU) |
| Clinical Cut-off | 500 ng/mL | 230 ng/mL | 500 ng/mL (FEU) |
2
510(k) Summary (Cont.)
Summary Performance Data:
Precision
Within run (repeatability) and total (within device) precision was assessed over multiple runs using the two levels of HemosIL D-Dimer HS 500 Controls and a low D-Dimer plasma pool on an ACL TOP instrument:
| ACL TOP Family | Mean (U/mL) | CV % (Within run) | CV % (Total) |
|---|---|---|---|
| D-Dimer Plasma Pool | 423 | 7.2 | 9.5 |
| Low D-Dimer HS 500 Control | 877 | 2.9 | 8.9 |
| High D-Dimer HS 500 Control | 2469 | 2.5 | 7.3 |
Method Comparison
An in-house method comparison study was performed to compare the performance of HemosIL D-Dimer HS 500 on an ACL TOP instrument versus the VIDAS D-Dimer Exclusion Assay with the following results:
| n | Slope | r |
|---|---|---|
| 100 | 1.00 | 0.981 |
Outcome Study
An outcome study was performed on 295 frozen samples from patients admitted consecutively to an emergency unit with suspected PE or DVT (frequency of venous thromboembolic disease: 25.4%). Of the 295 samples, 75 were confirmed as VTE positive (47 PE and 28 DVT) by standard objective tests and the remaining 220 were confirmed as negative.
| Instrument | N | Cut-off | % Sensitivity
(95% CI) | % Specificity
(95% CI) | % NPV
(95% CI) |
|------------|-----|-----------|---------------------------|---------------------------|-------------------------|
| ACL TOP | 295 | 500 ng/mL | 100%
(95.2% to 100%) | 42.3%
(35.7% - 49.1%) | 100%
(96.1% to 100%) |
3
510(k) Summary (Cont.)
Summary Performance Data (Cont.):
A multi-center management study was performed at four hospitals on 747 samples from patients admitted consecutively to the emergency unit with suspected DVT or PE . 401 patients were suspected of DVT and 346 patients were suspected of PE. As part of the study, patients underwent a PTP (pretest probability) assessment using the Wells model and were classified as having a high, moderate or low probability of DVT or PE. Patients with a negative D-Dimer test result and a low PTP score underwent no further diagnostic testing and were followed-up after 3 months for development of DVT or PE. For patients with a negative D-Dimer test result and a moderate PTP, it was the physician's decision whether to follow-up after 3 months or to undergo imaging techniques. Patients with a positive D-Dimer test result or a high PTP score underwent imaging techniques.
The overall prevalence DVT in the total population of samples was 22.4% (90/401). The overall prevalence of PE in the total population of samples was 15.0% (52/346). As of the 3 month follow-up, none of the patients that were negative through D-Dimer testing had developed DVT or PE.
The sensitivity, specificity and negative predictive value (NPV) of HemosIL D-Dimer HS 500 for DVT and PE using the previously established clinical cut-off of 500 ng/mL is summarized below with the corresponding 95% confidence intervals (CI):
| DVT Performance | All samples | High PTP | Low + Moderate
PTP |
|------------------------------|------------------------------------|----------------------------------|------------------------------------|
| n | 401 | 79 | 322 |
| Sensitivity | 100.0% (90/90)
(96.0%-100.0%) | 100.0% (45/45)
(92.1%-100.0%) | 100.0% (45/45)
(92.1%-100.0%) |
| Specificity | 42.1% (131/311)
(36.6%-47.8%) | 32.4% (11/34)
(17.4%-50.5%) | 43.3% (120/277)
(37.4%-49.4%) |
| Negative
Predictive value | 100.0% (131/131)
(97.2%-100.0%) | 100.0% (11/11)
(71.5%-100.0%) | 100.0% (120/120)
(97.0%-100.0%) |
| Positive
Predictive value | 33.3% (90/270)
(27.7%-39.3%) | 66.2% (45/68)
(53.7%-77.2%) | 22.3% (45/202)
(16.7%-28.6%) |
| Prevalence | 22.4% (90/401)
(18.5%-26.8%) | 57.0% (45/79)
(45.3%-68.1%) | 14.0% (45/322)
(10.4%-18.2%) |
| PE Performance | All samples | High PTP | Low + Moderate
PTP |
|------------------------------|------------------------------------|--------------------------------|------------------------------------|
| n | 346 | 24 | 322 |
| Sensitivity | 100.0% (52/52)
(93.2%-100.0%) | 100.0% (9/9)
(66.4%-100.0%) | 100.0% (43/43)
(91.8%-100.0%) |
| Specificity | 48.3% (142/294)
(42.5%-54.2%) | 33.3% (5/15)
(11.8%-61.6%) | 49.1% (137/279)
(43.1%-55.1%) |
| Negative
Predictive value | 100.0% (142/142)
(97.4%-100.0%) | 100.0% (5/5)
(47.8%-100.0%) | 100.0% (137/137)
(97.3%-100.0%) |
| Positive
Predictive value | 25.5% (52/204)
(19.7%-32.0%) | 47.4% (9/19)
(24.4%-71.1%) | 23.2% (43/185)
(17.4%-30.0%) |
| Prevalence | 15.0% (52/346)
(11.4%-19.2%) | 37.5% (9/24)
(18.8%-59.4%) | 13.4% (43/322)
(9.8%-17.6%) |
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
FEB 0 5 2010
Instrumentation Laboratory Co. c/o Ms. Carol Marble, Regulatory Affairs Director 113 Hartwell Avenue Lexington, MA 02421
Re: K090264
Trade/Device Name: HemosIL D-Dimer HS 500 and HemosIL D-Dimer HS 500 Controls Regulation Number: 21 CFR 864.7320 Regulation Name: Fibrinogen/fibrin degradation products assay Regulatory Class: Class II Product Code: DAP, GGN Dated: August 12, 2009 Received: August 13, 2009
Dear Ms. Marble:
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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice
5
Page 2 - Ms. Carol Marble
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportalProblem/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/cdrh/industry/support/index.html.
Sincerely yours,
Lenek. S.
Maria M. Chan, Ph.D. Director Division Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
6
Indications for Use Statement
510(k) Number (if known): K090264
HemosIL® D-Dimer HS 500 Device Names: HemosIL® D-Dimer HS 500 Controls
Indications for Use:
HemosIL D-Dimer HS 500 is an automated latex enhanced immunoassay for the quantitative determination of D-Dimer in human citrated plasma on the ACL TOP® Family Systems for use, in conjunction with a clinical pretest probability (PTP) assessment model to exclude venous thromboembolism (VTE) in outpatients suspected of deep venous thrombosis (DVT) and pulmonary embolism (PE).
HemosIL D-Dimer HS 500 Controls are intended for the quality control of the D-Dimer HS 500 assay performed on the ACL TOP® Family Systems.
For in vitro diagnostic use.
V Prescription Use (Part 21 CFR 801 Subpart D) OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
51000 K090264
HemosIL D-Dimer HS 500 Kit and Controls 510(k)
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