(276 days)
No
The device is a turbidimetric immunoassay and the summary does not mention any AI/ML components. The use of a clinical pretest probability model (Wells model) is mentioned, but this is a standard clinical assessment tool, not an AI/ML component of the device itself.
No
The device is an in vitro diagnostic (IVD) immunoassay designed for quantitative determination of D-Dimer, used to exclude venous thromboembolism (VTE) in conjunction with a clinical PTP assessment. It measures a biomarker and provides diagnostic information, but does not directly treat or prevent a disease.
Yes
The device is described as an "automated latex enhanced immunoassay for the quantitative determination of D-Dimer," used "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)." This clearly indicates its use in diagnosing or ruling out a medical condition.
No
The device description clearly states it is a "suspension of polystyrene latex particles" and a "Latex Reagent," which are physical components, not software. It also describes a turbidimetric immunoassay process involving light measurement, indicating hardware is involved.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative determination of D-Dimer in human citrated plasma". This involves testing a sample taken from the human body (plasma) in vitro (outside the body) to provide diagnostic information.
- Device Description: The description details a "latex enhanced immunoassay" that measures the concentration of D-Dimer in a plasma sample. This is a common method used in IVD devices.
- Performance Studies: The document describes a multi-center management study where the device was used to test patient samples and the results were compared to clinical outcomes (development of DVT or PE). This is typical of performance studies for IVD devices.
- Key Metrics: The document provides key performance metrics like Sensitivity, Specificity, and Negative Predictive Value, which are crucial for evaluating the diagnostic accuracy of an IVD device.
- Predicate and Reference Devices: The mention of predicate and reference devices with K numbers (which are FDA submission numbers for medical devices, including IVDs) further confirms its classification as a medical device, specifically an IVD given the context.
Therefore, based on the provided information, the HemosIL D-Dimer device clearly fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
HemosIL D-Dimer is an automated latex enhanced immunoassay for the quantitative determination of D-Dimer in human citrated plasma on IL Coagulation 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 cmbolism (PE).
Product codes (comma separated list FDA assigned to the subject device)
DAP
Device Description
The D-Dimer Latex Reagent is a suspension of polystyrenc latex particles of uniform size coated with a monoclonal antibody highly specific for the D-Dimer domain included in fibrin soluble derivatives. When a plasma containing D-Dimer is mixed with the Latex Reagent and the Reaction Buffer included in the D-Dimer 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 the transmitted light at 405 nm caused by the aggregates (turbidimetric immunoassay).
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
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
A multi-center management study was performed at four hospitals on patients admitted consecutively to the emergency unit with suspected DVT or PE.
Data Source: 632 samples on an ACL TOP and 629 samples on an ACL ELITE.
Annotation protocol: 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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Multi-center management study.
Sample size: 632 samples on the ACL TOP (302 for DVT, 330 for PE) and 629 samples on the ACL ELITE (298 for DVT, 331 for PE).
Key results:
On ACL TOP:
DVT Performance (All samples, n=302): Sensitivity 100.0% (59/59), Specificity 41.6% (101/243), NPV 100.0% (101/101), PPV 29.4% (59/201). Prevalence 19.5% (59/302).
PE Performance (All samples, n=330): Sensitivity 100.0% (50/50), Specificity 29.3% (82/280), NPV 100.0% (82/82), PPV 20.2% (50/248).
On ACL ELITE:
DVT Performance (All samples, n=298): Sensitivity 100.0% (61/61), Specificity 33.8% (80/237), NPV 100.0% (80/80), PPV 28.0% (61/218). Prevalence 20.5% (61/298).
PE Performance (All samples, n=331): Sensitivity 98.0% (49/50), Specificity 41.3% (116/281), NPV 99.1% (116/117), PPV 22.9% (49/214).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
ACL TOP DVT Performance:
Sensitivity: 100.0% (59/59) (All samples), 100.0% (27/27) (High PTP), 100.0% (32/32) (Low + Moderate PTP)
Specificity: 41.6% (101/243) (All samples), 34.6% (9/26) (High PTP), 42.4% (92/217) (Low + Moderate PTP)
Negative Predictive value: 100.0% (101/101) (All samples), 100.0% (9/9) (High PTP), 100.0% (92/92) (Low + Moderate PTP)
Positive Predictive value: 29.4% (59/201) (All samples), 61.4% (27/44) (High PTP), 20.4% (32/157) (Low + Moderate PTP)
Prevalence: 19.5% (59/302) (All samples), 50.9% (27/53) (High PTP), 12.9% (32/249) (Low + Moderate PTP)
ACL TOP PE Performance:
Sensitivity: 100.0% (50/50) (All samples), 100.0% (7/7) (High PTP), 100.0% (43/43) (Low + Moderate PTP)
Specificity: 29.3% (82/280) (All samples), 17.6% (3/17) (High PTP), 30.0% (79/263) (Low + Moderate PTP)
Negative Predictive value: 100.0% (82/82) (All samples), 100.0% (3/3) (High PTP), 100.0% (79/79) (Low + Moderate PTP)
Positive Predictive value: 20.2% (50/248) (All samples), 33.3% (7/21) (High PTP), 18.9% (43/227) (Low + Moderate PTP)
Prevalence: 15.2% (50/330) (All samples), 29.2% (7/24) (High PTP), 14.1% (43/306) (Low + Moderate PTP)
ACL ELITE DVT Performance:
Sensitivity: 100.0% (61/61) (All samples), 100.0% (29/29) (High PTP), 100.0% (32/32) (Low + Moderate PTP)
Specificity: 33.8% (80/237) (All samples), 24.0% (6/25) (High PTP), 34.9% (74/212) (Low + Moderate PTP)
Negative Predictive Value: 100.0% (80/80) (All samples), 100.0% (6/6) (High PTP), 100.0% (74/74) (Low + Moderate PTP)
Positive Predictive Value: 28.0% (61/218) (All samples), 60.4% (29/48) (High PTP), 18.8% (32/170) (Low + Moderate PTP)
Prevalence: 20.5% (61/298) (All samples), 53.7% (29/54) (High PTP), 13.1% (32/244) (Low + Moderate PTP)
ACL ELITE PE Performance:
Sensitivity: 98.0% (49/50) (All samples), 100.0% (8/8) (High PTP), 97.6% (41/42) (Low + Moderate PTP)
Specificity: 41.3% (116/281) (All samples), 41.2% (7/17) (High PTP), 41.3% (109/264) (Low + Moderate PTP)
Negative Predictive Value: 99.1% (116/117) (All samples), 100.0% (7/7) (High PTP), 99.1% (109/110) (Low + Moderate PTP)
Positive Predictive Value: 22.9% (49/214) (All samples), 44.4% (8/18) (High PTP), 20.9% (41/196) (Low + Moderate PTP)
Prevalence: 15.1% (50/331) (All samples), 32.0% (8/25) (High PTP), 13.7% (42/306) (Low + Moderate PTP)
Predicate Device(s)
K070927 HemosIL D-Dimer HS
Reference Device(s)
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
X073042
HemosIL D-Dimer 510(k) Summary (Summary of Safety and Effectiveness)
Applicant Contact Information:
| Applicant: | Instrumentation Laboratory Co. | |
|---|---|---|
| Address: | 113 Hartwell Avenue | |
| Lexington, MA 02421 | JUL 31 2008 | |
| Contact Person: | Carol Marble, Regulatory Affairs Director | |
| Phone Number: | 781-861-4467 | |
| Fax Number: | 781-861-4207 | |
| Preparation Date: | June 27, 2008 |
Device Trade Name:
HemosIL D-Dimer
Regulatory Information:
| Classification Name: | Fibrinogen and Fibrin Split Products, Antigen, Antiserum, Control |
|---|---|
| Device Class: | Class II |
| Regulation No.: | 864.7320 |
| Product Code: | DAP |
| Panel: | Hematology |
Predicate Device:
K070927 HemosIL D-Dimer HS
Device Intended Use:
HemosIL D-Dimer is an automated latex enhanced immunoassay for the quantitative determination of D-Dimer in human citrated plasma on IL Coagulation 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 cmbolism (PE).
Device Description:
The D-Dimer Latex Reagent is a suspension of polystyrenc latex particles of uniform size coated with a monoclonal antibody highly specific for the D-Dimer domain included in fibrin soluble derivatives. When a plasma containing D-Dimer is mixed with the Latex Reagent and the Reaction Buffer included in the D-Dimer 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 the transmitted light at 405 nm caused by the aggregates (turbidimetric immunoassay).
Technological Characteristic Summary:
The HemosIL D-Dimer assay is equivalent to the currently marketed HemosIL D-Dimer assay (K050278), except for the Intended Use. For purposes of the Intended Use expansion, we also claim equivalence to the HemosIL D-Dimer HS assay (K070927).
Attachment B
1
| Characteristic | Modified Device:
HemosIL D-Dimer | Predicate Device:
Current HemosIL D-Dimer
(K050278) | Predicate Device:
HemosIL D-Dimer HS
(K070927) |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | HemosIL D-Dimer is an automated latex
enhanced immunoassay for the
quantitative determination of D-Dimer in
human citrated plasma on IL Coagulation
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 is an automated
latex enhanced immunoassay for the
quantitative determination of
D-Dimer in human citrated plasma
on IL Coagulation Systems as an aid
in the diagnosis of venous
thromboembolism (VTE) [deep
venous thrombosis (DVT) and
pulmonary embolism (PE)]. | HemosIL D-Dimer HS is an
automated latex enhanced
immunoassay for the quantitative
determination of D-Dimer in human
citrated plasma on the ACL TOP for
use in conjunction with a clinical
pretest probability (PTP) assessment
model to exclude venous
thromboembolism (VTE) [deep
venous thrombosis (DVT) and
pulmonary embolism (PE)]. |
| Assay principle | Latex-enhanced
immunoturbidmetric assay | Same | Same |
| Instruments | IL Coagulation Systems | Same | ACL TOP instruments only |
| Sample type | Citrated plasma | Same | Same |
| Calibrator | Kit Calibrator | Same | Same |
| Quality Control | HemosIL D-Dimer Controls | Same | Same |
| Measuring Range | 200 - 5250 ng/mL
with automatic rerun | Same | 150 - 69000 ng/mL
with automatic rerun |
| Detection Limit | ACL Family
ACL Futura/ACL Advance
ACL TOP | Same | 21 ng/mL
ACL TOP |
| | 140 ng/mL
156 ng/mL
69 ng/mL | | |
| Characteristic | Modified Device:
HemosIL D-Dimer | Predicate Device:
HemosIL D-Dimer
(K050278) | Predicate Device:
HemosIL D-Dimer HS
(K070927) |
| Within-run
Precision (% CV) | ACL Family:
4.5% at 246 ng/mL 6.01% at 310 ng/mL 2.42% at 732 ng/mL ACL Futura/ACL Advance: 11.82% at 304 ng/mL 3.59% at 813 ng/mL ACL TOP: 6.8% at 282 ng/mL 4.6% at 340 ng/mL 2.5% at 729 ng/mL | Same | ACL TOP: 8.3% at 180 ng/mL 3.7% at 314 ng/mL 2.0% at 677 ng/mL |
| Interferences | ACL Family and
ACL Futura/ACL Advance Systems: Hemoglobin up to 50 mg/dL Bilirubin up to 5 mg/dL Lipids up to 1000 mg/dL Rheumatoid Factor up to 60 IU/mL ACL TOP Hemoglobin up to 100 mg/dL Bilirubin up to 10 mg/dL Triglycerides up to 1500 mg/dL The presence of Rheumatoid Factor may produce an overestimation of the test result | Same | ACL TOP: Hemoglobin up to 500 mg/dL Bilirubin up to 18 mg/dL Triglycerides up to 1327 mg/dL Rheumatoid Factor up to 1400 UI/mL |
| Clinical Cut-off | 230 ng/mL | Same | Same |
Substantial Equivalence Comparison Table
Attachment B
Page 2 of 5
2
Substantial Equivalence Comparison Table (Cont.)
Attachment B
3
Performance Data:
A multi-center management study was performed at four hospitals on patients admitted consecutively to the emergency unit with suspected DVT or PE using representative IL Coagulation Systems: an ACL TOP (632 samples) and an ACL ELITE (629 samples). 302 patients on the ACL TOP and 298 patients on an ACL ELITE were suspected of DVT; 330 patients on the ACL TOP and 331 patients on the ACL ELITE 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.
There was one case during the study where a patient with a moderate PTP score and a negative D-Dimer test result on the ACL ELITE was confirmed for PE through imaging techniques. This same sample gave a positive D-Dimer test result on the ACL TOP.
The overall prevalence of DVT in the total population of samples was 19.5% (59/302) on the ACL TOP and 20.5% (61/298) on the ACL ELITE. The overall prevalence of PE in the total population of samples was 15.2% (50/330) on the ACL. TOP and 15.1% (50/331) on the ACL ELITE.
The sensitivity, specificity and negative predictive value (NPV) of HemosIL D-Dimer on the ACL. TOP and ACL ELITE for DVT and PE using the previously established clinical cut-off of 230 ng/mL is summarized below with the corresponding 95% confidence intervals (CI):
| ACL TOP | |||
|---|---|---|---|
| DVT Performance | All samples | High PTP | Low + Moderate |
| PTP | |||
| n | 302 | 53 | 249 |
| Sensitivity | 100.0% (59/59) | ||
| (93.9%-100.0%) | 100.0% (27/27) | ||
| (87.2%-100.0%) | 100.0% (32/32) | ||
| (89.1%-100.0%) | |||
| Specificity | 41.6% (101/243) | ||
| (35.3%-48.0%) | 34.6% (9/26) | ||
| (17.2%-55.7%) | 42.4% (92/217) | ||
| (35.7%-49.3%) | |||
| Negative | |||
| Predictive value | 100.0% (101/101) | ||
| (96.4%-100.0%) | 100.0% (9/9) | ||
| (66.4%-100.0%) | 100.0% (92/92) | ||
| (96.1%-100.0%) | |||
| Positive | |||
| Predictive value | 29.4% (59/201) | ||
| (23.2%-36.2%) | 61.4% (27/44) | ||
| (45.5%-75.6%) | 20.4% (32/157) | ||
| (14.4%-27.5%) | |||
| Prevalence | 19.5% (59/302) | ||
| (15.2%-24.5%) | 50.9% (27/53) | ||
| (36.8%-64.9%) | 12.9% (32/249) | ||
| (9.0%-17.7%) | |||
| PE Performance | All samples | High PTP | Low + Moderate |
| PTP | |||
| n | 330 | 24 | 306 |
| Sensitivity | 100.0% (50/50) | ||
| (92.9%-100.0%) | 100.0% (7/7) | ||
| (59.0%-100.0%) | 100.0% (43/43) | ||
| (91.8%-100.0%) | |||
| Specificity | 29.3% (82/280) | ||
| (24.0%-35.0%) | 17.6% (3/17) | ||
| (3.8%-43.4%) | 30.0% (79/263) | ||
| (24.6%-36.0%) | |||
| Negative | |||
| Predictive value | 100.0% (82/82) | ||
| (95.6%-100.0%) | 100.0% (3/3) | ||
| (29.2%-100.0%) | 100.0% (79/79) | ||
| (95.4%-100.0%) | |||
| Positive | |||
| Predictive value | 20.2% (50/248) | ||
| (15.4%-25.7%) | 33.3% (7/21) | ||
| (14.6%-57.0%) | 18.9% (43/227) | ||
| (14.1%-24.7%) | |||
| 15.2% (50/330) | 29.2% (7/24) | 14.1% (43/306) |
HemosIL D-Dimer 510(k) Response (06/27/08)
4
Performance Data (Cont.):
| ACL ELITE | |||
|---|---|---|---|
| DVT Performance | All samples | High PTP | Low + Moderate |
| PTP | |||
| n | 298 | 54 | 244 |
| Sensitivity | 100.0% (61/61) | ||
| (94.1%-100.0%) | 100.0% (29/29) | ||
| (88.1%-100.0%) | 100.0% (32/32) | ||
| (89.1%-100.0%) | |||
| Specificity | 33.8% (80/237) | ||
| (27.8%-40.2%) | 24.0% (6/25) | ||
| (9.4%-45.1%) | 34.9% (74/212) | ||
| (28.5%-41.7%) | |||
| Negative Predictive Value | 100.0% (80/80) | ||
| (95.5%-100.0%) | 100.0% (6/6) | ||
| (54.1%-100.0%) | 100.0% (74/74) | ||
| (95.1%-100.0%) | |||
| Positive Predictive Value | 28.0% (61/218) | ||
| (22.1%-34.4%) | 60.4% (29/48) | ||
| (45.3%-74.2%) | 18.8% (32/170) | ||
| (13.2%-25.5%) | |||
| Prevalence | 20.5% (61/298) | ||
| (16.0%-25.5%) | 53.7% (29/54) | ||
| (39.6%-67.4%) | 13.1% (32/244) | ||
| (9.1%-18.0%) | |||
| PE Performance | All samples | High PTP | Low + Moderate |
| PTP | |||
| n | 331 | 25 | 306 |
| Sensitivity | 98.0% (49/50) | ||
| (89.4%-99.9%) | 100.0% (8/8) | ||
| (63.1%-100.0%) | 97.6% (41/42) | ||
| (87.4%-99.9%) | |||
| Specificity | 41.3% (116/281) | ||
| (35.5%-47.3%) | 41.2% (7/17) | ||
| (18.4%-67.1%) | 41.3% (109/264) | ||
| (35.3%-47.5%) | |||
| Negative Predictive Value | 99.1% (116/117) | ||
| (95.3%-100.0%) | 100.0% (7/7) | ||
| (59.0%-100.0%) | 99.1% (109/110) | ||
| (95.0%-100.0%) | |||
| Positive Predictive Value | 22.9% (49/214) | ||
| (17.4%-29.1%) | 44.4% (8/18) | ||
| (21.5%-69.2%) | 20.9% (41/196) | ||
| (15.4%-27.3%) | |||
| Prevalence | 15.1% (50/331) | 32.0% (8/25) | 13.7% (42/306) |
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized 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 pattern around the bird-like figure.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL 31 2008
Instrumentation Laboratory c/o Carol Marble Regulatory Affairs Director 113 Hartwell Avenue Lexington, Massachusetts 02421
Re: K073042
Trade/Device Name: Hemosil D-Dimer Regulation Number: 21 CFR 864.7320 Regulation Name: Fibrinogen/Fibrin Degradation Product Assay Regulatory Class: Class II Product Code: DAP Dated: June 27, 2008 Received: June 30, 2008
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 either class II (Special Controls) or class III (PMA), 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); and good manufacturing practice 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
6
Page 2 - Instrumentation Laboratory
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 Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mana In Chan
Maria M. Chan, Ph.D. Acting Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
7
Indications for Use Statement
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: HemosIL D-Dimer
Indications for Use:
HemosIL D-Dimer is an automated latex enhanced immunoassay for the quantitative determination of D-Dimer in human citrated plasma on II. Coagulation 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).
For in vitro diagnostic use.
Prescription Use (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 Devices (OIVD)
Josephine Bautista
Division Sign Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K073042
HemosIL D-Dimer 510(k)
- (2) -- (2)