(31 days)
Not Verified
No
The device description details a turbidimetric immunoassay based on latex agglutination, which is a standard laboratory technique and does not involve AI or ML. The summary also explicitly states "Not Found" for mentions of AI, DNN, or ML, and there is no description of training or test sets typically associated with AI/ML development.
No.
Explanation: The device is an immunoassay for the quantitative determination of D-Dimer, used as an aid in diagnosis, not for treatment.
Yes
The device is described as 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)". The phrase "aid in the diagnosis" clearly indicates its diagnostic purpose.
No
The device description clearly outlines a physical reagent (latex particles coated with antibodies) and a process involving agglutination and turbidimetric measurement, indicating a hardware-dependent immunoassay system, not a software-only device.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for the "quantitative determination of D-Dimer in human citrated plasma". This involves testing a sample taken from the body (in vitro) to provide diagnostic information.
- Device Description: The description details a laboratory test using reagents and a sample of plasma to measure a substance (D-Dimer) within that sample. This is characteristic of an in vitro diagnostic test.
- Input Imaging Modality: The "Not Applicable (Immunoassay)" indicates it's a lab-based test, not an imaging device.
- Anatomical Site: "Not Applicable (Blood sample)" further confirms it's a test performed on a sample outside the body.
The definition of an IVD is a medical device that is used to examine specimens, such as blood, urine, or tissue, taken from the human body to detect diseases, conditions, or infections. This device fits that definition perfectly.
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 as an aid in the diagnosis of venous thromboembolism (VTE) [deep venous thrombosis (DVT) and pulmonary embolism (PE)]. For in vitro diagnostic use.
Product codes (comma separated list FDA assigned to the subject device)
DAP
Device Description
The D-Dimer Latex Reagent is a suspension of latex particles coated with a monoclonal antibody specific for the D-Dimer domain included in fibrin soluble derivatives. When plasma containing D-Dimer is mixed with the D-Dimer Latex Reagent and Reaction Buffer, the coated latex particles agelutinate. 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 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
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)
ACL 9000: N=297, Cut-off=230 ng/mL, % Sensitivity (95% CI)=100% (95.2% - 100%), % Specificity (95% CI)=38% (31.4% - 44.6%), % NPV=100% (95.7%-100%)
ACL TOP: N=294, Cut-off=230 ng/mL, % Sensitivity (95% CI)=100% (95.1%-100%), % Specificity (95% CI)=36% (29.6%-42.6%), % NPV=100% (95.4%-100%)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
% Sensitivity, % Specificity, % NPV
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
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হ
MAR 1 0 2005
Section 3 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 | |
| Contact Person: | Carol Marble, Regulatory Affairs Director |
| Phone Number: | 781-861-4467 |
| Fax Number: | 781-861-4207 |
| Preparation Date: | February 4, 2005 |
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:
HemosIL D-Dimer K972696
Device Indications for Use/Description:
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)].
The D-Dimer Latex Reagent is a suspension of latex particles coated with a monoclonal antibody specific for the D-Dimer domain included in fibrin soluble derivatives. When plasma containing D-Dimer is mixed with the D-Dimer Latex Reagent and Reaction Buffer, the coated latex particles agelutinate. 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 caused by the aggregates (turbidimetric immunoassay).
Technological Characteristic Summary:
HemosIL D-Dimer is identical to the predicate device except for the clarifications for use and the introduction of additional performance data in the product labeling.
| Instrument | N | Cut-off | % Sensitivity
(95% CI) | % Specificity
(95% CI) | % NPV |
|------------|-----|-----------|---------------------------|---------------------------|----------------------|
| ACL 9000 | 297 | 230 ng/mL | 100%
(95.2% - 100%) | 38%
(31.4% - 44.6%) | 100%
(95.7%-100%) |
| ACL TOP | 294 | 230 ng/mL | 100%
(95.1%-100%) | 36%
(29.6%-42.6%) | 100%
(95.4%-100%) |
Performance Data Summary:
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name arranged in a circular pattern around a symbol. The symbol is a stylized representation of an eagle with three wave-like lines emanating from its head, symbolizing health and human services.
MAR 1 0 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Carol Marble Regulatory Affairs Director Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, Massachusetts 02421
K050278 Re: Trade/Device Name: HemosIL D-Dimer Regulation Number: 21 CFR § 864.7320 Regulation Name: Fibrinogen/Fibrin Degradation Product Assay Regulatory Class: II Product Code: DAP Dated: February 4, 2005 Received: February 7, 2005
Dear Ms. Marble:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use stated in the encrebare) 76 ttg enactment date of the Medical Device Amendments, or to conninered pror to may 20, 1978) in accordance with the provisions of the Federal Food, Drug, devices mat have been rechassinou in asse approval of a premarket approval application (PMA). and Cosmette 7 for (110) that as nevice, subject to the general controls provisions of the Act. The r ou may, dicrorere, mains 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 r your device is elassinod (over as 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 I Toase oc advisod that I Dr a retiren that your device complies with other requirements of the Act that I DA has made a acterimations administered by other Federal agencies. You must of any i cacial stutures and regeranents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice CTN Part 8075, adoming (DF CFR Crains (QS) regulation (21 CFR Part 820). This letter requirements as bet form in are quanded as described in your Section 510(k) premarket will anow you to begin mation.org your antial equivalence of your device to a legally marketed nonfreation. The results in a classification for your device and thus, permits your device to proceed to the market.
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If you desire specific information about the application of labeling requirements to your device, of In If you desire specific information acount in the office , please contact the Office of In
or questions on the promotion and advertises of your and any of 0.0.0.0184. Also, ma of questions on the promotion and advertising or your be may be and the Vitro Diagnostic Device Lyaniation and Barey as (21)Expands (21CFR Part 807.97).
regulation entitled, "Misbranding by reference to premarket notification the Ast from the You may obtain other general information on your responsibilities under the Act from the You may outain other general mornational on your copyisumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Robert Beckerh
Robert L. Becker, Jr., MD, PA Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K050278
Device Name: HemosIL D-Dimer
Indications for Use:
HemosIL D-Dimer is an automated latex enhanced immunoassay for the quantitative Hemosil - D-Dimer in human citrated plasma on IL Coagulation Systems an aid in the delerinmation of D-Dimer in namal enable (VTE) [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 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
510(k) K050278
HemosIL D-Dimer 510(k)