(109 days)
No
The device description details a turbidimetric immunoassay based on latex particle agglutination, a standard biochemical method. There is no mention of AI, ML, image processing, or any data-driven algorithms in the provided text.
No
This device is an in vitro diagnostic (IVD) test used to determine D-Dimer levels in human plasma, which is a diagnostic function, not a therapeutic one.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states "permits the quantitative in vitro diagnostic determination of D-Dimer".
No
The device description clearly outlines a physical reagent (latex particles coated with antibodies) and a measurement method based on light transmission (turbidimetric immunoassay), indicating it is a hardware-based in vitro diagnostic device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states: "IL Test™ D-Dimer permits the quantitative in vitro diagnostic determination of D-Dimer in human plasma by turbidimetry." The phrase "in vitro diagnostic" is a direct indicator.
- Device Description: The description details how the device interacts with a biological sample (human plasma) outside of the body ("in vitro") to provide diagnostic information (quantitative determination of D-Dimer).
- Methodology: The method described (turbidimetric immunoassay) is a common technique used in in vitro diagnostics to measure substances in biological fluids.
N/A
Intended Use / Indications for Use
IL Test™ D-Dimer permits the quantitative in vitro diagnostic determination of D-Dimer in human plasma by turbidimetry. The IL Test™ 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 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 caused by the aggregates (turbidimetric immunoassay).
Product codes
DAP
Device Description
IL Test™ D-Dimer permits the quantitative in vitro diagnostic determination of D-Dimer in human plasma by turbidimetry. The IL Test™ 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 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 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
In a method comparison study evaluating 105 plasma samples, the correlation (r) of IL Test™ D-Dimer to the predicate device was 0.998 on both the ACL 6000 and on the ACL. On the ACL 6000, within precision accessed over multiple runs gave a CV of 4.4% (at a mean of 390 ng/mL), 2.4% (at a mean of 888 ng/mL) and 2.2% (at a mean of 1055 ng/mL). On the ACL Futura, within run precision accessed over multiple runs gave a CV of 6.9% (at a mean of 411 ng/mL), 2.1% (at a mean of 912 ng/mL) and 2.7% (at a mean of 1051 ng/mL).
Key Metrics
Correlation (r) of IL Test™ D-Dimer to the predicate device was 0.998. Within precision CV on ACL 6000: 4.4% (at 390 ng/mL), 2.4% (at 888 ng/mL), 2.2% (at 1055 ng/mL). Within run precision CV on ACL Futura: 6.9% (at 411 ng/mL), 2.1% (at 912 ng/mL), 2.7% (at 1051 ng/mL).
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
SECTION 3 IL Test™ D-Dimer - 510(k) SUMMARY (Summary of Safety and Effectiveness)
Submitted by:
Betty Lane Director, Regulatory Affairs Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02173 Phone: (617) 861-4182 (617) 861-4464 Fax: --
Contact Persons:
Betty Lane Phone: (617) 861-4182
Carol Marble Alternate: Phone: (617) 861-4467
Summary Prepared:
July 9, 1997
Name of the device:
IL Test™ D-Dimer
Classification name(s):
| 864.7320 | Fibrinogen/fibrin degradation products assay | Class II |
|---|---|---|
| 81 DAP | Fibrinogen and Fibrin Split Products, Antigen, Antiserum, Control |
Identification of predicate device(s):
AGEN's Dimertest® Gold EIA Kit K945642
Description of the device/intended use(s):
IL Test™ D-Dimer permits the quantitative in vitro diagnostic determination of D-Dimer in human plasma by turbidimetry. The IL Test™ D-Dimer Latex Reagent is a suspension of latex particles coated with a monoclonal antibody specific for the D-Dimer domain included in fibrin When plasma containing D-Dimer is mixed with the D-Dimer Latex soluble derivatives. Reagent and Reaction Buffer, 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 caused by the aggregates (turbidimetric immunoassay).
Statement of how the Technological Characteristics of the Device compare to the Predicate device:
IL Test™ D-Dimer is a quantitative D-Dimer test like the predicate Dimertest® Gold EIA Kit and is substantially equivalent in performance, intended use, and safety and effectiveness.
Summary of Performance Data:
In a method comparison study evaluating 105 plasma samples, the correlation (r) of IL Test™ D-Dimer to the predicate device was 0.998 on both the ACL 6000 and on the ACL. On the ACL 6000, within precision accessed over multiple runs gave a CV of 4.4% (at a mean of 390 ng/mL), 2.4% (at a mean of 888 ng/mL) and 2.2% (at a mean of 1055 ng/mL). On the ACL Futura, within run precision accessed over multiple runs gave a CV of 6.9% (at a mean of 411 ng/mL), 2.1% (at a mean of 912 ng/mL) and 2.7% (at a mean of 1051 ng/mL).
ﻤﺴﺘﻌﻤﻠﻬﺎ
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Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
NOV - 4 1997
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Betty Lane ---------Director of Regulatory Affairs Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, Massachusetts 02173
Re : K972696/S1 Trade Name: IL Test™ D-Dimer Product Code: DAP Requlatory Class: II GHH II September 8, 1997 Dated: Received: September 9, 1997
Dear Ms. Lane:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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, labelinq, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Requlations.
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Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use Statement
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: IL Test™ D-Dimer
Indications for Use:
IL Test™ D-Dimer permits the quantitative in vitro diagnostic determination of D-Dimer in human plasma by turbidimetry. The IL Test™ 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 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 caused by the aggregates (turbidimetric immunoassay).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K972696 |
| Prescription Use
| (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---|---|---|
| ------------------------------------------ | ---- | ---------------------- |
Section 2
IL Test™ D-Dimer 510(k)