(80 days)
Not Found
No
The description details a standard immunoassay based on latex agglutination and turbidimetry, with no mention of AI or ML algorithms for data analysis or interpretation.
No
This device is an in vitro diagnostic (IVD) immunoassay designed for the quantitative determination of D-Dimer in human plasma. It is used to measure a substance for diagnostic purposes, not to treat or therapeutically affect the human body.
Yes
Explanation: The device quantitatively determines D-Dimer in human plasma, which is used to aid in the diagnosis of conditions like deep vein thrombosis and pulmonary embolism.
No
The device is a latex enhanced immunoassay kit, which is a chemical reagent kit used on automated clinical chemistry analyzers. It is a physical product, not software.
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 (in vitro) to provide diagnostic information.
- Device Description: The description details a "latex enhanced immunoassay" that measures a substance (D-Dimer) in a biological sample (human citrated plasma). This is a classic description of an in vitro diagnostic test.
- Performance Studies: The performance studies describe evaluating the device using "citrated plasma samples" and comparing it to a "predicate device" which is also an IVD (IL Test D-Dimer). This further confirms its use in a diagnostic laboratory setting.
- Predicate Device: The mention of a predicate device (K972696 IL Test D-Dimer) which is a known IVD reinforces that this device falls into the same category.
All these points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
N/A
Intended Use / Indications for Use
Quantex D-DIMER is a latex enhanced immunoassay for the quantitative determination of D-Dimer in human citrated plasma on automated clinical chemistry analyzers.
Product codes
DAP, GHH
Device Description
Quantex D-DIMER is a latex enhanced immunoassay for the quantitative determination of D-Dimer in human citrated plasma on automated clinical chemistry analyzers.
The quantex D-DIMER Latex Reagent is a suspension of polystyrene 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 quantex 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 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 137 citrated plasma samples, the correlation (r) of quantex D-Dimer on an ILab 600 compared to the predicate device on an ACL Futura was 0.987.
Within precision assessed over multiple runs using the quantex D-DIMER controls I/II on an ILab 600 gave a CV of 4.0% (at a mean of 302 ng/mL) and 2.2% (at a mean of 637 ng/mL).
Key Metrics
Not Found
Predicate Device(s)
K972696 IL Test D-Dimer
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).
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KO32419
OCT 2 4 2003
SECTION 3 quantex D-DIMER - 510(k) Summary (Summary of Safety and Effectiveness)
Submitted by:
Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02421 Phone: 781-861-4467 781-861-4207 Fax:
Contact Person:
Carol Marble, Regulatory Affairs Director Phone: 781-861-4467 / Fax: 781-861-4207
Summary Prepared:
August 4, 2003
Name of the device:
quantex 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):
K972696 IL Test D-Dimer
Description of the device/intended use(s):
Quantex D-DIMER is a latex enhanced immunoassay for the quantitative determination of D-Dimer in human citrated plasma on automated clinical chemistry analyzers.
The quantex D-DIMER Latex Reagent is a suspension of polystyrene 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 quantex 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 caused by the aggregates (turbidimetric immunoassay).
Statement of Technological Characteristics of the Device Compared to Predicate Device:
Quantex D-DIMER is substantially equivalent to the commercially available predicate device IL Test D-Dimer in performance and intended use.
Summary of Performance Data:
In a method comparison study evaluating 137 citrated plasma samples, the correlation (r) of quantex D-Dimer on an ILab 600 compared to the predicate device on an ACL Futura was 0.987.
Within precision assessed over multiple runs using the quantex D-DIMER controls I/II on an ILab 600 gave a CV of 4.0% (at a mean of 302 ng/mL) and 2.2% (at a mean of 637 ng/mL).
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and healing. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Carol Marble Regulatory Affairs Manager Instrumentation Laboratory Company 101 Hartwell Avenue Lexington, Massachusetts 02421-3125
Re: K032419
Trade/Device Name: quantex D-DIMER Regulation Number: 21 CFR § 864.7320 Regulation Name: Fibrinogen/Fibrin Degradation Products Assay Regulatory Class: II Product Code: DAP. GHH Dated: September 16, 2003 Received: September 26, 2003
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.
OCT 2 4 2003
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 predicate device 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, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: quantex D-DIMER
Indications for Use:
Quantex D-DIMER is a latex enhanced immunoassay for the quantitative determination of D-Dimer in human citrated plasma on automated clinical chemistry analyzers.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off
Office of In Vitro Diagnostic Device
Evaluation and Safety
| 510(k) | K032419 |
|---|---|
| -------- | --------- |
| Prescription Use
| (Per 21 CFR 801.019) | OR Over-The-Counter Use |
|---|---|
| ------------------------------------------ | ------------------------- |
quantex D-DIMER 510(k)
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