Quantex D-DIMER is a latex enhanced immunoassay for the quantitative determination of D-Dimer in human citrated plasma on automated clinical chemistry analyzers.

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).

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the quantex D-DIMER device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document (K032419 for quantex D-DIMER) does not explicitly state pre-defined acceptance criteria values in the way one might see for diagnostic accuracy metrics (e.g., "sensitivity must be >90%"). Instead, the performance is demonstrated through a method comparison with a predicate device and precision studies, indicating that the new device's performance should be substantially equivalent to the predicate.

Given the information provided, we can infer the performance metrics reported:

Performance Metric	Acceptance Criteria (Implied/Compared to Predicate)	Reported Device Performance (quantex D-DIMER)
Method Comparison (Correlation)	Substantially equivalent to predicate device performance (ideally high correlation).	Correlation (r) = 0.987 (compared to IL Test D-Dimer on ACL Futura)
Within-run Precision (CV)	Acceptable precision for a diagnostic assay (typically <10% for clinical chemistry, often lower for high-use assays).	4.0% (at mean of 302 ng/mL) 2.2% (at mean of 637 ng/mL)

Important Note: The acceptance criteria are implicitly met if the reported performance demonstrates "substantial equivalence" to the predicate device, as determined by the FDA. The high correlation coefficient (0.987) and acceptable CVs suggest this was the case.

General Study Information for quantex D-DIMER

Feature	Details
2. Sample Size & Data Provenance (Test Set)	Sample Size: 137 citrated plasma samples were used for the method comparison study. Data Provenance: Not explicitly stated (e.g., country of origin, specific clinics). The study appears to be retrospective as it involved "evaluating 137 citrated plasma samples" which implies pre-collected samples.
3. Number of Experts & Qualifications (Ground Truth)	Not applicable. This device is a quantitative immunoassay. The "ground truth" for the test set is established by the measurement on the predicate device, which itself is a quantitative assay. It does not rely on expert interpretation for individual sample results.
4. Adjudication Method (Test Set)	Not applicable. As a quantitative immunoassay, there is no manual interpretation or adjudication of results in the traditional sense. The "gold standard" for comparison is the predicate device's measurement.
5. MRMC Comparative Effectiveness Study	No. This is a submission for a standalone in vitro diagnostic device, not an AI-assisted interpretation tool for human readers. Therefore, an MRMC study assessing human reader improvement with AI assistance is not relevant or reported.
6. Standalone Performance	Yes. The method comparison study and precision studies describe the standalone performance of the quantex D-DIMER device operating on an ILab 600 analyzer. It assesses the device's output against the output of a predicate device, without human intervention in the result generation.
7. Type of Ground Truth Used	The "ground truth" in this context is the quantitative measurement of D-Dimer using the predicate device (IL Test D-Dimer on an ACL Futura). This is a form of comparative ground truth, where the new device's performance is validated against an already legally marketed and accepted method.
8. Sample Size for Training Set	The document does not provide information on a "training set" in the context of machine learning or AI models. This is a traditional immunoassay, and its development would involve reagent optimization and assay development, rather than machine learning training. Therefore, a specific sample size for a training set (as understood in AI/ML) is not applicable or provided.
9. How Ground Truth for Training Set was Established	Not applicable, as there is no specific "training set" in the AI/ML sense. The development of an immunoassay involves rigorous biochemical validation, reagent selection, antibody characterization, and analytical performance testing (linearity, limit of detection, interference, etc.) to establish the assay's performance and ensure it accurately measures D-Dimer. The "ground truth" for these developmental stages would be established through known D-Dimer concentrations often prepared from purified D-Dimer antigen or characterized plasma samples.

Summary

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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
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Prescription Use(Per 21 CFR 801.019)	OR Over-The-Counter Use
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quantex D-DIMER 510(k)

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Regulation Number and Section

§ 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).