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).

AI/ML Overview

Here's an analysis of the acceptance criteria and study details for the IL Test™ D-Dimer, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implicitly based on predicate equivalence)	Reported Device Performance (IL Test™ D-Dimer)
Correlation to Predicate	r ≥ 0.95 (typical for method comparison studies)	0.998 on ACL 6000 and ACL Futura
Precision (CV)	Generally < 10% for clinical assays	ACL 6000:4.4% (at 390 ng/mL)2.4% (at 888 ng/mL)2.2% (at 1055 ng/mL)ACL Futura:6.9% (at 411 ng/mL)2.1% (at 912 ng/mL)2.7% (at 1051 ng/mL)
Intended Use	Quantitative in vitro diagnostic determination of D-Dimer in human plasma by turbidimetry	Matches predicate's intended use
Safety and Effectiveness	Substantially equivalent to predicate device	Substantially equivalent to predicate device

Note: The document doesn't explicitly state numerical acceptance criteria for correlation or precision. However, for a 510(k) submission, the device must demonstrate performance that is "substantially equivalent" to a legally marketed predicate device. This implies that the performance metrics (like correlation and precision) of the new device should be comparable to or better than generally accepted standards for such assays, and in this case, implicitly compared to the performance of the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: 105 plasma samples.
Data Provenance: Not explicitly stated (e.g., country of origin). The study involved "human plasma," which suggests it's likely from human subjects. The text does not specify if the data was retrospective or prospective, but clinical method comparison studies typically use prospectively collected or retrospectively accessed existing clinical samples.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable / Not explicitly stated. This study is a method comparison study between a new device and a predicate device (AGEN's Dimertest® Gold EIA Kit K945642). The "ground truth" for each sample's D-Dimer concentration is established by the reading from the predicate device itself. It doesn't involve expert interpretation of images or clinical outcomes that require a panel of human experts for ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable. As this is a quantitative assay comparison against a predicate device, there is no expert adjudication process for establishing ground truth for individual cases, unlike studies involving subjective interpretation (e.g., radiology reads). The agreement is based on numerical correlation between the two assay methods.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This is not a MRMC comparative effectiveness study. It's a method comparison study for an in vitro diagnostic (IVD) assay, comparing the performance of a new automated D-Dimer test to an existing one. Such studies typically involve human readers interpreting complex medical data (like images) and analyzing the improvement with AI assistance.

6. Standalone Performance Study

Yes. The data presented focuses on the standalone performance of the IL Test™ D-Dimer device. It evaluates its correlation with the predicate device and its precision independently. The device itself is an automated in vitro diagnostic test, meaning its output (D-Dimer concentration) is generated by the algorithm/instrument without direct human-in-the-loop interpretation during the measurement process.

7. Type of Ground Truth Used

Comparison to a Predicate Device. The "ground truth" for the performance evaluation of the IL Test™ D-Dimer is the D-Dimer concentration determined by the legally marketed predicate device, AGEN's Dimertest® Gold EIA Kit (K945642). This is a common approach for IVD 510(k) clearances, demonstrating substantial equivalence rather than absolute accuracy against a gold standard like pathology or clinical outcomes for every sample.

8. Sample Size for the Training Set

Not explicitly stated in the provided text. For IVD devices, a "training set" in the context of machine learning (AI) as commonly understood today (neural networks, etc.) is not typically described in these older 510(k) submissions, as these were often traditional algorithms/reagent systems. The "training" for such systems would involve assay development and optimization, which isn't described in terms of a specific data set size here. If the device uses a statistical model or calibration curve, the data used to establish that curve would be analogous to a training set, but its size is not specified.

9. How the Ground Truth for the Training Set Was Established

Not applicable / Not explicitly stated. Similar to point 8, the concept of a "training set" with established ground truth for an AI algorithm is not directly relevant or explicitly discussed in this context. The "ground truth" for any internal calibration or development work for this type of turbidimetric immunoassay would typically involve reference materials with known D-Dimer concentrations, often calibrated against international standards if available, or against highly characterized internal reference preparations.

Summary

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K972696

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).

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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

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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
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Section 2

IL Test™ D-Dimer 510(k)

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).