(302 days)
The CARDIAC D-Dimer Assay is intended for the quantitative determination of d-dimer in anticoagulated venous whole blood with the CARDIAC Reader instrument.
D-Dimer is a degradation product of crosslinked firbrin. The d-dimer concentration is a measure of the fibrinolytic activity of plasmin in the vascular system. Elevated concentrations of d-dimer indicate increased coagulatory and fibrinolytic activity. In general, a validated d-dimer assay may be useful in ruling out deep venous thrombosis or pulmonary embolism.
The Cardiac D-Dimer Assay is intended for the quantitative determination of d-dimer in anticoagulated venous whole blood with the Cardiac Reader Instrument.
The test is based on the dual monoclonal antibody "sandwich" principle using a poly-(streptavidin)-biotin capture system with a gold sol particle label. The test is initiated by the addition of whole blood to the Cardiac D-Dimer Assay, which separates red blood cells from plasma. D-Dimer in plasma combines with both biotinylated anti-d-dimer antibody conjugated to gold sol particles, to form a "sandwich". This "sandwich" combines with poly-(streptavidin), which is immobilized in a stripe or line across the read window of the Cardiac D-Dimer Assay, producing a reddish purple line. The intensity and speed at which the color forms are related to the concentration of d-dimer in the blood.
Here's an analysis of the provided text regarding the Cardiac D-Dimer Assay and its acceptance criteria, structured according to your request.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes the device and its intended use but does not explicitly state specific acceptance criteria (e.g., minimum sensitivity, specificity, accuracy thresholds) for its performance. Instead, it focuses on demonstrating substantial equivalence to a predicate device.
The reported device performance is described through its measurement range and how results are displayed.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| (Not explicitly stated in terms of performance thresholds) | |
| Measuring Range: | 0.1 ug/ml - 4 ug/ml |
| Result Display: | Less than 0.1 ug/ml: "D-Dimer Low" |
| Between 0.1 and 4 ug/ml: Displays quantitative result | |
| Greater than 4 ug/ml: "D-Dimer High > 4 ug/ml" | |
| Comparison to Predicate Device (Tina-quant® D-Dimer Test System): | |
| Intended Use | Cardiac D-Dimer Assay: Quantitative determination of d-dimer in anticoagulated venous whole blood. (Predicate: Quantitative determination D-dimer in citrated plasma or heparin plasma.) |
| Test Principle | Cardiac D-Dimer Assay: Dual monoclonal antibody "sandwich" principle with poly-(streptavidin)-biotin capture system and gold sol particle label. (Predicate: Latex particles coated with monoclonal antibodies; turbidity measurement.) |
| Reagents | Cardiac D-Dimer Assay: Buffer, biotinylated anti-d-dimer antibody (mouse monoclonal), gold-labeled anti-d-dimer antibody (mouse monoclonal). (Predicate: Buffer, Anti-D-Dimer latex suspension with monoclonal anti-human D-Dimer antibodies (mouse)). |
| Measuring Range | Cardiac D-Dimer Assay: 0.1 ug/ml - 4 ug/ml. (Predicate: 0.15 - 9.0 ug/ml) |
| Result Display | Cardiac D-Dimer Assay: Semi-Quantitative (Low, quantitative result, High). (Predicate: Quantitative) |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not include information about the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective study design). It describes the device, its intended use, and its similarities/differences to a predicate device for the purpose of demonstrating substantial equivalence. Clinical study data, including sample sizes and origins, are typically found in the full 510(k) submission, not just the summary.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided in the 510(k) summary. Given that this is an in-vitro diagnostic device for D-Dimer levels, the "ground truth" would likely be established by a reference method or predicate device rather than expert consensus on images or clinical assessments.
4. Adjudication Method for the Test Set
This information is not provided in the 510(k) summary. Adjudication methods are typically relevant for studies involving human interpretation (e.g., radiologists reviewing images), which is not explicitly described here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
This information is not provided in the 510(k) summary. MRMC studies are primarily for evaluating AI's impact on human reader performance, usually in imaging diagnostics. This document describes an in-vitro diagnostic assay, not an imaging AI.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The device itself, the "Cardiac D-Dimer Assay," is an in-vitro diagnostic device that provides a quantitative or semi-quantitative output. It is a standalone algorithm/device in the sense that its output is a direct measurement of D-Dimer. It's not an AI system that provides interpretations that a human then uses to make a decision, but rather a diagnostic test whose result directly informs clinical decision-making. No "human-in-the-loop" performance is described for the assay itself, as its function is to measure a biomarker.
7. The Type of Ground Truth Used
Based on the nature of the device (a quantitative D-Dimer assay), the ground truth for evaluating its performance would typically involve:
- Reference Method Comparison: Comparing the device's results against a well-established, more accurate reference method (e.g., a gold standard laboratory D-Dimer assay).
- Predicate Device Comparison: As shown in the summary, substantial equivalence is claimed against the Roche Diagnostics Tina-quant® D-Dimer Test System (K002706). This implies that the performance of the new device was compared to the predicate device, using the predicate's results as a de facto "ground truth" for demonstrating similar performance characteristics.
The specific "type of ground truth" used for validation studies leading to the 510(k) is not detailed, but it would almost certainly be based on laboratory analytical methods or comparison to a legally marketed predicate device.
8. The Sample Size for the Training Set
The provided 510(k) summary does not mention a training set or its sample size. This type of information is typically associated with machine learning or AI models, which are not explicitly described as the core component of this D-Dimer assay in the summary. While the assay has a "test principle," it's a biochemical reaction and measurement, not a machine learning algorithm requiring a distinct "training set" in the conventional AI sense.
9. How the Ground Truth for the Training Set Was Established
Since a "training set" is not mentioned or implied for this type of in-vitro diagnostic device in the provided text, this question is not applicable. The device operates on a biochemical principle, not by learning from a training dataset like a typical AI algorithm.
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SEP - 1 2004
| 510(k) Summary | K033491 | |
|---|---|---|
| -- | ---------------- | --------- |
Introduction
According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.
| 1) Submitter name, address, contact | Roche Diagnostics Corporation 9115 Hague Rd. Indianapolis, IN 46250 |
|---|---|
| Contact Person: Jennifer Tribbett | |
| Date Prepared: August 11, 2004 |
| 2) Device name | |
|---|---|
| Proprietary name: | Cardiac D-Dimer Assay |
| Common name: | D-Dimer |
| Classification name: | Fibrinogen/Fibrin Degradation Product Assay |
| 3) Predicate device | The Roche Diagnostics Cardiac D-Dimer Assay is substantially equivalent to other devices legally marketed in the United States. We claim equivalence to the Roche Diagnostics Tina-quant® D-Dimer Test System (K002706). |
|---|---|
| --------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| 4) Device Description | The Cardiac D-Dimer Assay is intended for the quantitative determination of d-dimer in anticoagulated venous whole blood with the Cardiac Reader Instrument. |
|---|---|
| The test is based on the dual monoclonal antibody "sandwich" principle using a poly-(streptavidin)-biotin capture system with a gold sol particle label. The test is initiated by the addition of whole blood to the Cardiac D-Dimer Assay, which separates red blood cells from plasma. D-Dimer in plasma combines with both biotinylated anti-d-dimer antibody conjugated to gold sol particles, to form a "sandwich". This "sandwich" combines with poly-(streptavidin), which is immobilized in a stripe or line across the read window of the Cardiac D-Dimer Assay, producing a reddish purple line. The intensity and speed at which the color forms are related to the concentration of d-dimer in the blood. |
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| 5) Intended use | The Cardiac D-Dimer Assay is intended for the quantitative determination ofd-dimer in anticoagulated venous whole blood with the Cardiac ReaderInstrument. |
|---|---|
| 6) Substantialequivalence -Similarities andDifferences | The following tables show the comparison of the Cardiac D-Dimer Assay tothe Tina-quant® D-Dimer Test System. |
| Topic | Tina-quant® D-Dimer Test System(K002706)Cardiac D-Dimer Assay |
|---|---|
| Intended Use | Quantitative determination D-dimerin citrated plasma or heparin plasma.Quantitative determination of d-dimer inanticoagulated venous whole blood. |
| Test Principle | Latex particles of uniform size arecoated with monoclonal antibodies tothe D-Dimer epitope.The antigen/antibody complexesproduced by the addition of samplescontaining D-Dimer lead to anincrease in the turbidity of the testreactants. The change in absorbancewith time is dependent on theconcentration of D-Dimer epitopes inthe sample.The test is based on the dual monoclonalantibody "sandwich" principle using apoly-(streptavidin)-biotin capture systemwith a gold sol particle label. The test isinitiated by the addition of whole bloodto the Cardiac D-Dimer Assay, whichseparates red blood cells from plasma.D-Dimer in plasma combines with bothbiotinylated anti-d-dimer antibodyconjugated to gold sol particles, to forma "sandwich". This "sandwich"combines with poly-(streptavidin),which is immobilized in a stripe or lineacross the read window of the CardiacD-Dimer Assay, producing a reddishpurple line. The intensity and speed atwhich the color forms are related to theconcentration of d-dimer in the blood. |
Continued on next page
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| Topic | Tina-quant® D-Dimer TestSystem (K002706) | Cardiac D-Dimer Assay |
|---|---|---|
| Reagents | •Buffer•Anti-D-Dimer latexsuspension ofconsisting of latex particlescoated with monoclonal anti-human D-Dimer antibodies(mouse) | •Buffer•Biotinylated anti-d-dimer antibody (mouse monoclonal)•Gold-labeled anti-d-dimer antibody (mouse monoclonal) |
| MeasuringRange | 0.15 - 9.0 ug/ml | 0.1 ug/ml - 4 ug/ml |
| Result Display | Quantitative | Semi-Quantitative |
| D-Dimer concentration Display Format | ||
| Less than 0.1 ug/ml "D-Dimer Low" | ||
| Between 0.1 and 4 ug/ml Displays quantitative result | ||
| Greater than 4 ug/ml "D-Dimer High > 4 ug/ml" |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The seal is black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Jennifer Tribbett Regulatory Affairs Principal Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, Indiana 46250-0457
SEP = 1 2004
K033491 Re:
Trade/Device Name: Cardiac D-Dimer Assay Regulation Number: 21 CFR § 864.7320 Regulation Name: Fibrin Degradation Products Regulatory Class: II Product Code: DAP, GHH Dated: August 11, 2004 Received: August 12, 2004
Dear Ms. Tribbett:
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 Mcdical 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 adultcration.
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 Scction 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,
Robert L. Becker, Jr.
Robert L. Becker, Jr., M.D., Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K033491
Device Name: The CARDIAC D-Dimer Assay
Indications For Use:
The CARDIAC D-Dimer Assay is intended for the quantitative determination of d-dimer in anticoagulated venous whole blood with the CARDIAC Reader instrument.
D-Dimer is a degradation product of crosslinked firbrin. The d-dimer concentration is a measure of the fibrinolytic activity of plasmin in the vascular system. Elevated concentrations of d-dimer indicate increased coagulatory and fibrinolytic activity. In general, a validated d-dimer assay may be useful in ruling out deep venous thrombosis or pulmonary embolism.
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)
Josephine Bautista
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K03349/
Page 1 of 1
§ 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).