← Product Code [DAP](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/DAP) · K032419 # QUANTEX D-DIMER (K032419) _Instrumentation Laboratory CO · DAP · Oct 24, 2003 · Hematology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/DAP/K032419 ## Device Facts - **Applicant:** Instrumentation Laboratory CO - **Product Code:** [DAP](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/DAP.md) - **Decision Date:** Oct 24, 2003 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 864.7320 - **Device Class:** Class 2 - **Review Panel:** Hematology ## Indications for Use The Instrumentation Laboratory Co. (IL) 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 Story Quantex D-DIMER is a latex-enhanced turbidimetric immunoassay; utilizes polystyrene latex particles coated with monoclonal antibody (MA-8D3) specific for D-Dimer domain in fibrin soluble derivatives. Input: human citrated plasma samples. Operation: mixing plasma with latex reagent and phosphate buffer causes particle agglutination; degree of agglutination is directly proportional to D-Dimer concentration. Output: quantitative D-Dimer concentration measured via decrease in transmitted light. Used in clinical laboratory settings on automated clinical chemistry analyzers (e.g., ILab 600). Healthcare providers use results to aid in clinical decision-making regarding fibrin degradation products. Benefits include automated, quantitative assessment of D-Dimer levels. ## Clinical Evidence Bench testing only. Precision evaluated per NCCLS EP5-T2 (N=60, Total CV 2.83-5.75%). Linearity confirmed over 154–3212 ng/mL (R2=0.9997). Analytical specificity showed no interference from heparin, bilirubin, hemoglobin, or triglycerides. Method comparison (N=137) against predicate yielded slope 1.059, r=0.987. Field study (N=112) across ER, DIC, DVT, and PE patient samples showed correlation (slope 0.752, r=0.984). Normal range established using 125 healthy donors (mean 92 ng/mL, UL 198 ng/mL). ## Technological Characteristics Latex-enhanced turbidimetric immunoassay. Reagents: polystyrene latex particles coated with monoclonal antibody (MA-8D3), phosphate buffer. Calibrators/controls: partially purified D-Dimer from human fibrin digested with human plasmin. Preservative: 0.02% Bronidox. Measurement: turbidimetric (decrease in transmitted light). System: automated clinical chemistry analyzer (ILab 600). Storage: 2-8°C. ## Predicate Devices - Instrumentation Laboratory Co. IL Test D-Dimer ([K972696](/device/K972696.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY DEVICE ONLY TEMPLATE A. 510(k) Number: #K032419 B. Analyte: Fibrin degradation product (D-Dimer) C. Type of Test: Quantitative D. Applicant: Instrumentation Laboratory Co. E. Proprietary and Established Names: quantex D-DIMER; Fibrin Degradation Products Assay (D-Dimer) F. Regulatory Information: 1. Regulation section: CFR 864.7320 2. Classification: Class II 3. Product Code: DAP, GHH 4. Panel: Hematology (81) G. Intended Use: 1. Intended use(s): The Instrumentation Laboratory Co. (IL) quantex D-DIMER is a latex enhanced immunoassay for the quantitative determination of D-Dimer in human citrated plasma on automated clinical chemistry analyzers. 2. Indication(s) 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. 3. Special condition for use statement(s): N/A 4. Special instrument Requirements: The automated ILab 600 Clinical Chemistry System (#K980757) H. Device Description: The IL quantex D-DIMER Kit consists of Latex Reagent, Phosphate Buffer, Calibrator and Controls I/II. The 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. The Calibrator and Controls are solutions of partially purified D-Dimer from human fibrin digested with human plasmin. The quantex D-DIMER turbidimetric immunoassay measures the decrease in transmitted light caused by aggregates formed by latex particle agglutination in the presence of D-Dimer. {1} Page 2 of 6 I. Substantial Equivalence Information: 1. Predicate device name(s): Instrumentation Laboratory Co. IL Test D-Dimer 2. Predicate K number(s): #K972696 3. Comparison with predicate: | Similarities | | | | --- | --- | --- | | Item | Device | Predicate | | Assay type | Latex enhanced immuno-assay | SAME | | Monoclonal anti-body (MAB) | MA-8D3 | SAME | | Test principle | Turbidimetric agglutination | SAME | | Buffer | Phosphate buffer | SAME | | Calibrator/Controls | Lyophilized solution of partially purified D-Dimer, from human fibrin digested with human plasmin. | SAME | | Storage | 2 - 8° C. | SAME | | Differences | | | | Item | Device | Predicate | | Instrumentation | Automated clinical chemistry analyzers | Automated coagulation analyzers | | Preservatives for Calibrator and Latex Reagent | 0.02% Bronidox | < 0.1% Sodium azide | | Linear range | 150 – 3200 ng/mL | 200 – 1050 ng/mL | | Calibrator target value | 3200 ng/mL | 1000 ng/mL | {2} Page 3 of 6 J. Standard/Guidance Document Referenced (if applicable): N/A K. Test Principle: Polystyrene latex particles are coated with a monoclonal antibody highly specific for the D-Dimer domain included in fibrin soluble derivatives. When 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. The concentration is determined by measuring the decrease in light transmitted when the particles agglutinate in the presence of D-Dimer. L. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Controls I/II (N=60) were run on the ILab 600 Clinical Chemistry System, according to NCCLS EP5-T2 document. Results are as follows: | | Level I | Level II | | --- | --- | --- | | Mean | 301.6 ng/mL | 636.8 ng/mL | | Within-run | 3.99%CV | 2.17%CV | | Between-run | 2.78%CV | 0.00%CV | | Total | 5.75%CV | 2.83%CV | b. Linearity/assay reportable range: Calibrator/saline dilutions (12 levels) were tested in triplicate, over (2) separate runs. They generated values over a range of 154 – 3212 ng/mL. The regression study of expected vs reported values yielded this equation: $y = 1.01x + 0.1663$ ; $R2 = 0.9997$ c. Traceability (controls, calibrators, or method): d. Detection limit: 77 ng/mL A saline study was performed, using (3) assay reagent lots (20 replicates). The mean +3SD (2 calibrations/lot) was calculated. The maximum value obtained was determined to be the detection limit. e. Analytical specificity: Interference testing demonstrated no significant interference as follows: - Unfractionated heparin (UFH) - < 1.5 IU/mL - Low molecular weight heparin (LMWH) - < 1.5 IU/mL - Bilirubin - < 18mg/dL - Hemoglobin - < 500 mg/dL - Triglycerides - < 1280 mg/dL {3} Page 4 of 6 f. Assay cut-off: 198 ng/mL The upper limit (UL) of normal (mean of 92 ng/mL + 2SD of 53 ng/mL) was determined from a study performed on citrated plasmas from normal blood bank donors (N=125). 2. Comparison studies: a. Method comparison with predicate device: An in-house study was performed on duplicate citrated plasma samples (N=137), obtained from the emergency room, Hospital de San Paul in Spain. The samples ranged in value 17 – 24149 ng/mL. The quantex D-Dimer/ILab 600 combination was compared to the IL Test D-Dimer/ACL Futura (#K951891) combination. Regression results on the mean of duplicates were: Slope – 1.059, Intercept – 50.2, r – 0.987 Singlet results were statistically similar: Slope – 1.053, Intercept – 51.6, r – 0.979 b. Matrix comparison: N/A 3. Clinical studies: a. Clinical sensitivity: N/A b. Clinical specificity: N/A c. Other clinical supportive data (when a and b are not applicable): A field site study was performed at Hospital St. Joan de Reus, also in Spain, on patient plasma samples (N=112), comparing the quantex D-Dimer to the IL Test D-Dimer on the ACL 7000 (#K961991). Single determinations were made on these samples: ER (N=44); DIC (N=30); DVT (N=20); PE (N=18). The study yielded these regression statistics: Slope – 0.752, Intercept – 52.5, r – 0.984 4. Clinical cut-off: N/A 5. Expected values/Reference range: {4} Page 5 of 6 Mean = 92 ng/mL The normal range study was performed on citrated plasma from normal blood bank donors, males and females (N = 125), ranging in age 18-66 years. Test results yielded a mean of 92 ng/ml; and a UL of normal of 198 ng/mL (mean + 2 SD). Five outliers were donor samples that tested above the UL; and (3) donor samples had insufficient quantities and could not be tested. M. Conclusion: The company provided performance data that was within acceptable analytical limits for this type of device. Based upon the data presented, this device may be found substantially equivalent to a legally marketed device. {5} Page 6 of 6 --- **Source:** [https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/DAP/K032419](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/DAP/K032419) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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