K032419 · Instrumentation Laboratory CO · DAP · Oct 24, 2003 · Hematology
Device Facts
Record ID
K032419
Device Name
QUANTEX D-DIMER
Applicant
Instrumentation Laboratory CO
Product Code
DAP · Hematology
Decision Date
Oct 24, 2003
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 864.7320
Device Class
Class 2
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.
Indications for Use
Indicated for the quantitative determination of D-Dimer in human citrated plasma using automated clinical chemistry analyzers.
Predicate Devices
Instrumentation Laboratory Co. IL Test D-Dimer (K972696)
Submission Summary (Full Text)
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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.
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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 |
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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
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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:
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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.
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