(79 days)
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No
The device description and performance studies detail a standard immunoassay based on particle agglutination and competitive binding, with results calculated from a calibration curve. There is no mention of AI or ML algorithms being used for data analysis, interpretation, or any other function.
No
This device is an in vitro diagnostic assay used for the quantitative determination of quinidine levels in human serum or plasma. It helps in the diagnosis and treatment of quinidine overdose and in monitoring drug levels, which are diagnostic/monitoring functions, not therapeutic.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The results obtained are used in the diagnosis and treatment of quinidine overdose and in monitoring levels of quinidine to help ensure appropriate therapy." This indicates its role in identifying or confirming a medical condition (quinidine overdose).
No
The device description explicitly states it is an "assay system" consisting of "reagents R1: anti-quinidine monoconal and R2: quinidine-oated microparticles," which are physical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "for the quantitative determination of quinidine in human serum or plasma". This indicates the device is used to analyze a biological sample (serum or plasma) from the human body.
- Purpose: The results are used "in the diagnosis and treatment of quinidine overdose and in monitoring levels of quinidine to help ensure appropriate therapy." This clearly links the use of the device to medical purposes related to diagnosis and treatment.
- Device Description: The description details a "homogeneous assay utilizing particle agglutination technology" and reagents (anti-quinidine monoclonal and quinidine-coated microparticles) that interact with the sample to produce a measurable result. This is characteristic of an in vitro diagnostic test.
- Performance Studies: The document includes performance studies like Accuracy, Linearity, Sensitivity, Method Comparison, Precision, Specificity, and Interferences, which are standard evaluations for IVD devices to demonstrate their analytical performance.
- Predicate Device: The mention of a "Predicate Device(s)" (Abbott TDx/TDxFLx Quinidine) is common in regulatory submissions for IVDs, where a new device is compared to an already approved device.
All these elements strongly indicate that the QMS® Quinidine assay is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The QMS® Quinidine assay is intended for the quantitative determination of quinidine in human serum or plasma on automated clinical chemistry analyzers.
The results obtained are used in the diagnosis and treatment of quinidine overdose and in monitoring levels of quinidine to help ensure appropriate therapy.
Product codes (comma separated list FDA assigned to the subject device)
LBZ
Device Description
The QMS® Quinidine assay system is a homogeneous assay utilizing particle agglutination technology and is based on the competitive binding principle.
In particle agglutination assays, the degree of agglutination is inversely proportional to the quantity of free drug in the reaction well. Hence, if no drug is present in the sample, the antibodies in the QMS® Quinidine Antibody Reagent (R1) will bind only to the bound drug on the particle which will cause it to agglutinate and will result in higher absorbance. If increased amount of competing drug is present in the sample, this will result in decreased binding of bound drug by the antibody, resulting in a relative decrease in particle agglutination. This in turn results in lower absorbance.
The precise relationship between particle agglutination of the unlabeled drug in the sample is established by measuring the absorbance values of calibrators with known concentration of the The absorbance of unknown samples can be interpolated from the absorbance values of the drug, calibration curve and the concentration of the drug present in the sample can be calculated.
The assay consists of reagents R1: anti-quinidine monoconal and R2: quinidine-oated microparticles. A six-level set of QMS® Quinidine Calibrators (A throu
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
human serum or plasma
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Accuracy
Accuracy by Recovery was determined by spiking USP traceable quinidine into human serum negative for the drug to achieve concentrations across the assay range. The samples were analyzed in duplicate with the QMS Quinidine assay.
THEORETICAL CONC. (µg/mL): 2.0; Rep 1: 2.06; Rep 2: 1.81; Mean Recovered Conc.: 1.94; SD: 0.12; CV: 6.50; % Recovery Acceptance Criteria: 100±10%: 97.00
THEORETICAL CONC. (µg/mL): 4.0; Rep 1: 3.94; Rep 2: 3.95; Mean Recovered Conc.: 3.95; SD: 0.01; CV: 0.13; % Recovery Acceptance Criteria: 100±10%: 98.75
THEORETICAL CONC. (µg/mL): 8.0; Rep 1: 7.81; Rep 2: 7.76; Mean Recovered Conc.: 7.79; SD: 0.02; CV: 0.32; % Recovery Acceptance Criteria: 100±10%: 97.38
Mean Percent Recovery 97.71
Linearity
Linearity by Dilution was determined by a study based on the NCCLS guideline EP6: Evaluation of the Linearity of Quantitative Measurement.
A linear regression analysis plot of USP Quinidine against recovered quinidine resulted in a line with a correlation coefficient (R2) of 0.9995, demonstrating that the assay is linear.
THEORETICAL CONC. (µg/mL): 0.25; Rep 1: 0.25; Rep 2: 0.18; Mean Recovered Conc.: 0.22; SD: 0.04; CV: 15.90; % Recovery: 88.00
THEORETICAL CONC. (µg/mL): 0.75; Rep 1: 0.71; Rep 2: 0.73; Mean Recovered Conc.: 0.72; SD: 0.01; CV: 1.39; % Recovery: 96.00
THEORETICAL CONC. (µg/mL): 1.5; Rep 1: 1.42; Rep 2: 1.41; Mean Recovered Conc.: 1.42; SD: 0.01; CV: 0.35; % Recovery: 94.67
THEORETICAL CONC. (µg/mL): 3.0; Rep 1: 2.98; Rep 2: 2.98; Mean Recovered Conc.: 2.98; SD: 0.00; CV: 0.00; % Recovery: 99.33
THEORETICAL CONC. (µg/mL): 6.0; Rep 1: 6.22; Rep 2: 6.18; Mean Recovered Conc.: 6.20; SD: 0.02; CV: 0.32; % Recovery: 103.33
Mean Percent Recovery: 96.27
Sensitivity
The Analytical Sensitivity or Least Detectable Dose (LDD) of the assay is defined as the concentration at which the lowest concentration is distinguishable from zero with 95% confidence.
The average LDD is 0.09 ug/mL, supporting a claim of 0.2 ug/mL
Assay Range
Based on the Accuracy, Linearity, and Sensitivity (LDD) data, the package insert claim for the reportable range for the assay will be 0.2 to 8.0 µg/mL.
Method Comparison
A study was conducted according to NCCLS Guideline EP9: Method Comparison and Bias Estimation Using Patient Samples to compare accuracy of recovery of quinidine in serum assayed by the QMS® Quinidine assay to the Abbott TDx/TDxFLx® Quinidine assay.
Mean values for the TDx reference method were plotted against those for the QMS on Hitachi 717. The results using Passing - Bablok parameters are:
N = 50 Slope = 1.062 y-intercept = -0.213 R² = 0.978
Results show excellent correlation between the two assays.
Precision
A precision study was performed using the National Committee for Clinical Laboratory Standards (NCCLS) guideline EP5: Evaluation of Precision Performance of Clinical Chemistry Devices.
Control: 1; N: 80; Mean (µg/mL): 1.02; Within Run SD: 0.06; Within Run CV (%): 5.83; BETWEEN DAY SD: 0.01; BETWEEN DAY CV (%): 1.53; Total SD: 0.09; Total CV (%): 9.09
Control: 2; N: 80; Mean (µg/mL): 3.17; Within Run SD: 0.08; Within Run CV (%): 2.45; BETWEEN DAY SD: 0.00; BETWEEN DAY CV (%): 0.00; Total SD: 0.20; Total CV (%): 6.37
Control: 3; N: 80; Mean (µg/mL): 5.18; Within Run SD: 0.08; Within Run CV (%): 1.62; BETWEEN DAY SD: 0.00; BETWEEN DAY CV (%): 0.00; Total SD: 0.30; Total CV (%): 5.83
Acceptance Criteria:
§ 862.3320 Digoxin test system.
(a)
Identification. A digoxin test system is a device intended to measure digoxin, a cardiovascular drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to ensure appropriate therapy.(b)
Classification. Class II.
0
DEC 2 3 2005
510K SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92
The assigned 510(k) number is: K052826
COMPANY/CONTACT PERSON
Seradyn, Inc 7998 Georgetown Road, Suite 1000 Indianapolis, IN 46268
Establishment registration No: 1836010
Jack Rogers Manager of Requlatory Affairs Telephone: (317) 610-3823 Fax: (317) 610-0018
DATE PREPARED
October 4, 2005
DEVICE NAME
| Trade Name: | QMS® Quinidine |
|---|---|
| Common Name: | Homogeneous Particle-Enhanced Turbidimetric Immunoassay |
| Device Classification: | 21 CFR 862.3320; Enzyme Immunoassay, Quinidine; Class II |
INTENDED USE
The QMS® Quinidine assay is intended for the quantitative determination of quinidine in human serum or plasma on automated clinical chemistry analyzers.
The results obtained are used in the diagnosis and treatment of quinidine overdose and in monitoring levels of quinidine to help ensure appropriate therapy.
LEGALLY MARKETED DEVICE TO WHICH EQUIVALENCY IS CLAIMED
Abbott TDx/TDxFLx Quinidine
DESCRIPTION OF DEVICE
The QMS® Quinidine assay system is a homogeneous assay utilizing particle agglutination technology and is based on the competitive binding principle.
In particle agglutination assays, the degree of agglutination is inversely proportional to the quantity of free drug in the reaction well. Hence, if no drug is present in the sample, the antibodies in the QMS® Quinidine Antibody Reagent (R1) will bind only to the bound drug on the particle which will cause it to agglutinate and will result in higher absorbance. If increased amount of competing drug is present in the sample, this will result in decreased binding of bound drug by the antibody, resulting in a relative decrease in particle agglutination. This in turn results in lower absorbance.
The precise relationship between particle agglutination of the unlabeled drug in the sample is established by measuring the absorbance values of calibrators with known concentration of the The absorbance of unknown samples can be interpolated from the absorbance values of the drug, calibration curve and the concentration of the drug present in the sample can be calculated.
The assay consists of reagents R1: anti-quinidine monoconal and R2: quinidine-oated
microparticles. A six-level set of QMS® Quinidine Calibrators (A throu
1
| | Device
Seradyn QMS® Quinidine | Predicate
Abbott TDx/TDxFLx Quinidine |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The QMS® Quinidine assay is
intended for the quantitative
determination of quinidine in human
serum or plasma on automated
clinical chemistry analyzers. | The TDx/TDxFIx Quinidine assay is a
reagent system for the quantitative
measurement of quinidine in serum or
plasma. |
| Indications
for Use | The measurements obtained are used
in the diagnosis and treatment of
quinidine overdose and in monitoring
levels of quinidine to ensure
appropriate therapy. | The measurements obtained are used
in monitoring levels of quinidine to
ensure appropriate therapy. |
| Methodology | Homogeneous particle-enhanced
turbidimetric immunoassay (particle
agglutination) | Fluorescence Polarization
Immunoassay (FPIA) technology. |
| Reagent
Components | Two (2) reagent system:
• Anti-Quinidine Antibody Reagent
(R1) in buffers containing protein
stabilizers with sodium azide
• Quinidine-coated Microparticle
Reagent (R2) in buffer containing
surfactant as stabilizers with
sodium azide | Three (3) reagent system:
• Pretreatment Solution (P)
Surfactant in buffer containing N-
N-dimethylformamide and protein
stabilizer and sodium azide.
• S Quinidine Antiserum (Goat) in
buffer with protein stabilizer and
Sodium azide.
• T Quinidine Fluorescein Tracer in
buffer with protein stabilizer
surfactant N-N-dimethylformamide
and Sodium azide |
| Calibration | QMS Quinidine
Calibrators - six levels | X Systems Quinidine
Calibrators - six levels |
SUMMARY OF CLINICAL TESTING
Accuracy
Accuracy by Recovery was determined by spiking USP traceable quinidine into human serum negative for the drug to achieve concentrations across the assay range. The samples were analyzed in duplicate with the QMS Quinidine assay.
| THEORETICAL
CONC.
(µg/mL) | Rep 1 | Rep 2 | Mean
Recovered
Conc. | SD | CV | % Recovery
Acceptance
Criteria:
100±10% |
|---------------------------------|-----------------------------|-------|----------------------------|------|------|--------------------------------------------------|
| 2.0 | 2.06 | 1.81 | 1.94 | 0.12 | 6.50 | 97.00 |
| 4.0 | 3.94 | 3.95 | 3.95 | 0.01 | 0.13 | 98.75 |
| 8.0 | 7.81 | 7.76 | 7.79 | 0.02 | 0.32 | 97.38 |
| | Mean Percent Recovery 97.71 | | | | | |
2
Linearity
Linearity by Dilution was determined by a study based on the NCCLS guideline EP6: Evaluation of the Linearity of Quantitative Measurement.
A linear regression analysis plot of USP Quinidine against recovered quinidine resulted in a line with a correlation coefficient (R2) of 0.9995, demonstrating that the assay is linear.
| THEORETICAL
CONC.
(µg/mL) | Rep 1 | Rep 2 | Mean
Recovered
Conc. | SD | CV | % Recovery | |
|---------------------------------|-----------------------|-------|----------------------------|------|-------|------------|-------|
| 0.25 | 0.25 | 0.18 | 0.22 | 0.04 | 15.90 | 88.00 | |
| 0.75 | 0.71 | 0.73 | 0.72 | 0.01 | 1.39 | 96.00 | |
| 1.5 | 1.42 | 1.41 | 1.42 | 0.01 | 0.35 | 94.67 | |
| 3.0 | 2.98 | 2.98 | 2.98 | 0.00 | 0.00 | 99.33 | |
| 6.0 | 6.22 | 6.18 | 6.2 | 0.02 | 0.32 | 103.33 | |
| | Mean Percent Recovery | | | | | | 96.27 |
Sensitivity
The Analytical Sensitivity or Least Detectable Dose (LDD) of the assay is defined as the concentration at which the lowest concentration is distinguishable from zero with 95% confidence.
The average LDD is 0.09 ug/mL, supporting a claim of 0.2 ug/mL
Assay Range
Based on the Accuracy, Linearity, and Sensitivity (LDD) data, the package insert claim for the reportable range for the assay will be 0.2 to 8.0 µg/mL.
Method Comparison
A study was conducted according to NCCLS Guideline EP9: Method Comparison and Bias Estimation Using Patient Samples to compare accuracy of recovery of quinidine in serum assayed by the QMS® Quinidine assay to the Abbott TDx/TDxFLx® Quinidine assay.
Mean values for the TDx reference method were plotted against those for the QMS on Hitachi 717. The results using Passing - Bablok parameters are:
N = 50 Slope = 1.062 y-intercept = -0.213 R² = 0.978
Results show excellent correlation between the two assays.
3
Precision
A precision study was performed using the National Committee for Clinical Laboratory Standards (NCCLS) guideline EP5: Evaluation of Precision Performance of Clinical Chemistry Devices.
| Control | N | Mean
(µg/mL) | Within Run | | BETWEEN DAY | | Total | |
|---------|----|-----------------|------------|--------|-------------|--------|-------|--------|
| | | | SD | CV (%) | SD | CV (%) | SD | CV (%) |
| 1 | 80 | 1.02 | 0.06 | 5.83 | 0.01 | 1.53 | 0.09 | 9.09 |
| 2 | 80 | 3.17 | 0.08 | 2.45 | 0.00 | 0.00 | 0.20 | 6.37 |
| 3 | 80 | 5.18 | 0.08 | 1.62 | 0.00 | 0.00 | 0.30 | 5.83 |
Acceptance Criteria: