(42 days)
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No
The device description details a standard immunoassay based on chemical reactions and photometric measurement, with no mention of AI or ML algorithms for data analysis or interpretation. The performance studies focus on traditional analytical metrics like precision, accuracy, linearity, and specificity.
No
Explanation: This device is an in-vitro diagnostic assay used to quantify vancomycin levels in human serum or plasma. It is used in the diagnosis and monitoring of vancomycin levels to ensure appropriate therapy, not to directly treat a medical condition.
Yes.
The device is intended for the quantitative determination of vancomycin in human serum or plasma. The results are used in the diagnosis and treatment of vancomycin overdose and in monitoring levels of vancomycin to ensure appropriate therapy. This directly aligns with the definition of a diagnostic device as it provides information for diagnosis and treatment.
No
The device description clearly outlines a homogeneous particle-enhanced turbidimetric immunoassay involving chemical reagents (R1 and R2) and microparticles, which are physical components, not software. The assay is performed on a Hitachi 717 analyzer, which is a hardware device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states the assay is for the "quantitative determination of vancomycin in human serum or plasma." This indicates the analysis of biological samples in vitro (outside the body).
- Purpose: The results are used "in the diagnosis and treatment of vancomycin overdose and in monitoring levels of vancomycin to ensure appropriate therapy." This directly relates to providing information for medical diagnosis and treatment decisions.
- Device Description: The description details a laboratory-based immunoassay technique performed on a specific analyzer (Hitachi 717), which is characteristic of IVD devices.
- Performance Studies: The document includes various performance studies (Precision, Accuracy, Linearity, Sensitivity, Specificity, Interferences, Method Comparison) that are standard for evaluating the performance of IVD assays.
- Predicate Device: The mention of a predicate device (K813218; TDX® Vancomycin) which is also an IVD, further supports the classification of this device as an IVD.
All these elements align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The QMS® Vancomycin assay is intended for the quantitative determination of vancomycin in human serum or plasma on the Hitachi 717 analyzer.
The results obtained are used in the diagnosis and treatment of vancomycin overdose and in monitoring levels of vancomycin to ensure appropriate therapy.
Product codes (comma separated list FDA assigned to the subject device)
LEH
Device Description
The QMS® Vancomycin assay is a homogeneous particle-enhanced turbidimetric immunoassay. The assay is based on competition between drug in the sample and drug coated onto a microparticle for antibody binding sites of the vancomycin antibody reagent. The vancomycin-coated microparticle reagent is rapidly aqglutinated in the presence of the anti-vancomycin antibody reagent and in the absence of any competing drug in the sample. The rate of absorbance change is measured photometrically, and is directly proportional to the rate of agglutination of the particles. When a sample containing vancomycin is added, the agglutination reaction is partially inhibited, slowing down the rate of absorbance change. A concentrationdependent classic agglutination inhibition curve can be obtained, with maximum rate of agglutination at the lowest vancomycin concentration and the lowest agglutination rate at the highest vancomycin concentration.
The assay consists of reagents R1: vancomycin monoclonal and R2: vancomycin-coated microparticles.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Precision Study: A precision study was performed using the National Committee for Clinical Laboratory Standards (NCCLS) guideline EP5-A: Evaluation of Precision Performance of Clinical Chemistry Devices. Representative results are shown below.
Low Control (N=80): Mean 7.57, SD 0.27 (Within Run), 0.43 (Between Run), 0.43 (Between Day), 0.70 (Total); CV(%) 3.59 (Within Run), 5.70 (Between Run), 5.72 (Between Day), 8.84 (Total).
Mid Control (N=80): Mean 20.79, SD 0.51 (Within Run), 0.69 (Between Run), 0.97 (Between Day), 1.29 (Total); CV(%) 2.44 (Within Run), 3.30 (Between Run), 4.66 (Between Day), 6.21 (Total).
High Control (N=80): Mean 33.65, SD 0.80 (Within Run), 1.19 (Between Run), 0.95 (Between Day), 1.72 (Total); CV(%) 2.37 (Within Run), 3.54 (Between Run), 2.83 (Between Day), 5.12 (Total).
Accuracy by Recovery: Determined by spiking USP traceable vancomycin into human serum negative. The samples were analyzed in triplicate with the QMS Vancomycin assay. Mean Percent Recovery was 99.61%.
Linearity by Dilution: Determined by a study based on the NCCLS guideline EP6-A: Evaluation of the Linearity of Quantitative Measurement. Mean Percent Recovery was 100.17%. Relationship between recovered vancomycin and midpoints shows a linear relationship (y = 1.0115x - 0.3769, R-squared = 0.9998).
Sensitivity: The Analytical Sensitivity or Least Detectable Dose (LDD) was determined to be 0.46 ug/mL, supporting a claim of 0.55 µg/mL.
Specificity: Percent cross-reactivity with CDP-I (metabolite) was tested at 100 µg/mL in serum containing 25 µg/mL vancomycin and was determined according to NCCLS guidance EP7-A. Results show that CDP-1 has
§ 862.3950 Vancomycin test system.
(a)
Identification. A vancomycin test system is a device intended to measure vancomycin, an antibiotic drug, in serum. Measurements obtained by this device are used in the diagnosis and treatment of vancomycin overdose and in monitoring the level of vancomycin to ensure appropriate therapy.(b)
Classification. Class II.
0
APR - 1 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: K051
er is: KD50419
COMPANY/CONTACT PERSON
Seradyn, Inc 7998 Georgetown Road, Suite 1000 Indianapolis, IN 46268
Establishment registration No: 1836010
Jack Rogers Manager of Regulatory Affairs Telephone: (317) 610-3823 Fax: (317) 610-0018
DATE PREPARED
February 17, 2005
DEVICE NAME
| Trade Name: | QMS® Vancomycin |
|---|---|
| Common Name: | Vancomycin Test System |
| Device Classification: | 21 CFR 862.3950; Class I |
INTENDED USE
The QMS® Vancomycin assay is intended for the quantitative determination of vancomycin in human serum or plasma on the Hitachi 717 analyzer.
The results obtained are used in the diagnosis and treatment of vancomycin overdose and in monitoring levels of vancomycin to ensure appropriate therapy.
LEGALLY MARKETED DEVICE TO WHICH EQUIVALENCY IS CLAIMED
TDX® Vancomycin (K813218)
DESCRIPTION OF DEVICE
The QMS® Vancomycin assay is a homogeneous particle-enhanced turbidimetric immunoassay. The assay is based on competition between drug in the sample and drug coated onto a microparticle for antibody binding sites of the vancomycin antibody reagent. The vancomycin-coated microparticle reagent is rapidly aqglutinated in the presence of the anti-vancomycin antibody reagent and in the absence of any competing drug in the sample. The rate of absorbance change is measured photometrically, and is directly proportional to the rate of agglutination of the particles. When a sample containing vancomycin is added, the agglutination reaction is partially inhibited, slowing down the rate of absorbance change. A concentrationdependent classic agglutination inhibition curve can be obtained, with maximum rate of agglutination at the lowest vancomycin concentration and the lowest agglutination rate at the highest vancomycin concentration.
The assay consists of reagents R1: vancomycin monoclonal and R2: vancomycin-coated
microparticles. A six-level set of QMS® Vancomycin Calibrators (A through F) i
1
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
| | Device
Seradyn QMS® Vancomycin | Predicate
Abbott TDx®/TDxFLx® Vancomycin |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The QMS® Vancomycin assay is intended
for the quantitative determination of
vancomycin in human serum or plasma on
the Hitachi 717 analyzer. | The TDx/TDxFLx Vancomycin assay is a
reagent system for the quantitative
measurement of vancomycin, an antibiotic
drug, in serum or plasma. |
| Indications for
Use | The results obtained are used in the
diagnosis and treatment of vancomycin
overdose and in monitoring levels of
vancomycin to ensure appropriate
therapy. | The measurements obtained are used in the
diagnosis and treatment of vancomycin
overdose and in monitoring levels of
vancomycin to ensure appropriate therapy. |
| Methodology | Homogeneous particle-enhanced
turbidimetric immunoassay (particle
agglutination) | Fluorescence Polarization Immunoassay
(FPIA) |
| Reagent
Components | Two (2) reagent system:
• Anti-Vancomycin Antibody Reagent
(R1) in buffers containing protein
stabilizers
• Vancomycin-coated Microparticle
Reagent (R2) in buffer containing
surfactant as stabilizers with sodium
azide | Three (3) Reagent System:
• Vancomycin Antiserum in buffer with
protein stabilizers
• Vancomycin Fluorescein Tracer in buffer
containing surfactants and protein
stabilizers with sodium azide
• Pretreatment Solution. Surfactants in
buffer containing protein stabilizers with
sodium azide |
| Calibration | Seradyn QMS Vancomycin Calibrators -
six levels | TDx/TDxFLx Vancomycin Calibrators -
six levels |
| Assay Range | 0 - 100 µg/mL | 0 - 100 µg/mL |
SUMMARY OF CLINICAL TESTING
Precision
A precision study was performed using the National Committee for Clinical Laboratory Standards (NCCLS) guideline EP5-A: Evaluation of Precision Performance of Clinical Chemistry Devices. Representative results are shown below.
| Within Run | Between Run | BETWEEN DAY | Total | |||||||
|---|---|---|---|---|---|---|---|---|---|---|
| N | Mean | SD | CV (%) | SD | CV (%) | SD | CV (%) | SD | CV (%) | |
| Low Control | 80 | 7.57 | 0.27 | 3.59 | 0.43 | 5.70 | 0.43 | 5.72 | 0.70 | 8.84 |
| Mid Control | 80 | 20.79 | 0.51 | 2.44 | 0.69 | 3.30 | 0.97 | 4.66 | 1.29 | 6.21 |
| High Control | 80 | 33.65 | 0.80 | 2.37 | 1.19 | 3.54 | 0.95 | 2.83 | 1.72 | 5.12 |
2
Accuracy
Accuracy by Recovery was determined by spiking USP traceable vancomycin into human serum negative Accuration of Roovery was accomments on say range. The samples were analyzed in triplicate with the QMS Vancomycin assay. Representative results are shown below.
| THEORETICAL
CONC.
(µG/ML) | Rep 1 | Rep 2 | Rep 3 | Mean
Recovered
Conc. | SD | CV | % Recovery |
|---------------------------------|-------|-------|-------|----------------------------|------|------|------------|
| 100.00 | 93.50 | 95.68 | 95.87 | 95.02 | 1.32 | 1.39 | 95.02 |
| 75.00 | 73.82 | 76.14 | 69.76 | 73.24 | 3.23 | 4.41 | 97.65 |
| 50.00 | 52.45 | 50.66 | 53.64 | 52.25 | 1.50 | 2.87 | 104.50 |
| 37.50 | 42.15 | 38.36 | 38.60 | 39.70 | 2.12 | 5.35 | 105.88 |
| 25.00 | 27.30 | 28.71 | 26.95 | 27.65 | 0.93 | 3.37 | 110.61 |
| 17.50 | 16.53 | 18.45 | 17.36 | 17.45 | 0.96 | 5.52 | 99.70 |
| 10.00 | 9.20 | 9.39 | 9.22 | 9.27 | 0.10 | 1.13 | 92.70 |
| 7.50 | 6.79 | 6.93 | 6.78 | 6.83 | 0.08 | 1.23 | 91.11 |
| 5.00 | 5.11 | 4.89 | 4.90 | 4.97 | 0.12 | 2.50 | 99.33 |
| Mean Percent Recovery | | | | | | | 99.61 |
Linearity
Linearity by Dilution was determined by a study based on the NCCLS guideline EP6-A: Evaluation of the Linearity of Quantitative Measurement. Representative results are shown below.
| THEORETICAL
CONC.
$(µg/mL)$ | Rep 1 | Rep 2 | Rep 3 | Mean
Recovered
Conc. | SD | CV | % Recovery |
|-----------------------------------|-----------------------|-------|-------|----------------------------|------|------|------------|
| 75.00 | 76.68 | 74.77 | 75.85 | 75.77 | 0.96 | 1.26 | 101.02 |
| 37.50 | 37.45 | 36.86 | 37.30 | 37.20 | 0.31 | 0.82 | 99.21 |
| 17.50 | 17.03 | 16.54 | 16.68 | 16.75 | 0.25 | 1.51 | 95.71 |
| 7.50 | 7.37 | 7.36 | 7.25 | 7.33 | 0.07 | 0.91 | 97.69 |
| 2.50 | 3.15 | 2.64 | 2.72 | 2.68 | 0.06 | 2.11 | 107.20 |
| | Mean Percent Recovery | | | | | | 100.17 |
Image /page/2/Figure/6 description: This image is a scatter plot that shows the relationship between recovered vancomycin and midpoints. The x-axis represents midpoints in ug/mL, and the y-axis represents recovered vancomycin in ug/mL. The plot shows a linear relationship between the two variables, with the equation of the line being y = 1.0115x - 0.3769 and an R-squared value of 0.9998.
3
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 LDD was calculated using the following formula:
$$\begin{array}{rcl} \texttt{LLD} & = & \underline{\texttt{Z} \times \langle \texttt{SD} ,\texttt{mAbs} ,\texttt{of},\texttt{Zero},\texttt{Cal}\rangle} ; \texttt{} \end{array}$$
Where:
- . Zero Cal = Cal A (0ug/mL)
- . SD Zero Cal = standard deviation of the duplicate determinations
- 15t Non-Zero Cal = Cal B (5ug/mL) .
The LDD was determined to be 0.46 ug/mL, supporting a claim of 0.55 µg/mL.
Specificity
In vivo, vancomycin degrades to its metabolite CDP-I (crystalline degradation product-1).
Percent cross-reactivity was tested with the metobolite at 100 µg/mL in serum containing 25 µg/mL vancomycin and was determined according to NCCLS guidance EP7-A: Interference Testing in Clinical Chemistry.
Results show that CDP-1 has