(42 days)
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.
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
Here's a summary of the acceptance criteria and study findings for the QMS® Vancomycin assay, based on the provided 510(k) summary:
Acceptance Criteria and Device Performance for QMS® Vancomycin Assay
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state pre-defined "acceptance criteria" with numerical thresholds for all tests. Instead, it presents study results and implies that the observed performance characteristics were deemed acceptable for substantial equivalence to the predicate device. For the purpose of this table, "Acceptance Criteria (Implied)" are derived from the overall goal of demonstrating equivalency or typical performance expectations for such assays, and "Reported Device Performance" are the results presented in the summary.
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Precision | Acceptable within-run, between-run, between-day, and total CVs for clinical use. | Low Control (7.57 µg/mL): Total CV 8.84% Mid Control (20.79 µg/mL): Total CV 6.21% High Control (33.65 µg/mL): Total CV 5.12% |
| Accuracy (Recovery) | Mean Percent Recovery close to 100% across the assay range (e.g., 90-110%). | Mean Percent Recovery: 99.61% (ranging from 91.11% to 110.61% across 9 theoretical concentrations from 5.00 to 100.00 µg/mL). |
| Linearity (Dilution) | Mean Percent Recovery close to 100% across the dilution range. | Mean Percent Recovery: 100.17% (ranging from 95.71% to 107.20% across 5 theoretical concentrations from 2.50 to 75.00 µg/mL). R2= 0.9998 (from scatter plot). |
| Sensitivity (LDD) | Least Detectable Dose (LDD) must support the claimed lower limit of detection. | LDD: 0.46 µg/mL, supporting a claim of 0.55 µg/mL. |
| Specificity (CDP-I) | Cross-reactivity with the vancomycin metabolite CDP-I should be low (e.g., <10%). | CDP-I Cross-reactivity: <5% at 100 µg/mL CDP-I in serum containing 25 µg/mL vancomycin. |
| Interferences (Endogenous) | Less than 10% error in vancomycin detection with common endogenous substances at specified concentrations. | All tested substances (Albumin, Bilirubin, Cholesterol, IgG, Hemoglobin, Heparin, Triglyceride, Rheumatoid Factor) resulted in less than 10% error at their respective tested concentrations (ranging from 91.64% to 100.07% recovery). |
| Interferences (HAMA) | HAMA interference should not lead to significantly falsely elevated results. The recovery for HAMA samples should be comparable to control samples. | HAMA Type-1: Mean % Recovery 105.31% vs. Control 26.85 µg/mL. HAMA Type-2: Mean % Recovery 103.91% vs. Control 28.55 µg/mL. (Implied acceptable level of non-interference). |
| Interferences (Co-Administered Drugs) | Cross-reactivity with common co-administered drugs should be very low (e.g., <1%). | All 44 listed co-administered drugs showed <0.3% cross-reactivity at 500 µg/mL in a vancomycin spiked serum pool at 25 µg/mL. |
| Interferences (Structurally Related Drug) | Cross-reactivity with structurally similar compounds like teicoplanin should be low. | Teicoplanin Cross-reactivity: 0.03% to 0.68% across concentrations of 10-100 µg/mL teicoplanin. |
| Method Comparison | Excellent correlation with a legally marketed predicate device (Abbott TDx® Vancomycin assay), demonstrating substantial equivalence. Slope-1, intercept-0, high R^2. | N=146 patient serum samples. Slope: 1.031 y-intercept: 1.115 R^2: 0.970 (Results considered to show "excellent correlation"). |
| On-Board Stability | Calibration curve and reagents should demonstrate adequate stability for practical use. | Calibration Curve Stability: 31 days supported by data. Reagent On-Board Stability: 62 days supported by data. |
2. Sample Sizes Used for the Test Set and Data Provenance
- Precision: 80 replicates for each of the three control levels (Low, Mid, High) over multiple runs and days.
- Accuracy: Triplicate measurements for 9 different theoretical concentrations.
- Linearity: Triplicate measurements for 5 different theoretical concentrations.
- Sensitivity: Determined using standard deviation of duplicate determinations of the zero calibrator and the 1st non-zero calibrator (Cal B, 5µg/mL).
- Specificity (CDP-I): Not explicitly stated, but implies a sufficient number of replicates to determine cross-reactivity percentage at a specified concentration.
- Interferences (Endogenous): Triplicate measurements for each of the 8 interfering substances tested.
- Interferences (HAMA): Triplicate measurements for HAMA Type-1, HAMA Type-2, and their respective controls.
- Interferences (Co-Administered Drugs): Not explicitly stated for each drug, but for all 44 drugs, measured at 500 µg/mL in a vancomycin spiked serum pool at 25 µg/mL, compared to a control serum.
- Interferences (Structurally Related Drug - Teicoplanin): Not explicitly stated, but implies sufficient measurements at 4 different teicoplanin concentrations.
- Method Comparison: 146 serum samples from patients.
Data Provenance: The document does not explicitly state the country of origin for any data or whether the studies were retrospective or prospective, beyond stating "human serum or plasma" for the intended use and "patient serum samples" for method comparison. Given the context of a 510(k) submission in the US, it's likely conducted or overseen in the US.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This device is an in-vitro diagnostic assay for measuring vancomycin concentration. The "ground truth" for the test set (e.g., actual vancomycin concentrations, absence/presence of interfering substances) would be established by the precise formulation of controls, calibrators, spiked samples, and highly accurate reference methods or laboratory standards, rather than expert human interpretation. For the method comparison study, the "ground truth" for the patient samples was established by the predicate device, the Abbott TDx® Vancomycin assay. Therefore, the concept of "experts establishing ground truth" in the typical sense of radiologists or pathologists is not directly applicable here.
4. Adjudication Method for the Test Set
Adjudication methods (like 2+1 or 3+1) are typically used in studies involving subjective interpretation of medical images or clinical data where human readers might disagree. For an in-vitro diagnostic device that provides quantitative measurements, the "adjudication" is inherent in the analytical methods used to establish reference values (e.g., highly pure reference materials, established laboratory protocols, or a predicate device). No human expert adjudication was involved in generating the values used as "ground truth" for the performance studies presented.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was mentioned. This type of study is designed to evaluate the impact of a new diagnostic tool on decisions or performance of human readers, typically in image interpretation. This is not relevant for a quantitative laboratory assay like QMS® Vancomycin, which provides a numerical output for drug concentration.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, the studies presented are all standalone performance evaluations of the QMS® Vancomycin assay. The device directly measures vancomycin concentration in a sample, and the performance characteristics (precision, accuracy, sensitivity, specificity, interference, method comparison) are assessed based solely on its own analytical output. There is no "human-in-the-loop" interaction in the immediate result generation for a quantitative assay of this nature.
7. Type of Ground Truth Used
The ground truth used for various studies includes:
- Precision: Defined concentrations of vancomycin in control materials.
- Accuracy (Recovery): Known theoretical concentrations of USP traceable vancomycin spiked into human serum.
- Linearity (Dilution): Known theoretical concentrations of vancomycin prepared by dilution.
- Sensitivity: Relies on the statistical properties of measurements of a zero calibrator and a known low-concentration calibrator (Cal B at 5 µg/mL).
- Specificity & Interferences: Known concentrations of vancomycin, the metabolite CDP-I, various endogenous substances, HAMA, co-administered drugs, and teicoplanin, either alone or spiked into vancomycin-containing serum.
- Method Comparison: Results obtained from the predicate device, the Abbott TDx® Vancomycin assay, used as the reference method for patient serum samples.
8. Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of device development. For an immunoassay like QMS® Vancomycin, the development typically involves extensive characterization of reagents, optimization of assay parameters, and formulation of calibrators and controls. This process would involve numerous experiments and data points before the final performance studies (summarized here) are conducted to demonstrate suitability for market clearance. The data provided focuses solely on the validation/test performance of the finalized device.
9. How the Ground Truth for the Training Set Was Established
As noted above, a formal "training set" as understood in machine learning (where an algorithm learns from data with established ground truth) is not directly applicable to the development of a homogeneous particle-enhanced turbidimetric immunoassay. Instead, the "ground truth" during development would be established through:
- Chemical and biological characterization of reagents: Ensuring the quality and specificity of antibodies and microparticles.
- Use of highly purified vancomycin standards (e.g., USP traceable): To prepare calibrators and to spike samples for recovery and linearity studies.
- Reference laboratory methods: Potentially used during early development to confirm the accuracy of initial assay designs or to validate the content of control materials.
- Industry standards and guidelines: Extensive experimentation guided by principles for developing accurate and precise quantitative immunoassays.
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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
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COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
| DeviceSeradyn QMS® Vancomycin | PredicateAbbott TDx®/TDxFLx® Vancomycin | |
|---|---|---|
| Intended Use | The QMS® Vancomycin assay is intendedfor the quantitative determination ofvancomycin in human serum or plasma onthe Hitachi 717 analyzer. | The TDx/TDxFLx Vancomycin assay is areagent system for the quantitativemeasurement of vancomycin, an antibioticdrug, in serum or plasma. |
| Indications forUse | The results obtained are used in thediagnosis and treatment of vancomycinoverdose and in monitoring levels ofvancomycin to ensure appropriatetherapy. | The measurements obtained are used in thediagnosis and treatment of vancomycinoverdose and in monitoring levels ofvancomycin to ensure appropriate therapy. |
| Methodology | Homogeneous particle-enhancedturbidimetric immunoassay (particleagglutination) | Fluorescence Polarization Immunoassay(FPIA) |
| ReagentComponents | Two (2) reagent system:• Anti-Vancomycin Antibody Reagent(R1) in buffers containing proteinstabilizers• Vancomycin-coated MicroparticleReagent (R2) in buffer containingsurfactant as stabilizers with sodiumazide | Three (3) Reagent System:• Vancomycin Antiserum in buffer withprotein stabilizers• Vancomycin Fluorescein Tracer in buffercontaining surfactants and proteinstabilizers with sodium azide• Pretreatment Solution. Surfactants inbuffer containing protein stabilizers withsodium 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 |
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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.
| THEORETICALCONC.(µG/ML) | Rep 1 | Rep 2 | Rep 3 | MeanRecoveredConc. | 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.
| THEORETICALCONC.$(µg/mL)$ | Rep 1 | Rep 2 | Rep 3 | MeanRecoveredConc. | 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.
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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 <5% cross-reactivity.
Interferences
Interference studies were conducted using NCCLS Guideline EP7-A: Interference Testing in Clinical Chemistry.
1) Endogenous Substances
The following compounds, when tested at the concentrations indicated, resulted in less than 10% error in detecting vancomycin. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| Interfering Substance | InterferentConcentration | N | Target(No Interferent)µg/mL | MeanRecoveryµg/mL | % Recovery |
|---|---|---|---|---|---|
| Albumin | 10 g/dL | 3 | 26.61 | 24.92 | 93.64 |
| Bilirubin | 70 mg/dL | 3 | 26.98 | 27.00 | 100.07 |
| Cholesterol | 500 mg/dL | 3 | 26.61 | 25.97 | 97.58 |
| IgG(Gamma Globulin) | 6 g/dL | 3 | 26.61 | 25.90 | 97.34 |
| Hemoglobin | 1150 mg/dL | 3 | 23.12 | 21.18 | 91.64 |
| Heparin | 500 units/mL | 3 | 26.61 | 26.46 | 99.44 |
| Triglyceride | 1000 mg/dL | 3 | 10.16 | 9.41 | 92.62 |
| RheumatoidFactor | 1100 IU/mL | 3 | 7.19 | 6.70 | 93.23 |
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2)
As with any assay employing mouse antibodies, the possibility exists for interference by human antimouse antibodies (HAMA) in the sample, which could cause falsely elevated results.
HAMA Type-1 and Type-2 samples were spiked to achieve 25 ug/mL vancomycin. The mean recovery for each (Type-1 and Type-2) of the triplicate HAMA samples was compared to the mean recovery of each respective Control (normal human serum). Representative results are shown below.
| Rep 1µg/mL | Rep 2µg/mL | Rep 3µg/mL | MeanRecoveryµg/mL | SD | CV | % Recovery | |
|---|---|---|---|---|---|---|---|
| HAMAType-1 | 29.45 | 28.51 | 26.86 | 28.27 | 1.31 | 4.63 | 105.31 |
| Control | 27.75 | 27.05 | 25.74 | 26.85 | 1.02 | 3.80 | |
| HAMAType-2 | 29.36 | 30.20 | 29.43 | 29.66 | 0.47 | 1.58 | 103.91 |
| Control | 29.67 | 28.13 | 27.84 | 28.55 | 0.98 | 3.43 |
Common Co-Administered Drugs 3)
Cross-reactivity was tested with drugs that are routinely administered with vancomycin. Testing also determined whether these compounds affect the quantitation of vancomycin concentrations. Crossreactants were analyzed at 500ug/mL in a vancomycin spiked serum pool at 25μg/mL. The samples were assayed and the vancomycin concentrations of the spiked samples were compared to a control serum. All of the following cross-reactants showed <0.3% cross-reactivity.
| Cross-Reactants | ||
|---|---|---|
| Acetaminophen | Ethambutol | Oxytetracycline |
| Amikacin | 5-Fluorocytosine | Penicillin G |
| Amphotericin B | Furosemide | Penicillin V |
| Ampicillin | Fusidic Acid | Phenacetin |
| Bendroflumethiazide | Gentamicin | Nitrofurantoin |
| Caffeine | Hydrochlorothiazide | Prednisolone |
| Carbenicillin | Ibuprofen | Prednisone |
| Cefamandole Nafate | Isoniazide | Rifampicin |
| Cefazolin | Kanamycin A | Salicyclic Acid |
| Cephalexin | Kanamycin B | Sisomycin |
| Cephalosporin C | Lincomycin | Spectinomycin |
| Cephalothin | Methotrexate | Sulfadiazine |
| Chloramphenicol | Methylprednisolone | Sulfamethoxazole |
| Chlorothiazide | Nalidixic Acid | Sulfisoxazole |
| Clindamycin | Naproxen | Tetracycline |
| Erythromycin | Neomycin Sulfate | Tobramycin |
| Ethacrynic Acid | Niacin | Trimethoprim |
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4) Structurally Related Drug
The cross-reactivity of the QMS® Vancomycin antibody to teicoplanin, a structurally similar compound, was examined. Teicoplanin was spiked into human serum containing 25μg/mL vancomvcin and tested in the QMS Vancomycin assay. Representative results are shown below.
% cross-reactivity = measured concentration of vancomycin_x 100 teicoplanin concentration
| Teicoplanin Concentration(µg/mL) | % Cross- Reactivity |
|---|---|
| 100 | 0.68 |
| 50 | 0.29 |
| 25 | 0.20 |
| 10 | 0.03 |
Method Comparison
A study was conducted according to NCCLS Guideline EP9-A: Method Comparison and Bias Estimation Using Patient Samples to compare accuracy of recovery of vancomycin in serum assayed by the QMSC Vancomycin assay to the Abbott TDx® Vancomycin assay.
Serum samples, ranging from 0.04 to 100 ug/mL vancomycin, were first tested using Abbott's TDx Vancomycin assay. The same samples were then tested by the QMS Vancomycin assay on Hitachi 717 analyzers using two reagent lots on two separate calibration curves.
Mean values for the TDx reference method were plotted against those for the QMS on Hitachi 717. The results using Passing-Bablok Linear Regression are:
N = 146 Slope = 1.031 y-intercept = 1.115 R2= 0.970
Results show excellent correlation between the two assays.
On-Board Stability
1) Calibration Curve stability
Calibration curve stability for a period of 31 days is supported by the data.
2) Reagent On-Board Stability
A 62 day on-board reagent stability claim is supported by the data.
CONCLUSION
As summarized above, the QMS® Vancomycin assay is substantially equivalent to the Abbott TDx 7TDxFLx Vancomycin assay. Substantial equivalence has been demonstrated through performance testing to verify that the device functions as intended and that design specifications have been satisfied.
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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes extending from its head, representing the department's commitment to health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR - 1 2005
Mr. Jack Rogers, MS, RAC Manger of Regulatory Affairs Seradyn, Inc. 7998 Georgetown Road Suite 1000 Indianapolis, IN 46268-5620
K050419 Re:
Trade/Device Name: QMS® Vancomycin Regulation Number: 21 CFR 862.3950 Regulation Name: Vancomycin test system Regulatory Class: Class II Product Code: LEH Dated: February 17, 2005 Received: February 18, 2005
Dear Mr. Rogers
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your everermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for assession to May 28, 1976, the enactment date of the Medical Device Amendments, or to conninered pror co rial 2011-12-11 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). and Cosmeter Act (110) that the device, subject to the general controls provisions of the Act. The 1 ou may, diererere, mains of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
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 it may be subject to Sach additions (CFR), Parts 800 to 895. In additions (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 t that FDA has made a determination that your device complies with other requirements of the Act that I DA has made a determinations administered by other Federal agencies. You must or any it caches and regulations and and and limited to: registration and listing (21 compry with and the rive (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2 -
This letter will allow you to begin marketing your device as described in your Section 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.
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 (240)276-0484. 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/industry/support/index.html
Sincerely yours,
Kim M. Cooper, MS, DUM
Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology 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): K050419
QMS® Vancomycin Device Name:
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.
X Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 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)
Alle to Gath
Division Sign-Off) Division of Clinical Laboratory Deviees 510(k) Number
Page 1 of
§ 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.