(81 days)
Not Found
No
The device description details a standard immunoassay technology based on spectrophotometric measurement of agglutination, which is a well-established chemical/biological process and does not involve AI or ML. The analysis of the results is based on a pre-defined calibration curve, not a learned model.
No.
This device is an in-vitro diagnostic assay used for quantitating valproic acid levels, which aids in monitoring drug concentrations but does not directly treat a condition.
Yes
The device quantifies valproic acid levels in human samples, and the results are used by physicians to aid in adjusting patient dosage and achieving optimal therapeutic effect, which is a diagnostic purpose.
No
The device description clearly outlines physical reagent components (microparticle reagent, antibody reagent) and relies on a specific hardware system (Abbott AEROSET® System) to perform the assay. It is a laboratory assay kit, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is "used for the quantitation of valproic acid in human serum or plasma". This involves testing biological samples (serum or plasma) in vitro (outside the body) to provide information about a patient's health status (valproic acid levels).
- Device Description: The description details a "homogeneous Particle Enhanced Turbidimetric Immunoassay" that uses reagents to measure a substance in a biological sample. This is a common method used in IVD devices.
- Performance Studies: The document describes various performance studies (Specificity, Accuracy, Sensitivity, Precision, Method Comparison, Interfering Substances) which are standard evaluations for IVD devices to demonstrate their analytical performance.
- Predicate Device: The mention of a "Predicate Device" (K941615; Abbott AxSYM® Valproic Acid) is a strong indicator that this device is being submitted for regulatory clearance as an IVD, as predicate devices are used for comparison in the regulatory process for IVDs.
N/A
Intended Use / Indications for Use
The SERADYN QMS™ / MULTIGENT™ VALPROIC ACID assay is used for the quantitation of valproic acid in human serum or plasma on the Abbott AEROSET® System.
Valproic acid (VPA; 2-propylpentanoic acid; Depakene®) is a broad-spectrum anticonvulsant drug used solely or in combination with other anticonvulsant drugs for the treatment of absence seizures. It also has demonstrated effectiveness in the management of generalized tonic-clonic and myoclonic seizures, as well as atypical absence, simple and complex partial and mixed grand mal and petit mal seizures. The capability of treating many types of seizures with a single anticonvulsant has resulted in the wide-spread use of valproic acid, particularly in . children in whom tonic-clonic and myoclonic seizures are most prevalent. Valproic acid has proven effective in the treatment of many patients otherwise refractory to other anticonvulsant treatments. Most patients receiving valproic acid do not develop a tolerance to its anticonvulsant effects.
Monitoring serum valproic acid levels combined with other clinical data can provide the physician with useful information to aid in adjusting patient dosage and achieving optimal therapeutic effect while avoiding useless sub-therapeutic or harmful toxic dosage levels.
Product codes
LEG, JIS
Device Description
The Seradyn QMS™ / MULTIGENT™ Valproic Acid Assay is a homogeneous Particle Enhanced Turbidimetric Immunoassay used for the quantitation of valproic acid in serum or plasma. The assay is intended for use on the Abbott AEROSET® System, using the Seradyn QMS™ / MULTIGENT™ Valproic Acid Calibrators.
The reagent system components are 1) Valproic acid coated microparticle reagent, and 2) the antibody reagent which consists of a mouse monoclonal antibody specific for valproic acid.
The technology is based on competition between the valproic acid in the sample and valproic acid coated onto the microparticles, for the antibody-binding sites of the anti-Valproic Acid antibody reagent. In the absence of valproic acid in the sample, the specific antibody in the antibody reagent binds the valoroic acid on the particle, and results in rapid agglutination of the microparticles. In the presence of valproic acid in the sample, the valproic acid in the sample competes for antibody binding sites of the specific antibody in the antibody reagent, and partially inhibits the agglutination of the microparticles. The rate of agglutination (turbidity) is directly proportional to the rate in absorbance change of incident light and is measured spectrophotometrically by the Abbott AEROSET® System at a wavelength of 604 nm.
A six level Seradyn QMS™ / MULTIGENT™ Valproic Acid Calibrator set, with known valproic acid concentrations is used to quantitate the assay. An internal concentrationdependent calibration curve is generated by the AEROSET® System, by measuring the rate of absorbance change of each calibrator level. Maximum absorbance rate is at the lowest valproic acid concentration and the lowest absorbance rate at the highest valproic acid concentration.
By monitoring the change in rate of a specimen with unknown valproic acid concentration, and comparing to the internal calibration curve, a sample's concentration can readily be obtained and reported as valproic acid concentration in either ug/mL or umol/L.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
particularly in children
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Specificity:
Cross-reactivity was tested for minor Valproic Acid active metabolites: 3-keto-valproic acid, 2-N-Propylglutaric Acid, 2-N-Propyl-4-pentenoic Acid, and 2-Ethyl-2-phenylmalonamide, as well as structurally related or potentially co-administered compounds: Carbamazepine, Ethosuximide, Phenobarbital, Phenytoin, Carbamazepine-10,11-epoxide, Primidone, and Salicylate. Each substance was tested at 10 times the highest concentration for its therapeutic or normal range, spiked at a volume not exceeding 1% of the total volume of serum. Control sera and spiked samples were assayed in triplicate using the Seradyn QMS™ / MULTIGENT™ Valproic Acid assay on the AEROSET®.
Accuracy by Recovery:
Accuracy by analyte spike recovery was determined by adding a concentrated valproic acid solution to human serum at three different concentrations (144.51 µg/mL, 72.25 µg/mL, 36.13 µg/mL). Percent recoveries were calculated.
Results: 100% (144.51 µg/mL), 102.6% (72.25 µg/mL), 104.7% (36.13 µg/mL). Acceptable Recovery: 100 ± 10% of theoretical value.
Sensitivity:
The least detectable dose is 3.0 ug/mL (20.79 umol/L).
Accuracy & Linearity by Dilution:
Accuracy and linearity were determined using NCCLS proposed guideline EP6-P. A 150.0 µg/mL VPA Calibrator was diluted at 80%, 60%, 20%, 10%, and 2.5% with 0.0 ug/mL Valproic Acid Calibrator. The diluted samples and the 150.0 µg/mL calibrator were analyzed in duplicate on the AEROSET®.
Results: Percent recovery ranged from 95.5% to 109.3%. Acceptable Recovery: 100 ± 10% of theoretical value.
Linearity was assessed by linear regression analysis: y = 0.9569x +1.688; R = 0.999.
Precision:
Precision was determined using NCCLS protocol EP5. A tri-level human serum based commercial control containing valproic acid was assayed in duplicate twice a day for twenty days (sample size 80 for each level).
Results:
Sample 1 (mean 32.81 µg/mL): Total SD 0.626, CV 1.91%
Sample 2 (mean 70.56 µg/mL): Total SD 0.987, CV 1.40%
Sample 3 (mean 116.40 µg/mL): Total SD 3.124, CV 2.68%
Method Comparison:
Correlation Studies were performed using NCCLS Protocol EP9-A comparing the Seradyn QMS™ MULTIGENT™ Valproic Acid assay on the AEROSET® with the Abbott VPA assay on the AxSYM®. Clinical specimens ranged from 14.65 ug/mL to 131.03 ug/mL (sample size 53).
Results: y-intercept = 3.58, Slope = 0.955, Correlation Coefficient = 0.986.
Interfering Substances:
Interference studies were conducted using NCCLS protocol EP7-P as a guideline document. Abnormal bilirubin, hemoglobin, and lipid levels were prepared by spiking human serum containing approximately 100 ug/mL of valproic acid. Specimens with and without interferents were assayed.
Results:
Bilirubin (20 mg/dL): Mean Recovery 87.98 µg/mL, 99.5% of Target.
Hemoglobin (1,000 mg/dL): Mean Recovery 91.58 µg/mL, 100% of Target.
Intralipid (2,000 mg/dL): Mean Recovery 90.64 µg/mL, 99% of Target.
Acceptance criteria: recoveries of 100 ±10%.
HAMA Interference:
Normal human serum pool (control), and HAMA type 1 and HAMA type 2 samples were spiked with the same amounts of valproic acid. Assayed in duplicate.
Results:
Control: Mean 98.24, 100% Recovery.
HAMA 1: Mean 90.96, 93% Recovery.
HAMA 2: Mean 94.20, 96% Recovery.
Acceptance criteria: recovery of 100 ±10%.
Reagent Stability Data:
Instrument on-board stability (uncapped reagents) demonstrated acceptable data for a claim of 54 days.
Instrument Calibration Stability:
Instrument calibration stability study demonstrated acceptable data for a claim of 27 days.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: The least detectable dose, defined as the lowest valproic acid concentration that can be distinguished from zero with 95% confidence, is 3.0 ug/mL (20.79 umol/L).
Accuracy by Recovery: % Recovery = ("mean recovered concentration" divided by "theoretical concentration") x 100. Range: 100% - 104.7%.
Accuracy & Linearity by Dilution: % Recovery = ("mean recovered concentration" divided by "theoretical concentration") x 100. Range: 95.5% - 109.3%. Linear regression: R = 0.999.
Precision: Total %CV values for 3 levels: 1.91%, 1.40%, 2.68%.
Method Comparison: Correlation Coefficient = 0.986.
Interfering Substances: Observed (% of Target) ranged from 99% to 100%.
HAMA Interference: % Recovery ranged from 93% to 96%.
Predicate Device(s)
Abbott AxSYM® Valproic Acid cleared under K941615.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3645 Neuroleptic drugs radioreceptor assay test system.
(a)
Identification. A neuroleptic drugs radioceptor assay test system is a device intended to measure in serum or plasma the dopamine receptor blocking activity of neuroleptic drugs and their active metabolites. A neuroleptic drug has anti-psychotic action affecting principally psychomotor activity, is generally without hypnotic effects, and is a tranquilizer. Measurements obtained by this device are used to aid in determining whether a patient is taking the prescribed dosage level of such drugs.(b)
Classification. Class II.
0
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: KO3040 S
- Company/contact person:
Seradyn. Inc. 7998 Georgetown Road, Suite 1000 Indianapolis, IN 46268
Establishment registration No: 1836010
Les Padilla Senior Scientist Manager of Manufacturing Support Telephone: (317) 610-3823 Fax: (317) 610-0018 e-mail: lpadilla@seradyn.com
2. Prepared:
February 4, 2003
3. Device Name:
| a. Proprietary Name: | QMS TM / MULTIGENT TM Valproic Acid on the Abbott
AEROSET ® System |
|-------------------------|-------------------------------------------------------------------------------------|
| b. Common Name: | Valproic Acid Particle Enhanced Immunoturbidmetric Assay |
| c. Classification Name: | 862.3645 Enzyme Immunoassay, Valproic Acid |
4. Legally marketed devices to which equivalency is claimed:
Seradyn QMS™ / MULTIGENT™ Valproic Acid on the Abbott AEROSET® System is substantially equivalent to the Abbott AxSYM® Valproic Acid cleared under K941615.
5. Description of Device:
The Seradyn QMS™ / MULTIGENT™ Valproic Acid Assay is a homogeneous Particle Enhanced Turbidimetric Immunoassay used for the quantitation of valproic acid in serum or plasma. The assay is intended for use on the Abbott AEROSET® System, using the Seradyn QMS™ / MULTIGENT™ Valproic Acid Calibrators.
1
The reagent system components are 1) Valproic acid coated microparticle reagent, and 2) the antibody reagent which consists of a mouse monoclonal antibody specific for valproic acid.
The technology is based on competition between the valproic acid in the sample and valproic acid coated onto the microparticles, for the antibody-binding sites of the anti-Valproic Acid antibody reagent. In the absence of valproic acid in the sample, the specific antibody in the antibody reagent binds the valoroic acid on the particle, and results in rapid agglutination of the microparticles. In the presence of valproic acid in the sample, the valproic acid in the sample competes for antibody binding sites of the specific antibody in the antibody reagent, and partially inhibits the agglutination of the microparticles. The rate of agglutination (turbidity) is directly proportional to the rate in absorbance change of incident light and is measured spectrophotometrically by the Abbott AEROSET® System at a wavelength of 604 nm.
A six level Seradyn QMS™ / MULTIGENT™ Valproic Acid Calibrator set, with known valproic acid concentrations is used to quantitate the assay. An internal concentrationdependent calibration curve is generated by the AEROSET® System, by measuring the rate of absorbance change of each calibrator level. Maximum absorbance rate is at the lowest valproic acid concentration and the lowest absorbance rate at the highest valproic acid concentration.
By monitoring the change in rate of a specimen with unknown valproic acid concentration, and comparing to the internal calibration curve, a sample's concentration can readily be obtained and reported as valproic acid concentration in either ug/mL or umol/L.
6. Intended Use:
The SERADYN QMS™ / MULTIGENT ™ VALPROIC ACID assay is used for the quantitation of valproic acid in human serum or plasma.
| Device Name | ||
|---|---|---|
| QMS TM / MULTIGENTTM Valproic Acid | Abbott AxSYM® Valproic Acid | |
| Indications | ||
| for Use | The Seradyn QMSTM / MULTIGENTTM Valproic | |
| Acid assay is used for the quantitation of valproic | ||
| acid in human serum or plasma on the Abbott | ||
| AEROSET® System. | ||
| Valproic acid is a broad-spectrum anticonvulsant | ||
| drug used solely or in combination with other | ||
| anticonvulsant drugs for the treatment of absence | ||
| seizures. It also has demonstrated effectiveness in | ||
| the management of generalized tonic-clonic and | ||
| myoclonic seizures, as well as atypical absence, | ||
| simple and complex partial and mixed grand mal | ||
| and petit mal seizures. The capability of treating | The AxSYM® Valproic Acid assay is a | |
| reagent for the quantitative measurement of | ||
| valproic acid, an anticonvulsant drug, in | ||
| serum or plasma. The measurements | ||
| obtained are used in monitoring levels of | ||
| valproic acid to ensure appropriate therapy. |
7. Comparison of Technological Characteristics:
2
100 - 100 - 100 -
| | many types of seizures with a single
anticonvulsant has resulted in the wide-spread use
of valproic acid, particularly in children in whom
tonic-clonic and myclonic seizures are most
prevalent. | |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Reagent
Components | Two (2) reagent system
• Anti-Valproic Acid Antibody reagent (R1)
• Valproic Acid coated Microparticle reagent
(R2) | Three (3) reagent system
• Valproic Acid Antiserum in phosphate
buffer with protein stabilizers.
• Pretreatment Solution, surfactant in tris
buffer.
• Valproic Acid Fluorescein Tracer in Tris
buffer containing surfactant. |
| Calibration | Seradyn QMSTM / MULTIGENTTM Valproic Acid
Calibrators - Six levels | AxSYM® Valproic Acid Calibrators - Six
levels |
| Assay Range | 3.0 to 150.0 µg/mL
(20.8 to 1039 µmol/L) | 0.70 – 150.0 µg/mL
(4.85 to 1039 µmol/L) |
| Method
Principles | The Seradyn QMSTM / MULTIGENTTM Valproic
Acid Assay is a homogeneous, competitive
binding, Particle Enhanced Turbidimetric
Immunoassay based on the principle of
spectrophotometrically measuring turbidity and
changes in absorbed light, which result when
activated microspheres agglutinate. | The AxSYM® Valproic Acid assay utilizes
Fluorescence Polarization Immunoassay
(FPIA) technology. |
and the state of the states of the states of the states of the states of the states of the states and
.
:
:
3
8. Summary of Non-clinical Testing:
NONE
9. Summary of Clinical Testing:
The results of the clinical testing (Performance Characteristics) of the Seradyn QMS 100 / MULTIGENT™ Valproic Acid assay were compared to results of the studies reported in the Abbott AxSYM® Valproic Acid Package Insert.
A. Specificity
Cross-reactivity was tested for the minor Valproic Acid active metabolites: 2-ethyl-2phenylmalonamide, 2-N-propylglutaric acid and 2-N-propyl-4-pentenoic acid. In the same study, structurally related or potentially co-administered compounds were also tested using Seradyn QMSTM / MULTIGENT™ Valproic Acid reagents. Each substance was tested at 10 times the highest concentration for its therapeutic or normal range. The cross contaminants were spiked at a volume not exceeding 1% of the total volume of serum. The control sera and spiked samples were assayed in triplicate using the Seradyn QMS™ / MULTIGENT™ Valproic Acid assay on the AEROSET®. The means of the duplicate determinations were determined and used to calculate the percent cross-reactivity using the following formula:
(Equivalent VPA conc of spiked sample - VPA conc of sample without cross reactant) X 100 Conc of cross reactant
| | Conc. of
Cross-
Reactant
Spiked
(µg/mL) | Equivalent
VPA Conc. of
spiked
sample
(µg/mL) | Conc of
Serum
without
Cross-
reactant
(µg/mL) | Observed
Recovery
(ug/mL) | % Cross-
Reactivity |
|-----------------------------|-----------------------------------------------------|-----------------------------------------------------------|--------------------------------------------------------------|---------------------------------|------------------------|
| Substance | | | | | |
| 3-keto-valproic acid | 16.67 | 93.66 | 92.86 | 0.80 | 4.80% |
| 2-N-Propylglutaric Acid | 100 | 101.98 | 95.35 | 6.63 | 6.63% |
| 2-N-Propyl-4-pentenoic Acid | 100 | 126.48 | 95.35 | 31.13 | 31.13% |
| 2-Ethyl-2-phenylmalonamide | 100 | 94.72 | 95.35 | -0.63 | -0.63% |
| Carbamazepine | 140 | 94.27 | 95.35 | -1.08 | -0.77% |
| Ethosuximide | 1000 | 95.96 | 95.35 | 0.61 | 0.06% |
| Phenobarbital | 400 | 98.40 | 95.35 | 3.05 | 0.76% |
| Phenytoin | 200 | 95.79 | 95.35 | 0.44 | 0.22% |
| Carbamazepine-10,11-epoxide | 140 | 94.78 | 95.35 | -0.57 | -0.41% |
| Primidone | 120 | 95.11 | 95.35 | -0.24 | -0.20% |
| Salicylate | 100 | 93.86 | 95.35 | -1.49 | -1.49% |
Cross Reactivity Results (Refer to Table 1 of Attached Data):
4
B. Accuracy by Recovery
Accuracy by analyte spike recovery was determined by adding a concentrated valproic acid solution to human serum at three different concentrations. Percent recoveries for each level were calculated using the following formula:
% Recovery = ("mean recovered concentration" divided by "theoretical concentration") x 100
Data summary are shown below.
| % Analyte
Added | Added
(Theoretical)
Concentration
(µg/mL) | Mean
Recovered
Concentration
(µg/mL) | Percent (%)
Recovery |
|--------------------|----------------------------------------------------|-----------------------------------------------|-------------------------|
| 100% | 144.51 | 144.51 | 100% |
| 50% | 72.25 | 74.15 | 102.6% |
| 25% | 36.13 | 37.83 | 104.7% |
Acceptable Recovery: 100 ± 10% of theoretical value
The Abbott AxSYM® package insert reports accuracy by recovery throughout of the whole therapeutic range.
C. Sensitivity
The least detectable dose, defined as the lowest valproic acid concentration that can be distinguished from zero with 95% confidence, is 3.0 ug/mL ( 20.79 umol/L).
The Abbott AxSYM® assay reports a lower detection limit of 0.70 µg/mL (4.85 µmol/L).
D. Accuracy & Linearity bv Dilution
Accuracy and linearity by dilution was determined using a procedure described in the National Committee for Clinical Laboratory Standards (NCCLS) proposed guideline EP6-P. A 150.0 µg/mL VPA Calibrator (different from the material used to calibrate the instrument) was diluted with the 0.0 ug/mL Valproic Acid Calibrator at 80%, 60%, 20%, 10% and 2.5%. The diluted samples, as well as the 150.0 µg/mL calibrator were analyzed in duplicate on the AEROSET® using the Seradyn OMS™ MULTIGENT™ Valproic Acid assay. A mean of the duplicates for each sample was determined. Percent recoveries for each level were calculated using the following formula:
% Recovery = ("mean recovered concentration" divided by "theoretical concentration") x 100
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| Dilution | Theoretical
Concentration
(µg/mL) | Mean Recovered
Concentration
(µg/mL) | Percent (%)
Recovery |
|----------|-----------------------------------------|--------------------------------------------|-------------------------|
| Neat | 150 | 145.14 | 96.8% |
| 80% | 120 | 114.62 | 95.5% |
| 60% | 90 | 89.29 | 99.2% |
| 40% | 60 | 60.13 | 100.2% |
| 20% | 30 | 32.78 | 109.3% |
| 10% | 15 | 14.70 | 98.0% |
| 2.5% | 3.75 | 3.71 | 98.9% |
Representative data are shown below.
Acceptable Recovery: 100 ± 10% of theoretical value.
Linearity was assessed by performing linear regression analysis using the least squares method. The expected values were plotted on the x-axis against the observed values on the y-axis. Linear regression statistics yielded: y = 0.9569x +1.688; R = 0.999
The Abbott AxSYM® package insert reports on accuracy and linearity by dilution.
E. Precision
Precision was determined as described in the National Committee for Clinical Laboratory Standards (NCCLS) protocol EP5 (including an additional estimate of between day precision). A tri-level human serum based commercial control containing valproic acid was assayed in duplicate twice a day for twenty days. The between run, within run, and total SD and %CVs were calculated.
The following are representative results from pooled data:
| Mean | Within Run | Between Day | Run to Run | Total | ||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Sample | n | µg/mL | SD | CV(%) | SD | CV(%) | SD | CV(%) | SD | CV(%) |
| 1 | 80 | 32.81 | 0.360 | 1.10% | 0.512 | 1.56% | 0.000 | 0.00% | 0.626 | 1.91% |
| 2 | 80 | 70.56 | 0.729 | 1.03% | 0.637 | 0.90% | 0.189 | 0.27% | 0.987 | 1.40% |
| 3 | 80 | 116.40 | 2.214 | 1.90% | 1.598 | 1.37% | 1.518 | 1.30% | 3.124 | 2.68% |
The Abbott AxSYM® assay reports the following imprecision, using an internal protocol, run to run was not reported:
| Mean | Within Run | Between Day | Total Run | |||||
|---|---|---|---|---|---|---|---|---|
| Sample | n | (µg/mL) | SD | CV(%) | SD | CV(%) | SD | CV(%) |
| 1 | 80 | 38.82 | 1.32 | 3.4% | 0.56 | 1.4% | 1.56 | 4.0% |
| 2 | 80 | 78.27 | 3.23 | 4.1% | 0.40 | 0.5% | 3.20 | 4.1% |
| 3 | 80 | 127.34 | 4.44 | 3.5% | 2.75 | 2.2% | 5.93 | 4.7% |
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F. Method Comparison
Correlation Studies were performed using NCCLS Protocol EP9-A. Results from the Seradyn QMS™ MULTIGENT™ Valproic Acid assay on the AEROSET® System were compared to the Abbott VPA assay on the AxSYM®. The clinical specimens ranged from 14.65 ug/mL (101.5 umol/L) to 131.03 ug/mL (908.0 umol/L) by the Seradyn QMS™ / MULTIGENT™ Valproic Acid method. Results of the specimen testing are shown below.
| AxSYM® | |
|---|---|
| y-intercept | 3.58 |
| Slope | 0.955 |
| Correlation Coefficient | 0.986 |
| Number of samples | 53 |
G. Interfering Substances
Interference studies were conducted using NCCLS protocol EP7-P as a guideline document.
Abnormal bilirubin levels were prepared by using a human serum pool containing approximately 100 ug/mL of valproic acid and spiking with bilirubin. Abnormal hemoglobin levels were prepared by addition of red blood cell lysate to the same human serum pool. Abnormal lipid levels were prepared by addition of Intralipid® to the same human serum pool.
The specimens, with and without the interferents, were assayed for VPA using the QMS™/MULTIGENT™ Valproic Acid assay on the Abbott AEROSET® System
| Interfering
Substance | Interferent Concentration | n | Target
(no Interferent)
(µg/mL) | Mean
Recovery
(µg/mL) | Observed
(% of
Target) |
|--------------------------|---------------------------|---|---------------------------------------|-----------------------------|------------------------------|
| Bilirubin | 20 mg/dL | 2 | 88.38 | 87.98 | 99.5% |
| Hemoglobin | 1,000 mg/dL (10 g/L) | 2 | 91.46 | 91.58 | 100% |
| Intralipid | 2,000 mg/dL | 2 | 91.59 | 90.64 | 99% |
Results showed no interference at the following levels:
Acceptance criteria are recoveries of 100 ±10% for hemoglobin, bilirubin and lipids.
The Abbott AxSYM® package insert reports "no significant interference" up to approximately 20 mg/dL of bilirubin, approximately 1,000 mg/dL of hemoglobin, and approximately 1,100 mg/dL of triglyceride.
HAMA Interference
As with any assay employing mouse antibodies, the possibility exists for interference by human anti-mouse antibodies (HAMA) in the sample, which could cause falsely elevated results. A normal human serum pool (control), and HAMA type 1 and HAMA type 2 samples were spiked with the same amounts of valproic acid. Each of the samples were
7
assayed in duplicate on the Abbott AEROSET® System using the Seradyn QMS™ / MULTIGENT™Valproic Acid assay. The means of each duplicate HAMA sample were compared to the mean of the control normal human serum.
Results are as follows:
| Rep 1 | Rep 2 | Mean | % Recovery | |
|---|---|---|---|---|
| Control | 98.54 | 97.94 | 98.24 | 100% |
| HAMA 1 | 92.27 | 89.65 | 90.96 | 93% |
| HAMA 2 | 93.76 | 94.65 | 94.20 | 96% |
Acceptance criteria is a recovery of 100 ±10%.
The Abbott AxSYM® package insert reports no HAMA interference study.
H. Reagent Stability Data
Instrument on-board stability
On-board stability (uncapped reagents) studies demonstrated acceptable data to make a claim of 54 days. One re-calibration was required during the study.
Abbott AxSYM® reports an instrument on-board stability of 14 days for their reagents.
I. Instrument Calibration Stability:
Instrument calibration stability study demonstrated acceptable data to make a claim of 27 days.
Abbott AxSYM® reports no calibration stability claim.
10. Conclusions:
The results of clinical testing demonstrate that the performance and effectiveness of the Seradyn QMS™ / MULTIGENT™ Valproic Acid Assay are substantially equivalent to those of the Abbott AxSYM® Valproic Acid assay.
Refer to the Abbott AxSYM® Valproic Acid Package Insert for Specific Performance data.
11. Other Information:
None
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Image /page/8/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three curved lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
APR 2 8 2003
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Les Padilla Senior Scientist Seradyn, Inc. 7998 Georgetown Road - Suite 1000 Indianapolis, IN 46268
Re: K030405
Trade/Device Name: Seradyn QMS™M/Multigent™ Valporic Acid on the Abbott Aeroset® System Regulation Number: 21 CFR 862.3645 Regulation Name: Neuroleptic drugs radioreceptor assay test system Regulatory Class: Class II Product Code: LEG; JIS Dated: February 4, 2003 Received: February 6 2003
Dear Mr. Padilla:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified 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), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting 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 can be found in Title 21, Code of Federal Regulations (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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (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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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 (301) 594-3084. 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/dsma/dsmamain.html.
Sincerely yours,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE FORM
K030405 510(k) Number (if known): Not known at this time
SERADYN QMS™ /MULTIGENT™ VALPROIC ACID ON THE Device Name: ABBOTT AEROSET® SYSTEM
Indications For Use:
The SERADYN OMS™ / MULTIGENT™ VALPROIC ACID assay is used for the quantitation of valproic acid in human serum or plasma on the Abbott AEROSET® System.
Valproic acid (VPA; 2-propylpentanoic acid; Depakene®) is a broad-spectrum anticonvulsant drug used solely or in combination with other anticonvulsant drugs for the treatment of absence seizures. It also has demonstrated effectiveness in the management of generalized tonic-clonic and myoclonic seizures, as well as atypical absence, simple and complex partial and mixed grand mal and petit mal seizures. The capability of treating many types of seizures with a single anticonvulsant has resulted in the wide-spread use of valproic acid, particularly in . children in whom tonic-clonic and myoclonic seizures are most prevalent. Valproic acid has proven effective in the treatment of many patients otherwise refractory to other anticonvulsant treatments. Most patients receiving valproic acid do not develop a tolerance to its anticonvulsant effects.
Monitoring serum valproic acid levels combined with other clinical data can provide the physician with useful information to aid in adjusting patient dosage and achieving optimal therapeutic effect while avoiding useless sub-therapeutic or harmful toxic dosage levels.
Sean Cross
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K030405
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use