(143 days)
Not Found
No
The description focuses on a traditional immunoassay method and does not mention any AI or ML components for data analysis or interpretation.
No
This device is for in vitro diagnostic use, measuring phenobarbital levels to aid in diagnosis, treatment, and monitoring, not for direct therapeutic intervention.
Yes
The "Intended Use / Indications for Use" section states: "Measurements obtained by this device are used as an aid in the diagnosis and treatment of phenobarbital use or overdose and in monitoring levels of phenobarbital to help ensure appropriate therapy." This explicitly indicates a diagnostic purpose.
No
The device description clearly details a physical, multilayered analytical element (the VITROS PHBR Slide) and its chemical/enzymatic reaction process, indicating it is a hardware-based in vitro diagnostic device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The very first line explicitly states "For in vitro diagnostic and laboratory professional use." It also describes measuring phenobarbital concentration in serum and plasma, which are biological samples taken from the body. The purpose is to aid in diagnosis and treatment, which is a key characteristic of IVDs.
- Device Description: The description details an "analytical element" and an "immunoassay format" that analyzes a "drop of patient sample." This process of analyzing biological samples outside of the body is the definition of in vitro diagnostics.
- Intended User/Care Setting: It specifies "laboratory professional use," indicating that the device is used in a laboratory setting to perform diagnostic tests.
All of these points strongly support the classification of this device as an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
For in vitro diagnostic and laboratory professional use.
VITROS Chemistry Products PHBR Slides quantitatively measure phenobarbital (PHBR) concentration in serum and plasma (lithium heparin) using the automated VITROS 5600 Integrated System.
Measurements obtained by this device are used as an aid in the diagnosis and treatment of phenobarbital use or overdose and in monitoring levels of phenobarbital to help ensure appropriate therapy.
Product codes
DLZ
Device Description
The VITROS PHBR Slide is a multilayered, analytical element coated on a polyester support. The phenobarbital assay is based on an enzymatic heterogeneous, competitive immunoassay format. Immobilized anti-phenobarbital antibody and phenobarbital-peroxidase conjugate are present in the spreading layer.
A drop of patient sample is deposited on the slide and is evenly distributed by the spreading layer to the underlying layers. Phenobarbital in the sample competes with the phenobarbitalperoxidase conjugate for a limited number of antibody binding sites during Incubation 1. The subsequent addition of 12 µL of VITROS Immuno-Wash Fluid to the slide removes unbound phenobarbital-peroxidase conjugate from the read area, while also providing a substrate for the enzyme mediated oxidation of leuco dye.
The rate of dye formation, as monitored by reflectance spectrophotometry for Incubation 2, is inversely proportional to the phenobarbital concentration in the sample. To determine if an adequate wash has occurred, a wash detection dye is read at 540 nm during Incubation 2.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
For in vitro diagnostic and laboratory professional use.
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Method Comparison:
- Study Type: Method Comparison following CLSI Protocol EP09-A3, Measurement Procedure Comparison and Bias Estimation Using Patient Samples.
- Sample Size: 142
- Key Results: Passing-Bablok Regression was performed. Slope: 0.92, Correlation Coefficient: 0.983, Range of Samples: 5.6 - 76.1 ug/mL, Intercept: -2.0 ug/mL, Sv.x: 2.6.
Precision:
- Study Type: Precision evaluation following CLSI Protocol EP05-A3, Evaluation of Precision Performance of Quantitative Methods; Approved Guideline-Third Edition.
- Sample Size: 88 observations (2 replicates per run, 2 runs per day over 22 days).
- Key Results: Data presented as a guideline for test performance. Variables such as sample handling, storage, reagent handling, laboratory environment, and system maintenance can affect reproducibility.
- Repeatability (SD/%CV):
- 5.0 µg/mL: 0.20/3.9%
- 9.1 µg/mL: 0.27/2.9%
- 11.0 µg/mL: 0.30/2.7%
- 23.0 µg/mL: 0.50/2.2%
- 25.1 µg/mL: 0.59/2.4%
- 38.1 µg/mL: 0.79/2.1%
- 59.3 µg/mL: 1.50/2.5%
- Within Lab (SD/%CV):
- 5.0 µg/mL: 0.25/5.0%
- 9.1 µg/mL: 0.33/3.6%
- 11.0 µg/mL: 0.44/4.0%
- 23.0 µg/mL: 0.65/2.8%
- 25.1 µg/mL: 0.81/3.2%
- 38.1 µg/mL: 1.09/2.9%
- 59.3 µg/mL: 2.11/3.6%
- Repeatability (SD/%CV):
Detection Limits:
- Study Type: Determined consistent with CLSI document EP17.: Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures.
- Key Results:
- Limit of Detection (LoD): 1.3 ug/mL.
- Limit of Quantitation (LoQ): 3.0 µg/mL (Total allowable error goal for LoQ: ≤ 1.5 µg/mL).
Linearity:
- Study Type: Studies performed according to CLSI EP06-A. Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approved Guideline (2003). Each sample tested in duplicate.
- Key Results:
- Lower Limit of Linearity Interval (LLLI): 0.5 µg/mL.
- Upper Limit of Linearity Interval (ULLI): 83.5 µg/mL.
- Deviation from linearity: within ± 1.3 µg/mL at phenobarbital concentrations 10 ug/mL.
- Measuring range: 3.0 - 80.0 µg/mL.
- Serum and plasma samples with values greater than the measuring range may be diluted with 1 part sample and 1 part diluent. VITROS Chemistry Products Specialty Diluent is an acceptable diluent.
Specificity:
- Study Type: Screened for interfering substances following CLSI document EP07-A3, Interference Testing in Clinical Chemistry. Supplemental tables in CLSI document EP37 were referenced. Dose-response analysis conducted for substances exceeding acceptance criterion.
- Key Results:
- Nine (9) substances interfered (bias > 1.8 ug/mL at ~15 ug/mL PHBR or bias > 5.2 ug/mL at ~50 ug/mL PHBR). The bias is an estimate of the maximum bias observed.
- At PHBR Conc. ~15 µg/mL:
- Conjugated bilirubin (13.7 mg/dL): 2.1 µg/mL
- Ethamsylate (4.5 mg/dL): 3.4 µg/mL
- Hemoglobin (300 mg/dL): -2.3 µg/mL
- Mephobarbital (0.79 mg/dL): 2.6 µg/mL
- Thiamylal (7.4 mg/dL): 3.1 µg/mL
- Thiopental (2.5 mg/dL): 4.2 µg/mL
- Total protein (13.0 g/dL): -2.8 µg/mL
- Valproic acid (18.4 mg/dL): 2.3 µg/mL
- At PHBR Conc. ~50 µg/mL:
- Conjugated Bilirubin (27.4 mg/dL): 6.3 µg/mL
- Ethamsylate (3.0 mg/dL): 7.2 µg/mL
- Ethanol (6.0 mg/mL): 7.7 µg/mL
- Hemoglobin (225 mg/dL): -8.9 µg/mL
- Mephobarbital (0.79 mg/dL): 6.6 µg/mL
- Thiamylal (7.4 mg/dL): 8.5 µg/mL
- Thiopental (10.1 mg/dL): 9.1 µg/mL
- Total protein (13.0 g/dL): -13.5 µg/mL
- At PHBR Conc. ~15 µg/mL:
- Sixty-one (61) test substances did not interfere (bias ≤ 1.8 µg/mL at ~15 µg/mL PHBR or bias ≤ 5.2 µg/mL at ~50 ug/mL PHBR).
- Nine (9) substances interfered (bias > 1.8 ug/mL at ~15 ug/mL PHBR or bias > 5.2 ug/mL at ~50 ug/mL PHBR). The bias is an estimate of the maximum bias observed.
Cross-Reactivity:
- Study Type: Evaluated by adding substances (amobarbital, aprobarbital, butabarbital, butalbital, hexobarbital, mephobarbital, phenylethyl-malonamide (pema), phenytoin, primidone, secobarbital, thiamylal, and thiopental) to serum samples containing phenobarbital concentrations of approximately 15 and 50 µg/mL.
- Key Results: Results are provided for reference in the customer instructions for use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
ARCHITECT iPhenobarbital Assay K081231
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.3660 Phenobarbital test system.
(a)
Identification. A phenobarbitol test system is a device intended to measure phenobarbital, an antiepileptic and sedative-hypnotic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of phenobarbital use or overdose and in monitoring levels of phenobarbital to ensure appropriate therapy.(b)
Classification. Class II.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
August 13, 2021
Ortho-Clinical Diagnostics, Inc. Darlene Phillips Manager, Regulatory Affairs 100 Indigo Creek Drive Rochester, New York 14626-5101
Re: K210858
Trade/Device Name: VITROS Chemistry Products PHBR Slides Regulation Number: 21 CFR 862.3660 Regulation Name: Phenobarbital Test System Regulatory Class: Class II Product Code: DLZ Dated: March 22, 2021 Received: March 23, 2021
Dear Darlene Phillips:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Marianela Perez-Torres, Ph.D. Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K210858
Device Name VITROS Chemistry Products PHBR Slides
Indications for Use (Describe)
Rx Only
For in vitro diagnostic and laboratory professional use.
VITROS Chemistry Products PHBR Slides quantitatively measure phenobarbital (PHBR) concentration in serum and plasma (lithium heparin) using the automated VITROS 5600 Integrated System.
Measurements obtained by this device are used as an aid in the diagnosis and treatment of phenobarbital use or overdose and in monitoring levels of phenobarbital to help ensure appropriate therapy.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) 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: K210858
Submitter's Information
Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, New York 14626-5101 Phone: (585) 453-4253 Fax: (585) 453-4110
Contact Person:
Darlene J Phillips, RAC Manager, Regulatory Affairs
Date of Preparation:
22-March-2021
Device Proprietary Name(s):
VITROS Chemistry Products PHBR Slides
Common Names:
Phenobarbital assay
Classification Names
| Product
| Code | Class | Regulation Section | Panel |
|---|---|---|---|
| DLZ | II | 21 CFR 862.3660 | |
| Phenobarbital test system | Clinical Chemistry (75) |
Predicate Device(s)
| Predicate Device | FDA 510(k) Number |
|---|---|
| ARCHITECT iPhenobarbital Assay | K081231 |
Intended Use Statement(s)
VITROS Chemistry Products PHBR Slides
Rx Only
For in vitro diagnostic and laboratory professional use.
VITROS Chemistry Products PHBR Slides quantitatively measure phenobarbital (PHBR) concentration in serum and plasma(lithium heparin) using the automated VITROS 5600
4
Integrated Systems. Measurements obtained by this device are used as an aid in the diagnosis and treatment of phenobarbital use or overdose and in monitoring levels of phenobarbital to help ensure appropriate therapy.
Device Description
The VITROS PHBR Slide is a multilayered, analytical element coated on a polyester support. The phenobarbital assay is based on an enzymatic heterogeneous, competitive immunoassay format. Immobilized anti-phenobarbital antibody and phenobarbital-peroxidase conjugate are present in the spreading layer.
A drop of patient sample is deposited on the slide and is evenly distributed by the spreading layer to the underlying layers. Phenobarbital in the sample competes with the phenobarbitalperoxidase conjugate for a limited number of antibody binding sites during Incubation 1. The subsequent addition of 12 µL of VITROS Immuno-Wash Fluid to the slide removes unbound phenobarbital-peroxidase conjugate from the read area, while also providing a substrate for the enzyme mediated oxidation of leuco dye.
The rate of dye formation, as monitored by reflectance spectrophotometry for Incubation 2, is inversely proportional to the phenobarbital concentration in the sample. To determine if an adequate wash has occurred, a wash detection dye is read at 540 nm during Incubation 2.
Comparison to Predicate Devices
Indications for use/intended use of candidate and predicate devices are the same. The following tables show similarities and differences between the new and predicate devices.
| Summary of the technological characteristics of the device compared to the predicate device | ||
|---|---|---|
| Device | ||
| Characteristic | New Device | |
| VITROS PHBR Slide | ||
| (New) | Predicate Device | |
| ARCHITECT iPhenobarbital Assay | ||
| [K081231] | ||
| Intended Use | For in vitro diagnostic use only. | |
| Same | For in vitro diagnostic use only. | |
| Quantitative measurement of | ||
| phenobarbital in human serum or | ||
| plasma | ||
| Device | ||
| Description | Multilayered, analytical element | |
| coated on a polyester support | Two ready-to-use solutions | |
| Basic Principle | Multi-point immunorate assay | Chemiluminescent Microparticle |
| Immunoassay (CMIA) | ||
| Sample type | Serum and lithium heparin plasma | Serum and plasma |
| Sample Volume | 11 μL | 20 μL |
| Assay Range | 3.0 – 80.0 μg/mL | 1.10 – 80.00 μg/mL |
| Calibrators | VITROS Chemistry Products | |
| Calibrator Kit 9 | ARCHITECT iPhenobarbital Calibrator | |
| Kit | ||
| Controls | VITROS Chemistry Products | |
| TDM Performance Verifiers | Abbott Immunoassay-MCC (Liquid) or | |
| other commercial controls | ||
| Instrumentation | VITROS 5600 Integrated System | ARCHITECT i System |
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Non-Clinical Testing Analytical Performance
Method Comparison
Method Comparison testing followed CLSI Protocol EP09-A3, Measurement Procedure Comparison and Bias Estimation Using Patient Samples. Serum samples were evaluated on the VITROS Chemistry Products PHBR Slides using the VITROS 5600 Integrated System and the ARCHITECT iPhenobarbital assay. Passing-Bablok Regression was performed to determine the correlation.
| N | Slope | Correlation
Coefficient | Range of Samples
ug/mL | Intercept
ug/mL | Sv.x |
|-----|-------|----------------------------|---------------------------|--------------------|------|
| 142 | 0.92 | 0.983 | 5.6 - 76.1 | -2.0 | 2.6 |
Precision
Precision was evaluated with patient pools and quality control materials following CLSI Protocol EP05-A3, Evaluation of Precision Performance of Quantitative Methods; Approved Guideline-Third Edition, using the VITROS Chemistry Products PHBR Slides on the VITROS 5600 Integrated System. The test included 88 observations (2 replicates per run, 2 runs per day over 22 days).
The data presented are a representation of test performance and are provided as a guideline. Variables such as sample handling and storage, reagent handling and storage, laboratory environment, and system maintenance can affect reproducibility of test results.
| Mean | Conventional Units (µg/mL) | |||||
|---|---|---|---|---|---|---|
| PHBR | ||||||
| Conc. | Repeatability* | Within Lab** | No. of | |||
| Days | No. of | |||||
| Obs. | ||||||
| SD | %CV | SD | %CV | |||
| 5.0 | 0.20 | 3.9% | 0.25 | 5.0% | 22 | 88 |
| 9.1 | 0.27 | 2.9% | 0.33 | 3.6% | 22 | 88 |
| 11.0 | 0.30 | 2.7% | 0.44 | 4.0% | 22 | 88 |
| 23.0 | 0.50 | 2.2% | 0.65 | 2.8% | 22 | 88 |
| 25.1 | 0.59 | 2.4% | 0.81 | 3.2% | 22 | 88 |
| 38.1 | 0.79 | 2.1% | 1.09 | 2.9% | 22 | 88 |
| 59.3 | 1.50 | 2.5% | 2.11 | 3.6% | 22 | 88 |
*Repeatability was determined using two replicates per run.
** Within Lab precision was determined using a single lot of slides and a single calibration
Detection Limits
The Limit of Detection (LoD) and Limit of Quantitation (LoQ) were determined for the VITROS PHBR Slides assay consistent with CLSI document EP17.: Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures. The total allowable error goal used to accept the LoQ was ≤ 1.5 µg/mL.
The limit of detection (LoD) for the VITROS PHBR Slides assay is 1.3 ug/mL.
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The claimed limit of quantification (LoQ) is 3.0 µg/mL. The Total Error goal used to accept the LoQ was ≤ 1.5 µg/mL.
Linearity
Linearity studies were performed according to CLSI EP06-A. Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approved Guideline (2003). VITROS PHBR Slides were tested on the VITROS 5600 Integrated System. A series of fourteen proportionally related admixtures of low and high concentration fluids were tested to verify linearity of the VITROS PHBR Slides test; each sample was tested in duplicate.
| Lower Limit of Linearity Interval (LLLI) | Upper Limit of Linearity Interval (ULLI) |
|---|---|
| 0.5 µg/mL | 83.5 µg/mL |
The deviation from linearity was within the allowable deviation of ± 1.3 µg/mL at phenobarbital concentrations 10 ug/mL.
The VITROS Chemistry Product PHBR Slides assay is linear over the measuring range of 3.0 - 80.0 µg/mL.
Serum and plasma samples with values greater than the VITROS PHBR Slides test measuring range may be diluted with 1part sample and 1part diluent. VITROS Chemistry Products Specialty Diluent is an acceptable diluent for the VITROS PHBR Slides test.
Expected Values
The expected values of the VITROS PHBR Slides are based on the therapeutic range* of 10.0 to 40.0 µg/mL.
*Burtis CA, Bruns DE. Tietz Fundamentals of Clinical Chemistry and Molecular Diagnostics. 7th ed. St. Louis, MO: Elsevier Saunders; 2015:pg 545.
Each laboratory should confirm the validity of these intervals for the population it serves.
Specificity
The VITROS Chemistry Products PHBR Slide test was screened for interfering substances following CLSI document EP07-A3, Interference Testing in Clinical Chemistry. The supplemental tables in CLSI document EP37 were referenced for recommended testing concentrations for analytes and endogenous substances that may interfere in clinical chemistry measurement procedures.
Point estimates of the effects of potential interferents on the VITROS PHBR Slides were made using the paired difference method. Dose-response analysis was conducted to characterize the degree of interference for each substance that exceeded the acceptance criterion in the initial screening test, and expected bias was reported at the lowest test level which did not meet acceptance criteria for bias as shown in the product claims.
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Nine (9) substances were found to interfere with the VITROS Chemistry Products PHBR Slides, bias > 1.8 ug/mL at a phenobarbital concentration of approximately 15 ug/mL or bias > 5.2 ug/mL at a phenobarbital concentration of approximately 50 ug/mL.
The substances listed in the table, when tested at the concentrations indicated, caused the bias shown. The bias is an estimate of the maximum bias observed.
| Interferent | Conventional Units | ||
|---|---|---|---|
| PHBR Conc. | |||
| (µg/mL) | Interferent | ||
| Concentration | Bias | ||
| (µg/mL) | |||
| Conjugated bilirubin | 15 | 13.7 mg/dL | 2.1 |
| Ethamsylate | 4.5 mg/dL | 3.4 | |
| Hemoglobin | 300 mg/dL | -2.3 | |
| Mephobarbital | 0.79 mg/dL | 2.6 | |
| Thiamylal | 7.4 mg/dL | 3.1 | |
| Thiopental | 2.5 mg/dL | 4.2 | |
| Total protein | 13.0 g/dL | -2.8 | |
| Valproic acid | 18.4 mg/dL | 2.3 |
| Interferent | Conventional Units | ||
|---|---|---|---|
| PHBR Conc. | |||
| (µg/mL) | Interferent | ||
| Concentration | Bias | ||
| (µg/mL) | |||
| Conjugated Bilirubin | 27.4 mg/dL | 6.3 | |
| Ethamsylate | 3.0 mg/dL | 7.2 | |
| Ethanol | 6.0 mg/mL | 7.7 | |
| Hemoglobin | 50 | 225 mg/dL | -8.9 |
| Mephobarbital | 0.79 mg/dL | 6.6 | |
| Thiamylal | 7.4 mg/dL | 8.5 | |
| Thiopental | 10.1 mg/dL | 9.1 | |
| Total protein | 13.0 g/dL | -13.5 |
These results are representative. It is possible that other interfering substances may be encountered in the patient population. The degree of interference at concentrations other than those listed might not be predictable.
Sixty-one (61) test substances, when tested at the concentrations indicated, were found not to interfere with the VITROS PHBR Slides, not to cause bias > 1.8 µg/mL at a phenobarbital concentration of approximately 15 µg/mL or bias > 5.2 µg/mL at a phenobarbital concentration of approximately 50 ug/mL. These will be listed in the customer instructions for use.
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Cross-Reactivity
The most common drugs concurrently prescribed with anti-convulsant therapies were reviewed for selection for testing, as well as compounds structurally related to phenobarbital. Substances tested included amobarbital, aprobarbital, butabarbital, butalbital, hexobarbital, mephobarbital, phenylethyl-malonamide (pema), phenytoin, primidone, secobarbital, thiamylal, and thiopental. The cross-reactivity of the VITROS Chemistry Products PHBR Slides method was evaluated by adding the substances to serum samples containing phenobarbital concentrations of approximately 15 and 50 µg/mL. Results are provided for reference in the customer instructions for use.
Other Limitations
Certain drugs and clinical conditions are known to alter phenobarbital concentrations in vivo.
Conclusion
The conclusions drawn from the nonclinical tests (discussed above) demonstrate the VITROS Chemistry Products PHBR Slides for use on the VITROS 5600 Integrated System is as safe, effective, and performs as well as the predicate device. The information submitted in the premarket notification is complete and supports a substantial equivalence decision.