(361 days)
Not Found
No
The device description and performance studies focus on standard immunoassay and turbidimetric techniques, with no mention of AI or ML.
No
Explanation: This device is an in vitro diagnostic (IVD) assay designed to detect phencyclidine or measure vancomycin levels in human samples. Its output is used for diagnosis, monitoring, or establishing quality control procedures, not for direct therapeutic intervention.
Yes
The "Intended Use / Indications for Use" section explicitly states that the assays are "for in vitro diagnostic use" for the measurement of specific substances (phencyclidine and vancomycin) in human samples. This falls directly under the definition of a diagnostic device.
No
The device description clearly outlines chemical assays (enzyme immunoassay and turbidimetric immunoassay) that rely on physical reagents and reactions measured spectrophotometrically. These are hardware-dependent processes, not software-only functions.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use / Indications for Use: Both the Atellica CH Phencyclidine (Pcp) assay and the Atellica CH Vancomycin (Vanc) assay explicitly state they are for "in vitro diagnostic use".
- Device Description: The descriptions detail how the assays work to measure specific substances (phencyclidine and vancomycin) in human biological specimens (urine, serum, and plasma). This is the core function of an IVD.
- Performance Studies: The document describes performance studies conducted to evaluate the accuracy, precision, and specificity of the assays using human samples. This is a standard requirement for demonstrating the performance of an IVD.
- Predicate Devices: The mention of predicate devices (K163220 and K160202) indicates that these assays are being compared to previously cleared IVD devices.
The information clearly aligns with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Atellica® CH Phencyclidine (Pcp) assay:
The Atellica® CH Phencyclidine (Pcp) assay is for in vitro diagnostic use in the qualitative or semiquantitative analyses of phencyclidine in human urine using the Atellica® CI Analyzer, using a cutoff of 25 ng/mL. The Pcp assay provides only a preliminary analytical test result. A more specific alternative chemical must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as gas chromatography/mass spectrometry (GC-MS) or liquid chromatography/tandem mass spectrometry (LC-MS/MS) or permitting laboratories to establish quality control procedures.
Clinical consideration and professional judgment should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used.
Atellica® CH Vancomycin (Vanc) assay:
The Atellica® CH Vancomycin (Vanc) assay is for in vitro diagnostic use in the quantitative measurement of vancomycin in human serum and plasma (lithium heparin) using the Atellica® CI Analyzer. Vanc test results may be 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, LCM
Device Description
4.1. Atellica CH Pcp
The Atellica CH Pcp assay is a homogenous enzyme immunoassay based on competition between drug in the specimen and drug labeled with glucose-6-phosphate dehydrogenase (G6PDH) for antibody binding sites. G6PDH activity decreases upon binding to the antibody, so the drug concentration in the specimen can be measured in terms of enzyme activity. Active enzyme converts nicotinamide adenine dinucleotide (NAD+) to NADH in the presence of glucose-6-phosphate (G6P), resulting in an absorbance change that is measured spectrophotometrically at 340/410 nm. Endogenous G6PDH does not interfere because the coenzyme NAD+ functions only with the bacterial (Leuconostoc mesenteroides) enzyme employed in the assay.
4.2. Atellica CH Vanc
The Atellica CH Vanc assay is based on a homogeneous particle enhanced turbidimetric inhibition immunoassay (PETINIA) technique which uses a synthetic particle-vancomycin conjugate (PR) and monoclonal vancomycin specific antibody (Ab). Vancomycin present in the sample competes with vancomycin on the particles for available antibody, thereby decreasing the rate of aggregation. Hence, the rate of aggregation is inversely proportional to the concentration of vancomycin in the sample. The rate of aggregation is measured using bichromatic turbidimetric readings at 545 and 694 nm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Human urine, human serum and plasma (lithium heparin)
Indicated Patient Age Range
Not Found
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
Atellica CH Pcp:
A total of one-hundred fifty-seven (157) phencyclidine samples were analyzed using the Atellica CH Pcp assay and the reference method GC/MS. All assays used a 25 ng/mL cutoff. Thirty-four (34) samples were within ± 50% of the cutoff by GC/MS. The agreement of the assay may vary depending on the study design, comparative assay, and sample population.
Precision was determined by assaying negative urine pools spiked with phencyclidine at nine different levels. Samples were assayed on an Atellica CI Analyzer in duplicate in 2 runs per day for 20 days (n = 80 for each sample). The results in the qualitative mode and semi-quantitative mode are identical.
Reproducibility samples were assayed n=5 in 1 run for 5 days using 3 instruments and 3 reagent lots.
Recovery of Pcp samples were prepared by spiking known amounts of phencyclidine into negative urine pools. Each spiked sample was analyzed using the Atellica CH Pcp assay.
Endogenous substances were evaluated qualitatively at the concentrations listed. The substances were spiked into two levels of controls at ±25% (19 ng/mL and 31 ng/mL) of the cutoff concentration.
The interference of structurally unrelated compounds and common over the counter drugs was evaluated qualitatively at the concentrations listed. The compounds were spiked into two levels of controls at ±25% (19 ng/mL and 31 ng/mL) of the cutoff concentration.
Negative urine pools with specific gravity values ranging from 1.000–1.030 and pH values ranging from 3–10 were tested in the presence of two levels of controls at ±25% of the cutoff concentration (19 ng/mL and 31 ng/mL).
Atellica CH Vanc:
Detection capability was determined using 450 determinations, with 225 blank and 225 low level replicates.
The LoQ of the Vanc assay was determined using n=5 replicates per sample that were assayed using 3 reagent lots, over a period of 3 days.
Precision samples were assayed on an Atellica CI Analyzer in duplicate in 2 runs per day for at least 20 days (N ≥ 80 for each sample).
Reproducibility samples were assayed n=5 in 1 run for 5 days using 3 instruments and 3 reagent lots.
Assay comparison was determined using the Deming regression model; 107 serum samples with concentrations ranging from 4.1–45.9 µg/mL (2.8–38.6 µmol/L) were tested.
Specimen equivalency was determined using the Deming regression model; 50 samples of plasma (lithium heparin) and serum, with concentrations ranging from 4.5–43.9 μg/mL (3.1–30.3 μmol/L), were tested.
Interfering substances (hemoglobin, bilirubin, and lipemia) were tested at indicated levels using the Atellica CH Vanc assay.
Non-interfering substances were tested at indicated concentrations.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
8.1. Atellica CH Pcp
Assay Comparison
Qualitative and Semiquantitative Results
A total of one-hundred fifty-seven (157) phencyclidine samples were analyzed using the Atellica CH Pcp assay and the reference method GC/MS. All assays used a 25 ng/mL cutoff. Thirty-four (34) samples were within ± 50% of the cutoff by GC/MS.
- Qualitative Summary: Atellica CH POS Agreement: 95%, Atellica CH NEG Agreement: 94%
- Semiquantitative Summary: Atellica CH POS Agreement: 95%, Atellica CH NEG Agreement: 94%
Precision
Repeatability and within-lab precision were determined by assaying negative urine pools spiked with phencyclidine at nine different levels. Samples were assayed on an Atellica CI Analyzer in duplicate in 2 runs per day for 20 days (n = 80 for each sample).
Results for qualitative and semi-quantitative analysis at different urine pool concentrations (ng/mL) show varying levels of Repeatability (SD, CV%) and Within-Lab (SD, CV%).
Reproducibility
Reproducibility was determined by assaying samples n=5 in 1 run for 5 days using 3 instruments and 3 reagent lots.
Results show repeatability, between-day, between-instrument, between-lot, and total reproducibility (SD and CV%) for three urine QC samples.
Recovery
Recovery of Pcp samples were prepared by spiking known amounts of phencyclidine into negative urine pools.
Mean Recovery ranged from 90% to 107% across various target concentrations (4 ng/mL to 80 ng/mL).
Endogenous Substances
Endogenous substances were evaluated qualitatively at the concentrations listed. The substances were spiked into two levels of controls at ±25% (19 ng/mL and 31 ng/mL) of the cutoff concentration.
At the stated concentration, the samples did not give a false response relative to the 25 ng/mL cutoff, maintaining Negative results for -25% Cutoff Pool and Positive results for +25% Cutoff Pool.
Specificity (Structurally Unrelated Compounds)
Interference was determined in accordance with CLSI Document EP07. Compounds were spiked into two levels of controls at ±25% (19 ng/mL and 31 ng/mL) of the cutoff concentration.
At the stated concentrations, the samples did not give a false response relative to the 25 ng/mL cutoff, maintaining Negative results for -25% Cutoff Pool and Positive results for +25% Cutoff Pool.
Specificity (Structurally Related Compounds)
Cross-reactivity percentage for structurally related compounds was determined.
Cross-Reactivity ranged from 0.0% to 184.4%, with PCP showing 96.8%.
Specific Gravity and pH
Negative urine pools with specific gravity values ranging from 1.000–1.030 and pH values ranging from 3–10 were tested in the presence of two levels of controls at ±25% of the cutoff concentration (19 ng/mL and 31 ng/mL).
No interference was observed.
8.2. Atellica CH Vanc
Detection Capability
The assay is designed to have a limit of blank (LoB) 10% is considered interference.
Percent Bias for HIL substances ranged from 0% to 8%, indicating interference is ≤ 8%.
Non-Interfering Substances
The substances tested do not interfere with the Atellica CH Vanc assay when present in serum and lithium plasma at the concentrations indicated.
Bias due to these substances is ≤ 10% at an analyte concentration of 10.0 and 40.0 µg/mL (6.9 and 27.6 µmol/L).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found (Specific numeric values for sensitivity, specificity, PPV, NPV are not explicitly provided, though accuracy and agreement rates are given in performance studies).
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.
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
§ 862.3950 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
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Siemens Healthcare Diagnostics Inc. Joy Anoop Clinical Regulatory Affairs Specialist 511 Benedict Avenue Tarrytown, NY 10591
Re: K222439
Trade/Device Name: Atellica® CH Vancomycin (Vanc), Atellica® CH Phencyclidine (Pcp) Regulation Number: 21 CFR 862.3950 Regulation Name: Vancomycin Test System Regulatory Class: Class II Product Code: LEH, LCM Dated: January 16, 2023 Received: January 17, 2023
Dear Joy Anoop:
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.
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
1
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, Joseph A. Digitally signed by Kotarek -S Date: 2023.08.08 Joseph Kotarek, Ph.D. Branch Chief Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K222439
Device Name Atellica® CH Phencyclidine (Pcp) Atellica® CH Vancomycin (Vanc)
Indications for Use (Describe)
The Atellica® CH Phencyclidine (Pcp) assay is for in the qualitative or semiguantitative analyses of phencyclidine in human urine using the Atellica® CI Analyzer, using a cutoff of 25 ng/mL. The Pop assay provides only a preliminary analytical test result. A more specific alternative chemical must be used to obtain a confirmed analytical result. Gas chromatographymass spectrometry (GCMS) is the preferred confirmatory method. The semiquantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as gas chromatography/mass spectrometry (GC-MS) or liquid chromatography/tandem mass spectrometry (LC-MS/MS) or permitting laboratories to establish quality control procedures.
Clinical consideration and professional judgment should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used.
The Atellica® CH Vancomycin (Vanc) assay is for in vitro diagnostic use in the quantitative measurement of vancomycin in human serum and plasma (lithium heparin) using the Atellica® CI Analyzer. Vanc test results may be used in the diagnosis and treatment of vancomycin overdose and in monitoring levels of vancomycin to 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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3
510(k) Summary of Safety and Effectiveness
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: K222439
1. APPLICANT
Siemens Healthcare Diagnostics Inc. 511 Benedict Avenue, Tarrytown, NY 10591 USA
Anoop Jov Contact: Clinical Regulatory Affairs Specialist Phone: (516) 232-3307 E-mail: anoop.joy@siemens-healthineers.com
Date Prepared: March 28, 2023
2. Regulatory Information
Assay: Atellica CH Phencyclidine (Pcp)
Classification Name: Enzyme Immunoassay, Phencyclidine Regulation Section: unclassified Trade Name: Atellica® CH Phencyclidine (Pcp) Classification: Unclassified, 510(k) required Product Code: LCM Panel: Toxicology
Assay: Atellica CH Vancomycin (Vanc)
Classification Name: Vancomycin test system Regulation Section: 21 CFR 862.3950 Trade Name: Atellica® CH Vancomycin (Vanc) Classification: Class II Product Code: LEH Panel: Toxicology
4
3. PREDICATE DEVICE INFORMATION
| Predicate Device | Candidate Device | 510(k) # | Class | Code |
|---|---|---|---|---|
| Atellica CH Phencyclidine (Pcp) | Atellica CH Phencyclidine (Pcp) | K163220 | unclassified | LCM |
| Trinidad CH Vancomycin (Vanc) | Atellica CH Vancomycin (Vanc) | K160202 | Class II | LEH |
4. DEVICE DESCRIPTION
4.1. Atellica CH Pcp
The Atellica CH Pcp assay is a homogenous enzyme immunoassay based on competition between drug in the specimen and drug labeled with glucose-6-phosphate dehydrogenase (G6PDH) for antibody binding sites. G6PDH activity decreases upon binding to the antibody, so the drug concentration in the specimen can be measured in terms of enzyme activity. Active enzyme converts nicotinamide adenine dinucleotide (NAD+) to NADH in the presence of glucose-6-phosphate (G6P), resulting in an absorbance change that is measured spectrophotometrically at 340/410 nm. Endogenous G6PDH does not interfere because the coenzyme NAD+ functions only with the bacterial (Leuconostoc mesenteroides) enzyme employed in the assay.
4.2. Atellica CH Vanc
The Atellica CH Vanc assay is based on a homogeneous particle enhanced turbidimetric inhibition immunoassay (PETINIA) technique which uses a synthetic particle-vancomycin conjugate (PR) and monoclonal vancomycin specific antibody (Ab). Vancomycin present in the sample competes with vancomycin on the particles for available antibody, thereby decreasing the rate of aggregation. Hence, the rate of aggregation is inversely proportional to the concentration of vancomycin in the sample. The rate of aggregation is measured using bichromatic turbidimetric readings at 545 and 694 nm.
5. INTENDED USE
5.1 Atellica CH Pcp
The Atellica® CH Phencyclidine (Pcp) assay is for in vitro diagnostic use in the qualitative or semiquantitative analyses of phencyclidine in human urine using the Atellica® CI Analyzer, using a cutoff of 25 ng/mL. The Pcp assay provides only a preliminary analytical test result. A more specific alternative chemical must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as gas chromatography/mass spectrometry (GC-MS) or liquid chromatography/tandem mass spectrometry (LC-MS/MS) or permitting laboratories to establish quality control procedures.
5
Clinical consideration and professional judgment should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used.
5.2Atellica CH Vanc
The Atellica® CH Vancomycin (Vanc) assay is for in vitro diagnostic use in the quantitative measurement of vancomycin in human serum and plasma (lithium heparin) using the Atellica® CI Analyzer. Vanc test results may be used in the diagnosis and treatment of vancomycin overdose and in monitoring levels of vancomycin to ensure appropriate therapy.
6. INDICATIONS FOR USE
Same as Intended use
7. COMPARISION OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The following table provides a comparison between the predicate and candidate device.
7.1. Atellica CH Pcp
Below is a features comparison for the Atellica CH Pcp assay on the Atellica CI Analyzer and the predicate device Atellica IM Analyzer
| Feature | Predicate Device:
Atellica CH Phencyclidine
(Pcp) on Atellica CH
Analyzer | New
Device:
Atellica CH Phencyclidine
(Pcp) on Atellica Cl Analyzer |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use : | The Atellica CH
Phencyclidine (Pcp) assay
is for in vitro diagnostic use
in the qualitative or
semiquantitative analyses
of phencyclidine in human
urine using the Atellica CH
Analyzer, using a cutoff of
25 ng/mL. The Pcp assay
provides only a preliminary
analytical test result. A
more specific alternative
chemical method must be
used to obtain a confirmed
analytical result. Gas
chromatography/mass
spectrometry (GC/MS) is
the preferred confirmatory
method. The semi- | The Atellica CH
Phencyclidine (Pcp) assay
is for in vitro diagnostic use
in the qualitative or
semiquantitative analyses
of phencyclidine in human
urine using the Atellica Cl
Analyzer, using a cutoff of
25 ng/mL. The Pcp assay
provides only a preliminary
analytical test result. A
more specific alternative
chemical method must be
used to obtain a confirmed
analytical result. Gas
chromatography/mass
spectrometry (GC/MS) is
the preferred confirmatory
method. The semi- |
| | quantitative mode is for
purposes of enabling
laboratories to determine
an appropriate dilution of
the specimen for
confirmation by a
confirmatory method such
as gas
chromatography/mass-
spectrometry (GC-MS) or
liquid
chromatography/tandem
mass spectrometry (LC-
MS/MS) or permitting
laboratories to establish
quality control procedures.
Clinical consideration and
professional judgment
should be applied to any
drug-of- abuse test result,
particularly when
preliminary positive results
are used. | quantitative mode is for
purposes of enabling
laboratories to determine
an appropriate dilution of
the specimen for
confirmation by a
confirmatory method such
as gas
chromatography/mass
spectrometry (GC-MS) or
liquid
chromatography/tandem
mass spectrometry (LC-
MS/MS) or permitting
laboratories to establish
quality control procedures.
Clinical consideration and
professional judgment
should be applied to any
drug-of-abuse test result,
particularly when
preliminary positive results
are used |
| Type of Product: | Analytical Reagents | Same |
| Measured Analyte: | Pcp | Same |
| Test Matrix: | Urine | Same |
| Device Technology: | Enzyme Immunoassay | Same |
| Materials: | Matched lots of polyclonal
antibody reactive to
phencyclidine and
phencyclidine labeled with
glucose-6-phosphate
dehydrogenase are used in
this Syva® Emit® II Plus
methodology. | Same |
| Cutoff Levels: | 25 ng/mL PCP | Same |
| Confirmatory
Method: | Gas Chromatography/mass
spectrometry | Same |
| Calibration
Frequency: | 60 days | 130 days |
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7
7.2. Atellica CH Vanc
Below is a features comparison for the Atellica CH Vanc assay on the Atellica CI Analyzer and the predicate device Atellica IM Analyzer
| Feature | Predicate Device:
Trinidad CH Vancomycin
(Vanc) on Trinidad CH System | New Device:
Atellica CH Vancomycin
(Vanc) on Atellica CI
Analyzer |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use : | The Trinidad CH Vancomycin
(Vanc) assay is for in vitro
diagnostic use in the
quantitative measurement of
vancomycin in human serum
and plasma (lithium heparin)
using the Trinidad CH
System. | The Atellica CH
Vancomycin (Vanc) assay
is for in vitro diagnostic
use in the quantitative
measurement of
vancomycin in human
serum and plasma (lithium
heparin) using the Atellica
CI Analyzer. |
| Indications for Use: | Vanc test results may be
used in the diagnosis and
treatment of vancomycin
overdose and in monitoring
levels of vancomycin to
ensure appropriate therapy. | Same |
| Device Technology: | Homogeneous particle
enhanced turbidimetric
inhibition immunoassay
(PETINIA) technique | Same |
| Sample Type: | Serum/ Lithium Heparin
plasma | Same |
| Therapeutic Interval: | Peak Intervals: Samples from
adult volunteers drawn two
hours after the completion of
a 60-minute infusion of
vancomycin ranged from 18 –
26 µg/mL.
Samples drawn one hour
after the completion of a 60
minute vancomycin infusion
ranged from 25 – 40 µg/mL.
Samples drawn 30 minutes
after the completion of a 60
minute infusion of vancomycin
ranged from 30 – 40 µg/mL.
Trough Intervals: Samples
should be drawn just before the
next dose. A trough interval of 5
– 10 µg/mL is generally
considered to be effective. | Same |
| Standardization: | Traceable to United States
Pharmacopeia (USP) standards. Same | Same |
| Calibration Frequency: | 30 days | Same |
| Analytical Measuring
Interval: | 3.0 – 50.0 µg/mL | Same |
| Interferences: | Bilirubin (Conjugated &
Unconjugated) – 20 mg/dL
Lipemia (Intralipid®) – 1000
mg/dL
Hemoglobin – 600 mg/dL | Bilirubin (Conjugated &
Unconjugated) – 30 mg/dL
Lipemia (Intralipid®) – 2000
mg/dL
Hemoglobin – 1000 mg/dL |
| Calibrators: | Atellica CH Drug CAL II | Same |
8
9
10
8. PERFORMANCE CHARACTERISTICS DATA
8.1. Atellica CH Pcp
Assay Comparison
Qualitative and Semiquantitative Results
A total of one-hundred fifty-seven (157) phencyclidine samples were analyzed using the Atellica CH Pcp assay and the reference method GC/MS. All assays used a 25 ng/mL cutoff. Thirty-four (34) samples were within ± 50% of the cutoff by GC/MS. The agreement of the assay may vary depending on the study design, comparative assay, and sample population. Qualitative and Semiquantitative Accuracy Summary of Atellica CH Pcp Assay versus GC/MS
| | | LOW NEG
50% above the
cutoff
(> 38 ng/mL) | % Agree-
ment |
|--------------------------|-----|------------------------------------------------------|--------------------------------------------------------|--------------------------------------------------------|-------------------------------------------------------|------------------|
| Qualitative Summary | | | | | | |
| Atellica CH | POS | 0 | 3 | 19 | 81 | 95 |
| | NEG | 42 | 7 | 5 | 0 | 94 |
| Semiquantitative Summary | | | | | | |
| Atellica CH | POS | 0 | 3 | 19 | 81 | 95 |
| | NEG | 42 | 7 | 5 | 0 | 94 |
Discordant Result Summary between Atellica CH Pcp Assay and GC/MS
| Sample # | Atellica CI Pcp
(ng/mL) | GC/MS Phencyclidine
(ng/mL) | Atellica CI Pcp vs GC/MS
(POS/NEG) |
|----------|----------------------------|--------------------------------|---------------------------------------|
| 47 | 27 | 18.0 | +/- |
| 51 | 30 | 24.2 | +/- |
| 52 | 26 | 24.8 | +/- |
| 53 | 21 | 25.8 | -/+ |
| 54 | 20 | 26.7 | -/+ |
| 56 | 22 | 27.6 | -/+ |
| 57 | 24 | 27.8 | -/+ |
| 58 | 24 | 28.5 | -/+ |
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Precision
Precision was determined in accordance with CLSI Document EP05-A3. Repeatability and within-lab precision were determined by assaying negative urine pools spiked with phencyclidine at nine different levels. The assay is designed to classify the levels as positive or negative relative to the cutoff for the spiked sample pools. Samples were assayed on an Atellica CI Analyzer in duplicate in 2 runs per day for 20 days (n = 80 for each sample). The results in the qualitative mode and semi-quantitative mode are identical. The results are summarized below.
| Precision Qualitative and Semi-Quantitative Analysis | ||||||||
|---|---|---|---|---|---|---|---|---|
| Urine Pool | ||||||||
| (ng/mL) | % of | |||||||
| Cutoff | # of | |||||||
| Results | Mean | |||||||
| (ng/mL) | Repeatability | Within-Lab | ||||||
| 0 | -100 | 80 | 0 | 0.1 | N/A | 0.20 | N/A | |
| 6.25 | -75 | 80 | 6 | 0.4 | 6.7 | 0.6 | 10.0 | |
| 12.5 | -50 | 80 | 12 | 0.4 | 3.3 | 0.6 | 5.0 | |
| 18.75 | -25 | 80 | 18 | 0.4 | 2.2 | 0.8 | 4.4 | |
| 25 | Cutoff | 80 | 25 | 0.6 | 2.4 | 1.1 | 4.4 | |
| 31.25 | 25 | 80 | 32 | 0.9 | 2.8 | 1.7 | 5.3 | |
| 37.5 | 50 | 80 | 39 | 0.9 | 2.3 | 2.3 | 5.9 | |
| 43.75 | 75 | 80 | 43 | 1.1 | 2.6 | 2.5 | 5.8 | |
| 50 | 100 | 80 | 52 | 1.7 | 3.3 | 3.7 | 7.1 |
Reproducibility
Reproducibility was determined in accordance with CLSI Document EP05-A3. Samples were assayed n=5 in 1 run for 5 days using 3 instruments and 3 reagent lots. The data were analyzed to calculate the following components of precision: repeatability, between-day, between-lot, between-instrument, and reproducibility (total). The following results were obtained:
| Repeatability | Between-Day | Between-Instrument | Between-Lot | Total Reproducibility | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sample | Na | Mean | ||||||||||||||
| (ng/mL) | SD | |||||||||||||||
| (ng/mL) | CV | |||||||||||||||
| (%) | SD | |||||||||||||||
| (ng/mL) | CV | |||||||||||||||
| (%) | SD | |||||||||||||||
| (ng/mL) | CV | |||||||||||||||
| (%) | SD | |||||||||||||||
| (ng/mL) | CV | |||||||||||||||
| (%) | SD | |||||||||||||||
| (ng/mL) | CV | |||||||||||||||
| (%) | ||||||||||||||||
| Urine QC 1 | 225 | 18 | 0.5 | 2.8 | 0.6 | 3.3 | 0.3 | 1.7 | 0.7 | 3.9 | 1.1 | 6.1 | ||||
| Urine QC 2 | 225 | 24 | 0.5 | 2.1 | 0.9 | 3.8 | 0.7 | 2.9 | 0.6 | 2.5 | 1.4 | 5.8 | ||||
| Urine QC 3 | 225 | 34 | 0.8 | 2.4 | 1.5 | 4.4 | 1.2 | 3.5 | 0.8 | 2.4 | 2.2 | 6.5 |
a Number of results.
b Standard deviation.
Coefficient of variation.
12
Recovery
Recovery of Pcp samples were prepared by spiking known amounts of phencyclidine into negative urine pools. Each spiked sample was analyzed using the Atellica CH Pcp assay. Results of recovery are shown below.
| Target Concentration
(ng/mL) | Mean Measured Concentration
(ng/mL) | Mean Recovery
% |
|---------------------------------|----------------------------------------|--------------------|
| 0 | 0 | N/A |
| 4 | 4 | 101 |
| 5 | 5 | 100 |
| 10 | 9 | 90 |
| 15 | 15 | 100 |
| 20 | 19 | 95 |
| 25 | 24 | 96 |
| 30 | 30 | 100 |
| 40 | 43 | 107 |
| 60 | 64 | 107 |
| 80 | 82 | 103 |
Endogenous Substances
The protocol used follows the CLSI Document, EP07. The endogenous substances were evaluated qualitatively at the concentrations listed below. The substances were spiked into two levels of controls at ±25% (19 ng/mL and 31 ng/mL) of the cutoff concentration. At the stated concentration, the sample did not give a false response relative to the 25 ng/mL cutoff.
| Compound | Concentration
Tested | -25% Cutoff Pool
Result
(19 ng/mL) | +25% Cutoff Pool
Result
(31 ng/mL) |
|----------------------|-------------------------|------------------------------------------|------------------------------------------|
| Acetone | 1.0 g/dL | Negative | Positive |
| Ascorbic Acid | 0.75 g/dL | Negative | Positive |
| Conjugated bilirubin | 0.25 mg/dL | Negative | Positive |
| Creatinine | 0.5 g/dL | Negative | Positive |
| Ethanol | 1.0 g/dL | Negative | Positive |
| Gamma Globulin | 0.5 g/dL | Negative | Positive |
| Galactose | 0.01 g/dL | Negative | Positive |
| Glucose | 2.0 g/dL | Negative | Positive |
| Hemoglobin | 115 mg/dL | Negative | Positive |
| Human Serum Albumin | 0.5 g/dL | Negative | Positive |
| Oxalic Acid | 0.1 g/dL | Negative | Positive |
| Riboflavin | 7.5 mg/dL | Negative | Positive |
13
| Sodium Azide | 1% (w/v) | Negative | Positive |
|---|---|---|---|
| Sodium Chloride | 1.5 g/dL | Negative | Positive |
| Sodium Fluoride | 1% (w/v) | Negative | Positive |
| Urea | 6.0 g/dL | Negative | Positive |
Specificity
Interference was determined in accordance with CLSI Document EP07. The interference of structurally unrelated compounds and common over the counter drugs was evaluated qualitatively at the concentrations listed below. The compounds were spiked into two levels of controls at ±25% (19 ng/mL and 31 ng/mL) of the cutoff concentration. At the stated concentration, the sample did not give a false response relative to the 25 ng/mL cutoff.
Structurally Unrelated Compounds
| Compound | Concentration
Tested | -25% Cutoff Pool
Result
(19 ng/mL) | +25% Cutoff Pool
Result
(31 ng/mL) |
|--------------------------------------------------------------|-------------------------|------------------------------------------|------------------------------------------|
| Acetaminophen | 500,000 ng/mL | Negative | Positive |
| I-a-AcetyImethadol (LAAM) | 25,000 ng/mL | Negative | Positive |
| N-Acetyl procainamide (NAPA) | 100,000 ng/mL | Negative | Positive |
| AcetyIsalicylic Acid | 500,000 ng/mL | Negative | Positive |
| Amitriptyline | 8,750 ng/mL | Negative | Positive |
| S-(+)-Amphetamine | 100,000 ng/mL | Negative | Positive |
| Benzoylecgonine | 100,000 ng/mL | Negative | Positive |
| Boric Acid | 1% (w/v) | Negative | Positive |
| Buprenorphine | 100,000 ng/mL | Negative | Positive |
| Caffeine | 500,000 ng/mL | Negative | Positive |
| Cannabinol | 100,000 ng/mL | Negative | Positive |
| Carbamazepine | 100,000 ng/mL | Negative | Positive |
| Chlordiazepoxide | 100,000 ng/mL | Negative | Positive |
| Cimetidine | 100,000 ng/mL | Negative | Positive |
| Clonidine | 100,000 ng/mL | Negative | Positive |
| Codeine | 25,000 ng/mL | Negative | Positive |
| Cotinine | 100,000 ng/mL | Negative | Positive |
| Desipramine | 75,000 ng/mL | Negative | Positive |
| Dextrorphan | 781 ng/mL | Negative | Positive |
| Diazepam | 100,000 ng/mL | Negative | Positive |
| Digoxin | 100,000 ng/mL | Negative | Positive |
| 2-Ethylidene-1,5-dimethyl-3,3-
diphenylpyrrolidine (EDDP) | 12,500 ng/mL | Negative | Positive |
| EMDP | 100,000 ng/mL | Negative | Positive |
| 1R,2S-Ephedrine | 100,000 ng/mL | Negative | Positive |
| Compound | Concentration
Tested | -25% Cutoff Pool
Result
(19 ng/mL) | +25% Cutoff Pool
Result
(31 ng/mL) |
| 1S,2R-Ephedrine | 100,000 ng/mL | Negative | Positive |
| Fluoxetine | 75,000 ng/mL | Negative | Positive |
| Flurazepam | 50,000 ng/mL | Negative | Positive |
| Glutethimide | 100,000 ng/mL | Negative | Positive |
| Haloperidol | 100,000 ng/mL | Negative | Positive |
| Heroin | 25,000 ng/mL | Negative | Positive |
| Hydrocodone | 25,000 ng/mL | Negative | Positive |
| lbuprofen | 500,000 ng/mL | Negative | Positive |
| Ketamine | 75,000 ng/mL | Negative | Positive |
| Ketorolac Tromethamine | 100,000 ng/mL | Negative | Positive |
| Lidocaine | 100,000 ng/mL | Negative | Positive |
| Lorazepam | 100,000 ng/mL | Negative | Positive |
| Lormetazepam | 100,000 ng/mL | Negative | Positive |
| LSD | 100,000 ng/mL | Negative | Positive |
| MDMA | 100,000 ng/mL | Negative | Positive |
| Meperidine | 1,563 ng/mL | Negative | Positive |
| Methadone | 50,000 ng/mL | Negative | Positive |
| S(+) - Methamphetamine | 100,000 ng/mL | Negative | Positive |
| Methaqualone | 100,000 ng/mL | Negative | Positive |
| Morphine | 75,000 ng/mL | Negative | Positive |
| Naproxen | 100,000 ng/mL | Negative | Positive |
| Nordiazepam | 100,000 ng/mL | Negative | Positive |
| Nortriptyline | 75,000 ng/mL | Negative | Positive |
| Oxazepam | 100,000 ng/mL | Negative | Positive |
| Oxycodone | 100,000 ng/mL | Negative | Positive |
| Phenobarbital | 100,000 ng/mL | Negative | Positive |
| Phenylephrine | 100,000 ng/mL | Negative | Positive |
| Phenytoin | 100,000 ng/mL | Negative | Positive |
| Promethazine | 3,125 ng/mL | Negative | Positive |
| Propoxyphene | 100,000 ng/mL | Negative | Positive |
| Propranolol | 100,000 ng/mL | Negative | Positive |
| Protriptyline | 75,000 ng/mL | Negative | Positive |
| R,R - Pseudoephedrine | 100,000 ng/mL | Negative | Positive |
| S,S - Pseudoephedrine | 100,000 ng/mL | Negative | Positive |
| Ranitidine | 100,000 ng/mL | Negative | Positive |
| Ritalinic Acid | 100,000 ng/mL | Negative | Positive |
| Salicylic Acid | 100,000 ng/mL | Negative | Positive |
| Compound | Concentration
Tested | -25% Cutoff Pool
Result
(19 ng/mL) | +25% Cutoff Pool
Result
(31 ng/mL) |
| Scopolamine | 100,000 ng/mL | Negative | Positive |
| Secobarbital | 100,000 ng/mL | Negative | Positive |
| Tapentadol | 50,000 ng/mL | Negative | Positive |
| 11-nor-Δ9-THC-9-COOH | 100,000 ng/mL | Negative | Positive |
| Tramadol | 50,000 ng/mL | Negative | Positive |
| Trazodone | 100,000 ng/mL | Negative | Positive |
| Tyramine | 100,000 ng/mL | Negative | Positive |
| Verapamil | 60,000 ng/mL | Negative | Positive |
| Zidovudine (AZT) | 100,000 ng/mL | Negative | Positive |
| Zolpidem | 100,000 ng/mL | Negative | Positive |
14
15
1
Structurally Related Compounds
| Compound | Concentration
Tested
(ng/mL) | Mean
Observed Pcp
Response
(ng/mL) | Cross-Reactivity
% |
|-----------------------------------------------------------------|------------------------------------|---------------------------------------------|-----------------------|
| Chloropromazine | 100,000 | 24.0 | 0.0 |
| Clomipramine | 100,000 | 20.8 | 0.0 |
| Cyclobenzaprine | 25,000 | 7.0 | 0.0 |
| Dextromethorphan | 80,000 | 22.6 | 0.0 |
| Diphenhydramine | 100,000 | 10.8 | 0.0 |
| Doxepin | 90,000 | 13.2 | 0.0 |
| Imipramine | 100,000 | 16.2 | 0.0 |
| Methoxetamine | 36,000 | 14.0 | 0.0 |
| 4-Methoxyphencyclidine | 700 | 59.4 | 8.5 |
| Thioridazine | 100,000 | 48.4 | 0.0 |
| Venlafaxine | 100,000 | 7.2 | 0.0 |
| РСР | 25 | 24.2 | 96.8 |
| 1-(4-Hydroxypiperidino)phenylcyclohexane | 419 | 26.0 | 6.2 |
| 1-(1-Phenylcyclohexyl)pyrrolidine (PCPy)
(Rolicyclidine) | 54 | 83.4 | 154.4 |
| 1-[1-(2-Thienyl)-cyclohexyl]piperidine (TCP)
(Tenocyclidine) | 37 | 7.0 | 18.9 |
| trans-4-phenyl-4-Piperidinocyclohexanol | 32 | 59.0 | 184.4 |
16
Specific Gravity and pH
Negative urine pools with specific gravity values ranging from 1.000–1.030 and pH values ranging from 3–10 were tested in the presence of two levels of controls at ±25% of the cutoff concentration (19 ng/mL and 31 ng/mL). No interference was observed.
Standardization
The Atellica CH Pcp assay is traceable to the Emit Calibrators/Controls which are referenced to gravimetrically prepared standards. These standards are qualified by GC/MS from an independent laboratory and must quantitate within ±10% of nominal.
17
8.2. Atellica CH Vanc
Detection Capability
Detection capability was determined in accordance with CLSI Document EP17-A2. The assay is designed to have a limit of blank (LoB) 10% is considered interference. Analyte results should not be corrected based on this bias.
| Substance | Substance Test Concentration
Common Units (SI Units) | Analyte Concentration
µg/mL (μmol/L) | Percent Biasa |
|------------------------------|---------------------------------------------------------|-----------------------------------------|---------------|
| Hemoglobin | 1000 mg/dL (10.0 g/L) | 9.4 (6.5) | 2 |
| Hemoglobin | 1000 mg/dL (10.0 g/L) | 38.1 (26.3) | 6 |
| Bilirubin, conjugated | 30 mg/dL (513 μmol/L) | 9.2 (6.3) | 0 |
| Bilirubin, conjugated | 30 mg/dL (513 μmol/L) | 37.1 (25.6) | 1 |
| Bilirubin, unconjugated | 30 mg/dL (513 μmol/L) | 9.5 (6.6) | -2 |
| Bilirubin, unconjugated | 30 mg/dL (513 μmol/L) | 39.1 (27.0) | -1 |
| Lipemia (Intralipid®) | 2000 mg/dL (20.0 g/L) | 9.7 (6.7) | 8 |
| Lipemia (Intralipid®) | 2000 mg/dL (20.0 g/L) | 37.1 (25.6) | 6 |
| Lipemia (from trig fraction) | 2000 mg/dL (20.0 g/L) | 9.9 (6.8) | 6 |
| Lipemia (from trig fraction) | 2000 mg/dL (20.0 g/L) | 38.4 (26.5) | 8 |
a Analyte results should not be corrected based on this bias.
Non-Interfering Substances
The following substances do not interfere with the Atellica CH Vanc assay when present in serum and lithium plasma at the concentrations indicated in the table below. Bias due to these substances is ≤ 10% at an analyte concentration of 10.0 and 40.0 µg/mL (6.9 and 27.6 µmol/L).
| Substance | Substance Test Concentration
Common Units (SI Units) | Percent Bias |
|----------------------|---------------------------------------------------------|--------------|
| Acetaminophen | 20 mg/dL (1323 $ \mu $ mol/L) | ≤ 10% |
| Acetylsalicylic Acid | 50 mg/dL (2778 $ \mu $ mol/L) | ≤ 10% |
| Amikacin | 100 $ \mu $ g/mL (171 $ \mu $ mol/L) | ≤ 10% |
| Substance | Substance Test Concentration
Common Units (SI Units) | Percent Bias |
| Amobarbital | 10 mg/dL (442 µmol/L) | ≤ 10% |
| Ampicillin | 5 mg/dL (143 µmol/L) | ≤ 10% |
| Ascorbic Acid | 3 mg/dL (170.3 µmol/L) | ≤ 10% |
| Caffeine | 10 mg/dL (515 µmol/L) | ≤ 10% |
| Carbamazepine | 12 mg/dL (508 µmol/L) | ≤ 10% |
| Cefazolin | 500 µg/mL (1100 µmol/L) | ≤ 10% |
| Cefotaxime | 1000 µg/mL (2195 µmol/L) | ≤ 10% |
| Chloramphenicol | 100 µg/mL (309 µmol/L) | ≤ 10% |
| Chlordiazepoxide | 2 mg/dL (67 µmol/L) | ≤ 10% |
| Chlorpromazine | 5 mg/dL (157 µmol/L) | ≤ 10% |
| Cimetidine | 10 mg/dL (396 µmol/L) | ≤ 10% |
| Clindamycin | 300 µg/dL (675 µmol/L) | ≤ 10% |
| Codeine | 10 mg/dL (334 µmol/L) | ≤ 10% |
| Creatinine | 30 mg/dL (2652 µmol/L) | ≤ 10% |
| Dextran 40 | 6000 mg/dL (1500 µmol/L) | ≤ 10% |
| Dextran 70 | 2500 mg/dL (357 µmol/L) | ≤ 10% |
| Diazepam | 4 mg/dL (140 µmol/L) | ≤ 10% |
| Digoxin | 5 ng/dL (6.4 nmol/L) | ≤ 10% |
| Erythromycin | 20 mg/dL (273 µmol/L) | ≤ 10% |
| Ethanol | 350 mg/dL (76 mmol/L) | ≤ 10% |
| Ethosuximide | 30 mg/dL (2125 µmol/L) | ≤ 10% |
| Furosemide | 2 mg/dL (61 µmol/L) | ≤ 10% |
| Fusidic Acid | 500 µg/mL (968 µmol/L) | ≤ 10% |
| Gentamicin | 12 mg/dL (25 µmol/L) | ≤ 10% |
| Heparin (Porcine) | 8000 U/L (8000 U/L) | ≤ 10% |
| Ibuprofen | 40 mg/dL (1939 µmol/L) | ≤ 10% |
| Substance | Substance Test Concentration
Common Units (SI Units) | Percent Bias |
| Lidocaine | 6 mg/dL (256 µmol/L) | ≤ 10% |
| Lithium | 3.5 mg/dL (5.04 mmol/L) | ≤ 10% |
| Methicillin | 500 µg/mL (1318 µmol/L) | ≤ 10% |
| Netilmicin | 500 µg/mL (1050 µmol/L) | ≤ 10% |
| Nicotine | 2 mg/dL (123 µmol/L) | ≤ 10% |
| Penicillin V | 80 mg/dL (2247 µmol/L) | ≤ 10% |
| Pentobarbital | 10 mg/dL (442 µmol/L) | ≤ 10% |
| Phenobarbital | 15 mg/dL (646 µmol/L) | ≤ 10% |
| Phenytoin | 10 mg/dL (396 µmol/L) | ≤ 10% |
| Primidone | 10 mg/dL (458 µmol/L) | ≤ 10% |
| Propoxyphene | 0.4 mg/dL (12 µmol/L) | ≤ 10% |
| Protein - Albumin | 12 g/dL (120 g/L) | ≤ 10% |
| Protein - IgG | 5 g/dL (50 g/L) | ≤ 10% |
| Protein - Total | 12 g/dL (120 g/L) | ≤ 10% |
| Rheumatoid Factor | 1465 IU/L (1465 IU/L) | ≤ 10% |
| Rifampin | 50 µg/mL (61 µmol/L) | ≤ 10% |
| Salicylic Acid | 50 mg/dL (3.62 mmol/L) | ≤ 10% |
| Secobarbital | 5 mg/dL (209.8 µmol/L) | ≤ 10% |
| Sodium Fluoride | 1 mg/dL (0.24 mmol/L) | ≤ 10% |
| Sulfamethoxazole | 25 µg/mL (99 µmol/L) | ≤ 10% |
| Theophylline | 25 mg/dL (1388 µmol/L) | ≤ 10% |
| Tobramycin | 100 µg/mL (214 µmol/L) | ≤ 10% |
| Trimethoprim | 25 µg/mL (86 µmol/L) | ≤ 10% |
| Urea | 500 mg/dL (83.3 mmol/L) | ≤ 10% |
| Uric Acid | 20 mg/dL (1.2 mmol/L) | ≤ 10% |
| Valproic Acid | 50 mg/dL (3467 µmol/L) | ≤ 10% |
20
21
Standardization
The Atellica CH Vanc assay is traceable to United States Pharmacopeia (USP) material. Assigned values for calibrators are traceable to this standardization
22
9. CONCLUSION
The candidate devices are substantially equivalent to the Predicate devices and yields substantially equivalent Performance Characteristics. The performance data demonstrates that the devices provide consistent, reproducible, and accurate results and raises no concerns about Safety and Effectiveness.