(361 days)
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 chromatography-mass 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.
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.
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.
This document describes the analytical performance of two in vitro diagnostic (IVD) assays, the Atellica® CH Phencyclidine (Pcp) assay and the Atellica® CH Vancomycin (Vanc) assay, and does not contain information related to AI/ML clinical studies or multi-reader multi-case (MRMC) comparative effectiveness studies. Therefore, it is not possible to address acceptance criteria and study designs typically found in AI/ML performance evaluations (e.g., sample size for training/test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, etc.).
However, I can extract and present the analytical performance criteria and reported device performance based on the provided text, which are relevant for IVD devices.
Analytical Acceptance Criteria and Reported Device Performance
Atellica® CH Phencyclidine (Pcp) Assay
This assay is for qualitative or semi-quantitative analysis of phencyclidine in human urine. The primary "acceptance" is demonstrated through agreement with a confirmatory method (GC/MS) and robust precision and recovery.
Table 1: Atellica® CH Phencyclidine (Pcp) Assay - Analytical Performance
| Acceptance Criteria / Performance Characteristic | Reported Device Performance (Pcp Assay) |
|---|---|
| Qualitative and Semiquantitative Accuracy (vs. GC/MS) | Agreement Summary:- Overall POS agreement: 95% (19 true positives + 81 high positives / 108 total positives by Atellica CH)- Overall NEG agreement: 94% (42 low negatives + 7 negatives / 54 total negatives by Atellica CH)Discordant Results (Atellica CI Pcp vs GC/MS cut-off 25 ng/mL):- Atellica POS, GC/MS NEG: Samples 47 (27 ng/mL vs 18.0 ng/mL), 51 (30 ng/mL vs 24.2 ng/mL), 52 (26 ng/mL vs 24.8 ng/mL) - 3 false positives relative to GC/MS cut-off- Atellica NEG, GC/MS POS: Samples 53 (21 ng/mL vs 25.8 ng/mL), 54 (20 ng/mL vs 26.7 ng/mL), 56 (22 ng/mL vs 27.6 ng/mL), 57 (24 ng/mL vs 27.8 ng/mL), 58 (24 ng/mL vs 28.5 ng/mL) - 5 false negatives relative to GC/MS cut-off |
| Precision (Repeatability) | Overall Low CV% (e.g., 2.2% at 18.75 ng/mL, 2.4% at 25 ng/mL, 2.8% at 31.25 ng/mL)- 0 ng/mL: SD 0.1, N/A CV- 6.25 ng/mL: SD 0.4, 6.7% CV- 12.5 ng/mL: SD 0.4, 3.3% CV- 18.75 ng/mL: SD 0.4, 2.2% CV- 25 ng/mL (Cutoff): SD 0.6, 2.4% CV- 31.25 ng/mL: SD 0.9, 2.8% CV- 37.5 ng/mL: SD 0.9, 2.3% CV- 43.75 ng/mL: SD 1.1, 2.6% CV- 50 ng/mL: SD 1.7, 3.3% CV |
| Precision (Within-Lab) | Overall Low CV% (e.g., 4.4% at 18.75 ng/mL and 25 ng/mL, 5.3% at 31.25 ng/mL)- 0 ng/mL: SD 0.20, N/A CV- 6.25 ng/mL: SD 0.6, 10.0% CV- 12.5 ng/mL: SD 0.6, 5.0% CV- 18.75 ng/mL: SD 0.8, 4.4% CV- 25 ng/mL (Cutoff): SD 1.1, 4.4% CV- 31.25 ng/mL: SD 1.7, 5.3% CV- 37.5 ng/mL: SD 2.3, 5.9% CV- 43.75 ng/mL: SD 2.5, 5.8% CV- 50 ng/mL: SD 3.7, 7.1% CV |
| Reproducibility (Total) | Overall Low CV% (e.g., 6.1% for Urine QC 1, 5.8% for Urine QC 2, 6.5% for Urine QC 3)- Urine QC 1 (18 ng/mL): SD 1.1, 6.1% CV- Urine QC 2 (24 ng/mL): SD 1.4, 5.8% CV- Urine QC 3 (34 ng/mL): SD 2.2, 6.5% CV |
| Recovery | Mean Recovery ranging from 90% to 107% across various concentrations. - 0 ng/mL: 0 ng/mL (N/A %)- 4 ng/mL: 4 ng/mL (101 %)- 5 ng/mL: 5 ng/mL (100 %)- 10 ng/mL: 9 ng/mL (90 %)- 15 ng/mL: 15 ng/mL (100 %)- 20 ng/mL: 19 ng/mL (95 %)- 25 ng/mL: 24 ng/mL (96 %)- 30 ng/mL: 30 ng/mL (100 %)- 40 ng/mL: 43 ng/mL (107 %)- 60 ng/mL: 64 ng/mL (107 %)- 80 ng/mL: 82 ng/mL (103 %) |
| Endogenous Substances Interference | No false response relative to the 25 ng/mL cutoff for tested substances (Acetone, Ascorbic Acid, Conjugated bilirubin, Creatinine, Ethanol, Gamma Globulin, Galactose, Glucose, Hemoglobin, Human Serum Albumin, Oxalic Acid, Riboflavin, Sodium Azide, Sodium Chloride, Sodium Fluoride, Urea) at specified concentrations when spiked into control pools (19 ng/mL and 31 ng/mL). |
| Specificity (Structurally Unrelated Compounds) | No false response relative to the 25 ng/mL cutoff for listed structurally unrelated compounds (e.g., Acetaminophen, Amitriptyline, Caffeine, Ibuprofen, etc.) at specified concentrations when spiked into control pools (19 ng/mL and 31 ng/mL). |
| Specificity (Structurally Related Compounds - Cross-Reactivity) | Values range from 0.0% to 184.4% for structurally related compounds, indicating varying levels of cross-reactivity. Notably, 1-(1-Phenylcyclohexyl)pyrrolidine (PCPy) showed 154.4% and trans-4-phenyl-4-Piperidinocyclohexanol showed 184.4% cross-reactivity. This typically means these compounds may cause a positive result even if PCP itself is not present, emphasizing the need for confirmatory testing. |
| Specific Gravity and pH Interference | No interference observed for negative urine pools with specific gravity 1.000–1.030 and pH 3–10, when tested at ±25% of the cutoff concentration. |
| Standardization Traceability | Traceable to Emit Calibrators/Controls, which are referenced to gravimetrically prepared standards qualified by GC/MS from an independent laboratory (within ±10% of nominal). |
Atellica® CH Vancomycin (Vanc) Assay
This assay is for quantitative measurement of vancomycin in human serum and plasma.
Table 2: Atellica® CH Vancomycin (Vanc) Assay - Analytical Performance
| Acceptance Criteria / Performance Characteristic | Reported Device Performance (Vanc Assay) |
|---|---|
| Limit of Detection (LoD) | LoD ≤ 1.0 µg/mL. Reported LoD is 1.0 µg/mL (0.7 µmol/L). The Limit of Blank (LoB) is 0.6 µg/mL (0.4 µmol/L). |
| Limit of Quantitation (LoQ) | LoQ ≤ 3.0 µg/mL. Reported LoQ is 3.0 µg/mL (2.1 µmol/L) (defined by total allowable error ≤ 20%). |
| Precision (Repeatability) | Overall Low CV% (e.g., 0.8% - 2.3%).- Serum QC 1 (6.1 µg/mL): SD 0.14, 2.3% CV- Serum 1 (13.4 µg/mL): SD 0.13, 1.0% CV- Serum QC 2 (19.5 µg/mL): SD 0.15, 0.8% CV- Serum QC 3 (32.6 µg/mL): SD 0.34, 1.0% CV- Serum 2 (46.1 µg/mL): SD 0.54, 1.2% CV |
| Precision (Within-Laboratory) | Overall Low CV% (e.g., 1.5% - 2.8%).- Serum QC 1 (6.1 µg/mL): SD 0.17, 2.8% CV- Serum 1 (13.4 µg/mL): SD 0.20, 1.5% CV- Serum QC 2 (19.5 µg/mL): SD 0.33, 1.7% CV- Serum QC 3 (32.6 µg/mL): SD 0.61, 1.9% CV- Serum 2 (46.1 µg/mL): SD 0.89, 1.9% CV |
| Reproducibility (Total) | Overall Low CV% (e.g., 1.8% - 4.0%).- Serum QC 1 (6.0 µg/mL): SD 0.24, 4.0% CV- Serum 1 (13.4 µg/mL): SD 0.27, 2.0% CV- Serum QC 2 (19.7 µg/mL): SD 0.38, 1.9% CV- Serum QC 3 (32.9 µg/mL): SD 0.62, 1.9% CV- Serum 2 (45.9 µg/mL): SD 0.81, 1.8% CV |
| Assay Comparison (Correlation vs. Predicate) | Correlation coefficient ≥ 0.980 and slope 1.00 ± 0.10.- Regression Equation: y = 0.97x + 0.3 µg/mL (y = 0.97x + 0.2 µmol/L)- Correlation coefficient (r): 0.999 (for 107 serum samples in range 4.1–45.9 µg/mL). Meets criteria. |
| Specimen Equivalency (Serum vs. Plasma (Lithium Heparin)) | Demonstrated equivalency between plasma and serum.- Regression Equation: y = 1.00x - 0.1 µg/mL (y = 1.00x - 0.7 µmol/L)- Correlation coefficient (r): 0.996 (for 50 samples in range 4.5–43.9 µg/mL). |
| Interferences (Hemolysis, Icterus, Lipemia - HIL) | ≤ 10% bias.- Hemoglobin (1000 mg/dL): 2% and 6% bias at two analyte levels.- Bilirubin, conjugated (30 mg/dL): 0% and 1% bias.- Bilirubin, unconjugated (30 mg/dL): -2% and -1% bias.- Lipemia (Intralipid® 2000 mg/dL): 8% and 6% bias.- Lipemia (from trig fraction 2000 mg/dL): 6% and 8% bias. All results meet the <10% bias criteria. |
| Interferences (Non-Interfering Substances) | ≤ 10% bias for listed substances (e.g., Acetaminophen, Amikacin, Caffeine, Gentamicin, Ibuprofen, etc.) at specified concentrations when tested at 10.0 and 40.0 µg/mL analyte concentrations. All results meet the ≤ 10% bias criteria. |
| Standardization Traceability | Traceable to United States Pharmacopeia (USP) material. |
Regarding the other points relevant to AI/ML studies:
Since the provided text describes the analytical validation of in vitro diagnostic assays (chemical laboratory tests) and not an AI/ML-driven medical device, the following points are not applicable and thus cannot be addressed from the given information:
- Sample sizes used for the test set and the data provenance: Not an AI/ML device. The "test set" for the Pcp assay was 157 samples compared against GC/MS. For Vanc, various sample numbers were used for different analytical performance tests (e.g., 107 for assay comparison, 50 for specimen equivalency, 80 for precision studies). Data provenance is not specified (e.g., country of origin, retrospective/prospective).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable; ground truth is established by a reference analytical method (GC/MS for Pcp) or by defined reference materials and methods for quantitative assays (USP standards for Vanc).
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. These are lab assays, not AI algorithms.
- The type of ground truth used:
- For Atellica® CH Phencyclidine (Pcp) assay: The ground truth for accuracy was established using Gas Chromatography/Mass Spectrometry (GC/MS) as the reference method.
- For Atellica® CH Vancomycin (Vanc) assay: The ground truth/standardization is traceable to United States Pharmacopeia (USP) standards.
- The sample size for the training set: Not applicable. These assays are laboratory tests and do not involve "training sets" in the AI/ML sense. Validation is performed using established analytical testing protocols with various spiked and clinical samples.
- How the ground truth for the training set was established: Not applicable.
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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
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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
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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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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
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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.
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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 CHAnalyzer | NewDevice:Atellica CH Phencyclidine(Pcp) on Atellica Cl Analyzer |
|---|---|---|
| Intended Use : | The Atellica CHPhencyclidine (Pcp) assayis for in vitro diagnostic usein the qualitative orsemiquantitative analysesof phencyclidine in humanurine using the Atellica CHAnalyzer, using a cutoff of25 ng/mL. The Pcp assayprovides only a preliminaryanalytical test result. Amore specific alternativechemical method must beused to obtain a confirmedanalytical result. Gaschromatography/massspectrometry (GC/MS) isthe preferred confirmatorymethod. The semi- | The Atellica CHPhencyclidine (Pcp) assayis for in vitro diagnostic usein the qualitative orsemiquantitative analysesof phencyclidine in humanurine using the Atellica ClAnalyzer, using a cutoff of25 ng/mL. The Pcp assayprovides only a preliminaryanalytical test result. Amore specific alternativechemical method must beused to obtain a confirmedanalytical result. Gaschromatography/massspectrometry (GC/MS) isthe preferred confirmatorymethod. The semi- |
| quantitative mode is forpurposes of enablinglaboratories to determinean appropriate dilution ofthe specimen forconfirmation by aconfirmatory method suchas gaschromatography/mass-spectrometry (GC-MS) orliquidchromatography/tandemmass spectrometry (LC-MS/MS) or permittinglaboratories to establishquality control procedures.Clinical consideration andprofessional judgmentshould be applied to anydrug-of- abuse test result,particularly whenpreliminary positive resultsare used. | quantitative mode is forpurposes of enablinglaboratories to determinean appropriate dilution ofthe specimen forconfirmation by aconfirmatory method suchas gaschromatography/massspectrometry (GC-MS) orliquidchromatography/tandemmass spectrometry (LC-MS/MS) or permittinglaboratories to establishquality control procedures.Clinical consideration andprofessional judgmentshould be applied to anydrug-of-abuse test result,particularly whenpreliminary positive resultsare used | |
| Type of Product: | Analytical Reagents | Same |
| Measured Analyte: | Pcp | Same |
| Test Matrix: | Urine | Same |
| Device Technology: | Enzyme Immunoassay | Same |
| Materials: | Matched lots of polyclonalantibody reactive tophencyclidine andphencyclidine labeled withglucose-6-phosphatedehydrogenase are used inthis Syva® Emit® II Plusmethodology. | Same |
| Cutoff Levels: | 25 ng/mL PCP | Same |
| ConfirmatoryMethod: | Gas Chromatography/massspectrometry | Same |
| CalibrationFrequency: | 60 days | 130 days |
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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 CIAnalyzer |
|---|---|---|
| Intended Use : | The Trinidad CH Vancomycin(Vanc) assay is for in vitrodiagnostic use in thequantitative measurement ofvancomycin in human serumand plasma (lithium heparin)using the Trinidad CHSystem. | The Atellica CHVancomycin (Vanc) assayis for in vitro diagnosticuse in the quantitativemeasurement ofvancomycin in humanserum and plasma (lithiumheparin) using the AtellicaCI Analyzer. |
| Indications for Use: | Vanc test results may beused in the diagnosis andtreatment of vancomycinoverdose and in monitoringlevels of vancomycin toensure appropriate therapy. | Same |
| Device Technology: | Homogeneous particleenhanced turbidimetricinhibition immunoassay(PETINIA) technique | Same |
| Sample Type: | Serum/ Lithium Heparinplasma | Same |
| Therapeutic Interval: | Peak Intervals: Samples fromadult volunteers drawn twohours after the completion ofa 60-minute infusion ofvancomycin ranged from 18 –26 µg/mL.Samples drawn one hourafter the completion of a 60minute vancomycin infusionranged from 25 – 40 µg/mL.Samples drawn 30 minutesafter the completion of a 60minute infusion of vancomycinranged from 30 – 40 µg/mL.Trough Intervals: Samplesshould be drawn just before thenext dose. A trough interval of 5– 10 µg/mL is generallyconsidered to be effective. | Same |
| Standardization: | Traceable to United StatesPharmacopeia (USP) standards. Same | Same |
| Calibration Frequency: | 30 days | Same |
| Analytical MeasuringInterval: | 3.0 – 50.0 µg/mL | Same |
| Interferences: | Bilirubin (Conjugated &Unconjugated) – 20 mg/dLLipemia (Intralipid®) – 1000mg/dLHemoglobin – 600 mg/dL | Bilirubin (Conjugated &Unconjugated) – 30 mg/dLLipemia (Intralipid®) – 2000mg/dLHemoglobin – 1000 mg/dL |
| Calibrators: | Atellica CH Drug CAL II | Same |
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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% below thecutoff(< 13 ng/mL) | NEGWithin 50% belowthe cutoff(13-24 ng/mL) | POSWithin 50% abovethe cutoff(25-38 ng/mL) | HIGH POS> 50% above thecutoff(> 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 | -/+ |
{11}------------------------------------------------
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) | % ofCutoff | # ofResults | 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 | ConcentrationTested | -25% Cutoff PoolResult(19 ng/mL) | +25% Cutoff PoolResult(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 | ConcentrationTested | -25% Cutoff PoolResult(19 ng/mL) | +25% Cutoff PoolResult(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 | ConcentrationTested | -25% Cutoff PoolResult(19 ng/mL) | +25% Cutoff PoolResult(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 | ConcentrationTested | -25% Cutoff PoolResult(19 ng/mL) | +25% Cutoff PoolResult(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 | ConcentrationTested(ng/mL) | MeanObserved PcpResponse(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) < LoD. a limit of detection (LoD) ≤ 1.0 μg/mL, and a limit of quantitation (LoQ) ≤ 3.0 µg/mL . Assay results obtained at individual laboratories may vary from the data presented.
The LoD corresponds to the lowest concentration of vancomycin that can be detected with a probability of 95%. The LoD for the Atellica CH Vanc assay is 1.0 µg/mL (0.7 µmol/L), and was determined using 450 determinations, with 225 blank and 225 low level replicates, and a LoB of 0.6 µg/mL (0.4 µmol/L). Assay results obtained at individual laboratories may vary from the data presented.
The LoQ corresponds to the lowest amount of analyte in a sample that can be accurately quantitated with a total allowable error ≤ 20%. The LoQ of the Vanc assay is 3.0 µg/mL (2.1 umol/L), and was determined using n=5 replicates per sample that were assayed using 3 reagent lots, over a period of 3 days, using total analytical error definition of bias + 2SD.
Precision
Precision was determined in accordance with CLSI Document EP05-A3. 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). The following results were obtained:
| Sample Type | N | Meanµg/mL (µmol/L) | Repeatability | Within-Laboratory Precision | ||
|---|---|---|---|---|---|---|
| SDaµg/mL (µmol/L) | CVb(%) | SDaµg/mL (µmol/L) | CVb(%) | |||
| Serum QC 1 | 80 | 6.1 (4.2) | 0.14 (0.10) | 2.3 | 0.17 (0.12) | 2.8 |
| Serum 1 | 80 | 13.4 (9.2) | 0.13 (0.09) | 1.0 | 0.20 (0.14) | 1.5 |
| Serum QC 2 | 80 | 19.5 (13.5) | 0.15 (0.10) | 0.8 | 0.33 (0.23) | 1.7 |
| Serum QC 3 | 80 | 32.6 (22.5) | 0.34 (0.23) | 1.0 | 0.61 (0.42) | 1.9 |
| Serum 2 | 80 | 46.1 (31.8) | 0.54 (0.37) | 1.2 | 0.89 (0.61) | 1.9 |
Standard deviation. a
ﻣ Coefficient of variation.
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:
{18}------------------------------------------------
| Repeatability | Between-Day | Between-Instru-ment | Between-Lot | Total Repro-ducibility | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sample | Na | Meanµg/mL(µmol/L) | SDbµg/mL(µmol/L) | CVc(%) | SDµg/mL(µmol/L) | CV(%) | SDµg/mL(µmol/L) | CV(%) | SDµg/mL(µmol/L) | CV(%) | SDµg/mL(µmol/L) | CV(%) |
| Serum QC 1 | 225 | 6.0(4.1) | 0.11(0.1) | 1.8 | 0.18(0.1) | 3.0 | 0.09(0.1) | 1.5 | 0.07(0.0) | 1.2 | 0.24(0.2) | 4.0 |
| Serum 1 | 225 | 13.4(9.2) | 0.12(0.1) | 0.9 | 0.14(0.1) | 1.0 | 0.03(0.0) | 0.2 | 0.19(0.1) | 1.4 | 0.27(0.2) | 2.0 |
| Serum QC 2 | 225 | 19.7(13.6) | 0.16(0.1) | 0.8 | 0.29(0.2) | 1.5 | 0.10(0.1) | 0.5 | 0.15(0.1) | 0.8 | 0.38(0.3) | 1.9 |
| Serum QC 3 | 225 | 32.9(22.7) | 0.22(0.2) | 0.7 | 0.49(0.3) | 1.5 | 0.29(0.2) | 0.9 | 0.09(0.1) | 0.3 | 0.62(0.4) | 1.9 |
| Serum 2 | 225 | 45.9(31.7) | 0.36(0.2) | 0.8 | 0.50(0.3) | 1.1 | 0.48(0.3) | 1.0 | 0.25(0.2) | 0.5 | 0.81(0.6) | 1.8 |
a Number of results.
b Standard deviation.
Coefficient of variation.
Assay Comparison
The Atellica CH Vanc assay is designed to have a correlation coefficient of ≥ 0.980 and a slope of 1.00 ± 0.10 compared to Atellica CH Vanc on Atellica CH Analyzer. Assay comparison was determined using the Deming regression model in accordance with CLSI Document EP09c. The following results were obtained:
| Specimen | Comparative Assay (x) | Regression Equation | Sample Interval | Na | rb |
|---|---|---|---|---|---|
| Serum | Atellica CH Vanc onAtellica CH Analyzer | $y = 0.97x + 0.3 \mu g/mL$( $y = 0.97x + 0.2 \mu mol/L$ ) | 4.1–45.9 µg/mL(2.8–38.6 µmol/L) | 107 | 0.999 |
a Number of samples tested.
b Correlation coefficient.
Specimen Equivalency
Specimen equivalency was determined using the Deming regression model in accordance with CLSI Document EP09c. The following results were obtained:
| Specimen (y) | Reference Specimen (x) | Regression Equation | Sample Interval | Na | rb |
|---|---|---|---|---|---|
| Plasma (Lithium Heparin) | Serum | $y = 1.00x - 0.1 μg/mL$$(y = 1.00x - 0.7 μmol/L)$ | 4.5–43.9 μg/mL(3.1–30.3 μmol/L) | 50 | 0.996 |
a Number of samples tested.
b Correlation coefficient.
{19}------------------------------------------------
Interferences
Hemolysis, Icterus, and Lipemia (HIL)
The Atellica CH Vanc assay is designed to have ≤ 10% interference from hemoglobin, bilirubin, and lipemia. Interfering substances at the levels indicated in the table below were tested in accordance with CLSI Document EP07 using the Atellica CH Vanc assay. Bias is the difference in the results between the control sample (does not contain the interferent) and the test sample (contains the interferent) expressed in percent. Bias > 10% is considered interference. Analyte results should not be corrected based on this bias.
| Substance | Substance Test ConcentrationCommon Units (SI Units) | Analyte Concentrationµg/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 ConcentrationCommon 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 ConcentrationCommon 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 ConcentrationCommon 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.
§ 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.