(234 days)
The Siemens Atellica™ Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. The system is intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology for clinical use.
The Atellica™ A-L YTE Integrated Multisensor (Na, K, Cl) is intended for in vitro diagnostic use in the quantitative determination of sodium, potassium, and chloride (Na, K, Cl) in human serum, plasma, and urine using the Atellica™ CH system. Measurements of sodium obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. Measurements of potassium obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
The Atellica™ CH Albumin BCP Reagent (Alb P) is intended for in vitro diagnostic use in the quantitative measurement of albumin in human serum or plasma on Atellica™ CH system. Albumin measurements are used in the diagnosis and treatment of numerous diseases primarily involving the liver or kidneys.
The Atellica™ IM Thyroid Stimulating Hormone (TSH) assay is for in vitro diagnostic use in the quantitative determination of thyroid-stimulating hormone (TSH, thyrotropin) in human serum, and plasma (EDTA and lithium heparin) using the Atellica™ IM system. Measurements of the thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.
The Atellica™ CH Vancomycin (Vanc) assay is for in vitro diagnostic use in the quantitative measurement of vancomycin in human serum or plasma on the Atellica™ CH System. 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™ Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. The system is intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology for clinical use. The Atellica™ Solution consists of any combination of Atellica Sample Handler component, an Atellica Magline Magnetic Sample Transport system component, Atellica IM and all software and hardware needed to support a customizable array of analyzers. The submission also covers the Atellica™ A-LYTE Integrated Multisensor (Na, K, Cl), Atellica™ CH Albumin BCP Reagent (Alb P), Atellica™ IM Thyroid Stimulating Hormone (TSH) assay, and Atellica™ CH Vancomycin (Vanc) assay, which are reagents/assays used with the Atellica Solution.
The provided document is a 510(k) Premarket Notification from the FDA regarding the Siemens Atellica™ Solution. It details the device's indications for use, its substantial equivalence to predicate devices, and some performance characteristics.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative manner (e.g., "The device must achieve a precision CV of X% or less"). Instead, it demonstrates performance by comparing the new Atellica™ Solution (new device) to the predicate devices (Trinidad IM and CH modules) by showing precision and method comparison studies. The implicit acceptance criterion is that the new device's performance should be comparable to the predicate device, as confirmed by the statistical results (slope, intercept, correlation, and precision CVs falling within generally acceptable laboratory ranges).
Given the nature of this 510(k) submission, the "acceptance criteria" are implied by the performance demonstrated and compared to the established performance of the predicate devices. The clinical relevance of the reported performance is tied to the previously cleared predicate devices.
Implicit Acceptance Criteria (Performance should be comparable to predicate):
| Assay | Performance Metric | Acceptance Range/Goal (Implicitly comparable to predicate) | Reported Device Performance (Atellica™ Solution) |
|---|---|---|---|
| Na | Precision (Serum QC) | CV% typically < 1% for high concentrations | Repeatability CV: 0.3-0.5% |
| Within-Lab CV: 0.4-0.6% | |||
| Method Comparison (Correlation) | Close to 1.00 | 0.999 | |
| Method Comparison (Slope) | Close to 1.00 | 1.00 | |
| Method Comparison (Intercept) | Close to 0.00 | 0.00 | |
| K | Precision (Serum QC) | CV% typically < 1% at higher conc., slightly higher for low | Repeatability CV: 0.2-0.6% |
| Within-Lab CV: 0.4-1.2% | |||
| Method Comparison (Correlation) | Close to 1.00 | 0.999 | |
| Method Comparison (Slope) | Close to 1.00 | 1.00 | |
| Method Comparison (Intercept) | Close to 0.00 | 0.00 | |
| Cl | Precision (Serum QC) | CV% typically < 1% | Repeatability CV: 0.2-0.5% |
| Within-Lab CV: 0.4-0.6% | |||
| Method Comparison (Correlation) | Close to 1.00 | 0.999 | |
| Method Comparison (Slope) | Close to 1.00 (reported as 0.99) | 0.99 | |
| Method Comparison (Intercept) | Close to 0.00 (reported as 1.030) | 1.030 | |
| Albumin | Precision (Serum QC) | CV% typically < 2% | Repeatability CV: 0-1.2% |
| Within-Lab CV: 0-1.3% | |||
| Method Comparison (Correlation) | Close to 1.00 | 0.999 | |
| Method Comparison (Slope) | Close to 1.00 (reported as 0.994) | 0.994 | |
| Method Comparison (Intercept) | Close to 0.00 (reported as -0.006) | -0.006 | |
| Vancomycin | Precision (Serum QC) | CV% typically < 2% | Repeatability CV: 0.7-1.1% |
| Within-Lab CV: 1.1-1.5% | |||
| Method Comparison (Correlation) | Close to 1.00 | 0.997 | |
| Method Comparison (Slope) | Close to 1.00 (reported as 0.988) | 0.988 | |
| Method Comparison (Intercept) | Close to 0.00 (reported as -0.063) | -0.063 | |
| TSH | Precision (Serum QC) | CV% typically < 5-10% (especially at low conc.) | Repeatability CV: 1.3-2.5% |
| Within-Lab CV: 2.1-6.3% | |||
| Method Comparison (Correlation) | Close to 1.00 | 0.992 | |
| Method Comparison (Slope) | Close to 1.00 (reported as 1.02) | 1.02 | |
| Method Comparison (Intercept) | Close to 0.00 (reported as 0.069) | 0.069 |
2. Sample size used for the test set and the data provenance
- Precision Studies:
- Sample Size: N = 25 for each control/serum pool per assay. This means 5 replicates per day over 5 days (5 x 5 = 25).
- Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be prospective, conducted by Siemens Healthcare Diagnostics. The samples are described as "controls and serum pools."
- Method Comparison Studies:
- Sample Size:
- Na: 121
- K: 125
- Cl: 122
- Albumin (Alb_P): 105
- Vancomycin (Vanc): 112
- TSH: 116
- Data Provenance: Not explicitly stated (e.g., country of origin). The studies used "patient samples" as per CLSI EP09-A3. This implies a prospective collection for the purpose of the study or retrospective collection of anonymized patient samples.
- Sample Size:
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This document describes the performance of in-vitro diagnostic (IVD) assays, not the diagnostic performance of an image analysis algorithm or a device requiring human interpretation for ground truth. The "ground truth" for the method comparison studies is the result obtained from the predicate device's analytical modules (Trinidad IM and CH), which are already cleared for clinical use.
4. Adjudication method for the test set
Not applicable. As noted above, this is an IVD assay performance study, not a study requiring adjudication of expert interpretations.
5. 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. This is an IVD device, not an AI-assisted diagnostic tool that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, the performance studies described (Precision and Method Comparison) represent the standalone performance of the Atellica™ Solution analytical modules. There is no human-in-the-loop component mentioned for the analytical measurement process itself. The "device" in this context is the automated analyzer system.
7. The type of ground truth used
The "ground truth" for the method comparison studies is the measurement obtained from the predicate devices (Trinidad IM module and Trinidad CH module as cleared under K151792, K151767, and K160202). The new device's results are compared to these established methods. For precision studies, it's about the reproducibility of the device's own measurements against its internal calibration and controls.
8. The sample size for the training set
Not applicable. This is an IVD instrument and assay system, which does not involve a "training set" in the context of machine learning or AI models. The assays are based on established chemical and immunological principles, with parameters (e.g., calibration curves) set during manufacturing and validated through performance studies.
9. How the ground truth for the training set was established
Not applicable. See point 8.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three stylized human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 9, 2017
SIEMENS HEALTHCARE DIAGNOSTICS JUSTIN DIVALENTINO REGULATORY AFFAIRS SPECIALIST 511 BENEDICT AVENUE TARRYTOWN NY 10591
Re: K161954
Trade/Device Name: Atellica™ Solution, Atellica™ A-LYTE Integrated Multisensor (Na, K, Cl), Atellica™ CH Albumin BCP Reagent (Alb P), Atellica™ IM Thyroid Stimulating Hormone (TSH) assay, Atellica™ CH Vancomycin (Vanc) assay
Regulation Number: 21 CFR 862.1665 Regulation Name: Sodium test system Regulatory Class: II Product Code: JGS, JJE, CEM, CGZ, LEH, CJW, JLW Dated: February 8, 2017 Received: February 9, 2017
Dear Justin DiValentino:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the
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electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kellie B. Kelm -S
for Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K161954
Device Name
Atellicated Solution, Atellicand A-LYTE Integrated Multisensor (Na, K, C), Atellica™ CH Albumin BCP Reagent (Alb P)Atellica™ IM Thyroid Stimulating Hormone (TSH) assay, Atellica™ CH Vancomycin (Vanc) assay
Indications for Use (Describe)
The Siemens Atellica™ Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. The system is intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology for clinical use.
The Atellica™ A-L YTE Integrated Multisensor (Na, K, Cl) is intended for in vitro diagnostic use in the quantitative determination of sodium, potassium, and chloride (Na, K, Cl) in human serum, plasma, and urine using the Atellica™ CH system. Measurements of sodium obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. Measurements of potassium obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
The Atellica™ CH Albumin BCP Reagent (Alb P) is intended for in vitro diagnostic use in the quantitative measurement of albumin in human serum or plasma on Atellica™ CH system. Albumin measurements are used in the diagnosis and treatment of numerous diseases primarily involving the liver or kidneys.
The Atellica™ IM Thyroid Stimulating Hormone (TSH) assay is for in vitro diagnostic use in the quantitative determination of thyroid-stimulating hormone (TSH, thyrotropin) in human serum, and plasma (EDTA and lithium heparin) using the Atellica™ IM system. Measurements of the thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.
The Atellica™ CH Vancomycin (Vanc) assay is for in vitro diagnostic use in the quantitative measurement of vancomycin in human serum or plasma on the Atellica™ CH System. 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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1. 510k Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
1.1.1 510(k) Number: K161954
- 1.1.2 Date of original preparation: July 15, 2016 Date of revised preparation: February 23, 2017
Proprietary and Established Names: 1.1.3
Atellica™ Solution Atellica™ A-LYTE Integrated Multisensor (Na, K, Cl) Atellica™ CH Albumin BCP Reagent (Alb P) Atellica™ IM Thyroid Stimulating Hormone (TSH) assay Atellica™ CH Vancomycin (Vanc) assay
1.1.4 Applicant:
Siemens Healthcare Diagnostics Inc., 511 Benedict Ave, Tarrytown, NY 10591 Justin DiValentino, Regulatory Affairs Specialist and Compliance Office: (914) 524-2280 Fax: (914) 524-3579
1.1.5 Regulatory Information:
| ProductCode | Classification | Regulation Section | Panel |
|---|---|---|---|
| JGS | 21 CFR 862.1665 Sodium Test System | Clinical | |
| CEM | 21 CFR 862.1600 Potassium Test System | Chemistry (75) | |
| CGZ | 21 CFR 862.1170 Chloride Test System | ||
| CJW | 21 CFR 862.1035 Albumin Test System | ||
| JLW | Class II | 21 CFR § 862.1690 Thyroid stimulating hormone test system | ClinicalChemistry (75) |
| LEH | 21 CFR 862.3950; Vancomycin test system | Toxicology (91) | |
| JJE | Class I,exempt | 21 CFR 862.2160 Discrete Photometric AnalyzerChemistry For Clinical Use | ClinicalChemistry (75) |
1.1.6 Predicate Devices:
Trinidad IM module with Direct Load cleared under K151792 for TSH Measurement Trinidad CH module with Direct Load cleared under K151767 for Na, K, Cl and Albumin Measurement Trinidad CH module with Direct Load cleared under K160202 for Vancomycin Measurement
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1.1.7 Device Description:
1.1.7.1 Name change and alignment with prior clearance
The Atellica™ Solution is designed to support the Trinidad immunoassay (IM) analytical module, the Trinidad clinical chemistry (CH) analytical module and reagents cleared under 510(k submission# K151792, K151767 and K160202, respectively. These analytical modules and reagents will be marketed and sold under the name Atellica™ IM and Atellica™ CH.
| Name in prior clearance | Updated name |
|---|---|
| Trinidad Immunoassay (IM) system | Atellica™ IM |
| Trinidad Clinical Chemistry (CC) system | Atellica™ CH |
| Trinidad Clinical Chemistry (CC) Integrated Multisensor (Na, K, Cl) | Atellica™ A-LYTE Integrated Multisensor (Na, K, Cl) |
| Trinidad Clinical Chemistry (CC) Albumin BCP Reagent (Alb_P) | Atellica™ CH Albumin BCP Reagent (Alb_P) |
| Trinidad Clinical Chemistry (CC) IM Thyroid Stimulating Hormone (TSH) assay | Atellica™ IM Thyroid Stimulating Hormone (TSH) assay |
| Trinidad Clinical Chemistry (CC) Vancomycin (Vanc) assay | Atellica™ CH Vancomycin (Vanc) assay |
1.1.7.2 Atellica™ Solution
The Atellica™ Solution consists of any combination of Atellica Sample Handler component, an Atellica Magline Magnetic Sample Transport system component, Atellica IM and all software and hardware needed to support a customizable array of analyzers.
1.1.7.3 Assays
Atellica™ A-LYTE Integrated Multisensor (Na, K, Cl) Atellica™ CH Albumin BCP Reagent (Alb_P) Atellica™ IM Thyroid Stimulating Hormone (TSH) assay Atellica™ CH Vancomycin (Vanc) assay
1.1.8 Intended Use / Indications for Use:
The Siemens Atellica™ Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. The system is intended for the qualitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selectrode technology for clinical use.
The Atellica™ A-LYTE Integrated Multisensor (Na, K, Cl) is intended for in vitro diagnostic use in the quantitative determination of sodium, potassium, and chloride (Na, K, Cl) in human serum, plasma, and urine using the Atellica™ CH system. Measurements of sodium obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. Measurements of potassium obtained by this device are used to monitor electrolyte balance in the
{6}------------------------------------------------
diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
The Atellica™ CH Albumin BCP Reagent (Alb P) is intended for in vitro diagnostic use in the quantitative measurement of albumin in human serum or plasma on Atellica™ CH system. Albumin measurements are used in the diagnosis and treatment of numerous diseases primarily involving the liver or kidneys.
The Atellica™ IM Thyroid Stimulating Hormone (TSH) assay is for in vitro diagnostic use in the guantitative determination of thyroid-stimulating hormone (TSH, thyrotropin) in human serum, and plasma (EDTA and lithium heparin) using the Atellica™ IM system. Measurements of the thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.
The Atellica™ CH Vancomycin (Vanc) assay is for in vitro diagnostic use in the quantitative measurement of vancomycin in human serum or plasma on the Atellica™ CH System. Vanc test results may be used in the diagnosis and treatment of vancomycin overdose and in monitoring levels of vancomycin to ensure appropriate therapy.
1.1.9 Substantial Equivalence Information:
The Atellica Solution (New Device) and the Trinidad IM analyzer (Predicate Device cleared under K151792 for chemiluminescence technology) as well as the Trinidad CH analyzer (Predicate Device cleared under K151767 for ion selective electrode and photometric technology, and K160202 for turbidimetric technology) employ the same prepackaged reagents for use on automated test systems. The Intended Use / Indications for Use, Assay Principle and reagent formulations are the same. The major differences between the New and Predicate Devices are the sample loading and transport system as well as the ability to configure multiple analyzers. The New Device sample loading and transport system delivers the sample to the analytical module and does not pipet the sample to the analytical module nor perform any analytical pipetting. A comparison of the important similarities and differences of these systems are shown in the following tables:
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1.1.9.1 System
1.1.9.1.1 Analytical module similarities and differences
| Feature | Predicate Device: (K151767)Trinidad CH module (K151792) TrinidadIM module with Direct Load | New Device:Atellica Solution configured with theAtellica CH and Atellica IM module |
|---|---|---|
| Intended Use | For in vitro diagnostic use in thequantitative determination of sodium,potassium and chloride (Na, K, Cl) inhuman serum, plasma and urine andthe quantitative measurement ofVancomycin (Vanc) and Albumin(Alb_P) in human serum or plasma onthe Trinidad CH module, and thyroid-stimulating hormone (TSH,thyrotropin) in serum, heparinizedplasma, and EDTA plasma using theTrinidad IM system | Same |
| Cleared Assays | Sodium, Potassium, Chloride, AlbuminVancomycin, and thyroid-stimulating hormone | Same |
| Type of System | Random continuous access, batch,discrete processing | Same |
| Types ofMeasurements | Electrolyte, Photometric ,Turbidimetric - CH moduleChemiluminescence using magnetic-particle solid phase andchemiluminescent label - IM module | Same |
| Optical system | Water bath and cuvette optical pathlength (7 mm) - CH modulePMT used in photon counting mode -IM module | Same |
| Feature | Predicate Device: (K151767)Trinidad CH module (K151792) TrinidadIM module with Direct Load | New Device:Atellica Solution configured with theAtellica CH and Atellica IM module |
| Throughput Rate | 1800 tests/hour, 1200 tests/hourcolorimetric, 600 tests/hour ISE - CHmodule250 to 450 tests/hr - IM module | Same |
| Assay Capacity On-board | Up to 70 slots including 3 ISE | Same |
| Sample Handling | ||
| Sample Containers | Tubes - 5 mL, 7 mL, 10 mL Cups - 2 mLsample cups | Same |
| Sample Type | Whole blood, serum, plasma, CSF orurine | Same |
| Sample Tray | Samples identified and delivered byDirect Load - 60 positions | Samples identified and delivered byAtellica Sample Handler/Magline |
| Bar Codes | Same with addition of reagent packdata matrix 2D | Same |
| Dedicated STATPositions | All samples can be Stat processed.(Not dedicated) | Same |
| Universal RackHandler (URH) Option | Samples delivered byDirect load | Samples identified and delivered byAtellica Sample Handler/Magline |
| Auto-repeat | Automatic repeat testing from theretained pre-diluted sample. | Same |
| Auto-dilution | Automatic dilution from retained pre-diluted sample | Same |
| Liquid Level Sensing | Capacitance technology - CH moduleAir pressure fluid sensing anddisposable tip sensing; clog detectionmechanism to alert operator toclogged sample probe – IM module | Same |
| Feature | Predicate Device: (K151767)Trinidad CH module (K151792) TrinidadIM module with Direct Load | New Device:Atellica Solution configured with theAtellica CH and Atellica IM module |
| Automatic SamplePre-dilution | All samples diluted 1:5 (differentdilutions possible) – CH moduleAllowed on a per-assay basis;capability of dilution of samplesrequiring pretreatment - IM module | Same |
| Original samplevolume | 2 to 50 µL; system uses an average of2-3 µL per test – CH module10 to 100 µl – IM module | Same |
| Sample probes | Dilution probe picks up primarysample from primary tube or cup, anddispenses to dilution tray with salineto dilute sample.A secondary probe(Sample Probe) transfers an aliquot ofdiluted sample to reaction cuvette.All probes have liquid surfaceverification. | Same |
| Pre-diluted Sample | Retained until results are available | Same |
| Reaction Tray | 221 reusable plastic cuvettes | Same |
| Cuvette Optical PathLength | 7 mm | Same |
| Reaction Volume | 80-240 µL | Same |
| Reaction Bath | Water bath, 37°C | Same |
| Photometer | 11 fixed wavelengths | Same |
| TurbidimetricMeasurements | Made with photometer | Same |
| Feature | Predicate Device: (K151767)Trinidad CH module (K151792) TrinidadIM module with Direct Load | New Device:Atellica Solution configured with theAtellica CH and Atellica IM module |
| Light Source | 12 V, 50 W Halogen lamp / cooled bylamp coolant additive and one LED | Same |
| Assays | Endpoint, rate reaction, 2-point rate,sample blank correction | Same |
| Reaction Times | 3 to 10 minutes | Same |
| Reagent Handling | ||
| Reagent Tray | 2 refrigerated reagent trays;70 positions R170 Positions R2Up to 4 of the positions of R2 may beoccupied by wash solutions and/ordiluents. | Same |
| Reagent cooling | CH Module:4-12° CIM module:4-8° C | Same |
| Reagent Container | Approximate maximum wedge size of50 mL. Packs have two wells with 1 or2 wells filled (depending on assay) | Same |
| Reagent Capacity On-board | CH module:Up to 70 Reagentsand 3 ISEIM module:Assay reagent:Rotating refrigerated tray with 42positions; Reagent Pack contains bothSolid Phase and Tracer Reagent inseparate wellsAncillary Reagent:Rotating refrigerated compartmentwith 42 positions | Same |
| Dispensing System | 2 probes with liquid level sensing | Same |
| Reagent Dispensevolume | 10-100 µl per test | Same |
| Feature | Predicate Device: (K151767)Trinidad CH module (K151792) TrinidadIM module with Direct Load | New Device:Atellica Solution configured with theAtellica CH and Atellica IM module |
| Reagent InventoryManagement | Tracks tests remaining, lot number,on-board stability and expiration date | Same |
| Reagent Dilutions | Capability to dilute concentratedreagents on-board | Same |
| Method Principle | Ion Selective Electrode | Same |
| ISE Internal Standard | Internal Standard | Same |
| Sample Volume | CH module:25 μL | Same |
| IM module:10 μL-100 μL | ||
| Calibration | ||
| Calibration Frequency | Up to 60 days | Same |
| Auto-Calibration | User-defined time interval or withnew reagent cartridge | Same |
| Calibration/ControlTray | Calibrators and controls delivered byDirect Load / manual input. | Same |
| General Specification | ||
| Power Requirements | 200-240 VAC +/-10%, 8 Amp, 50/60Hz, 3.2 KVA | Varies based on configuration |
| Water Requirements | Direct plumb – Lab Grade Type 1 only | Same |
| Water Consumption | 33 liters per hour (maximum) | Varies based on configuration |
| Dimensions | Analytical Module:1363.5 (h) x 1452.5 (w) x 1183.3 (d) | Varies based on configuration |
| CH | ||
| Feature | Predicate Device: (K151767)Trinidad CH module (K151792) TrinidadIM module with Direct Load | New Device:Atellica Solution configured with theAtellica CH and Atellica IM module |
| Direct Load:1365 (h) x 425.3 (w) x 1150 (d) mmIM:880 mm (d) x 1350mm (l) x1500 mm(w) | ||
| Weight | CH Module:437 kgDirect Load:150 kgIM module:<750 kg | Varies based on configuration |
| Electrical Compliance | UL, cUL, CE | UL, cUL, CE |
| CPU | Intel processor using Windows 7 | Same |
| Display/Monitor | 24" display with touch screen | Same (note: one UIW screen interface forentire Atellica Solution) |
| GUI Application | Universal Instrument Workstation,which will be common to newSiemens IVD systems | Same |
| On-Line Help | Not available at this time | Same |
| LIS Interfaces | Not available at this time | Same |
| LAS Interfaces | Utilize pick and place sampling ratherthan point in space | Same |
| Feature | Predicate Device:Trinidad CH System; Na, K, Cl | New Device:Atellica SolutionNa, K, Cl |
| Intended Use | For in vitro diagnostic use in the quantitative determination ofsodium, potassium and chloride (Na, K, Cl) in human serum,plasma and urine using the Trinidad CH System. | Same |
| Indications for Use | Measurements of sodium obtained bythis device are used in the diagnosis and treatment ofaldosteronism (excessive secretion of the hormonealdosterone), diabetes insipidus (chronic excretion of largeamounts of dilute urine, accompanied byextreme thirst), adrenal hypertension, Addison's disease(caused by destruction of the adrenal glands),dehydration, inappropriate antidiuretic hormone secretion, orother diseases involving electrolyte imbalance. Measurementsof potassium obtained by this device are used to monitorelectrolyte balance in the diagnosis and treatment of diseaseconditions characterized by low or high blood potassiumlevels. Chloride measurements are used in the diagnosis andtreatment of electrolyte and metabolic disorderssuch as cystic fibrosis and diabetic acidosis. | Same |
| Device Technology | Indirect potentiometric measurements with IntegratedMultisensor Technology (IMT) | Same |
| Sample Type | Serum/plasma/urine | Same |
| AnalyticalMeasuring Interval | Serum/PlasmaNa: 50.0 to 200 mmol/LK: 1.0 to 10.0 mmol/LCl: 50.0 to 200 mmol/LUrineNa: 10 to 300 mmol/LK: 2 to 300 mmol/LCl: 20 to 330 mmol/L | Same |
| Reference Interval | Serum/PlasmaNa: 136-145 mmol/LK (serum): 3.5-5.1 mmol/LK (plasma): 3.4-4.5 mmol/LCl: 98-107 mmol/LUrine | Same |
| Na: 40 – 220 mmol/day | ||
| K: 25 – 125 mmol/day | ||
| Cl: 110 – 250 mmol/day | ||
| Interferences | Na: Bilirubin (Conjugated) – 60 mg/dLBilirubin (Unconjugated) – 60 mg/dLLipemia (Intralipid®) – 3000 mg/dLHemoglobin – 750 mg/dLK: Bilirubin (Conjugated) – 60 mg/dLBilirubin (Unconjugated) – 60 mg/dLLipemia (Intralipid®) – 3000 mg/dLCl: Bilirubin (Conjugated) – 60 mg/dLBilirubin (Unconjugated) – 60 mg/dLLipemia (Intralipid®) – 3000 mg/dLHemoglobin – 750 mg/dL | Same |
| Standardization | Na: Flame photometric method with NIST reference standardsK: Flame photometric method with NIST reference serumCl: Coulometric method with NIST standards | Same |
| CalibrationFrequency | Every 4 hours | Same |
| Calibrators | TD-LYTE IMT Standard A and TD-LYTE IMT Standard B + SaltBridge | Same |
| Calibrator Matrix | Na/K/Cl: Buffered Aqueous matrix | Same |
| Calibrator Form | Na/K/Cl: liquid | Same |
| Number ofCalibrator Levels | Two for serum/urine | Same |
| Feature | Predicate Device:Trinidad CH System; Alb_p assay | New Device:Atellica Solution;Alb_p assay |
| Intended Use | For in vitro diagnostic use in the quantitative measurement ofalbumin in human serum or plasma on Trinidad CH System. | Same |
| Indications for Use | Albumin measurements are used in the diagnosis andtreatment of numerous diseases primarily involving the liveror kidneys. | Same |
| Device Technology | bromocresol purple (BCP) dye-binding method | Same |
| Sample Type | Serum/plasma | Same |
| AnalyticalMeasuring Interval | 0.5-8.0 g/dL | Same |
| Reference Interval | 3.4-5.0 g/dL | Same |
| Interferences | Bilirubin (Conjugated) - 30 mg/dLBilirubin (Unconjugated) - 30 mg/dLLipemia — 500 mg/dLHemoglobin - 600 mg/dL | Same |
| Standardization | ERM-DA470k Reference Material | Same |
| CalibrationFrequency | Every 30 days | Same |
| Calibrators | Albumin BCP Calibrator | Same |
| Calibrator Matrix | Human Serum | Same |
| Calibrator Form | Lyophilized | Same |
| Number ofCalibrator Levels | One | Same |
| Feature | Predicate Device:Trinidad CH System, Vanc assay | New Device:Atellica Solution;Vanc assay |
| Intended Use | For in vitro diagnostic use in the quantitative measurement ofvancomycin in human serum or plasma on the Trinidad CHSystem. | Same |
| 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 |
| AnalyticalMeasuring Interval | 3.0-50.0 µg/mL | Same |
| Therapeutic Interval | Peak Intervals: Samples from adult volunteers drawn twohours after the completion of a 60 minute infusion ofvancomycin ranged from 18 – 26 µg/mL. Samples drawn onehour after the completion of a 60 minute vancomycin infusionranged from 25 – 40 µg/mL. Samples drawn 30 minutes afterthe completion of a 60 minute infusion of vancomycin rangedfrom 30 - 40 µg/mL. Trough Intervals: Samples should bedrawn just before the next dose. A trough interval of 5 –10ug/mL is recommended. | Same |
| Interferences | Bilirubin (Conjugated & Unconjugated) - 20 mg/dLLipemia (Intralipid®) – 1000 mg/dLHemoglobin - 600 mg/dL | Same |
| Standardization | Traceable to United States Pharmacopeia (USP) standards. | Same |
| CalibrationFrequency | 30 days | Same |
| Calibrators | Drug 3 Calibrator | Same |
| Calibrator Matrix | Bovine Serum Base | Same |
| Calibrator Form | Liquid | Same |
| Number ofCalibrator Levels | Five | Same |
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1.1.9.1.2
Na, K, Cl
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Alb_P
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Vanc
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TSH
| Feature | Predicate Device:Trinidad IM System, TSH assay | New Device:Atellica Solution, TSH assay |
|---|---|---|
| Intended Use | For in vitro diagnostic use in thequantitative determination of thyroid-stimulating hormone (TSH,thyrotropin) in serum, heparinizedplasma, and EDTA plasma using theTrinidad IM system | Same |
| Indications for Use | Measurements of thyroid stimulatinghormone produced by the anteriorpituitary are used in the diagnosis ofthyroid or pituitary disorders. | Same |
| Assay Principle | Sandwich immunoassay | |
| Device Technology | Chemiluminescence | Same |
| Sample Type | Serum and Plasma | Same |
| Detection Antibody | Monoclonal mouse anti-TSHantibody BSA conjugate labeled withacridinium ester (AE) | Same |
| Capture Antibody | Anti-fluorescein labeled (FITC)monoclonal mouse anti-TSHantibody covalently bound toparamagnetic particles (PMP) | Same |
| Assay Range | $0.008 - 150 \mu IU/mL$ | Same |
| Expected values | Infants: $0.87 - 6.15 \mu IU/mL$Children: $0.67 - 4.16 \mu IU/mL$Adolescent: $0.48- 4.17 \mu IU/mL$Adult: $0.55 - 4.78 \mu IU/mL$ | Same |
| Calibration | 2 point | Same |
| Calibrators | Atellica TSH Calibrators | Same |
| Number ofCalibrators | Two (2) levels | Same |
| Use of controls | Yes (recommended) | Same |
| Standardization | Standardized to internal standardsand is traceable to the World Health | Same |
| Calibratorspackaging | Organization (WHO) 3rdInternational standard for humanTSH (IRP 81/565)Provided with reagent kit | Same |
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1.1.10 Standard/Guidance Document Referenced (if applicable):
- CLSI EP15-A3 : User Verification of Precision and Estimation of Bias
- CLSI - EP09-A3: Method comparison and bias estimation using patient samples
- . IEC 61010-1 - Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General Requirements
- EN 61326-1:2012, Electrical equipment for measurement, control and laboratory use – EMC requirements - Part 1:General requirements
- . EN 61326-1:2012, Electrical equipment for measurement, control and laboratory use – Part 2-6: Particular Requirements – In vitro diagnostic (IVD) medical equipment
- IEC 61010-1:2010, Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General Requirements
- IEC 61010-1:2010, Safety requirements for electrical equipment for measurement, control, and laboratory use - Parts 2- 6: Particular Requirements – In vitro diagnostic (IVD) medical equipment
- EN ISO 14971:2012, Application of risk management to medical devices
1.1.11 Performance Characteristics
The below studies are submitted on the Atellica Solution to support the use of the Atellica SH with the Atellica CH and IM Systems cleared as the Trinidad CH and IM systems under K151767, K160202 and K151792 respectively. Full assay performance can be found in the assay associated 510(k)s.
Performance equivalence of the Atellica Solution was demonstrated by testing precision and running a method comparison of IM/CH assays on IM and CH modules fitted with a Direct Load component .
1.1.11.1 Precision
Precision was tested n = 5 replicates, one time a day for 5 days with controls and serum pools for the Na, K, Cl, Alb_P, Vanc and TSH assays on one instrument. This is consistent with the governing standard CLSI EP15-A3: User Verification of Precision and Estimation of Bias with 1 reagent lot.
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1.1.11.1.1 Sodium
| Sample | Specimen | N | Mean | Repeatability | Within-Lab | ||
|---|---|---|---|---|---|---|---|
| ID# | Type | (mmol/L) | SD (mmol/L) | CV (%) | SD (mmol/L) | CV (%) | |
| 4 | Serum | 25 | 72.7 | 0.23 | 0.3 | 0.45 | 0.6 |
| 1 | Serum QC | 25 | 114 | 0.62 | 0.5 | 0.62 | 0.5 |
| 2 | Serum QC | 25 | 141 | 0.4 | 0.3 | 0.6 | 0.4 |
| 3 | Serum QC | 25 | 155 | 0.82 | 0.5 | 0.82 | 0.5 |
1.1.11.1.2 Potassium
| Sample | Specimen | Mean | Repeatability | Within-Lab | |||
|---|---|---|---|---|---|---|---|
| ID# | Type | N | (mmol/L) | SD (mmol/L) | CV (%) | SD (mmol/L) | CV (%) |
| 1 | Serum QC | 25 | 2.72 | 0.01 | 0.4 | 0.01 | 0.4 |
| 2 | Serum QC | 25 | 4.04 | 0.01 | 0.2 | 0.05 | 1.2 |
| 6 | Serum | 25 | 5.86 | 0.02 | 0.4 | 0.03 | 0.4 |
| 3 | Serum QC | 25 | 7.34 | 0.04 | 0.6 | 0.04 | 0.6 |
1.1.11.1.3 Chloride
| Sample | Specimen | Mean | Repeatability | Within-Lab | |||
|---|---|---|---|---|---|---|---|
| ID# | Type | N | (mmol/L) | SD (mmol/L) | CV (%) | SD (mmol/L) | CV (%) |
| 1 | Serum QC | 25 | 77.2 | 0.14 | 0.2 | 0.31 | 0.4 |
| 2 | Serum QC | 25 | 100 | 0.42 | 0.4 | 0.57 | 0.6 |
| 3 | Serum QC | 25 | 114 | 0.55 | 0.5 | 0.58 | 0.5 |
| 5 | Serum | 25 | 188 | 0.68 | 0.4 | 0.81 | 0.4 |
1.1.11.1.4 Albumin
| SampleID# | SpecimenType | N | Mean(g/dL) | Repeatability | Within-Lab | ||
|---|---|---|---|---|---|---|---|
| SD (g/dL) | CV (%) | SD (g/dL) | CV (%) | ||||
| 1 | Serum QC | 25 | 2.3 | 0.02 | 0.9 | 0.02 | 0.9 |
| 2 | Serum | 25 | 2.9 | 0 | 0 | 0 | 0 |
| 3 | Serum | 25 | 4 | 0.05 | 1.2 | 0.05 | 1.3 |
| 4 | Serum QC | 25 | 4.9 | 0.03 | 0.6 | 0.03 | 0.6 |
| 5 | Serum | 25 | 6.4 | 0.06 | 0.9 | 0.06 | 0.9 |
1.1.11.1.5 Vancomycin
| Sample | Specimen | N | Mean | Repeatability | Within-Lab |
|---|---|---|---|---|---|
| -------- | ---------- | --- | ------ | --------------- | ------------ |
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| ID# | Type | (µg/mL) | SD (µg/mL) | CV (%) | SD (µg/mL) | CV (%) | |
|---|---|---|---|---|---|---|---|
| 1 | Serum QC | 25 | 6.9 | 0.08 | 1.1 | 0.1 | 1.5 |
| 2 | Serum | 25 | 11.7 | 0.12 | 1 | 0.14 | 1.2 |
| 3 | Serum QC | 25 | 18.4 | 0.13 | 0.7 | 0.24 | 1.3 |
| 4 | Serum | 25 | 34 | 0.32 | 0.9 | 0.38 | 1.1 |
| 5 | Serum | 25 | 43.1 | 0.38 | 0.9 | 0.46 | 1.1 |
1.1.11.1.6 TSH
| SampleID# | SpecimenType | N | Mean(µIU/mL) | Repeatability | Within-Lab | ||
|---|---|---|---|---|---|---|---|
| 8 | Serum QC | 25 | 0.067 | 0.001 | 2.1 | 0.001 | 2.1 |
| 1 | Serum | 25 | 1.124 | 0.027 | 2.4 | 0.037 | 3.3 |
| 2 | Serum | 25 | 6.285 | 0.155 | 2.5 | 0.189 | 3 |
| 3 | Serum | 25 | 11.126 | 0.15 | 1.3 | 0.353 | 3.2 |
| 4 | Serum | 25 | 31.683 | 0.497 | 1.6 | 1.36 | 4.3 |
| 5 | Serum | 25 | 59.332 | 0.974 | 1.6 | 3.758 | 6.3 |
| 7 | Serum | 25 | 103.003 | 1.706 | 1.7 | 5.772 | 5.6 |
| 6 | Serum | 25 | 122.49 | 2.225 | 1.8 | 6.914 | 5.6 |
1.1.11.2 Method Comparison
Method comparison studies were conducted with 1 reagent lot consistent with the governing standard CLSI EP09-A3: Measurement Procedure Comparison and Bias Estimation Using Patient Samples.
1.1.11.2.1 Sodium
| ComparativeAssay | AnalysisStatistics | SpecimenType | Slope | Intercept | SampleRange | Correlation | N |
|---|---|---|---|---|---|---|---|
| DL-CH module (Na)(K151767) | Passing &Bablok | serum | 1.00 | 0.00 | 58.70 to197.00 | 0.999 | 121 |
1.1.11.2.2 Potassium
| ComparativeAssay | AnalysisStatistics | SpecimenType | Slope | Intercept | SampleRange | Correlation | N |
|---|---|---|---|---|---|---|---|
| DL- CH module (K)(K151767) | Passing &Bablok | serum | 1.00 | 0.00 | 1.30 to 9.66 | 0.999 | 125 |
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| ComparativeAssay | AnalysisStatistics | SpecimenType | Slope | Intercept | SampleRange | Correlation | N |
|---|---|---|---|---|---|---|---|
| DL- CH module (Cl)(K151767) | Passing &Bablok | serum | 0.99 | 1.030 | 61.00 to189.00 | 0.999 | 122 |
1.1.11.2.4 Albumin
| ComparativeAssay | AnalysisStatistics | SpecimenType | Slope | Intercept | SampleRange | Correlation | N |
|---|---|---|---|---|---|---|---|
| DL- CH module(Alb_P) (K151767) | OrdinaryLeastSquare | serum | 0.994 | -0.006 | 0.90 to 5.80 | 0.999 | 105 |
1.1.11.2.5 Vancomycin
| ComparativeAssay | AnalysisStatistics | SpecimenType | Slope | Intercept | SampleRange | Correlation | N |
|---|---|---|---|---|---|---|---|
| DL-CH module(Vanc) (K160202) | Deming | serum | 0.988 | -0.063 | 6.10 to 48.80 | 0.997 | 112 |
1.1.11.2.6 TSH
| ComparativeAssay | AnalysisStatistics | SpecimenType | Slope | Intercept | SampleRange | Correlation | N |
|---|---|---|---|---|---|---|---|
| DL- IM module(TSH) (K151792) | WeightedDeming | serum | 1.02 | 0.069 | 0.008 to142.907 | 0.992 | 116 |
1.1.12 Conclusions
Comparative testing of Atellica™ Solution (Atellica™M and Atellica™IM and Atellica™CH analyzers) is substantially equivalent in principle and performance to the Predicate Devices, Trinidad IM immunoassay analyzer (cleared under K151792) and the Trinidad CH clinical chemistry analyzer (cleared under K151767 and K160202).
§ 862.1665 Sodium test system.
(a)
Identification. A sodium test system is a device intended to measure sodium in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.(b)
Classification. Class II.