(63 days)
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No
The summary describes a standard automated immunoassay analyzer with functions like sample handling, reagent addition, incubation, and data reduction. There is no mention of AI, ML, or related concepts in the intended use, device description, or specific sections for AI/ML mentions. The predicate device is also a previous version of the same analyzer, suggesting a continuation of existing technology rather than the introduction of AI/ML.
No.
The device is an in vitro diagnostic immunoassay analyzer used to perform tests on clinical specimens to aid in diagnosis, rather than directly treating a condition or restoring health.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "designed to perform in vitro diagnostic immunochemical assay analysis on clinical specimens."
No
The device description clearly outlines hardware components and functions such as aspirating, dispensing, adding reagents, incubating, separating waste, and measuring photon emissions, indicating it is a physical analyzer system, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"The Bayer ADVIA Centaur assay is an automated immunoassay analyzer designed to perform in vitro diagnostic immunochemical assay analysis on clinical specimens."
This statement directly identifies the device's purpose as performing in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Bayer ADVIA Centaur assay is an automated immunoassay analyzer designed to perform in vitro diagnostic immunochemical assay analysis on clinical specimens. The system menu will include endocrine, anemia, allergy, reproductive, cardiovascular, oncology, adrenal, bone metabolism, therapeutic drug, and infectious disease assays. All assays are based on chemiluminescent technology.
Product codes (comma separated list FDA assigned to the subject device)
CDZ, CEC, CEP, CFT, CGJ, CGN, CHP, DBF, DDR, DGC, DHX, DIS, DKB, JFT, JHI, JHX, JJE, JJX, JKD, JLS, JLW, JZO, KHQ, KLT, KXT, LCD, LCR, LEH, LFM, LFX, LGD, LGR, LGS, LOQ, LPS, LTK, MMI, MOI, NBC, NIG
Device Description
The ADVIA Centaur system is a stand-alone, continuous operation, immunochemistry analyzer. The system performs the following functions:
- Aspirates and dispenses samples .
- Performs dilutions ●
- Adds reagents .
- Incubates reaction vessels .
- Separates solid and liquid wastes ●
- Measures photon emissions .
- Performs data reduction ●
- Collects and maintains patient demographics and results .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 862.1810 Vitamin B
12 test system.(a)
Identification. A vitamin B12 test system is a device intended to measure vitamin B12 in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.(b)
Classification. Class II.
0
JUL - 2 2004
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS ADVIA® Centaur
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92.
The assigned 510(k) number is: _ _ 0 4 11 3 3
1. Intended Use
The Bayer ADVIA Centaur assay is an automated immunoassay analyzer designed to perform in vitro diagnostic immunochemical assay analysis on clinical specimens. The system menu will include endocrine, anemia, allergy, reproductive, cardiovascular, oncology, adrenal, bone metabolism, therapeutic drug, and infectious disease assays. All assays are based on chemiluminescent technology.
2. Predicate Device
Proprietary Name: Bayer ADVIA Centaur Analyzer Common name: Automated Immunoassay Analyzer Classification name: Photometric Analyzer for Clinical Use Classification number: 21 CFR 862.2160, Class I 510(k) Number: K032525
3. Device Information
Proprietary Name: Bayer ADVIA Centaur Analyzer Common name: Automated Immunoassay Analyzer Classification name: Photometric Analyzer for Clinical Use Classification number: 21 CFR 862.2160, Class I
4. Device Description
The ADVIA Centaur system is a stand-alone, continuous operation, immunochemistry analyzer. The system performs the following functions:
- Aspirates and dispenses samples .
- Performs dilutions ●
- Adds reagents .
- Incubates reaction vessels .
- Separates solid and liquid wastes ●
- Measures photon emissions .
- Performs data reduction ●
- Collects and maintains patient demographics and results .
1
5. Summary of Technological Characteristics
Assays that are dedicated for use on the ADVIA Centaur utilize acridinium ester as label and Assays that are areatedics as the solid phase. The ADVIA Centaur measures the amount of light emitted during the chemiluminescent reaction. There is a direct relationship between the amount of light emitted and the amount of ligand in the patient sample. The system will measure both competitive binding assays and sandwich assays.
The ADVIA Centaur system uses a Master Curve and a two-point, user-initiated calibration to calibrate all the assays. The Master Curve and the two-point calibration system eliminate the need to measure a full standard curve with each assay or to run calibrators each time the assay is run. The system stores the calibration for the interval specified in the assay product inserts.
| Feature | ADVIA Centaur V2.5
(K032525) | ADVIA Centaur V3.0 |
|--------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|
| Principles of Operation | - Chemiluminescence using magnetic-particle solid phase and chemiluminescent label | same |
| Optical System | - PMT used in photon counting mode | same |
| Temp control | - Reactions are controlled at 37°C
- Reagent Storage:
- Reagents stored at 4°C to 8°C | same |
| Dispense System | - Automated pipetting of samples and reagents - Precision syringes (sample and reagent) | same |
| Sample Probe : | - Air pressure fluid sensing - Air pressure disposable tip sensing
- Clog detection mechanism to alert operator to clogged sample probe | same |
| Reagent Probes: | - No level sense; probe sent to bottom of container - Fluid monitoring during aspiration | same |
| Reagent and Sample Handling | - Samples: 5 tube racks hold sample tube. The Sample Input, In-Process and Output Queue holds up to 180 samples; Tube size selected on sample tube rack using an encoded barcode. - Assay Reagents: Reagent Tray with 30 positions; Refrigeration; Reagent Pack contains both Solid Phase and Tracer Reagent in separate wells | same |
| Ancillary Reagents: Reagent Compartment with 15 positions; Refrigeration | same | |
| Test Processing | Random Access and Batch - Sample scheduling optimized for throughput; Continuous Operation | same |
| Assay Protocols | - 7.5 minute incubation, single step | same |
| | - 20 minute incubation, single step | same |
| | - 7.5 - 20 minute incubation, two step | same |
| | - 20 - 20 minute incubation, two Step | same |
| Human Interface - data Output | - 17" Color Monitor with Graphical User Interface | same |
| | - External printers | same |
| | - Serial bi-directional LIS Interface | same |
| | - Audible (adjustable) beeper | same |
| | - Computer LIS Interface | same |
| | - External Modem for Remote Diagnostics Interface | same |
| Human Interface - data Input | - 101 key keyboard | same |
| | - Hand-held barcode reader | same |
| | - Stationary barcode scanners for id of patient samples | same |
| | - Moving Barcode reader for primary reagents | same |
| | - Computer LIS Interface | same |
| | - LIS Software Enhancements | same |
| Human Interface - data analysis | - Automated data reduction | same |
| QC Software | - Assay-specific data reduction | same |
| | - Stored control results | same |
| | - L-J plotting | same |
| | - Statistical enhancements | same |
| | - Compatibility with CCD QC Reporting | same |
| | - Added New Features to QC Functionality | same |
| Specimens | - Serum or plasma, sample cups or primary tubes may be used | same |
| | - Dilutions allowed on a per-assay basis | same |
| | - Capability of Dilution of Samples Requiring Pretreatment | same |
| Disposables | - Sample cups | same |
| | - Reaction cuvettes | same |
| | - Cuvette loading and unloading allowed during run | same |
| | - Reagent I & 2 status tracked and displayed | same |
| | - Additional wash solutions (status tracked and displayed) | same |
| | - Sample Pipette Tips | same |
| | - All disposables may be loaded during operation | same |
| | | |
| Reagents | - Solid Phase | same |
| | - Chemiluminescent label (Acridinium Ester) | same |
| | - Reagent volume reporting | same |
| | - Reagent inventory tracks bottle usage | same |
| | - Ancillary Reagents with inventory tracking and volume reporting | same |
| Calibrators | - 6 to 10 point stored calibration for each reagent | same |
| | - 2 point user run calibration | same |
| | - Calibrators checked with barcode - Calibrator lot numbers stored and displayed | same |
| Controls | - Low, mid, and high constituent controls | same |
| | - Capability to dilute controls | same |
| Physical | - Floor Model-, 60Hx42Dx58L | same |
| | - 1200 Ibs. | same |
| | -