(68 days)
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No
The summary describes a standard automated chemistry analyzer with computer control for quantitative measurements. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies. The performance studies focus on method comparison and imprecision, which are typical for this type of device and do not suggest the use of AI/ML for data analysis or interpretation.
No
This device is an in vitro diagnostic (IVD) chemistry analyzer that measures specific components and therapeutic drugs in biological fluids. It is used for diagnostic purposes and does not directly provide therapy.
Yes
The device is intended for "in vitro quantitative measurement of therapeutic drugs and specific components of clinical use in biological fluids," which generates data used to aid in diagnosis or patient management.
No
The device description explicitly lists major hardware components including a reagent compartment, reagent cranes, reaction module, sample carousel and crane, sample hydropheumatics, electronics, and power supplies. This indicates it is a physical device with integrated software, not a software-only medical device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The IMMAGE Immunochemistry System is a fully automated, computer controlled, bench-top chemistry analyzer intended for the in vitro quantitative measurement of therapeutic drugs and specific components of clinical use in biological fluids."
The phrase "in vitro quantitative measurement" is a key indicator of an In Vitro Diagnostic device, as it describes testing performed outside of the body to measure specific substances. The "Device Description" further reinforces this by detailing how the system analyzes biological fluids.
N/A
Intended Use / Indications for Use
The IMMAGE™ Immunochemistry System is a fully automated, computer controlled, bench-top chemistry analyzer intended for the in vitro quantitative determination of specific components and therapeutic drugs of clinical interest in biological fluids such as serum, plasma, urine, and cerebral spinal fluid. The IMMAGE Immunochemistry System is a fully automated, computer controlled, bench-top chemistry analyzer intended for the in vitro quantitative measurement of therapeutic drugs and specific components of clinical use in biological fluids.
Product codes
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Device Description
The IMMAGE Immunochemistry System is a fully automated, computer controlled, bench-top chemistry analyzer intended for the in vitro quantitative determination of specific components and therapeutic drugs of clinical interest in biological fluids such as serum, plasma, urine, and cerebral spinal fluid. The analyzer operates in conjunction with reagents, calibrators, and controls designed for use with the system. The instrument features barcode identification of samples and reagents. It automatically dilutes samples and delivers them to the reaction cuvette along with reagents and reaction constituents. The system analyzes up to 72 samples per run with up to 24 analytes per sample. Major hardware components include a reagent compartment, and reagent cranes, reaction module, sample carousel and crane, sample hydropheumatics, electronics, and power supplies.
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
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
The data in the Premarket Notification on safety and effectiveness supports a finding of Substantial Equivalence is demonstrated through method comparison and imprecision results obtained from the IMMAGE Immunochemistry System to selected predicate methods.
Method Comparison Study Results:
Analyte, Slope, Intercept, r, Predicate
Apolipoprotein A, 0.9958, 1.78, 0.985, ARRAY System
Complement C3, 0.9789, 8.05, 0.990, ARRAY System
Digoxin, 1.0637, -0.02, 0.968, Abbott TDx
Immunoglobulin A, 1.0281, -4.61, 0.995, ARRAY System
Rheumatoid Factor, 1.0545, 0.41, 0.940, Behring N Latex RF
Theophylline, 0.9917, 0.12, 0.955, Abbott TDx
Transferrin/serum, 1.0316, -10.06, 0.985, ARRAY System
Transferrin/urine, 1.1108, -0.04, 0.998, ARRAY System
Estimated Within-run Imprecision:
MATERIAL, MEAN, SD, %CV, N
Apolipoprotein A (mg/dL), Level 1, 56.0, 1.92, 3.4, 80
Apolipoprotein A (mg/dL), Level 2, 103, 2.6, 2.5, 80
Apolipoprotein A (mg/dL), Level 3, 163, 2.5, 1.5, 80
Complement C3 (mg/dL), Level 1, 67.1, 1.3, 1.9, 80
Complement C3 (mg/dL), Level 2, 102, 2.2, 2.1, 80
Complement C3 (mg/dL), Level 3, 395, 8.7, 2.2, 80
Digoxin (ng/mL), Level 1, 1.18, 0.063, 5.3, 80
Digoxin (ng/mL), Level 2, 2.47, 0.177, 7.2, 80
Digoxin (ng/mL), Level 3, 4.16, 0.109, 2.6, 80
Immunoglobulin A (mg/dL), Level 1, 123, 2.1, 1.7, 80
Immunoglobulin A (mg/dL), Level 2, 261, 3.4, 1.3, 80
Immunoglobulin A (mg/dL), Level 3, 599, 19.2, 3.2, 80
Rheumatoid Factor (IU/mL), Level 1, 123, 1.5, 1.2, 80
Rheumatoid Factor (IU/mL), Level 2, 290, 3.1, 1.1, 80
Rheumatoid Factor (IU/mL), Level 3, 613, 8.7, 1.4, 80
Theophylline (µg/mL), Level 1, 8.12, 0.17, 2.2, 80
Theophylline (µg/mL), Level 2, 19.9, 0.30, 1.5, 80
Theophylline (µg/mL), Level 3, 32.4, 0.46, 1.4, 80
Transferrin/serum (mg/dL), Level 1, 241, 6.8, 2.8, 80
Transferrin/serum (mg/dL), Level 2, 364, 15.2, 4.2, 80
Transferrin/serum (mg/dL), Level 3, 680, 17.9, 2.6, 80
Transferrin/urine (mg/dL), Level 1, 0.38, 0.008, 2.2, 80
Transferrin/urine (mg/dL), Level 2, 1.56, 0.042, 2.7, 80
Transferrin/urine (mg/dL), Level 3, 3.06, 0.124, 4.1, 80
Key Metrics
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Predicate Device(s)
K922273, K771603, K780913, K926272, K862019, K810306, K924186/A, K882233, K932127, K942328
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.2700 Nephelometer for clinical use.
(a)
Identification. A nephelometer for clinical use is a device intended to estimate the concentration of particles in a suspension by measuring their light scattering properties (the deflection of light rays by opaque particles in their path). The device is used in conjunction with certain materials to measure the concentration of a variety of analytes.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
0
IMMAGE™ Immunochemistry System
1.0 Submitted Bv
Sheri Hall Manager, Product Submissions Beckman Instruments, Inc. 200 S. Kraemer Blvd. W-337 Brea. California 92622-8000 Telephone: (714) 993-8916 FAX: (714) 961-4457
AUG 21 1996
2.0 Date Submitted
15 June 1996
3.0 Device Name(s)
3.1 Proprietary Names
IMMAGE™ Immunochemistry System
3.2 Classification Names
Nephelometer for clinical use (21 CFR 862.2700) Discrete photometric chemistry analyzer for clinical use (21 CFR 862.2160)
4.0 Predicate Device(s)
Beckman ARRAY® 360 Immunochemistry System and Reagents (K922273, K771603, K780913. K926272. K862019, K810306) Seradyn LPIA-100 Instrument (K924186/A) Abbott TDx Immunochemistry Reagents (K882233, K932127) Behring N Latex RF (K942328)
5.0 Description
The IMMAGE Immunochemistry System is a fully automated, computer controlled, bench-top chemistry analyzer intended for the in vitro quantitative determination of specific components and therapeutic drugs of clinical interest in biological fluids such as serum, plasma, urine, and cerebral spinal fluid. The analyzer operates in conjunction with reagents, calibrators, and controls designed for use with the system. The instrument features barcode identification of samples and reagents. It automatically dilutes samples and delivers them to the reaction cuvette along with reagents and reaction constituents. The system analyzes up to 72 samples per run with up to 24 Major hardware components include a reagent compartment, analytes per sample. and reagent cranes, reaction module, sample carousel and crane, sample hydropheumatics, electronics, and power supplies.
6.0 Intended Use
The IMMAGE Immunochemistry System is a fully automated, computer controlled, bench-top chemistry analyzer intended for the in vitro quantitative measurement of therapeutic drugs and specific components of clinical use in biological fluids.
1
7.0 Comparison to Predicate(s)
The following table shows similarities and differences between the predicates identified in Section 4.0 of this summary.
| Aspect/Characteristic | Comments |
|---|---|
| SIMILARITIES | |
| Intended for: in vitro diagnostic quantitation of | |
| components of biological fluids by rate | |
| nephelometry and nephometric inhibition | same as ARRAY System |
| Measures nephelometric increase in light scatter | |
| due to immunoprecipitin formation between | |
| antigen and antibody | same as ARRAY System |
| Uses nephelometric inhibition immunoassay to | |
| measure drugs and small molecular weight | |
| constituents | same as ARRAY System |
| Uses non-linear math models to describe standard | |
| curve determined during reagent manufacturing | |
| and a single point calibration for routine instrument | |
| operation | same as ARRAY System |
| Uses plastic reaction cuvettes which are washed | |
| between samples | same as ARRAY System |
| Measures turbidimetric decrease in transmitted | |
| light due to immunoprecipitin formation between | |
| antigen and antibody where one is coupled to latex | |
| particles | same as LPIA 100 |
| Mathematically calculated absorbance units from | |
| the measured transmitted light intensity and | |
| calculated rate of change of absorbance during | |
| reaction | same as LPIA 100 |
| Measures turbidimetric transmitted light scatter in | |
| the forward direction (0°- 15°) | same as LPIA 100 |
| Cuvette light path 7 mm and reaction incubation | |
| temperature controlled at 37°C | same as LPIA 100 |
| DIFFERENCES | |
| IMMAGE System uses visible laser diode at 670 | |
| nm as the light source for nephelometry | ARRAY System uses a tungsten |
| halogen lamp at 400-620 | |
| IMMAGE System detects light scatter at 90° from | |
| the incident beam angle | ARRAY System detects light |
| scatter at 70° angle | |
| IMMAGE System maintains reaction temperature | |
| at 37°C | ARRAY System maintains |
| reaction temperature at 26.7°C | |
| IMMAGE System uses a LED at 940 nm as light | |
| source for turbidimetry | LPIA-100 uses a tungsten |
| halogen light source at 950 nm | |
| IMMAGE uses non-linear math models to describe | |
| standard curves during reagent manufacture and a | |
| single point calibration for routine instrument | |
| operation | LPIA-100 uses linear and |
| quadratic math models with a | |
| multipoint calibration during | |
| operation | |
| IMMAGE uses washable plastic reaction cuvettes | LPIA-100 uses disposable |
| plastic reaction cuvettes |
2
Summary of Performance Data 8.0
The data in the Premarket Notification on safety and effectiveness supports a finding of The duta in the romance to in viro diagnostic test systems already in commercial Substantial Equivalence is demonstrated through method comparison and imprecision distribution: Equiraliencesults obtained from the IMMAGE Immunochemistry System to selected predicate methods.
| Analyte | Slope | Intercept | r | Predicate |
|---|---|---|---|---|
| Apolipoprotein A | 0.9958 | 1.78 | 0.985 | ARRAY System |
| Complement C3 | 0.9789 | 8.05 | 0.990 | ARRAY System |
| Digoxin | 1.0637 | -0.02 | 0.968 | Abbott TDx* |
| Immunoglobulin A | 1.0281 | -4.61 | 0.995 | ARRAY System |
| Rheumatoid Factor | 1.0545 | 0.41 | 0.940 | Behring N Latex RF |
| Theophylline | 0.9917 | 0.12 | 0.955 | Abbott TDx |
| Transferrin/serum | 1.0316 | -10.06 | 0.985 | ARRAY System |
| Transferrin/urine | 1.1108 | -0.04 | 0.998 | ARRAY System |
Method Comparison Study Results IMMAGE Immunochemistry System vs Selected Predicate Methods
*TDx is a registered tradmark of Abbott Diagnostics
Estimated Within-run Imprecision
| MATERIAL | MEAN | SD | %CV | N |
|---|---|---|---|---|
| Apolipoprotein A (mg/dL) | ||||
| Level 1 | 56.0 | 1.92 | 3.4 | 80 |
| Level 2 | 103 | 2.6 | 2.5 | 80 |
| Level 3 | 163 | 2.5 | 1.5 | 80 |
| Complement C3 (mg/dL) | ||||
| Level 1 | 67.1 | 1.3 | 1.9 | 80 |
| Level 2 | 102 | 2.2 | 2.1 | 80 |
| Level 3 | 395 | 8.7 | 2.2 | 80 |
| Digoxin (ng/mL) | ||||
| Level 1 | 1.18 | 0.063 | 5.3 | 80 |
| Level 2 | 2.47 | 0.177 | 7.2 | 80 |
| Level 3 | 4.16 | 0.109 | 2.6 | 80 |
3
| Immunoglobulin A (mg/dL) | ||||
|---|---|---|---|---|
| Level 1 | 123 | 2.1 | 1.7 | 80 |
| Level 2 | 261 | 3.4 | 1.3 | 80 |
| Level 3 | 599 | 19.2 | 3.2 | 80 |
| Rheumatoid Factor (IU/mL) | ||||
| Level 1 | 123 | 1.5 | 1.2 | 80 |
| Level 2 | 290 | 3.1 | 1.1 | 80 |
| Level 3 | 613 | 8.7 | 1.4 | 80 |
| Theophylline (µg/mL) | ||||
| Level 1 | 8.12 | 0.17 | 2.2 | 80 |
| Level 2 | 19.9 | 0.30 | 1.5 | 80 |
| Level 3 | 32.4 | 0.46 | 1.4 | 80 |
| Transferrin/serum (mg/dL) | ||||
| Level 1 | 241 | 6.8 | 2.8 | 80 |
| Level 2 | 364 | 15.2 | 4.2 | 80 |
| Level 3 | 680 | 17.9 | 2.6 | 80 |
| Transferrin/urine (mg/dL) | ||||
| Level 1 | 0.38 | 0.008 | 2.2 | 80 |
| Level 2 | 1.56 | 0.042 | 2.7 | 80 |
| Level 3 | 3.06 | 0.124 | 4.1 | 80 |
This summary of safety and effectiveness is being submitted in accordance with the This summary of safety and enectivelless is being Submitted in according regulation 21 CFR 807.92.