← Product Code [JQX](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JQX) · K962294

# IMMAGE IMMUNOCHEMISTRY SYSTEM (K962294)

_Beckman Instruments, Inc. · JQX · Aug 21, 1996 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JQX/K962294

## Device Facts

- **Applicant:** Beckman Instruments, Inc.
- **Product Code:** [JQX](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JQX.md)
- **Decision Date:** Aug 21, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.2700
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Indications for 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.

## Device Story

Fully automated, computer-controlled, bench-top chemistry analyzer; performs in vitro quantitative determination of specific analytes and therapeutic drugs in biological fluids (serum, plasma, urine, CSF). System utilizes rate nephelometry (670 nm laser diode) and turbidimetric inhibition immunoassay (940 nm LED). Input: patient samples identified via barcode. Operation: automated sample dilution, delivery to reaction cuvettes, and incubation at 37°C. Output: quantitative concentration values derived from light scatter/transmission measurements. Used in clinical laboratory settings by trained personnel. Healthcare providers use results for clinical decision-making regarding patient therapeutic drug monitoring and diagnostic assessment of specific clinical components.

## Clinical Evidence

Bench testing only. Method comparison studies performed against predicate devices (ARRAY System, Abbott TDx, Behring N Latex RF) across 8 analytes (Apolipoprotein A, Complement C3, Digoxin, IgA, Rheumatoid Factor, Theophylline, Transferrin). Correlation coefficients (r) ranged from 0.940 to 0.998. Within-run imprecision evaluated with N=80 per level; %CVs ranged from 1.1% to 7.2% across various analytes and concentration levels.

## Technological Characteristics

Bench-top analyzer; 670 nm laser diode (nephelometry) and 940 nm LED (turbidimetry) light sources. Detects light scatter at 90° (nephelometry) and forward direction 0°-15° (turbidimetry). 7 mm cuvette light path; 37°C incubation. Washable plastic reaction cuvettes. Barcode sample/reagent identification. Computer-controlled automation.

## Regulatory 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.

## Predicate Devices

- Beckman ARRAY® 360 Immunochemistry System and Reagents ([K922273](/device/K922273.md), [K771603](/device/K771603.md), [K780913](/device/K780913.md), [K926272](/device/K926272.md), [K862019](/device/K862019.md), [K810306](/device/K810306.md))
- Seradyn LPIA-100 Instrument ([K924186](/device/K924186.md)/A)
- Abbott TDx Immunochemistry Reagents ([K882233](/device/K882233.md), [K932127](/device/K932127.md))
- Behring N Latex RF ([K942328](/device/K942328.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).

{0}

200 South Kraemer Boulevard, Box 8000, Brea CA 92622-8000 • (714) 993-5321

# BECKMAN

Summary of Safety & Effectiveness

IMMAGE™ Immunochemistry System

## 1.0 Submitted By

K962294

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 analytes per sample. Major hardware components include a reagent compartment, sample and reagent cranes, reaction module, sample carousel and crane, 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.

file: imgsystm.sse

Beckman Instruments, Inc.

twx: 910-592-1260 • telex: 06-78413

{1}

Beckman Instruments Inc. Section 510(k) Notification
IMMAGE™ Immunochemistry Systems
Summary of Safety & Effectiveness

# 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  |

file: imgsystm.sse

{2}

Beckman Instruments Inc. Section 510(k) Notification
IMMAGE™ Immunochemistry Systems
Summary of Safety & Effectiveness

## 8.0 Summary of Performance Data

The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to *in vitro* diagnostic test systems already in commercial distribution. Equivalence is demonstrated through method comparison and imprecision experiments that relate results obtained from the IMMAGE Immunochemistry System to selected predicate methods.

### Method Comparison Study Results
IMMAGE Immunochemistry System vs 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  |

*TDx is a registered trademark 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  |

file: imgsystm.sse

{3}

Beckman Instruments Inc. Section 510(k) Notification
IMMAGE™ Immunochemistry Systems
Summary of Safety & Effectiveness

|  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 requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92.

file: imgsystm.sse

---

**Source:** [https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JQX/K962294](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JQX/K962294)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com