K Number
K130122
Device Name
BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN, BECKMAN COULTER
Date Cleared
2014-01-07

(355 days)

Product Code
Regulation Number
866.5510
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
IMMAGE® Immunochemistry Systems IGMLC Reagent, when used in conjunction with IMMAGE® Immunochemistry Systems and Cerebrospinal Fluid Protein Calibrator, is intended for quantitative determination of immunoglobulin M in human serum or cerebrospinal fluid (CSF) by rate nephelometry. CSF Cal (Cerebrospinal Fluid Protein Calibrator), when used in conjunction with Beckman Coulter Low Concentration Immunoglobulin A (IGALC) and Low Concentration Immunoglobulin M (IGMLC) reagents is intended for use on Immage for the calibration of these reagents.
Device Description
The IMMAGE System Low Concentration Immunoglobulin M (IGMLC) Reagent, when used in conjunction with IMMAGE Immunochemistry Systems and Cerebrospinal Fluid Protein Calibrator is intended for the quantitative determination of human Immunoglobulin M in serum and cerebrospinal fluid (CSF) by rate nephelometry. The IMMAGE Immunochemistry System (cleared under K962294) is a high throughput, random access analyzer that uses rate nephelometry methodology to measure human immunoglobulin M concentration in serum and CSF samples. The IMMAGE Immunochemistry System automatically dilutes and delivers sample to the reaction cuvette along with reagents and other reaction constituents. During the reaction, particle bound anti-IgM antibody binds to IgM molecules in the sample via an antigen-antibody reaction. This results in the formation of insoluble complexes causing an increase in light scatter. The rate of increase in light scattered from the particles suspended in solution is directly proportional to the concentration of immunoglobulin M in the sample. The rate nephelometer measures the increase in the intensity of light scattered by particles suspended in a cuvette. The light source for the rate nephelometer is a 670 nm wavelength laser. The detector is placed at a 90° angle from the incident beam to measure light increase. At the end of the reaction, the system mathematically calculates the rate of change of the scatter signal.
More Information

No
The description focuses on standard nephelometry methodology and mathematical calculations of reaction rates, with no mention of AI or ML terms or concepts.

No
This device is for quantitative determination of immunoglobulin M in human serum or CSF, which is a diagnostic function, not a therapeutic one.

Yes

The device quantitatively determines immunoglobulin M in human serum or cerebrospinal fluid (CSF), which is a measurement used for diagnostic purposes.

No

The device description explicitly details hardware components like a laser, detector, and reaction cuvette, and describes a physical process (rate nephelometry) involving light scattering and chemical reactions. It is a reagent used with a larger hardware system.

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use explicitly states the quantitative determination of immunoglobulin M in human serum or cerebrospinal fluid (CSF). This involves testing samples taken from the human body.
  • Device Description: The description details a system that analyzes biological samples (serum and CSF) using a specific methodology (rate nephelometry) to measure a substance (immunoglobulin M) within those samples.
  • Performance Studies: The document includes performance studies (method comparison, precision, sensitivity) which are typical for IVD devices to demonstrate their analytical performance.
  • Predicate Device: The mention of a predicate device (K993547) which is also an IMMAGE system reagent and calibrator further supports its classification as an IVD.

The core function of the device is to perform a test on a biological sample in vitro (outside the body) to provide information about a patient's health status (in this case, the concentration of immunoglobulin M). This aligns directly with the definition of an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

IMMAGE® Immunochemistry Systems IGMLC Reagent, when used in conjunction with IMMAGE® Immunochemistry Systems and Cerebrospinal Fluid Protein Calibrator, is intended for quantitative determination of Immunoglobulin M (IGMLC) in human serum or cerebrospinal fluid (CSF) by rate nephelometry.

CSF Cal (Cerebrospinal Fluid Protein Calibrator), when used in conjunction with Beckman Coulter Low Concentration Immunoglobulin A (IGALC) and Low Concentration Immunoglobulin M (IGMLC) reagents is intended for use on Immage for the calibration of these reagents.

Product codes

CFN, JIX

Device Description

The IMMAGE System Low Concentration Immunoglobulin M (IGMLC) Reagent, when used in conjunction with IMMAGE Immunochemistry Systems and Cerebrospinal Fluid Protein Calibrator is intended for the quantitative determination of human Immunoglobulin M in serum and cerebrospinal fluid (CSF) by rate nephelometry.

The IMMAGE Immunochemistry System (cleared under K962294) is a high throughput, random access analyzer that uses rate nephelometry methodology to measure human immunoglobulin M concentration in serum and CSF samples. The IMMAGE Immunochemistry System automatically dilutes and delivers sample to the reaction cuvette along with reagents and other reaction constituents.

During the reaction, particle bound anti-IgM antibody binds to IgM molecules in the sample via an antigen-antibody reaction. This results in the formation of insoluble complexes causing an increase in light scatter. The rate of increase in light scattered from the particles suspended in solution is directly proportional to the concentration of immunoglobulin M in the sample.

The rate nephelometer measures the increase in the intensity of light scattered by particles suspended in a cuvette. The light source for the rate nephelometer is a 670 nm wavelength laser. The detector is placed at a 90° angle from the incident beam to measure light increase. At the end of the reaction, the system mathematically calculates the rate of change of the scatter signal.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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

Not Found

Summary of Performance Studies

The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. Equivalence is demonstrated through method comparison, linearity, and imprecision, and sensitivity experiments.

Method Comparison Study Results

  • Study Type: Method Comparison
  • Sample Size: N=80 for CSF, N=80 for Serum
  • Key Results:
    • CSF: Slope: 0.963, Intercept: -0.133, R: 0.997. Result: Pass (Acceptance Criteria: Slope: 1.0 +/- 0.10, Intercept:

§ 866.5510 Immunoglobulins A, G, M, D, and E immunological test system.

(a)
Identification. An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.(b)
Classification. Class II (performance standards).

0

510(k) SUMMARY

1.0 Submitted By:

Amanda Brown Regulatory Affairs Specialist Beckman Coulter, Inc. 250 S. Kraemer Boulevard M/S E1.2902 Brea, California 92821 Telephone: (714)961-6484 Email: abrown2@beckman.com

2.0 Date Submitted:

December 19, 2013

3.0 Device Name(s):

3.1 Proprietary Names

IMMAGE® Immunochemistry System Low Concentration Immunoglobulin M (IGMLC) Reagent IMMAGE® Immunochemistry System Cerebrospinal Fluid Protein Calibrator (CSF CAL)

3.2 Classification Name

Method, Nephelometric, Immunoglobulins (G, A, M) (21 CFR § 866.5510) [CFN]

Calibrator, multi-analyte mixture (21 CFR § 862.1150) [JIX]

4.0 Predicate Device:

| Candidate(s) | Predicate | Manufacturer | Docket
Number |
|---------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|--------------------------|------------------|
| Beckman Coulter
IMMAGE®
Immunochemistry
System Low
Concentration
Immunoglobulin M
(IGMLC) Reagent | Beckman Coulter
IMMAGE®
Immunochemistry System
Low Concentration
Immunoglobulin M
(IGMLC) Reagent | Beckman Coulter,
Inc. | K993547 |
| Beckman Coulter
Cerebrospinal Fluid
Protein Calibrator (CSF
CAL) | Beckman Coulter
Cerebrospinal Fluid
Protein Calibrator (CSF
CAL) | | |

1

5.0 Description:

The IMMAGE System Low Concentration Immunoglobulin M (IGMLC) Reagent, when used in conjunction with IMMAGE Immunochemistry Systems and Cerebrospinal Fluid Protein Calibrator is intended for the quantitative determination of human Immunoglobulin M in serum and cerebrospinal fluid (CSF) by rate nephelometry.

The IMMAGE Immunochemistry System (cleared under K962294) is a high throughput, random access analyzer that uses rate nephelometry methodology to measure human immunoglobulin M concentration in serum and CSF samples. The IMMAGE Immunochemistry System automatically dilutes and delivers sample to the reaction cuvette along with reagents and other reaction constituents.

During the reaction, particle bound anti-IgM antibody binds to IgM molecules in the sample via an antigen-antibody reaction. This results in the formation of insoluble complexes causing an increase in light scatter. The rate of increase in light scattered from the particles suspended in solution is directly proportional to the concentration of immunoglobulin M in the sample.

The rate nephelometer measures the increase in the intensity of light scattered by particles suspended in a cuvette. The light source for the rate nephelometer is a 670 nm wavelength laser. The detector is placed at a 90° angle from the incident beam to measure light increase. At the end of the reaction, the system mathematically calculates the rate of change of the scatter signal.

6.0 Intended Use:

IMMAGE® Immunochemistry Systems IGMLC Reagent, when used in conjunction with IMMAGE® Immunochemistry Systems and Cerebrospinal Fluid Protein Calibrator, is intended for quantitative determination of immunoglobulin M in human serum or cerebrospinal fluid (CSF) by rate nephelometry.

Clinical Siqnificance:

The concentration ratio of immunoglobulins in CSF and serum detects increased permeability of the blood-CSF barrier and intrathecal synthesis of immunoqlobulins. 1.2

The permeability of the blood-CSF barrier to plasma increases due to brain tumor, intracerebral hemorrhage, meningitis, encephalitis, and bacterial infections. The intrathecal synthesis of immunoglobulins is important in the diagnosis of diseases of the Central Nervous System (CNS) 3

  • European Neurology 1996; 36; 201-205 1.
  • ﻨ Journal of the Neurological Sciences 184 (2001) 101-122
  • Burtis, C. A., Ashwood, E. R., Tietz, Texbook of Clinical Chemistry, 3rd Edition, W. B. 3. Saunders, Philadelphia, PA (1999). '

2

7.0 Comparison to Predicate(s):

The following table shows similarities and differences between the predicate identified in Section 4.0 of this summary. Each modification was evaluated against the criteria for a Special 510(k) to insure that the particular change does not: (1) affect the intended use or (2) alter the fundamental scientific technology of the device.

Similarities
IMMAGE
IGMLC
ReagentIntended Use
Reagent formulation
Calibrator formulation
Technology
Methodology
Kit configuration
Specimen types
Stability
Reference Interval
Precision specification
Interferences
Differences
IMMAGE
IGMLC
ReagentReagent curve fit optimization
SensitivityAdditional standards added to the low end of the curve.
Current:
CSF: 0.3 mg/L
Serum: 64.8 mg/LNew:
0.15 mg/L
32.4 mg/L
Calibrator
traceabilityImproved traceability to the international standard,
ERM-DA-470(k)-IFCC.
Analytical
RangeCurrent:
CSF 0.3-10 mg/L
Serum 64.8-2160 mg/LNew:
0.15 - 10 mg/L
32.4 - 2160 mg/L
Imprecision
ValueIncluded CSF typical imprecision with sample
mean concentration between 0.15-0.30 mg/L and
updated low end serum sample with mean
concentration between 32.4-64.8 mg/L
EquivalencyCurrent:
CSF: Concordance to IFE method (obsolete)
Serum: Comparison to IGM assay
New:
CSF: Comparison to current assay
Serum: Comparison to current assay

3

8.0 Summary of Performance Data:

The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. Equivalence is demonstrated through method comparison, linearity, and imprecision, and sensitivity experiments.

| Sample Type | Acceptance
Criteria | N | R | Slope | Intercept | Result |
|-------------|---------------------------------------------------------------|----|-------|-------|-----------|--------|
| CSF | Slope: 1.0 +/- 0.10
Intercept: Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Image /page/6/Picture/13 description: The image shows the name "Elizabeth FDA Stafford -S" in a bold, sans-serif font. The word "Elizabeth" is on the left, followed by the letters "FDA" in a decorative, stylized font. The name "Stafford" is to the right of "FDA", and the letter "S" is on the far right.

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

7

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K130122

Device Name

IMMAGE® Immunochemistry Systems CSF-CAL Cerebrospinal Fluid Protein Calibrator

Indications for Use (Describe)

CSF Cal (Cerebrospinal Fluid Protein Calibrator), when used in conjunction with Beckman Coulter Low Concentration Immunoglobulin A (IGALC) and Low Concentration Immunoglobulin M (IGMLC) reagents is intended for use on Immage for the calibration of these reagents.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

.

Image /page/7/Picture/13 description: The image shows the name "Elizabeth A Stafford -S" in black font. The "A" is stylized with a pattern inside the letter. The text is horizontally oriented and appears to be a signature or nameplate.

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.