K Number

Device Name

IMMAGE SYSTEMS TOTAL IMMUNOGLOBULIN E (IGE) REAGENT IMMAGE IGE CALIBRATOR

Manufacturer

BECKMAN COULTER, INC.

Date Cleared

2003-02-24

(66 days)

Product Code

DGC

Regulation Number

866.5510

Intended Use

Total Immunoglobulin E (IGE) reagent, when used in conjunction with IMMAGE® Immunochemistry Systems and IGE Calibrator, is intended for the quantitative determination of total human immunoglobulin E (IgE) in serum or plasma by rate turbidimetry.

Device Description

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K930984

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a reagent and an immunochemistry system for quantitative determination of IgE using rate turbidimetry, a standard laboratory technique. There is no mention of AI, ML, image processing, or any other indicators of AI/ML technology. The performance studies focus on standard analytical validation metrics like method comparison, stability, linearity, and imprecision.

Therapeutic

No
The device is described as a reagent for the quantitative determination of total human immunoglobulin E (IgE) in serum or plasma, which is a diagnostic function, not a therapeutic one.

Diagnostic

Yes

This device is intended for the quantitative determination of total human immunoglobulin E (IgE) in serum or plasma, which provides information used to aid in the diagnosis and monitoring of conditions related to IgE levels.

SaMD (Software as a Medical Device)

The device is described as a reagent used in conjunction with a physical instrument (IMMAGE® Immunochemistry Systems) for a laboratory test, indicating it is a component of a hardware-based system, not a standalone software device.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use explicitly states it's for the "quantitative determination of total human immunoglobulin E (IgE) in serum or plasma". This involves testing biological samples (serum or plasma) outside of the body (in vitro).
Device Description: The description reiterates the intended use, confirming it's a reagent used for testing biological samples.
Method of Analysis: The method used is "rate turbidimetry," which is a common technique used in clinical chemistry for analyzing components in biological fluids.
Performance Studies: The performance studies describe experiments like "method comparison," "stability," "linearity," and "imprecision experiments," which are standard evaluations for IVD devices to demonstrate their accuracy and reliability in analyzing biological samples.
Predicate Device: The mention of a "Predicate Device" (Access® Total IgE) with a K number (K930984) indicates that this device is being compared to an already cleared IVD device, a common process for demonstrating substantial equivalence for new IVDs.

All these points strongly indicate that this device is designed and intended for in vitro diagnostic use.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

DGC

Device Description

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

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, stability, linearity, and imprecision experiments.

Method Comparison Study Results:
Analyte: IMMAGE Total IGE
Slope: 1.06
Intercept: 2.75
r: 0.991
n: 125
Predicate Method: Access Total IgE

IMMAG System IGE Estimated Imprecision:
Within-Run Imprecision:
Sample: Level 1, Mean (mg/dL): 16.5, S.D. (mg/dL): 0.97, %C.V.: 5.8, N: 80
Sample: Level 2, Mean (mg/dL): 145, S.D. (mg/dL): 7.4, %C.V.: 5.1, N: 80
Sample: Level 3, Mean (mg/dL): 383, S.D. (mg/dL): 19.9, %C.V.: 5.2, N: 80
Total Imprecision:
Sample: Level 1, Mean (mg/dL): 16.5, S.D. (mg/dL): 1.11, %C.V.: 6.7, N: 80
Sample: Level 2, Mean (mg/dL): 145, S.D. (mg/dL): 9.1, %C.V.: 6.3, N: 80
Sample: Level 3, Mean (mg/dL): 383, S.D. (mg/dL): 28.1, %C.V.: 7.3, N: 80

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

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.

K930984

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.

Not Found

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).

Not Found

Regulation Number and Section

§ 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).

Summary

1024210
FEB 24 2003

510(k) Summary IMMAGE® Immunochemistry System Total Immunoglobulin E Reagent (IGE) Reagent and Calibrator

1.0 Submitted By:

Annette Hellie Requlatory Affairs Manager Beckman Coulter, Inc. 200 S. Kraemer Blvd., W-104 Brea, California 92822-8000 Telephone: (714) 993-8767 FAX: (714) 961-4123

2.0 Date Submitted:

December 19, 2002

3.0 Device Name(s):

3.1 Proprietary Names

IMMAGE® Immunochemistry System Total Immunoglobulin E (IGE) Reagent IMMAGE® Immunochemistry System IGE Calibrator

3.2 Classification Name

Immunoglobulins A, G, M, D, and E test system (21 CFR § 866.5510) Calibrator (21 CFR § 862.1150)

4.0 Predicate Device:

| Candidate(s) | Predicate | Manufacturer | Docket
Number |
|----------------------------|-------------------|--------------------------|------------------|
| IMMAGE System
Total IGE | Access® Total IgE | Beckman
Coulter, Inc. | K930984 |

5.0 Description:

6.0 Intended Use:

Clinical Significance:

IgE is a member of the immunoglobulin family of proteins that was first described in the 1960's. IgE. like all immunodlobulins, is produced by plasma cells in response to antigenic stimuli. IgE is unique however in certain structural aspects and the role it plays in allergic diseases.

Measurement of total serum IgE is often used as a tool in the diagnosis and management of atopic diseases such as asthma, hay fever, atopic dermatitis and urticaria. It has been used to distinguish atopic from non-atopic individuals presenting allergy-like symptoms. In addition, studies have also shown that increased levels of IgE in cord blood and infants may be predictive of future atopic tendencies.

Normal levels of circulating IgE are extremely low in comparison to other immunoqlobulins. Levels of IgE at birth are almost undetectable but increase in non-allergic adults. Elevated levels are commonly seen in cases of allergic diseases, parasitic infections, pulmonary aspergillosis, Wiskott-Aldrich Syndrome, and myeloma.

Serum IqE levels may vary as a result of diet, genetic background, geographical location and other factors. It is therefore recommended that total IqE measurements be used in conjunction with other clinical tests when establishing diagnoses.

7.0 Comparison to Predicate(s):

The following table shows similarities and differences between the predicates identified in Section 4.0 of this summary.

	Similarities
IMMAGE System
Total IGE	Intended Use	Same as Access Total IgE
	Liquid stable reagent
	Antibody (mouse
monoclonal)
	Differences
IMMAGE System
Total IGE	Methodology	The IMMAGE uses rate nephelometry and
the Access uses chemiluminescent
immunoassay
	Measuring range	0.25-3000 IU/mL for Access
5.0 - 500 IU/mL (initial dilution) up to
30,000 (extended dilution) for IMMAGE

Summary of Performance Data: 8.0

Analyte	Slope	Intercept	r	n	Predicate Method
IMMAGE
Total IGE	1.06	2.75	0.991	125	Access Total IgE

Method Comparison Study Results

Sample	Mean (mg/dL)	S.D. (mg/dL)	%C.V.	N
Within-Run Imprecision
Level 1	16.5	0.97	5.8	80
Level 2	145	7.4	5.1	80
Level 3	383	19.9	5.2	80
Total Imprecision
Level 1	16.5	1.11	6.7	80
Level 2	145	9.1	6.3	80
Level 3	383	28.1	7.3	80

IMMAGE System IGE Estimated Imprecision

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.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a human figure.

Ms. Annette Hellie Regulatory Affairs Manager Beckman Coulter, Inc. 200 S. Kraemer Boulevard, W-104 P.O. Box 8000 Brea, California 92822-8000

FEB 24 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

024210
Trade/Device Name: IM
Rea
Regulation Number: 21 C
Regulation Name: Immu
Regulatory Class: II

FEB 2 4 2003

Re: K024210

Trade/Device Name: IMMAGE® Immunochemistry System Total Immunoglobulin E Reagent (IGE) Reagent and Calibrator Regulation Number: 21 CFR § 866.5510 Regulation Name: Immunoglobulins A, G, M, D, and E Test System Regulatory Class: II Product Code: DGC Dated: February 11, 2003 Received: February 12, 2003

Dear Ms. Hellie:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

Page 2 -

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

page ___ of _/

510(k) Number (if known): K02 42 /O

Device Name: IMMAGE® Immunochemistry System Total Immunoglobulin E Reagent (IGE) Reagent and Calibrator

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (per 21 CFR 801.109)	✓
---------------------------------------	---

Over-the-Counter Use
Optional Format 1-2-96

J. P. Reave for J. Bautista
(Division Sign-Off)
Division of Clinical Laboratory Devices

510(k) Number	1C054210
---------------	----------

Beckman Coulter, Inc., Section 510(k) Notification IMMAGE® Immunochemistry System Total Immunoglobulin E (IGE) IGE510K_Section1.doc, December 2002