K Number

Device Name

COPALIS RUBELLA IGM

Manufacturer

DIASORIN, INC.

Date Cleared

2000-02-10

(132 days)

Product Code

LFX

Regulation Number

866.3510

Intended Use

Device Description

The Copalis® Rubella IgM assay uses Coupled Particle Light Scattering (Copalis®) technology in a microparticle aggregation-based immunoassay for the qualitative detection of IgM antibodies to Rubella virus in human serum and EDTA, heparin or sodium citrate plasma using the Copalis® I Immunoassay System. The test is indicated for the presumptive diagnosis of primary rubella infection. KIT DESCRIPTION: Coupled Particle Light Scattering (Copalis®) technology Coupled Particle Light Scattering (Copalis®) technology provides a rapid method for the measurement of antibodies to specific viral or protozoan pathogens. The Copalis® Rubella IgM Assay is based on the principle of antibody-dependent particle aggregation as detected by measurement of changes in light scattering. The serum or plasma sample is manually pre-diluted in Sample Diluent to remove IgG and IdA antibodies. Polystyrene microparticles present in the Copalis® Test Cup are coated with Rubella viral antigen (HPV 77 strain). These microparticles aggregate in the presence of the pre-diluted human serum/plasma containing IgM antibodies to Rubella virus. After 10 minutes of agitation, the levels of aggregation are determined by measurement of the number of reacted and unreacted particles as they flow past a detector. Reactivity is assessed by the level of aggregation relative to a cutoff value. The Copalis® Rubella IgM Assay detects the presence of Rubella IgM-specific antibodies. Two levels of controls are used to monitor system performance.

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Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

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City

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Country Code

ZIP

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Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

Abbott Laboratories IMx Rubella IgM (MEIA)

Reference Devices

Abbott Laboratories IMx Rubella IgM (MEIA)

AI/ML (Artificial Intelligence / Machine Learning)

No
The description details a traditional immunoassay technology based on light scattering and particle aggregation, with no mention of AI or ML.

Therapeutic

No
The device is an in vitro diagnostic assay used for the qualitative detection of IgM antibodies to Rubella virus, indicated for presumptive diagnosis, not for treating or preventing disease.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states, "The test is indicated for the presumptive diagnosis of primary rubella infection."

SaMD (Software as a Medical Device)

The device description clearly outlines a physical kit containing reagents (microparticles coated with antigen) and a system (Copalis® I Immunoassay System) that performs a microparticle aggregation-based immunoassay. This involves physical components and chemical reactions, not solely software.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The "Intended Use / Indications for Use" section explicitly states that the assay is for the "qualitative detection of IgM antibodies to Rubella virus in human serum and EDTA, heparin or sodium citrate plasma". This indicates that the test is performed on biological samples taken from the human body.
Purpose: The intended use also states the test is for the "presumptive diagnosis of primary rubella infection". This clearly indicates the test is used to provide information for diagnostic purposes.
Device Description: The "Device Description" further elaborates on the technology and how it detects antibodies in human serum or plasma.
Clinical Correlation: The "Summary of Performance Studies" describes clinical trials where the assay's performance was evaluated using human samples and compared to another diagnostic test.

All of these points align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to monitor therapeutic measures.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

LFX

Device Description

The Copalis® Rubella IgM assay uses Coupled Particle Light Scattering (Copalis®) technology in a microparticle aggregation-based immunoassay for the qualitative detection of IgM antibodies to Rubella virus in human serum and EDTA, heparin or sodium citrate plasma using the Copalis® I Immunoassay System. The test is indicated for the presumptive diagnosis of primary rubella infection.
Coupled Particle Light Scattering (Copalis®) technology provides a rapid method for the measurement of antibodies to specific viral or protozoan pathogens.
The Copalis® Rubella IgM Assay is based on the principle of antibody-dependent particle aggregation as detected by measurement of changes in light scattering. The serum or plasma sample is manually pre-diluted in Sample Diluent to remove IgG and IdA antibodies. Polystyrene microparticles present in the Copalis® Test Cup are coated with Rubella viral antigen (HPV 77 strain). These microparticles aggregate in the presence of the pre-diluted human serum/plasma containing IgM antibodies to Rubella virus. After 10 minutes of agitation, the levels of aggregation are determined by measurement of the number of reacted and unreacted particles as they flow past a detector. Reactivity is assessed by the level of aggregation relative to a cutoff value. The Copalis® Rubella IgM Assay detects the presence of Rubella IgM-specific antibodies. Two levels of controls are used to monitor system performance.

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

Clinical Correlation: Clinical trials were conducted at 3 sites (1 hospital clinical laboratory, 1 state laboratory and at DiaSorin) to evaluate the performance of the Copalis® Rubella IgM Assay in detecting IgM antibodies to Rubella antigen on the Copalis® I Immunoassay System. The assay performance was compared to the Abbott IMx Rubella IgM test.
Summary of Acute Adult Population for Copalis® Rubella IgM Assay: Agreement 98.2% (108/110) [93.6 - 99.8%]
Summary of Obstetric Adult Population for Copalis® Rubella IgM Assay: Agreement 100.0% (50/50) [92.9 - 100.0%]
Summary of Seronegative Population for Copalis® Rubella IgM Assay: Agreement 100.0% (97/97) [96.3 - 100.0%]
Summary of Pediatric Population for Copalis® Rubella IgM Assay: Agreement 100.0% (20/20) [83.2 - 100.0%]
Reproducibility: Reproducibility studies were performed at three sites using one lot of Copalis® Rubella IgM reagents. Assay reproducibility was determined by assaying a reproducibility panel consisting of six serum samples that covered the range of the Copalis® Rubella IgM assay. Panel members were tested in duplicate once a day for five days. Results expressed in Copalis Test Results (CTR) are summarized by combined site results.
Plasma reproducibility studies were performed at DiaSorin using one lot of Copalis® Rubella IgM. Six sets of serum/ multiple plasma paired samples were prepared using EDTA. heparin and sodium citrate plasma and spanned the range of the assay. The samples were tested in duplicate once a day for 3 days.

Key Metrics

Clinical Correlation: Agreement [95% CI]
Acute Adult Population: 98.2% (108/110) [93.6 - 99.8%]
Obstetric Adult Population: 100.0% (50/50) [92.9 - 100.0%]
Seronegative Population: 100.0% (97/97) [96.3 — 100.0%]
Pediatric Population: 100.0% (20/20) [83.2 - 100.0%]
Reproducibility:
Copalis CTR:
Sample ID: Neg Control, Mean: 100, %CV: 1.7%
Sample ID: Pos Control, Mean: 136, %CV: 8.0%
Sample ID: NRM01-01, Mean: 102, %CV: 3.0%, Within Run %CV: 2.2%
Sample ID: NRM01-02, Mean: 102, %CV: 2.7%, Within Run %CV: 1.4%
Sample ID: PRM01-01, Mean: 156, %CV: 12.4%, Within Run %CV: 8.9%
Sample ID: PRM01-02, Mean: 142, %CV: 9.8%, Within Run %CV: 6.9%
Sample ID: PRM01-03, Mean: 117, %CV: 5.1%, Within Run %CV: 3.8%
Sample ID: PRM01-04, Mean: 364, %CV: 18.5%, Within Run %CV: 12.3%
Sample N: 30
Plasma reproducibility:
Serum: N1 Total %CV: 2.57, N1 Within Run %CV: 1.37; N2 Total %CV: 2.36, N2 Within Run %CV: 1.41; HP Total %CV: 6.23, HP Within Run %CV: 3.54; LP1 Total %CV: 4.32, LP1 Within Run %CV: 1.66; LP2 Total %CV: 4.90, LP2 Within Run %CV: 1.31
EDTA plasma: N1 Total %CV: 2.43, N1 Within Run %CV: 1.37; N2 Total %CV: 2.25, N2 Within Run %CV: 1.02; HP Total %CV: 8.01, HP Within Run %CV: 4.41; LP1 Total %CV: 5.13, LP1 Within Run %CV: 1.39; LP2 Total %CV: 5.73, LP2 Within Run %CV: 3.28
HEPARIN plasma: N1 Total %CV: 1.48, N1 Within Run %CV: 0.67; N2 Total %CV: 2.16, N2 Within Run %CV: 1.07; HP Total %CV: 5.71, HP Within Run %CV: 2.39; LP1 Total %CV: 2.90, LP1 Within Run %CV: 1.17; LP2 Total %CV: 4.10, LP2 Within Run %CV: 1.94
CITRATE plasma: N1 Total %CV: 1.20, N1 Within Run %CV: 0.35; N2 Total %CV: 31.54, N2 Within Run %CV: 1.39; HP Total %CV: 10.07, HP Within Run %CV: 2.53; LP1 Total %CV: 3.49, LP1 Within Run %CV: 0.57; LP2 Total %CV: 3.92, LP2 Within Run %CV: 1.22

Predicate Device(s)

Abbott Laboratories IMx Rubella IgM (MEIA)

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 866.3510 Rubella virus serological reagents.

(a)
Identification. Rubella virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to rubella virus in serum. The identification aids in the diagnosis of rubella (German measles) or confirmation of a person's immune status from past infections or immunizations and provides epidemiological information on German measles. Newborns infected in the uterus with rubella virus may be born with multiple congenital defects (rubella syndrome).(b)
Classification. Class II. The special controls for this device are:(1) National Committee for Clinical Laboratory Standards':
(i) 1/LA6 “Detection and Quantitation of Rubella IgG Antibody: Evaluation and Performance Criteria for Multiple Component Test Products, Speciment Handling, and Use of the Test Products in the Clinical Laboratory, October 1997,”
(ii) 1/LA18 “Specifications for Immunological Testing for Infectious Diseases, December 1994,”
(iii) D13 “Agglutination Characteristics, Methodology, Limitations, and Clinical Validation, October 1993,”
(iv) EP5 “Evaluation of Precision Performance of Clinical Chemistry Devices, February 1999,” and
(v) EP10 “Preliminary Evaluation of the Linearity of Quantitive Clinical Laboratory Methods, May 1998,”
(2) Centers for Disease Control's:
(i) Low Titer Rubella Standard,
(ii) Reference Panel of Well Characterized Rubella Sera, and
(3) World Health Organization's International Rubella Standard.

Summary

FFB 1 0 2000

K993291

January 8, 2000

510(k) Summarv

SUBMITTED BY:

Judith J. Smith DiaSorin, Inc. 9175 Guilford Rd. Suite 100 Columbia, MD 21046

NAME OF DEVICES: Trade Name:

Copalis® Rubella IgM Assay

Common Names/Descriptions:

Immunoassay for the Detection of IgM Antibodies to Rubella virus

Classification Names:

Rubella Serology Test

PREDICATE DEVICES:

Abbott Laboratories IMx Rubella IgM (MEIA)

DEVICE DESCRIPTION: INTENDED USE:

KIT DESCRIPTION: Coupled Particle Light Scattering (Copalis®) technology Coupled Particle Light Scattering (Copalis®) technology provides a rapid method for the measurement of antibodies to specific viral or protozoan pathogens.

The Copalis® Rubella IgM Assay is based on the principle of antibody-dependent particle aggregation as detected by measurement of changes in light scattering. The serum or plasma sample is manually pre-diluted in Sample Diluent to remove IgG and IdA antibodies. Polystyrene microparticles present in the Copalis® Test Cup are coated with Rubella viral antigen (HPV 77 strain). These microparticles aggregate in the presence of the pre-diluted human serum/plasma containing IgM antibodies to Rubella virus. After 10 minutes of agitation, the levels of aggregation are determined by measurement of the number of reacted and unreacted particles as they flow past a detector. Reactivity is assessed by the level of aggregation relative to a cutoff value. The Copalis® Rubella IgM Assay detects the presence of Rubella IgM-specific antibodies. Two levels of controls are used to monitor system performance.

PERFORMANCE DATA:

	Copalis Rubella IgM
IMx Rubella IgM	Pos	Neg	EQ	Grand Total
Pos	70	1	0	71
Neg	1	38	0	39
EQ	1	3	0	4
Grand Total	72	42	0	114

Summary of Acute Adult Population for Copalis® Rubella IgM Assay

Agreement [95% CI]

98.2% (108/110) [93.6 - 99.8%]

Summary of Obstetric Adult Population for Copalis® Rubella IgM Assay

	Copalis Rubella IgM
IMx Rubella IgM	Pos	Neg	EQ	Grand Total
Pos	0	0	0	0
Neg	0	50	0	50
EQ	0	0	0	0
Grand Total	0	50	0	50

Agreement [95% CI]

100.0% (50/50) [92.9 - 100.0%]

Summary of Seronegative Population for Copalis® Rubella IgM Assay

	Copalis Rubella IgM
IMx Rubella IgM	Pos	Neg	EQ	Grand Total
Pos	0	0	0	0
Neg	0	97	1	98
EQ	0	1	0	1
Grand Total	0	98	1	99

Agreement [95% CI]

100.0% (97/97) [96.3 — 100.0%]

Summary of Pediatric Population for Copalis® Rubella IgM Assay

	Copalis Rubella IgM
IMx Rubella IgM	Pos	Neg	EQ	Grand Total
Pos	3	0	0	3
Neg	0	17	0	17
EQ	0	0	0	0
Grand Total	3	17	0	20

Agreement [95% CI]

100.0% (20/20) [83.2 - 100.0%]

Reproducibility: Reproducibility studies were performed at three sites using one lot of Copalis® Rubella IgM reagents. Assay reproducibility was determined by assaying a reproducibility panel consisting of six serum samples that covered the range of the Copalis® Rubella IgM assay. Panel members were tested in duplicate once a day for five days. Results expressed in Copalis Test Results (CTR) are summarized by combined site results.

Copalis CTR
Sample ID	Mean	%CV	Within Run
%CV
Neg Control	100	1.7%	na
Pos Control	136	8.0%	na
NRM01-01	102	3.0%	2.2%
NRM01-02	102	2.7%	1.4%
PRM01-01	156	12.4%	8.9%
PRM01-02	142	9.8%	6.9%
PRM01-03	117	5.1%	3.8%
PRM01-04	364	18.5%	12.3%
Sample N	30	30	30

Copalis CTR Results Sites Combined - Copalis Rubella IgM Assay

Plasma reproducibility studies were performed at DiaSorin using one lot of Copalis® Rubella IgM. Six sets of serum/ multiple plasma paired samples were prepared using EDTA. heparin and sodium citrate plasma and spanned the range of the assay. The samples were tested in duplicate once a day for 3 days.

CTR	serum			EDTA plasma			HEPARIN plasma			CITRATE plasma
	total	within run		total	within run		total	within run		total	within run
	mean	%CV	%CV	mean	%CV	%CV	mean	%CV	%CV	mean	%CV	%CV
N1	102	2.57	1.37	102	2.43	1.37	106	1.48	0.67	102	1.20	0.35
N2	100	2.36	1.41	105	2.25	1.02	100	2.16	1.07	92	31.54	1.39
HP	200	6.23	3.54	196	8.01	4.41	176	5.71	2.39	191	10.07	2.53
LP1	130	4.32	1.66	131	5.13	1.39	125	2.90	1.17	124	3.49	0.57
LP2	139	4.90	1.31	144	5.73	3.28	145	4.10	1.94	143	3.92	1.22

Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three curved lines representing its wings and body. The eagle is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the border of the circle.

FEB 1 0 2000

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Judith J. Smith Process Owner, Worldwide Regulatory Affairs and Quality System DiaSorin, Inc. 9175 Guilford Road, Suite 100 Columbia, Maryland 21046

Re: K993291 Trade Name: Copalis® Rubella IgM Assay Regulatory Class: III Product Code: LFX Dated: December 13, 1999 Received: December 14, 1999

Dear Ms. Smith:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

Page 2

This letter will allow you to begin marketing your device as described in your 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

INDICATIONS FOR USE

510(k) Number (if known): K993291

Copalis® Rubella IgM Assay Device Name:

Indications For Use: The Copalis® Rubella IgM assay uses Coupled Particle Light Scattering (Copalis®) technology in a microparticle aggregation-based immunoassay for the qualitative detection of IgM antibodies to rubella virus in human serum and EDTA, heparin or sodium citrate plasma using the Copalis® I Immunoassay System. The test is indicated for the presumptive diagnosis of primary rubella infection.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Woody Duboe

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K993291

Prescription Use _ (Per 21 CFR 801.109)

Over-The-Counter Use __

(Optional Format 1-2-96)