K Number

Device Name

BIO-RAD PLATELIA TOXO IGM TMB

Manufacturer

BIO-RAD

Date Cleared

2002-09-30

(315 days)

Product Code

LGD

Regulation Number

866.3780

Intended Use

The Platelia Toxo IgM TMB kit is an in-vitro diagnostic test kit for the qualitative and quantitative detection of anti-Toxoplasma gondii IgM in human serum or plasma (EDTA, Heparin, Citrate). Note: - . Patient testing with the Platelia® Toxo IgM assay must be performed in conjunction with an anti-Toxoplasma gondii IgG antibody assay. - The Platelia® Toxo IgM assay is presumptive for the detection of anti-● Toxoplasma gondii IgM antibodies and presumptive for the diagnosis of acute, recent or reactivated Toxoplasma gondii infection. - The performance of the Platelia® Toxo IgM assay has not been established for ● neonate testing. - . The Platelia® Toxo IgM assay has not been cleared/approved by the FDA for blood/plasma donor screening.

Device Description

The Platelia® Toxo IgM TMB assay is a qualitative assay which utilizes an immunocnzymatic double sandwich method. Diluted samples and controls are placed into microplate wells coated with antibodies to human IgM. The IgM antibodies present in the samples are captured by the solid phase. Remaining antibodies (including any of the IgG class) and other serum proteins are removed by washing. A solution containing T. gondii antigen and conjugate (monoclonal antibody to T. gondii labeled with horseradish peroxidase) is placed into each well. T. gondii IgM antibodies in the test sample that are captured on the solid phase bind the T. gondii antigen-complex. Excess T. gondii antigen and conjugate are removed by washing. A peroxidase substrate and chromogen solution is added which reacts with the conjugate to initiate a color development reaction is stopped by the addition of an acid. The optical density readings for the test samples are obtained with a spectrophotometer set at a wavelength of 450 nm. The presence of T. gondii IgM antibodies in an individual sample is determined by comparing the optical density reading for the sample to the optical density reading of the cut-off control serum.

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

K89498

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description details a standard immunocnzymatic assay with spectrophotometric reading and comparison to a cut-off control, which does not involve AI/ML. The document explicitly states "Mentions AI, DNN, or ML: Not Found".

Therapeutic

No
The device is an in-vitro diagnostic test for detecting anti-Toxoplasma gondii IgM antibodies, which means it is used for diagnosis, not for treatment or therapy.

Diagnostic

Yes

Explanation: The "Intended Use / Indications for Use" section explicitly states that the kit is an "in-vitro diagnostic test kit for the qualitative and quantitative detection of anti-Toxoplasma gondii IgM in human serum or plasma." It further clarifies it's "presumptive for the diagnosis of acute, recent or reactivated Toxoplasma gondii infection." This directly indicates its purpose in diagnosing a medical condition.

SaMD (Software as a Medical Device)

The device is an in-vitro diagnostic test kit that utilizes a chemical reaction and spectrophotometer readings, indicating it is a hardware-based assay kit, not software only.

IVD (In Vitro Diagnostic)

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

The "Intended Use / Indications for Use" section explicitly states: "The Platelia Toxo IgM TMB kit is an in-vitro diagnostic test kit for the qualitative and quantitative detection of anti-Toxoplasma gondii IgM in human serum or plasma..."

This statement directly identifies the device as an in-vitro diagnostic test kit.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Platelia Toxo IgM TMB kit is an in-vitro diagnostic test kit for the qualitative and quantitative detection of anti-Toxoplasma gondii IgM in human serum or plasma (EDTA, Heparin, Citrate).

Note:

. Patient testing with the Platelia® Toxo IgM assay must be performed in conjunction with an anti-Toxoplasma gondii IgG antibody assay.
The Platelia® Toxo IgM assay is presumptive for the detection of anti-● Toxoplasma gondii IgM antibodies and presumptive for the diagnosis of acute, recent or reactivated Toxoplasma gondii infection.
The performance of the Platelia® Toxo IgM assay has not been established for ● neonate testing.
. The Platelia® Toxo IgM assay has not been cleared/approved by the FDA for blood/plasma donor screening.

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

LGD

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. Note: The performance of the Platelia® Toxo IgM assay has not been established for neonate testing.

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

Additional testing was performed using a serum panel obtained from the CDC consisting of 32 positive and 65 negative samples.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Precision Studies:
Inter-assay and intra-assay reproducibility were determined by assaying two T. gondir IgM negative samples and four T. gondii IgM positive samples in triplicate, on three different days at three laboratory sites (Site 1, Site 2, Site 3).
In addition, inter-assay and intra-assay reproducibility with plasma samples (Serum, EDTA, Citrate, Heparin) were determined by assaying three additional samples (one T. gondii IgM negative sample and two T. gondii IgM positive samples) in triplicate, on three different days, at one laboratory site.

Comparison Studies:
Performance of the Platelia Toxo IgM TMB assay was evaluated against another commercially available enzyme immunoassay (EIA) by testing 348 patient samples and 97 specimens from 40 seroconversion panels. The combined results of the patient and seroconversion panel testing demonstrate an agreement of 99.53%.

Negative agreement: 100.00% (271/271). The 95% confidence intervaled is 99.82 - 100.00%.
Positive agreement: 98.72% (154/156). The 95% confidence intervale is 96.61 - 100.00%.
Overall agreement: 99.53% (425/427). The 95% confidence interval-6 is 98.76% - 100.00%.

Expected Values:
A total of 445 fresh and frozen serum samples obtained from pregnant women during routine laboratory activities in the area of Paris, France were tested with the Platelia® Toxo IgM TMB assay. The distribution of serum / cut-off ratio values is shown in a chart.

CDC Test Panel:
The panel consists of 32 positive and 65 negative samples. The Platelia® Toxo IgM TMB assay demonstrated 100% agreement with the positive specimens and 100% agreement with the negative specimens.

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

Negative agreement: 100.00% (271/271)
Positive agreement: 98.72% (154/156)
Overall agreement: 99.53% (425/427)
CDC Panel: 100% agreement with positive specimens, 100% agreement with negative specimens.

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.

K89498

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

§ 866.3780

Toxoplasma gondii serological reagents.(a)
Identification. Toxoplasma gondii serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies toToxoplasma gondii in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identifyToxoplasma gondii from clinical specimens. The identification aids in the diagnosis of toxoplasmosis caused by the parasitic protozoanToxoplasma gondii and provides epidemiological information on this disease. Congenital toxoplasmosis is characterized by lesions of the central nervous system, which if undetected and untreated may lead to brain defects, blindness, and death of an unborn fetus. The disease is characterized in children by inflammation of the brain and spinal cord.(b)
Classification. Class II (performance standards).

Summary

Image /page/0/Picture/0 description: The image shows a logo with the text "O+RAD" in bold, white letters against a black background. The logo has a rounded rectangular shape. The plus sign in "O+RAD" is slightly smaller than the other letters.

SEP 3 0 2002

ATTACHMENT I 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: K013837

DATE:	September 10, 2002
APPLICANT:	Bio-Rad
3, Boulevard Raymond Poincaré
92430 Marnes-la-Coquette, France
PHONE:	33-1-47-95-6138
FAX:	33-1-47-95-6242
OFFICIAL CORRESPONDENT:	Sylvie Confida
PRODUCT TRADE NAME:	Bio-Rad Platelia® Toxo IgM TMB
COMMON NAME:	Toxoplasma IgM Enzyme Immunoassay (EIA)
CLASSIFICATION NAME:	21 CFR 866.3780, Enzyme Linked Immunoabsorbent Assay,
Toxoplasma Gondii
PREDICATE DEVICE:	Kallestad Diagnostics Platelia® Toxo IgM (K89498)

DEVICE DESCRIPTION

Image /page/1/Picture/0 description: The image shows the logo for Bio-Rad Laboratories, a company that manufactures and distributes products for the life science research and clinical diagnostics markets. The logo is in black and white and features the company name in bold, sans-serif letters. The logo is enclosed in a rounded rectangle.

INTENDED USE

The Platelia® Toxo IgM TMB kit is an in vitro diagnostic test kit allowing the qualitative detection of anti-Toxoplasma gondii in human serum or plasma (EDTA, Heparin, Citrate).

Note:

Patient testing with the Platelia® Toxo IgM assay must be performed in conjunction with an anti-. Toxoplasma gondii IgG antibody assay.
. The Platelia® Toxo IgM assay is presumptive for the detection of anti-Toxoplasma gondii IgM antibodies and presumptive for the diagnosis of acute, recent, or reactivated Toxoplasma gondii infection.
. The performance of the Platelia® Toxo IgM assay has not been cleared/approved by the FDA for blood/plasma donor screening.

TECHNOLOGICAL CHARACTERISTICS

The Platelia® Toxo IgM TMB kit is a modified version of the Platelia® Toxo IgM kit and remains similar in form and function. The following comparison table indicates significant similarities and differences between the kits:

Characteristics	Platelia® Toxo IgM (Predicate)	Platelia® Toxo IgM TMB
Format and Test Method	96-well microplate EIA,
non-breakaway wells	96-well microplate EIA,
breakaway wells
Intended Use	Assay for the qualitative
detection of anti- Toxoplasma
gondii IgM in human serum	Assay for the qualitative
detection of anti- Toxoplasma
gondii IgM in human serum or
plasma
Positive and Negative Controls	Pooled human serum, negative
for T. gondii , is used to
manufacture the negative control
and to dilute the positive control.	A synthetic matrix consisting of
Tris-NaCl buffer, BSA, glycerol,
and colorant is used to
manufacture the negative control
and to dilute the positive control.
Chromogen	o . phenylenediamine-2 HCL
(OPD) tablets	Tetramethylbenzidine (TMB)
solution
Wavelength	Dual wavelength reading at
492 nm and 620 nm.	Dual wavelength reading at
450 nm and 620 nm.

Comparison Table

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PERFORMANCE SUMMARY

A. Precision Studies

Inter-assay and intra-assay reproducibility were determined by assaying two T. gondir IgM negative samples and four T. gondii IgM positive samples in triplicate, on three different days at three laboratory sites.

Site 1

	Neg 1		Neg 2		Pos 1		Pos 2		Pos 3		Pos 4
	OD	S/CO	OD	S/CO	OD	S/CO	OD	S/CO	OD	S/CO	OD	S/CO
N=	9	9	9	9	9	9	9	9	9	9	9	9
Mean=	0.027	0.052	0.022	0.042	0.742	1.438	0.660	1.278	0.825	1.599	1.477	2.862
Within Run
(intra-assay) sd=	0.001	0.003	0.002	0.003	0.011	0.021	0.011	0.022	0.016	0.031	0.017	0.034
%CV=	5.2%	5.1%	7.5%	7.6%	1.5%	1.4%	1.7%	1.7%	1.9%	1.9%	1.2%	1.2%
Total
(inter-assay) sd=	0.002	0.005	0.001	0.003	0.020	0.041	0.013	0.038	0.013	0.048	0.032	0.050
%CV=	8.1%	9.7%	6.7%	6.3%	2.6%	2.8%	2.0%	3.0%	1.6%	3.0%	2.1%	1.7%

Site 2

		Neg 1		Neg 2		Pos 1		Pos 2		Pos 3		Pos 4
	OD	S/CO	OD	S/CO	OD	S/CO	OD	S/CO	OD	S/CO	OD	S/CO
N=	9	9	9	9	9	9	9	9	9	9	9	9
Mean=	0.031	0.050	0.029	0.048	0.746	1.206	0.669	1.083	0.776	1.255	1.511	2.444
Within Run
(intra-assay) sd=	0.007	0.011	0.007	0.011	0.025	0.040	0.015	0.024	0.009	0.015	0.051	0.082
%CV=	22.5%	23.0%	22.6%	23.2%	3.3%	3.3%	2.3%	2.3%	1.2%	1.2%	3.4%	3.4%
Total
(inter-assay) sd=	0.009	0.016	0.007	0.012	0.024	0.061	0.015	0.066	0.012	0.063	0.046	0.151
%CV=	29.9%	32.8%	22.3%	24.4%	3.2%	5.0%	2.2%	6.1%	1.5%	5.0%	3.0%	6.2%

Site 3

	Neg 1		Neg 2		Pos 1		Pos 2		Pos 3		Pos 4
	OD	S/CO	OD	S/CO	OD	S/CO	OD	S/CO	OD	S/CO	OD	S/CO
N=	9	9	9	9	9	9	9	9	9	9	9	9
Mean=	0.032	0.057	0.024	0.042	0.769	1.393	0.705	1.278	0.684	1.227	1.346	2.426
Within Run
(intra-assay) sd=	0.004	0.007	0.006	0.011	0.055	0.104	0.023	0.044	0.011	0.020	0.061	0.107
%CV=	11.6%	12.1%	24.0%	25.3%	7.1%	7.5%	3.3%	3.5%	1.6%	1.6%	4.5%	4.4%
Total
(inter-assay) sd=	0.014	0.022	0.010	0.016	0.073	0.203	0.077	0.212	0.119	0.150	0.098	0.150
%CV=	43.7%	38.7%	41.2%	36.8%	9.5%	14.6%	11.0%	16.6%	17.4%	12.2%	7.3%	6.2%

Image /page/3/Picture/0 description: The image shows the logo for Bio-Rad Laboratories, a company that manufactures and distributes products for the life science research and clinical diagnostics markets. The logo is in white text on a black background. The text is bold and sans-serif.

In addition, inter-assay and intra-assay reproducibility with plasma samples were determined by assaying three additional samples (one T. gondii IgM negative sample and two T. gondii IgM positive samples) in triplicate, on three different days, at one laboratory site.

Serum	Neg 1		Pos 1		Pos 2
	OD	S/CO	OD	S/CO	OD	S/CO
N =	9	9	9	9	9	9
Mean =	0.022	0.04	0.710	1.26	1.083	1.92
Within-Run
(intra-assay) sd =	0.002	0.003	0.019	0.034	0.029	0.052
%CV =	8.7%	8.8%	2.7%	2.7%	2.7%	2.7%
Total
(inter-assay) sd =	0.003	0.006	0.035	0.077	0.051	0.074
%CV =	14.5%	14.9%	4.9%	6.1%	4.8%	3.9%
EDTA	Neg 1		Pos 1		Pos 2
	OD	S/CO	OD	S/CO	OD	S/CO
N =	9	9	9	9	9	9
Mean =	0.024	0.04	0.761	1.35	1.063	1.88
Within-Run
(intra-assay) sd =	0.002	0.004	0.019	0.034	0.019	0.033
%CV =	8.3%	8.3%	2.5%	2.6%	1.7%	1.8%
Total
(inter-assay) sd =	0.002	0.004	0.036	0.030	0.056	0.076
%CV =	8.5%	9.4%	4.7%	2.2%	5.2%	4.0%
Citrate	Neg 1		Pos 1		Pos 2
	OD	S/CO	OD	S/CO	OD	S/CO
N =	9	9	9	9	9	9
Mean =	0.022	0.04	0.674	1.19	1.075	1.91
Within-Run
(intra-assay) sd =	0.001	0.002	0.017	0.029	0.020	0.036
%CV =	5.0%	5.0%	2.5%	2.5%	1.9%	1.9%
Total
(inter-assay) sd =	0.002	0.004	0.031	0.038	0.043	0.091
%CV =	9.9%	10.6%	4.5%	3.2%	4.0%	4.8%
Heparin	Neg 1		Pos 1		Pos 2
	OD	S/CO	OD	S/CO	OD	S/CO
N =	9	9	9	9	9	9
Mean =	0.022	0.04	0.719	1.27	1.034	1.83
Within-Run
(intra-assay) sd =	0.001	0.002	0.012	0.020	0.022	0.039
%CV =	4.4%	4.4%	1.6%	1.6%	2.1%	2.1%
Total
(inter-assay) sd =	0.002	0.003	0.024	0.031	0.059	0.115

Image /page/4/Picture/0 description: The image shows the logo for BIO-RAD. The logo is white text on a black rounded rectangle. The text is in all caps and bolded.

B. Comparison Studies

Performance of the Platelia Toxo IgM TMB assay was evaluated against another commercially available enzyme immunoassay (EIA) by testing 348 patient samples and 97 specimens from 40 seroconversion panels. The combined results of the patient and seroconversion panel testing demonstrate an agreement of 99.53%.

| | 1
= 445 | TMB | | |
|-----|------------|-----|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| | | Neg | Equivocal
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | Pos |
| lgM | Neg | 27 | | |
| EIA | Equivocal | | | |
| | Pos | | | ાર્ય |

Platelia Toxo IgM TMB vs IgM EIA Correlation Table (combined results)

Excluding equivocal samples / specimens, the combined results of comparative prospective and retrospective testing demonstrated the following:

Negative agreement : 100.00% (271/271). The 95% confidence intervaled is 99.82 - 100.00%. Positive agreement : 98.72% (154/156). The 95% confidence intervale is 96.61 - 100.00%. Overall agreement : 99.53% (425/427). The 95% confidence interval-6 is 98.76% - 100.00%.

C. Expected Values

A total of 445 fresh and frozen serum samples obtained from pregnant women during routine laboratory activities in the area of Paris, France were tested with the Platelia® Toxo IgM TMB assay. The distribution of serum / cut-off ratio values is shown in the following chart.

Image /page/4/Figure/9 description: The image is a bar chart titled "Platelia Toxo IgM TMB Expected Values". The x-axis is labeled "Ratio Serum / Cut-Off", and the y-axis is labeled "Frequency". The bar chart shows the frequency of different ratio serum/cut-off values. The bar chart shows that the most frequent ratio serum/cut-off value is less than 0.1, with a frequency of 214, and greater than or equal to 1.0, with a frequency of 154.

Image /page/5/Picture/0 description: The image shows the logo for Bio-Rad. The logo is white text on a black rounded rectangle. The text reads "BIO-RAD" with a plus sign between "BIO" and "RAD".

D. CDC Test Panel

The following information is from a serum panel obtained from the CDC and tested by Bio-Rad Laboratories. The results are presented as a means to convey further information on the performance of this assay with a masked, characterized serum panel. This does not imply an endorsement of the assay by the CDC.

The panel consists of 32 positive and 65 negative samples. The Platelia® Toxo IgM TMB assay demonstrated 100% agreement with the positive specimens and 100% agreement with the negative specimens.

Please Note: There should be no other statistical calculation or inferences drawn from the panel results.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP 3 0 2002

Mr. David Bhend Regulatory Affairs Associate Bio-Rad Laboratories Diagnostics Group 6565 18511 Avenue NE Redmond, WA 98052

Re: K013837

Trade/Device Name: Platelia® Toxo IgM TMB Regulation Number: 21 CFR 866.3780 Regulation Name: Toxoplasma gondii serological reagents Regulatory Class: Class II Product Code: LGD Dated: July 19, 2002 Received: July 23, 2002

Dear Mr. Bhend:

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 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 Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

ATTACHMENT G INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K013837

Device Name: Platelia® Toxo IgM TMB

Indications for Use:

The Platelia Toxo IgM TMB kit is an in-vitro diagnostic test kit for the qualitative and quantitative detection of anti-Toxoplasma gondii IgM in human serum or plasma (EDTA, Heparin, Citrate).

Note:

. Patient testing with the Platelia® Toxo IgM assay must be performed in conjunction with an anti-Toxoplasma gondii IgG antibody assay.
The Platelia® Toxo IgM assay is presumptive for the detection of anti-● Toxoplasma gondii IgM antibodies and presumptive for the diagnosis of acute, recent or reactivated Toxoplasma gondii infection.
The performance of the Platelia® Toxo IgM assay has not been established for ● neonate testing.
. The Platelia® Toxo IgM assay has not been cleared/approved by the FDA for blood/plasma donor screening.

Woody Deubler

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K013837

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Professional Use: ___________

Prescription Use: (Per 21 CFR 801.109

Over-The-Counter Use: (Optional Format 1-2-96)