K Number

Device Name

IS H. PYLORI IGG ELISA TEST SYSTEM

Manufacturer

COLUMBIA BIOSCIENCE, INC.

Date Cleared

1999-09-03

(203 days)

Product Code

LYR

Regulation Number

866.3110

Intended Use

For the qualitative determination of IgG antibodies to Helicobactor pylori antigen in human sera by indirect enzyme immunoasay. The H.pylori IgG assay may be used as an aid in the diagnosis of H. pylori infection in adult patients with gastrointestinal symptoms. The test can be performed either manually or in conjunction with the MAGO® PLUS Automated EIA Processor.

Device Description

The & H. pylori IgG ELISA Kit is an enzyme-linked immunosorbent assay (ELISA) for the detection of IgG antibodies to H. pylori antigen in human 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

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard ELISA kit and an automated processor for performing the assay. There is no mention of AI, ML, or any related concepts in the device description, intended use, or performance studies. The automation mentioned is for processing the assay, not for interpreting results using AI/ML.

Therapeutic

No.
This device is an in vitro diagnostic test used to aid in the diagnosis of H. pylori infection. It does not provide treatment or therapy.

Diagnostic

Yes
The "Intended Use / Indications for Use" section states that the "H.pylori IgG assay may be used as an aid in the diagnosis of H. pylori infection."

SaMD (Software as a Medical Device)

The device is an ELISA kit, which is a laboratory test kit containing reagents and other physical components, not solely software. While it can be used with an automated processor (MAGO® PLUS), the core device itself is a physical kit.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use explicitly states "For the qualitative determination of IgG antibodies to Helicobactor pylori antigen in human sera by indirect enzyme immunoasay." This describes a test performed on a sample taken from the human body (serum) to provide information about a disease state (H. pylori infection).
Device Description: The device is described as an "enzyme-linked immunosorbent assay (ELISA) for the detection of IgG antibodies to H. pylori antigen in human serum." This is a common type of in vitro diagnostic test.
Sample Type: The test is performed on "human sera," which is a biological sample taken from a patient.
Purpose: The test is used "as an aid in the diagnosis of H. pylori infection." This is a diagnostic purpose.

All of these characteristics align with the definition of an In Vitro Diagnostic device.

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)

LYR

Device Description

The & H. pylori IgG ELISA Kit is an enzyme-linked immunosorbent assay (ELISA) for the detection of IgG antibodies to H. pylori antigen in human serum.

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

adult patients

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

Frozen retrospective sera from two hundred forty-nine patients were characterized using biopsy with culture, stain and CLO results for H.pylori. Based on the results of this testing, the patient sera were characterized as follows :

121 sera were characterized as positive. These were positive for H. pylori by biopsy.
128 sera were characterized as negative. These were negative for H. pylori by biopsy.
The sera were tested on the 1s-H, pylori IgG Test Kit at a clinical commercial laboratory.

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

A. Sensitivity and Specificity Using Characterized Sera
Study Type: Sensitivity and Specificity Using Characterized Sera
Sample Size: 249 patients (121 positive for H. pylori by biopsy, 128 negative for H. pylori by biopsy)
Key Results:
Sensitivity = 112/118 = 94.9% (95% Cl 89.3-98.1%)
Specificity = 113/125 = 90.4% (95% Cl 83.8-94.9%)
Overall Agreement = 225/243 = 92.6% (95% Cl 88.5-95.6%)
*Equivocal results were excluded from the above calculations.

B. Relative Agreement Versus Another ELISA
Study Type: Relative Agreement Versus Another ELISA
Sample Size: 249 patients (same samples from Table 2)
Key Results:
Overall Relative Agreement = 238/239 = 99.6%
*Equivocal results were excluded from calculations.

C. Precision
Study Type: Precision
Sample Size: Six sera (4 positive, 2 negative) assayed ten times each in three different runs at three different sites (manufacturer, research & development laboratory, clinical commercial laboratory).
Key Results: Intra- and interassay precision data provided in Tables 4, 5, and 6 for each site.

D. Correlation of Manual and MAGO Plus Results
Study Type: Correlation of Manual and MAGO Plus Results
Sample Size: 100 serum samples
Key Results: Pearson Correlation Coefficient of 0.993. The data indicate good correlation between manual and MAGO Plus procedures.

E. MAGO Plus Precision
Study Type: MAGO Plus Precision
Sample Size: Six sera assayed ten times each in three different runs using the MAGO Plus Automated EIA Processor.
Key Results: Intra- and interassay precision data provided in Table 7 for MAGO Plus.

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

Sensitivity: 94.9% (95% Cl 89.3-98.1%)
Specificity: 90.4% (95% Cl 83.8-94.9%)
Overall Agreement: 92.6% (95% Cl 88.5-95.6%)
Overall Relative Agreement (versus another ELISA): 99.6%
Pearson Correlation Coefficient (Manual vs MAGO Plus): 0.993

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.

Wampole H. pylori IgG ELISA

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

§ 866.3110

Campylobacter fetus serological reagents.(a)
Identification. Campylobacter fetus serological reagents are devices that consist of antisera conjugated with a fluorescent dye used to identifyCampylobacter fetus from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by this bacterium and provides epidemiological information on these diseases.Campylobacter fetus is a frequent cause of abortion in sheep and cattle and is sometimes responsible for endocarditis (inflammation of certain membranes of the heart) and enteritis (inflammation of the intestines) in humans.(b)
Classification. Class I (general controls).

Summary

K990462

510k Summary of Safety and Effectiveness

SEP , 3 1999

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:

Applicant Information:

Date Prepared:
Name:	Columbia Bioscience, Inc.
Address:	8775 M Centre Park Drive, #559
Columbia, MD 21045

Contact Person:	Norman Jenkins
PhoneNumber.	410-995-1278
Fax Number.	410-995-0508

Device Information:

Trade Name:	Image: Logo H. pylori IgG ELISA Kit
Common Name.	H. pylori IgG EIA Test
Classification Name;	H. pylori IgG Serological Reagent

Equivalent Device:

Wampole H. pylori IgG ELISA

Device Description: The & H. pylori IgG ELISA Kit is an enzyme-linked immunosorbent assay (ELISA) for the detection of IgG antibodies to H. pylori antigen in human serum.

Intended Use: For the qualitative determination of IgG antibodies to Helicobactor pylori antigen in human sera by indirect enzyme immunoasay. The H.pylori IgG assay may be used as an aid in the diagnosis of H. pylori infection in adult patients with gastrointestinal symptoms. The test can be performed either manually or in conjunction with the MAGO® PLUS Automated EIA Processor.

Principle of Procedure:

Purified H. pylori antigen is bound to microwells. Diluted patient sera, Cut-Off Calibrator and controls are placed in the microwells and incubated. Anti-H. pylori IgG antibodies, if present, will bind to the antigen forming antibody complexes. Residual sample is eliminated by aspirating and washing. Conjugate (norseradish peroxidase-labeled anti-human IgG) is added and will bind to these complexes. Unbound conjugate is removed by aspiration and washing. Substrate is then added and incubated. In the presence of bound enzyme the substrate is converted to an end product. The absorbance of this end product can be read spectrophotometrically at 450 nm (reference 600-630 nm) and is directly proportional to the concentration of IgG antibodies to H. pylori present in the sample.

Performance Characteristics

A. Sensitivity and Specificity Using Characterized Sera

- 121 sera were characterized as positive. These were positive for H. pylori by biopsy.
- 128 sera were characterized as negative. These were negative for H. pylori by biopsy.

The sera were tested on the 1s-H, pylori IgG Test Kit at a clinical commercial laboratory. The data is summarized in Table 2.

TABLE 2

Is-H. pylori IgG

		POSITIVE	*EQUIVOCAL	NEGATIVE
H. pylori	POSITIVE	112	3	6
Clinical Status
(Biopsy)	INEGATIVE	12	3	113
	Sensitivity
Specificity
Overall Agreement =	ll	112/118 = 94.9%
113/125 = 90.4%
225/243 = 92.6%	95% Cl
89.3-98.1%
83.8-94.9%
88.5-95.6%

*Equivocal results were excluded from the above calculations.

B. Relative Agreement Versus Another ELISA

Frozen retrospective sera from two hundred forty-nine patients (same samples from Table 2) were tested at a clinical commercial laboratory using the 1s-H, pylori 1gG Test Kit and another commercially available kit for H. pylori IgG antibodies. The data in Table 3 illustrates the relative aggrement of the 1s-H. pylori lgG Test Kit versus another commercial ELISA.

TABLE 3

Is-H. pylori IgG

Another ELISA

	POSITIVE	* EQUIVOCAL	NEGATIVE
POSITIVE	122	3	0
*EQUIVOCAL	1	1	3
NEGATIVE	1	2	116

· Of the 125 sera positive on the alternate ELISAtested, 122 were positive for Is-H. pylori IgG, none were negative, and 3 were equivocal

· Of the 119 sera negative on the alternate ELISAtested, 1 was positive for Is-H. pylori IgG, 116 were negative, and 2 were equivocal

· Of the 5 sera equivocal on the alternate ELISAtested, 1 was positive for Is-H, pylori IgG, 1 was negative, and 3 were equivocal

· Overall Relative Agreement = 238/239 = 99.6%

Equivocal results were excluded from calculations

NOTE : Please be advised that 'relative' relers to the comparison of the assay's results to that of a similar assay. There was not an attempt to correlate the assay's results with disease presence or absence. No judgment can be made on the comparison's accuracy to predict disease.

C. Precision

To determine the precision of the Is-H. pyleri IgG Test Kit, four positive sera were assayed ten times each in thee different runs at three different sites included: the manufacturer, a research & development laboratory, and a clinical commercial laboratory. The intra- and interassay precision obtained at each site is shown in Tables 4,5, and 6.

SERUM		INTRA-ASSAY RUN 1		INTRA-ASSAY RUN 2		INTRA-ASSAY RUN 3		INTERASSAY
	MEAN
INDEX	CV%	MEAN
INDEX	CV%	MEAN
INDEX	CV%	MEAN
INDEX	CV%
A (POS)	1.51	3.85	1.47	5.05	1.45	4.97	1.47	4.80
B (POS)	2.60	2.16	2.58	4.20	2.59	3.69	2.59	3.35
C (POS)	2.23	3.66	2.23	3.65	2.20	2.98	2.22	3.39
D (POS)	1.73	3.82	1.72	2.19	1.70	3.57	1.71	3.24
E (NEG)	0.19	10.81	0.16	13.54	0.14	36.64	0.17	23.60
F (NEG)	0.36	37.22	0.32	16.08	0.34	11.54	0.34	24.91

TABLE 4 : Site #1 - Intra-Assay and Interassay Precision

TABLE 5 : Site #2- Intra-Assay and Interassay Precision

SERUM	INTRA-ASSAY RUN 1		INTRA-ASSAY RUN 2		INTRA-ASSAY RUN 3		INTERASSAY
	MEAN
INDEX	CV%	MEAN
INDEX	CV%	MEAN
INDEX	CV%	MEAN
INDEX	CV%
A (POS)	1.34	4.92	1.32	5.00	1.38	4.39	1.35	4.93
B (POS)	2.25	5.85	2.27	5.17	2.45	6.18	2.33	6.78
C (POS)	1.97	3.40	1.96	4.24	2.11	4.83	2.01	5.41
D (POS)	1.46	6.27	1.45	4.52	1.62	4.02	1.51	6.93
E (NEG)	0.18	12.48	0.17	11.70	0.22	10.28	0.19	15.39
F (NEG)	0.40	11.01	0.35	20.01	0.47	12.50	0.41	18.56

TABLE 6 : Site #3 - Intra-assay and Interassay Precision

SERUM	INTRA-ASSAY RUN 1		INTRA-ASSAY RUN 2		INTRA-ASSAY RUN 3		INTERASSAY
	MEAN
INDEX	CV%	MEAN
INDEX	CV%	MEAN
INDEX	CV%	MEAN
INDEX	CV%
A (POS)	1.41	7.59	1.30	5.70	1.27	4.60	1.33	7.64
B (POS)	2.54	4.41	2.30	3.74	2.19	2.52	2.34	7.31
C (POS)	2.13	5.91	1.96	4.89	1.90	3.43	2.00	6.94
D (POS)	1.56	6.16	1.50	4.59	1.45	2.08	1.50	5.42
E (NEG)	0.16	19.99	0.18	6.38	0.16	6.25	0.17	13.77
F (NEG)	0.34	10.92	0.34	13.65	0.27	15.74	0.32	16.60

D. Correlation of Manual and MAGO Plus Results

The Is-H. pylori IgG Test Kit has been developed for automated as . To demonstrate the equivalence of the manual and MAGO Plus procedures, the results of 100 serum samples tested by both methods were plotted. A scattergram and regression line of the results obtained with 95% confidence intervals is shown in Figure 3. The data indicate good correlation with a Pearson Correlation Coefficient of 0.993.

Image /page/3/Figure/10 description: The image is a scatter plot that shows the correlation between MANUAL Index Values and MAGO PLUS Index Values. The x-axis represents the MANUAL Index Values, ranging from 0.0 to 4.0, while the y-axis represents the MAGO PLUS Index Values, ranging from -0.5 to 5.0. The scatter plot shows a strong positive correlation between the two variables, with a correlation coefficient of r = 0.993. A regression line is plotted through the data points.

FIGURE 3 : Manual and MAGO Plus Result Correlation

E. MAGO Plus Precision

The precision of the assay when performed on the MAGO Plus Automated EIA Processor was determined by assaying six sera ten times each in three different runs. Table 7 shows the intra-and interassay precision obtained using the MAGO Plus.

SERUM	INTRA-ASSAY RUN 1		INTRA-ASSAY RUN 2		INTRA-ASSAY RUN 3		INTERASSAY
	MEAN
INDEX	CV%	MEAN
INDEX	CV%	MEAN
INDEX	CV%	MEAN
INDEX	CV%
A (POS)	1.19	8.36	1.02	15.19	1.25	5.66	1.15	12.83
B (POS)	2.12	4.87	2.20	9.34	2.27	2.97	2.20	6.71
C (POS)	1.97	4.18	1.89	5.82	1.90	4.96	1.92	5.19
D (POS)	1.37	6.01	1.45	4.88	1.54	7.62	1.45	7.82
E (NEG)	0.13	37.16	0.12	35.14	0.20	62.36	0.15	57.40
F (NEG)	0.32	24.65	0.34	24.80	0.34	15.19	0.33	21.33

TABLE 7 : Site #2- Intra-Assay and Interassay Precision - MAGO Plus

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text surrounding a stylized symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular fashion. The symbol in the center appears to be an abstract representation of a bird or a stylized human figure.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP 3 1999

Mr. William Boteler Immunoprobe, Inc. 1306F Bailes Lane Frederick, Maryland 21701

Re: K990462 Trade Name: Helicobactor pylori IgG ELISA Regulatory Class: I Product Code: LYR Dated: June 15, 1999 Received: June 16, 1999

Dear Mr. Boteler:

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 OS 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 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.

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" (21 CFR 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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/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

510(k) Number:

Device Name: 20 H. pylori IgG ELISA

Indications For Use: For the qualitative determination of IgG antibodies to Helicobactor pylori antigen in human sera by indirect enzyme immunoassay. The H.pylori IgG assay may be used as an aid in the diagnosis of H. pylori infection in adult patients with gastrointestinal symptoms. The test can be performed either manually or in conjunction with the MAGO® PLUS Automated EIA Processor.

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) OR

w===========================================================================================================================================================================

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

Woody Dubaes

(Division Sign Off) Division of Clinical Laboratory Devices 510(k) Number_19