The Mono G Test is a qualitative enzyme immunoassay (EIA) that detects IgG antibodies to Epstein-Barr virus capsid antigen (EBV-VCA), Epstein-Barr early nuclear antigen (EBV-EBNA), cytomegalovirus (CMV), and toxoplasma (toxo). When used in conjunction with Mono-M Test it is an aid in the serodiagnosis of infectious (EBV) mononucleosis and presumptive serodiagnosis of CMV or toxoplasma mononucleosis-like syndrome.

This assay has not been FDA cleared or approved for the screening of blood or plasma donors. Performance with this device has not been established for either prenatal screening or newborn testing. Performance for this assay has not been established in a non-clinical laboratory environment (e.g., point of care testing).

Device Description

The product is an ELISA test method detecting viral capsid antigen Epstein-Barr nuclear antigen, cytomegalovirus and toxoplasma IgG antibodies.

AI/ML Overview

Here's an analysis of the provided 510(k) summary, extracting the requested information about acceptance criteria and the supporting study:

The provided document describes the ImmunoDOT Mono G Test, an ELISA method for detecting IgG antibodies related to mononucleosis. The "acceptance criteria" in this context refer to the performance characteristics, specifically sensitivity and specificity, deemed acceptable for the device to be marketed.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as target values, but rather implied by the reported performance characteristics that establish substantial equivalence.

Performance Metric	Acceptance Criteria (Implied by Predicate & Regulatory Approval)	Reported Device Performance (ImmunoDOT Mono G Test)
EBV Infectious Mononucleosis
Sensitivity	Comparable to predicate device's established performance	98.8% (238/241) [Range: 96-99.7%]
Specificity	Comparable to predicate device's established performance	93% (42/45) [Range: 93-99%]
Mononucleosis Syndrome (Overall)
Sensitivity	Comparable to predicate device's established performance	98.7% (236/239) [Range: 96-99.7%]
Specificity	Comparable to predicate device's established performance	89% (42/47) [Range: 77-96%]

Note: The document implies that these performance characteristics were found to be substantially equivalent to a legally marketed predicate device, thus meeting the "acceptance criteria" for regulatory clearance.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set:
- EBV Performance Summary (Table 3):
  - Negative: 47 (42 negative, 3 current, 2 indeterminate)
  - Current: 40 (33 current, 1 past/recent, 6 indeterminate)
  - Past/Recent: 215 (1 past/recent, 204 past/recent, 8 indeterminate)
  - Total (including Indeterminate): 302 specimens
- Overall Performance Summary (Table 4):
  - Negative: 49 (42 negative, 5 current, 2 indeterminate)
  - Current: 43 (36 current, 1 past/recent, 6 indeterminate)
  - Past/Recent: 210 (2 past/recent, 199 past/recent, 8 indeterminate)
  - Total (including Indeterminate): 302 specimens
- Performance Characteristics (Table 5) (Excluding Indeterminates):
  - EBV Infectious Mononucleosis: 241 Current/Past/Recent + 45 Negative = 286 specimens
  - Mononucleosis Syndrome: 239 Current/Past/Recent + 47 Negative = 286 specimens
Data Provenance: The study was a "prospective study" conducted at "Site A" and "Site B." The country of origin is not explicitly stated, but the sponsor's address is San Diego, CA, USA, implying the study was likely conducted in the USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document refers to "Reference Results" for establishing ground truth, but does not specify the number of experts or their qualifications. It only states that these reference results were used to classify samples as Negative, Current, or Past/Recent mononucleosis.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set. It mentions "Reference Results" as the ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not performed. This device is an in-vitro diagnostic (ELISA test) that yields an objective result, not an imaging device requiring human reader interpretation in the same way an MRMC study would apply. Therefore, the effect size of human readers improving with AI vs without AI assistance is not applicable and not reported.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone performance study was done. The reported sensitivity and specificity values are for the ImmunoDOT Mono G Test device itself (algorithm only, if one considers the assay as a deterministic algorithm). There is no human-in-the-loop described for the interpretation of the primary quantitative results. The device provides a qualitative output (Negative, Current, Past/Recent, Indeterminate) based on the test's reaction, which is then objectively read.

7. The Type of Ground Truth Used

The ground truth used was based on "Reference Results" which classified samples into "Negative," "Current," and "Past/Recent" categories for mononucleosis. The specific methods or assays used for these reference results are not detailed, but it is implied to be a standard clinical diagnostic method for mononucleosis serodiagnosis. For the CMV and Toxoplasma IM cases, "reference results" were also used to confirm the presumptive diagnoses.

8. The Sample Size for the Training Set

The document does not explicitly mention a training set or its sample size. The performance data presented is from a "prospective study" used to assess assay performance, which would typically be analogous to a test or validation set in the context of device approval. For an ELISA assay, the "training" aspect is more related to assay development and optimization rather than a distinct dataset for machine learning.

9. How the Ground Truth for the Training Set Was Established

Since a distinct training set for this type of device (ELISA test) is not described, the method for establishing its ground truth is not applicable and not provided.

Summary

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K974226

510(k) Summarv

Contact	Bryan Kiehl
Address	GenBio15222-A Avenue of ScienceSan Diego, CA 92128
Telephone	(619) 592-9300 ext 309
FAX	(619) 592-9400
Email	Bryan@GenBio.com
Date:	17 September, 1998

DEVICE NAME	IMMUNODOT MONO G TEST
Common, usual, or classification name	Mononucleosis Test
Classification Number (if known)

Identification of the legally marketed device substantial equivalence is claimed: ImmunoDOT Infectious Mononucleosis Test, GenBio, San Diego, CA

Description of the new device:

The product is an ELISA test method detecting viral capsid antigen Epstein-Barr nuclear antigen, cytomegalovirus and toxoplasma IgG antibodies.

Intended Use of New Device:

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Similarities and/or differences

ITEM	PREDICATE DEVICE	NEW DEVICE
Methodology	ELISA	ELISA
Specimen Type	Serum	Serum
Test Objective	Mononucleosis Serology	Mononucleosis Serology
Product type, e.g.,calibrator, control, kit	Kit	Kit
Intended Use	Mononucleosis Serodiagnosis	Mononucleosis Serodiagnosis
Other	EBV, CMV and toxoplasmainfections. IgG and IgM aredetected within one assay.	EBV, CMV and toxoplasmainfections. IgG and IgM aredetected separately butreported together.

Relative Performance

A prospective study was performed to assess assay performance. Site A information based on profile comparison is presented in Table 1. Site B information is shown in Table 2 and the combined data can be seen in Table 3.

	Reference Results
ImmunoDOT	Negative	Current	Past/Recent
Negative	33	0	1
Current	2	23	1
Past/Recent	0	1	112
Indeterminate	0	6	7

Table 1: Site A EBV Performance

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	Reference Results
ImmunoDOT	Negative	Current	Past/Recent
Negative	9	0	0
Current	1	10	1
Past/Recent	0	0	92
Indeterminate	2	0	1

Table 2: Site B EBV Performance

Table 3: EBV Performance Summary

	Reference Results
ImmunoDOT	Negative	Current	Past/Recent
Negative	42	0	1
Current	3	33	2
Past/Recent	0	1	204
Indeterminate	2	6	8

There was no toxoplasma IM cases identified during the prospective trial period. Two CMV mononucleosis cases at Site A and three CMV mononucleosis cases at Site B were observed. Three of the five sera from presumptive CMV mononucleosis cases were positive according to reference results. These CMV results are included in Table 4 as ImmunoDOT current positives and summarize overall ImmunoDOT performance.

	Reference Results
ImmunoDOT	Negative	Current	Past/Recent
Negative	42	0	1
Current	5	36	2
Past/Recent	0	1	199
Indeterminate	2	6	8

Table 4: Overall Performance Summary

Using the above information, assay performance characteristics are shown in Table 5. Indeterminate results are not used for the calculations.

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	Sensitivity	SensitivityRange	Specificity	SpecificityRange
EBV Infectious Mononucleosis	98.8% (238/241)	96-99.7%	93% (42/45)	93-99%
Mononucleosis Syndrome	98.7% (236/239)	96-99.7%	89% (42/47)	77-96%

Table 5: Performance Characteristics

r a a

The intensity of the dot is directly related to precision. The darkest dots are most reliable while weaker reactions are proportionately less reliable. Site A and Site B laboratories were supplied masked specimens containing mixtures of the various analytes. Therefore, not all analytes tested the same number of replicates. Testing was conducted in triplicate each day. Tests were performed on six different days. The results are shown below. The results (Tables 12 and 13) show adequate qualitative discrimination for each analyte.

Antibody Level	Level 1Heterophil	Level 2Heterophil	VCA IgM	CMV IgM
Moderate	100%(36/36)	100%(36/36)	100%(36/36)	100%(72/72)
Low	100%(108/108)	100%(108/108)	100%(72/72)	100%(144/144)

Table 6: ImmunoDOT Mono M Precision Results

Table 7: ImmunoDOT Mono G Precision Results
---------------------------------------------	--	--	--

Antibody Level	VCA IgG	EBNA IgG	CMV IgG	Toxoplasma IgG
Moderate	100%(144/144)	100%(36/36)	100%(144/144)	100%(72/72)
Low	100%(72/72)	100%(144/144)	100%(72/72)	85%(122/144)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

SEP 2 2 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Bryan L. Kiehl, Ph.D. Vice President GenBio 15222 Avenue of Science, Suite A San Diego, California 92128

Re: K974226/S2 Trade Name: ImmunoDOT Mono-G Regulatory Class: I Product Code: LSE Dated: July 7, 1998 Received: July 8, 1998

Dear Dr. Kiehl:

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 Requlations, 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,.. J for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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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 leqally 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 (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Gutman

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

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Indications for Use

510(k) Number (if known):

Device Name: ImmunoDOT Mono-G

Indications for Use:

(Please do not write below this line - Continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE)

Woody Dubois

510(k) Nimber

Regulation Number and Section

§ 866.3235 Epstein-Barr virus serological reagents.

(a)
Identification. Epstein-Barr virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Epstein-Barr virus in serum. The identification aids in the diagnosis of Epstein-Barr virus infections and provides epidemiological information on diseases caused by these viruses. Epstein-Barr viruses are thought to cause infectious mononucleosis and have been associated with Burkitt's lymphoma (a tumor of the jaw in African children and young adults) and postnasal carcinoma (cancer).(b)
Classification. Class I (general controls).