The Adenovirus Antigen Detection ELISA Test System is an Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative determination of Adenovirus antigen in human fecal samples as an aid in the diagnosis of acute non-bacterial gastro-enteritis. Performance for this assay has not been established on children over the age of five and immunocompromised patients. The antibody utilized in this assay is a group specific antigen and cannot differentiate between types of adenovirus. Performance of this assay has not been established for specimens other than human feces. For in vitro diagnostic use only.

Device Description

The Adenovirus Antigen Detection ELISA test is an enzyme linked immunosorbent assay to detect adenovirus antigen in fecal samples. Purified monoclonal antibody specific to adenovirus is attached to a solid phase microtiter well. Diluted fecal sample is added to each well. If the adenovirus antigen is present, it will bind to the monoclonal antibody in the well. After incubation the wells are washed to remove unbound antigen. An enzyme labeled anti-adenovirus polyclonal antibody is added to each well. If antigen is present the conjugate antibody will bind to the antigen attached to the antibody on the well. After incubation the wells are washed to remove unbound conjugate. A substrate solution is added to each well. If enzyme is present the substrate will undergo a color change. After an incubation period the reaction is stopped and the color intensity is measured photometrically, producing an indirect measurement of specific antibody in the patient specimen.

AI/ML Overview

The Trinity Biotech plc. Adenovirus Antigen Detection ELISA Test System underwent several performance studies to establish its effectiveness. The acceptance criteria and reported device performance are summarized below, followed by details of each study.

1. Table of Acceptance Criteria and Reported Device Performance

Performance Characteristic	Acceptance Criteria (Implicit)	Reported Device Performance
Study 1: Relative to Cell Culture
Sensitivity (vs. Cell Culture)	High (e.g., >95%)*	100.0% (95% CI: 96.0-100.0%)
Specificity (vs. Cell Culture)	High (e.g., >90%)*	95.4% (95% CI: 88.9-100.0%)
Agreement (vs. Cell Culture)	High (e.g., >95%)*	98.3% (95% CI: 95.9-100.0%)
Study 2: Relative to Alternate EIA
Sensitivity (vs. Alternate EIA)	High (e.g., >85%)*	88.13% (95% CI: 83.01-93.24%)
Specificity (vs. Alternate EIA)	High (e.g., >90%)*	96.42% (95% CI: 94.30-98.54%)
Agreement (vs. Alternate EIA)	High (e.g., >90%)*	93.58% (95% CI: 91.31-95.85%)
Limit of Detection	Clearly defined PFU/mL	Adenovirus 40: 125 PFU; Adenovirus 41: 39 PFU
Precision (Inter-Assay)	Low coefficient of variation (CV%)	CV% range: 3.65% to 9.22% for samples; 4.23% for PC; 6.11% for NC
No false positives for negative samples	100% agreement	0/216 false positives
No false negatives for positive samples	100% agreement	0/216 false negatives
Cross-Reactivity	No significant cross-reactivity with tested organisms	No significant optical density observed for organisms alone.

*Note: Specific numerical acceptance criteria were not explicitly stated in the provided text, so they are inferred based on general expectations for diagnostic device performance. The reported performance values met the implicit high standards for sensitivity, specificity, and agreement compared to predicate methods and for reliability in precision within the context of an ELISA assay.

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

Study 1 (Relative to Cell Culture):
- Sample Size: 120 fecal specimens.
- Data Provenance: Retrospective, frozen fecal specimens sent to a University Virus Reference Laboratory in Ireland for routine testing. 90% of specimens were from adults.
Study 2 (Relative to Alternate EIA):
- Sample Size: 481 sera (likely a typo and should be fecal specimens given the device description)
- Data Provenance: Retrospective, frozen fecal specimens from a large public health lab in the UK. 57% of samples were from patients less than 5 years old and 43% from patients greater than five years old.
Precision Study:
- Sample Size: 6 samples (containing Type 2 adenovirus from cell culture), plus positive and negative controls. Each was run in triplicate over three days at three sites, totaling 216 determinations.
- Data Provenance: Not explicitly stated, but implies laboratory-prepared samples for internal validation.

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

The studies do not mention the use of "experts" in the traditional sense for establishing ground truth, such as radiologists or pathologists making diagnoses. Instead, the ground truth was established by established laboratory methods:

Study 1: Ground truth was established by cell culture isolation, with positive cultures confirmed by electron microscopy (EM) using a standard negative staining technique (considered presumptive for adenovirus types 40 and 41).
Study 2: Ground truth was primarily established by a commercially available alternate adenovirus EIA. For discordant samples, Electron Microscopy (EM) was used for confirmation.

No specific number or qualifications of "experts" (e.g., a board-certified virologist with X years of experience) were provided for interpreting these laboratory results; it is assumed that these benchmark methods were performed by qualified laboratory personnel following standard procedures.

4. Adjudication Method for the Test Set

Study 1: No specific adjudication method was described beyond the initial cell culture and EM confirmation. "Equivocals" (2 samples) were excluded from the final calculations but not explicitly adjudicated further.
Study 2: For samples where the device ELISA and the alternate EIA produced discordant results, these discrepant samples were re-tested, and any remaining discordant samples (15 in total) were then tested by Electron Microscopy (EM) for resolution. This implies a form of sequential adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study was done. This device is an in-vitro diagnostic ELISA test, not an AI-assisted diagnostic tool that involves human readers interpreting images or data alongside an AI.

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

Yes, the performance characteristics described (Sensitivity, Specificity, Limit of Detection, Precision, Cross-Reactivity) represent the standalone performance of the ELISA test system itself, without human-in-the-loop performance considerations beyond standard laboratory procedures for running the assay and interpreting the quantitative optical density readings against a cut-off.

7. The Type of Ground Truth Used

Study 1: The ground truth was based on a predicate laboratory method (cell culture isolation), confirmed by electron microscopy (EM). This is a form of laboratory gold standard for detecting the presence of adenovirus.
Study 2: The primary comparison was against an alternate commercially available adenovirus EIA. For discordant results, electron microscopy (EM) served as the confirmatory ground truth.

8. The Sample Size for the Training Set

No explicit "training set" is mentioned in the context of machine learning. For an ELISA test, the development process involves identifying antibodies and optimizing assay parameters. The performance studies detailed are validation studies for the finalized assay.

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

As this is an ELISA diagnostic kit and not an AI/machine learning device, the concept of a "training set" and establishing ground truth for it in the AI context does not directly apply. The development of the antibody and assay would have relied on known positive and negative controls and characterized samples to establish appropriate binding and detection parameters, but these are not referred to as a "training set" in the document.

Summary

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510(k) Summary Adenovirus Antigen Detection ELISA Test Kit

KA72406

DEC 2 4 1997

I. Trinity Biotech plc. Three Rocks Road Sandyford Industrial Estate Dublin 18, Ireland Contact person: Sinead Flynn Telephone: 011-353-1-295-5111 Date of preparation: June 23, 1997

II. Description of Device

III. Predicate Device

The Adenovirus Antigen Detection ELISA test is substantially equivalent to cell culture of adenovirus from fecal samples. Equivalence is demonstrated by the following comparative results:

{1}------------------------------------------------

Performance Characteristics

Relative sensitivity and specificity. One hundred and twenty retrospective frozen fecal specimens sent to a University Virus Reference Laboratory in Ireland for routine testing were tested with the Trinity Adenovirus Antigen detection ELISA and by cell culture isolation. 90% of the specimens were from adults. The samples were approximately 50% solid, and 50% liquid. The data in Table 1 illustrates good sensitivity and specificity of the Adenovirus Antigen Detection ELISA relative to cell culture isolation.

Table 1 Adenovirus Antigen Detection ELISA Sensitivity & Specificity Relative to Cell Culture Study 1

Wampole Adenovirus Antigen Detection ELISA

	+	E	-	Total
CellCulture	75	2	0	77
-	2	0	41	43
Total	77	2	41	120

Equivocals are not included in the following calculations:

Sensitivity = 75/75 = 100.0%	95% Confidence Interval = 96.0-100.0%*
Specificity = 41/43 = 95.4%	95% Confidence Interval = 88.9-100.0%
Agreement = 116/118 = 98.3%	95% confidence Interval = 95.9-100.0%

The 95% confidence intervals were calculated using the regular method. * The 95% confidence interval was calculated assuming one false negative.

Note: The positive cultures were identified by cytopathic effect (CPE) and confirmed by electron microscopy (EM) using a standard negative staining technique, which is considered presumptive for adenovirus types 40 and 41 when using fecal samples.

{2}------------------------------------------------

Four hundred eighty one sera were tested on the Adenovirus Antigen Detection ELISA and an alternate commercially available adenovirus EIA at a large public health lab in the UK. 57% of the samples were from patients less than 5 years old and 43 % were from patients greater than five years old. All were retrospective frozen fecal specimens with half being solid and half liquid. After retesting discrepants, the remaining descrepants were tested by EM. The data in Table 2 illustrates good sensitivity and specificity of the Adenovirus Antigen Detection ELISA relative to an alternate commercially available EIA.

Table 2 Adenovirus Antigen Detection ELISA Sensitivity & Specificity Relative to an Alternate adenovirus EIA Study 2

Wampole Adenovirus Antigen Detection ELISA

	+	E	-	Total
AlternateELISA	+	141	8	19	168
	-	11	6	296	313
	Total	152	14	315	481

Equivocals are not included in the following calculations:

Sensitivity = 141/160 = 88.13%	95% Confidence Interval = 83.01 - 93.24%
Specificity = 296/307 = 96.42%	95% Confidence Interval = 94.30 - 98.54%
Agreement = 437/467 = 93.58%	95% confidence Interval = 91.31 - 95.85%

The 95% confidence intervals were calculated using the normal method.

After retesting discordant samples on the Wampole Adenovirus Antigen Detection ELISA, 15 samples remained discordant and were tested by Electron Microscopy (EM). Eight of the 15 discordants were false negatives and two were false positives versus EM.

Please be advised that 'relative' refers to the comparison of this 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 assay's accuracy to predict disease.

{3}------------------------------------------------

Limit of Detection. Plaque assays were carried out in HEK-293 cells on fecal clinical samples of 2. Limit of Detection. Plaque assays were carrict our in rial played online milliliter
containing Adenovirus 40 and Adenovirus 41. The number of plaqued and assaved on the containing Adenovirus 40 and Adenovitus +1. The names. Wy diluted and assayed on the (PFU/mL) was established for each specificit with was found to be 125 PFU for Adenovirus 40 and 39 PFU for Adenovirus 41.

Limits of Detection: Enteric Adenoviruses
Adenovirus 40: 2 X $10^4$ PFU/mL			Adenovirus 41: 2.5 X $10^3$ PFU/mL
Dilution	OD	PFU/100ul	Dilution	OD	PFU/100ul
Neat	0.521	2 X $10^3$	Neat	0.259	2.5 X $10^2$
1/8	0.385	0.25 X $10^3$	1/8	0.161	0.312 X $10^2$
1/16	0.201*	0.125 X $10^3$	1/16	0.271	0.156 X $10^2$
1/32	0.165	0.062 X $10^3$	1/32	0.201	0.078 X $10^2$
1/64	0.063	0.031 X $10^3$	1/64	0.183*	0.039 X $10^2$
1/128	0.061	0.015 X $10^3$	1/128	0.126	0.019 X $10^2$
1/256	0.053	0.007 X $10^3$	1/256	0.092	0.009 X $10^2$
1/512	0.121	0.003 X $10^3$	1/512	0.063	0.004 X $10^2$
1/1024	0.041	0.001 X $10^3$	1/1024	0.065	0.002 X $10^2$
1/2048	-		1/2048	0.052	0.001 X $10^2$

*Limit of Detection

{4}------------------------------------------------

Precision. Six samples containing Type 2 adenovirus from cell culture and the positive and negative controls were each run in triplicate on three consecutive days at three different sites. The results are shown below in Table 3.

Table 3

Adenovirus Antigen Detection ELISA Inter Assay Precision Between Sites
Inter-Assay (n=27)
#	X	SD	CV	n
1.	1.558	0.091	5.87%	27
2.	1.275	0.051	4.01%	27
3.	0.501	0.018	3.65%	27
4.	0.435	0.016	3.78%	27
5.	0.295	0.012	4.12%	27
6.	0.054	0.005	9.22%	27
PC	1.211	0.051	4.23%	27
NC	0.050	0.003	6.11%	27

A total of 216 determinations were made at the three sites. In all 216 determinations there was not a case a positive result for a negative sample or a negative result for a positive sample.

X = Mean O.D. SD = standard deviation CV = coefficient of variation = SD/X x 100

The methods in NCCLS EP5 were utilized for precision parameters.

{5}------------------------------------------------

4. Cross-Reactivity.

The following common intestinal pathogens and other organisms occasionally found in feces were The tonewing common antigen detection kit. Specimens from the bacteria panel contained 3 X 10 particles per mL. The Chlamydia trachomatis L2 strain contained 1 X 106 inclusion forming units per ml. With the exception of Norwalk virus and Hepatitis A virus, all the viruses included in the panel were cell culture isolates which were passaged at least once. The titers of the viruses were unknown. The Norwalk virus was obtained from a vomitus sample shown to be positive by immune electron microscopy. The Hepatitis A sample was obtained from a hepatitis A specific immunoglobulin assay kit. The organisms were spiked with Type 2 adenovirus from cell culture harvests (titer unknown).

Bacteria Panel

Bacteria Panel
	Organism alone	Organism and Adenovirus
Haemophilus influenza	0.025	0.605
Actinobacter spp.	0.022	0.595
Bacillus spp.	0.017	0.554
Shigella sunnei	0.021	0.489
Neisseria meningitiidis	0.032	0.582
Pseudomonas aeruginosa	0.043	0.519
Candida albicans	0.022	0.441
Campylobacter spp.	0.029	0.489
Clostridium welchii	0.041	0.475
Escherichia coli	0.023	0.534
Aeromonas spp.	0.022	0.548
Salmonella spp.	0.037	0.526
Gardinella spp.	0.031	0.628
Klebsiella pneumoniae	0.026	0.497
Staphylococcus aureus (Cowan)	0.028	0.483
Streptococcus pneumoniae	0.035	0.440
Streptococcus group G	0.029	0.486
Streptococcus group F	0.034	0.573
Streptococcus group A	0.035	0.495
Chlamydia trachomatis L2 strain	0.026	0.562

{6}------------------------------------------------

Viral Panel

Varicella Zoster virus	0.022	0.655
Herpes Simplex type 1	0.026	0.770
Herpes Simplex type 2	0.027	0.653
Cytomegalovirus	0.018	0.762
Epstein-Barr virus	0.038	0.837
Rhinovirus	0.021	0.827
Poliovirus 1	0.022	0.655
Poliovirus 2	0.025	0.689
Poliovirus 3	0.035	0.741
Coxsackievirus B5	0.032	0.602
Coxsackievirus B4	0.028	0.676
Echovirus 7	0.042	0.592
Echovirus 20	0.035	0.681
RS virus	0.023	0.786
Parainfluenza virus 1	0.029	0.666
Parainfluenza virus 2	0.023	0.833
Parainfluenza virus 3	0.032	0.846
Influenza A virus	0.026	0.553
Influenza B virus	0.022	0.694
Hepatitis A virus	0.033	0.764
Rotavirus	0.022	0.712
Norwalk virus	0.031	0.654

{7}------------------------------------------------

Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 2 2 1997

William L. Boteler, Jr. President Immuno Probe, Inc. 1306F Bailes Lane Frederick, Maryland 21701

Re: K972406

Trade Name: Adenovirus Antigen Detection ELISA Test System Regulatory Class: I Product Code: GOD Dated: October 3, 1997 Received: October 6, 1997

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 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.

{8}------------------------------------------------

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 Autman

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

{9}------------------------------------------------

510(k) Summary Adenovirus Antigen Detection ELISA Test Kit

KA72406

DEC 2 4 1997

I. Trinity Biotech plc. Three Rocks Road Sandyford Industrial Estate Dublin 18, Ireland Contact person: Sinead Flynn Telephone: 011-353-1-295-5111 Date of preparation: June 23, 1997

II. Description of Device

III. Predicate Device

The Adenovirus Antigen Detection ELISA test is substantially equivalent to cell culture of adenovirus from fecal samples. Equivalence is demonstrated by the following comparative results:

{10}------------------------------------------------

Performance Characteristics

Relative sensitivity and specificity. One hundred and twenty retrospective frozen fecal specimens sent to a University Virus Reference Laboratory in Ireland for routine testing were tested with the Trinity Adenovirus Antigen detection ELISA and by cell culture isolation. 90% of the specimens were from adults. The samples were approximately 50% solid, and 50% liquid. The data in Table 1 illustrates good sensitivity and specificity of the Adenovirus Antigen Detection ELISA relative to cell culture isolation.

Table 1 Adenovirus Antigen Detection ELISA Sensitivity & Specificity Relative to Cell Culture Study 1

Wampole Adenovirus Antigen Detection ELISA

	+	E	-	Total
CellCulture	75	2	0	77
-	2	0	41	43
Total	77	2	41	120

Equivocals are not included in the following calculations:

Sensitivity = 75/75 = 100.0%	95% Confidence Interval = 96.0-100.0%*
Specificity = 41/43 = 95.4%	95% Confidence Interval = 88.9-100.0%
Agreement = 116/118 = 98.3%	95% confidence Interval = 95.9-100.0%

The 95% confidence intervals were calculated using the regular method. * The 95% confidence interval was calculated assuming one false negative.

{11}------------------------------------------------

Table 2 Adenovirus Antigen Detection ELISA Sensitivity & Specificity Relative to an Alternate adenovirus EIA Study 2

Wampole Adenovirus Antigen Detection ELISA

	+	E	-	Total
AlternateELISA	+	141	8	19	168
	-	11	6	296	313
	Total	152	14	315	481

Equivocals are not included in the following calculations:

Sensitivity = 141/160 = 88.13%	95% Confidence Interval = 83.01 - 93.24%
Specificity = 296/307 = 96.42%	95% Confidence Interval = 94.30 - 98.54%
Agreement = 437/467 = 93.58%	95% confidence Interval = 91.31 - 95.85%

The 95% confidence intervals were calculated using the normal method.

{12}------------------------------------------------

Limit of Detection. Plaque assays were carried out in HEK-293 cells on fecal clinical samples of 2. Limit of Detection. Plaque assays were carrict our in rial played online milliliter
containing Adenovirus 40 and Adenovirus 41. The number of plaqued and assaved on the containing Adenovirus 40 and Adenovitus +1. The names. Wy diluted and assayed on the (PFU/mL) was established for each specificit with was found to be 125 PFU for Adenovirus 40 and 39 PFU for Adenovirus 41.

Limits of Detection: Enteric Adenoviruses
	Adenovirus 40: 2 X $10^4$ PFU/mL	Adenovirus 41: 2.5 X $10^3$ PFU/mL
Dilution	OD	PFU/100ul	Dilution	OD	PFU/100ul
Neat	0.521	2 X $10^3$	Neat	0.259	2.5 X $10^2$
1/8	0.385	0.25 X $10^3$	1/8	0.161	0.312 X $10^2$
1/16	0.201*	0.125 X $10^3$	1/16	0.271	0.156 X $10^2$
1/32	0.165	0.062 X $10^3$	1/32	0.201	0.078 X $10^2$
1/64	0.063	0.031 X $10^3$	1/64	0.183*	0.039 X $10^2$
1/128	0.061	0.015 X $10^3$	1/128	0.126	0.019 X $10^2$
1/256	0.053	0.007 X $10^3$	1/256	0.092	0.009 X $10^2$
1/512	0.121	0.003 X $10^3$	1/512	0.063	0.004 X $10^2$
1/1024	0.041	0.001 X $10^3$	1/1024	0.065	0.002 X $10^2$
1/2048	-		1/2048	0.052	0.001 X $10^2$

*Limit of Detection

{13}------------------------------------------------

Precision. Six samples containing Type 2 adenovirus from cell culture and the positive and negative controls were each run in triplicate on three consecutive days at three different sites. The results are shown below in Table 3.

Table 3

Adenovirus Antigen Detection ELISA Inter Assay Precision Between Sites
Inter-Assay (n=27)
#	X	SD	CV	n
1.	1.558	0.091	5.87%	27
2.	1.275	0.051	4.01%	27
3.	0.501	0.018	3.65%	27
4.	0.435	0.016	3.78%	27
5.	0.295	0.012	4.12%	27
6.	0.054	0.005	9.22%	27
PC	1.211	0.051	4.23%	27
NC	0.050	0.003	6.11%	27

A total of 216 determinations were made at the three sites. In all 216 determinations there was not a case a positive result for a negative sample or a negative result for a positive sample.

X = Mean O.D. SD = standard deviation CV = coefficient of variation = SD/X x 100

The methods in NCCLS EP5 were utilized for precision parameters.

{14}------------------------------------------------

4. Cross-Reactivity.

Bacteria Panel

Bacteria Panel
	Organism alone	Organism and Adenovirus
Haemophilus influenza	0.025	0.605
Actinobacter spp.	0.022	0.595
Bacillus spp.	0.017	0.554
Shigella sunnei	0.021	0.489
Neisseria meningitiidis	0.032	0.582
Pseudomonas aeruginosa	0.043	0.519
Candida albicans	0.022	0.441
Campylobacter spp.	0.029	0.489
Clostridium welchii	0.041	0.475
Escherichia coli	0.023	0.534
Aeromonas spp.	0.022	0.548
Salmonella spp.	0.037	0.526
Gardinella spp.	0.031	0.628
Klebsiella pneumoniae	0.026	0.497
Staphylococcus aureus (Cowan)	0.028	0.483
Streptococcus pneumoniae	0.035	0.440
Streptococcus group G	0.029	0.486
Streptococcus group F	0.034	0.573
Streptococcus group A	0.035	0.495
Chlamydia trachomatis L2 strain	0.026	0.562

{15}------------------------------------------------

Viral Panel

Varicella Zoster virus	0.022	0.655
Herpes Simplex type 1	0.026	0.770
Herpes Simplex type 2	0.027	0.653
Cytomegalovirus	0.018	0.762
Epstein-Barr virus	0.038	0.837
Rhinovirus	0.021	0.827
Poliovirus 1	0.022	0.655
Poliovirus 2	0.025	0.689
Poliovirus 3	0.035	0.741
Coxsackievirus B5	0.032	0.602
Coxsackievirus B4	0.028	0.676
Echovirus 7	0.042	0.592
Echovirus 20	0.035	0.681
RS virus	0.023	0.786
Parainfluenza virus 1	0.029	0.666
Parainfluenza virus 2	0.023	0.833
Parainfluenza virus 3	0.032	0.846
Influenza A virus	0.026	0.553
Influenza B virus	0.022	0.694
Hepatitis A virus	0.033	0.764
Rotavirus	0.022	0.712
Norwalk virus	0.031	0.654

{16}------------------------------------------------

Image /page/16/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 2 2 1997

William L. Boteler, Jr. President Immuno Probe, Inc. 1306F Bailes Lane Frederick, Maryland 21701

Re: K972406

Trade Name: Adenovirus Antigen Detection ELISA Test System Regulatory Class: I Product Code: GOD Dated: October 3, 1997 Received: October 6, 1997

Dear Mr. Boteler:

{17}------------------------------------------------

Page 2

Sincerely yours.

Steven Autman

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

{18}------------------------------------------------

Page 1 of 1

510(k) Number: K972406

Device Name: Adenovirus Antigen Detection ELISA

Indications For Use: The Adenovirus Antigen Detection ELISA Test System is an Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative determination of Adenovirus antigen in human fecal samples as an aid in the diagnosis of acute nonbacterial gastro-enteritis. Performance for this assay has not been established on children over the age of five and immunocompromised patients. The antibody utilized in this assay is a group specific antigen and cannot differentiate between types of adenovirus. Performance of this assay has not been established for specimens other than human feces.

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)

ーターのホームのホームーーーーーーーーーー

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

Sally 1. Selipuk
An J. Teccehied

(Division Sign-Off) Division of Clinical Laboratory Devices

510(k) Number _

Regulation Number and Section

§ 866.3020 Adenovirus serological reagents.

(a)
Identification. Adenovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to adenovirus in serum. Additionally, some of these reagents consist of adenovirus antisera conjugated with a fluorescent dye and are used to identify adenoviruses directly from clinical specimens. The identification aids in the diagnosis of disease caused by adenoviruses and provides epidemiological information on these diseases. Adenovirus infections may cause pharyngitis (inflammation of the throat), acute respiratory diseases, and certain external diseases of the eye (e.g., conjunctivitis).(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.