The MUMPS IgG ELISA TEST is to be used in the testing of human serum specimens from asymptomatic and symptomatic children and adults for whom quantitation of the presence or the qualitative presence or absence of detectable IgG antibody to mumps virus is warranted in the determination of immunological experience pertaining to infection with mumps virus and as an aid in the diagnosis of mumps infection.

Device Description

The Mumps IgG ELISA Test is an in vitro diagnostic medical device intended for the qualitative and semi-quantitative detection of IgG antibody to the mumps virus in human serum by the enzyme-linked immunosorbent assay (ELISA) method. The Mumps IgG ELISA Test is comprised of the following items: Mumps Antigen-Coated ELISA Plate; IgG Specimen Diluent; Conjugate; Substrate Buffer; p-NPP Tablets; Stopping Reagent; Calibrator 1 and 2; Positive Control and Negative Control; Reference Serum; 20X Wash Solution; ELISA Plate Sealer; Resealable Storage Bag; ELISA Worksheet; Activity Units Graph Paper. When the Mumps IgG ELISA Test is employed, diluted patient serum is incubated with purified mumps virus antigen bound to the ELISA plate wells. If antibodies to the mumps virus are present, they bind to the antigen and do not rinse off. Subsequently when enzyme-labeled antihuman IgG is added to the reaction site it binds to the immobilized IgG antibodies. After washing and the addition of a chromogenic substrate and stopping reagent, specimens containing antibodies to the mumps virus produce a color endpoint reaction which can be read with a standard ELISA plate reader.

AI/ML Overview

I am sorry, but the provided text does not contain typical acceptance criteria and reported device performance in a structured format suitable for direct extraction into the requested table. The document describes a 510(k) submission for an in vitro diagnostic medical device (Mumps IgG ELISA Test) and focuses on demonstrating substantial equivalence to a predicate device.

Instead of explicit acceptance criteria, the document presents results from comparative studies against a predicate device, focusing on agreement, relative sensitivity, and relative specificity. These are measures of how well the new device performs compared to an existing, approved device, rather than against predefined absolute clinical performance benchmarks.

Therefore, I cannot generate the table as requested with "Acceptance Criteria" and "Reported Device Performance" in the traditional sense of a clinical trial's primary and secondary endpoints.

However, I can extract the performance data presented in the document by comparing the Mumps IgG ELISA Test to the Mumps Stat Test Kit (predicate device).

Here is the information extracted from the document based on your request, formatted to the best of my ability given the content:

Device Performance Information: Mumps IgG ELISA Test

The document describes several studies comparing the Mumps IgG ELISA Test to its predicate device, the Mumps Stat Test Kit. The performance is reported in terms of agreement, relative sensitivity, and relative specificity when compared to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, explicitly defined "acceptance criteria" for the Mumps IgG ELISA Test were not provided in the document. The studies aimed to demonstrate "substantial equivalence" to the predicate device. The reported performance metrics are presented below:

Performance Metric (vs. Mumps Stat Test Kit)	Blood Bank Study (N=144)	Hospital Study (Northeastern region) (N=123)	Hospital Study (Southwestern region) (N=123)
Overall Agreement	97.9% (139/142)	96.6% (114/117)	93.2% (109/117)
Relative Sensitivity (95% CI)	97.5% (119/122) (93.0% - 99.5%)	98.0% (96/98) (92.8% - 99.8%)	94.3% (99/110) (88.0% - 97.9%)
Relative Specificity (95% CI)	100% (20/20) (83.2% - 100%)	94.7% (18/19) (74.0% - 99.9%)	83.3% (10/13) (51.6% - 97.9%)
Excluded Equivocal Samples	2 samples	6 samples	6 samples

Note: The reported performance is relative to the predicate device, not an absolute measure against a true gold standard. The 95% Confidence Intervals (CI) were determined by the Exact Method.

2. Sample Size and Data Provenance for Test Set

Sample Sizes:
- Study 1 (Blood Bank): 144 donors. After excluding 2 equivocal samples, 142 samples were used for calculations (e.g., 122 positive and 20 negative for relative sensitivity/specificity).
- Study 2 (Hospital, Northeastern region): 123 patient specimens. After excluding 6 equivocal samples, 117 samples were used for calculations (e.g., 98 positive and 19 negative for relative sensitivity/specificity).
- Study 3 (Hospital, Southwestern region): 123 patient specimens. After excluding 6 equivocal samples, 117 samples were used for calculations (e.g., 110 positive and 13 negative for relative sensitivity/specificity).
Data Provenance:
- Study 1: Blood samples from a regional blood bank. Location not specified, but the submitter (Gull Laboratories, Inc.) is based in Salt Lake City, Utah, USA.
- Study 2: Clinical specimens from a hospital in the Northeastern region of the United States.
- Study 3: Clinical specimens from a hospital in the Southwestern region of the United States.
Retrospective/Prospective: Not explicitly stated, but the description "Blood samples from 144 donors were evaluated" and "Clinical specimens from 123 patients were tested" suggests these were retrospective analyses of collected samples.

3. Number of Experts and Qualifications for Ground Truth

Ground Truth Establishment: The ground truth for the test sets was established by comparing the results of the Mumps IgG ELISA Test directly against a predicate device, the "Mumps Stat Test Kit". This is a comparative study, not one where an independent "expert ground truth" was established.
Number/Qualifications of Experts: The document does not mention the involvement of independent experts to establish a "ground truth" for the test set. The predicate device itself served as the reference standard for comparison.

4. Adjudication Method for the Test Set

Adjudication Method: "Discordant samples were retested using the same two tests." This implies a re-testing mechanism for cases where the Mumps IgG ELISA Test and the Mumps Stat Test Kit initially disagreed. However, the reported results ("Without incorporating the results of retesting the discordant samples") do not include these retest results in the primary statistical calculations for agreement, sensitivity, and specificity. This means the initial read was used for the primary statistics. The document does not specify further adjudication if the retests remained discordant or what criteria were used to resolve discrepancies if the retest results were to be used.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC Study: This is an in vitro diagnostic test (ELISA). MRMC studies, which involve multiple human readers interpreting cases with and without AI assistance, are not applicable to this type of device. The device itself performs the detection of antibodies.

6. Standalone (Algorithm Only) Performance

Standalone Performance: Yes, the described studies represent the standalone performance of the "Mumps IgG ELISA Test" device. It is an "algorithm only (device only)" performance in the sense that the device delivers a result (qualitative or semi-quantitative detection of IgG antibody) without real-time human intervention in the result generation process itself, beyond standard laboratory procedures for running an ELISA. The comparison is between two such standalone diagnostic tests.

7. Type of Ground Truth Used

Type of Ground Truth: The ground truth was established by comparison to a predicate device (Mumps Stat Test Kit). The predicate device itself serves as the reference for determining relative performance. This is a common approach for demonstrating "substantial equivalence" for in vitro diagnostic devices under 510(k) pathway, rather than comparison to a definitive clinical or pathological gold standard.

8. Sample Size for the Training Set

Training Set Sample Size: The document does not mention a "training set" in the context of developing the Mumps IgG ELISA Test. ELISA tests are typically developed and optimized through laboratory experiments and verification studies using characterized samples, but these are generally not referred to as "training sets" in the same way as machine learning algorithms. The provided text focuses on the performance evaluation of the finalized device.

9. How Ground Truth for Training Set was Established

Not Applicable: As there is no mention of a "training set" in the machine learning sense, the method for establishing its ground truth is not described. The device's components (antigen, controls, etc.) would have been validated through standard analytical performance studies during development, but this is distinct from establishing ground truth for a dataset used to "train" an algorithm.

Summary

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NOV - 4 1997

EXHIBIT G - REVISED 07/31/97

510(k) SUMMARY FOR MUMPS IgG ELISA TEST

SUBMITTER:

Gull Laboratories, Inc. 1011 Murray Holladay Road Salt Lake City, UT 84117 (801) 263-3524

CONTACT PERSON:

Fred W. Rachford

DATE:

April 30, 1997

DEVICE NAME:

Trade/Proprietary Name:	Mumps IgG ELISA Test
Common/Usual Name:	Anti-Mumps IgG Antibody Test
Classification Name:	Mumps Virus Serological Reagent

PREDICATE DEVICE: Mumps Stat Test Kit / BioWhittaker, Inc.

DEVICE DESCRIPTION:

The Mumps IgG ELISA Test is comprised of the following items:

Mumps Antigen-Coated ELISA Plate: One 96-well plate comprised of 1 . twelve 8-well strips with breakaway wells, each well coated with partially purified mumps antigen (Enders Strain).

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IgG Specimen Diluent: One bottle containing 30 ml of a lavender colored 2. dilution buffer with sodium azide.
Conjugate: One bottle containing 15 ml of a pink colored solution of alkaline 3. phosphatase-labeled antihuman IgG (Caprine) with sodium azide.
Substrate Buffer: One bottle containing 30 ml of a blue colored buffer 4. solution with sodium azide.
p-NPP Tablets: One foil pack containing 6 tablets of p-nitrophenyl న్. phosphate (p-NPP).
Stopping Reagent: One bottle containing 30 ml of a colorless solution of 6. 1.5 N sodium hydroxide (NaOH).
Calibrator 1 and 2: One vial of each containing 200 ul of serum (human) 7. with sodium azide.
Positive Control and Negative Control: One vial of each containing 200 µl 8. of serum (human) with sodium azide.
Reference Serum: One vial containing 400 µl of serum (human) with 9. sodium azide.
20X Wash Solution: One bottle containing 60 ml of a green colored solution 10. with detergent and sodium azide.
ELISA Plate Sealer: One acetate sheet with contact adhesive. 11.
Resealable Storage Bag: One plastic sealable bag. 12.
1. ELISA Worksheet: One work sheet for recording data.
Activity Units Graph Paper: One sheet of graph paper for activity unit 14. computations.

When the Mumps IgG ELISA Test is employed, diluted patient serum is incubated with purified mumps virus antigen bound to the ELISA plate wells. If antibodies to the mumps virus are present, they bind to the antigen and do not rinse off. Subsequently when enzyme-labeled antihuman IgG is added to the reaction site it binds to the immobilized IgG antibodies. After washing and the addition of a chromogenic substrate and stopping reagent, specimens containing antibodies to the mumps virus produce a color endpoint reaction which can be read with a standard ELISA plate reader.

INTENDED USE:

The Mumps IgG ELISA Test is intended for the qualitative and semi-quantitative detection of IgG antibody to the mumps virus in human serum by the enzymelinked immunosorbent assay (ELISA) method. When performed according to instructions, the Mumps IgG ELISA Test is of value in the determination of

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immunological experience pertaining to infection with mumps virus and in the diagnosis of mumps virus associated disease.

TECHNOLOGICAL COMPARISON TO PREDICATE DEVICE:

The Mumps IgG ELISA Test and the Mumps Stat Test Kit both are technologically based on the enzyme-linked immunosorbent assay (ELISA) method.

SUBSTANTIAL EQUIVALENCE PERFORMANCE DATA:

Blood samples from 144 donors at a regional blood bank were evaluated for the presence of IgG antibody to mumps virus at Gull Laboratories, Inc. with the Mumps IgG ELISA Test and the Mumps Stat Test Kit. Discordant samples were retested using the same two tests. Without incorporating the results of retesting the discordant samples, the agreement between the two test systems was 97.9% (139/142). The relative sensitivity and relative specificity of the Mumps IgG ELISA Test were 97.5% (119/122) with a 95% confidence interval of 93.0% - 99.5% and 100% (20/20) with a 95% confidence interval of 83.2% - 100% when compared to the Mumps Stat Test Kit. Two equivocal samples were not included in the calculations which were based on a 95% confidence interval as determined by the Exact Method.

Clinical specimens from 123 patients were tested for IgG antibodies to mumps virus using the Mumps IgG ELISA Test and the Mumps Stat Test Kit in a hospital in the Northeastern region of the United States. Discordant samples were retested using the same two tests. Without incorporating the results of retesting the discordant samples, the agreement between the two test systems was 96.6% (114/117). The relative sensitivity and relative specificity of the Mumps IgG ELISA Test were 98.0 (96/98) with a 95% confidence interval of 92.8% - 99.8% and 94.7% (18/19) with a 95% confidence interval of 74.0% - 99.9% respectively when compared with the Mumps Stat Test Kit. Six equivocal samples were not included in the calculations which were based on a 95% confidence interval as determined by the Exact Method.

Clinical specimens from 123 patients were tested for IgG antibodies to mumps virus using the Mumps IgG ELISA Test and the Mumps Stat Test Kit in a hospital in the Southwestern region of the United States. Discordant samples were retested on the same two tests. Without incorporating the results of retesting the discordant samples, the agreement between the two test systems was 93.2% (109/117). The relative sensitivity and relative specificity of the Mumps IgG ELISA Test were 94.3% (99/110) with a 95% confidence interval of 88.0% - 97.9% and 83.3% (10/13) with a 95% confidence interval of 51.6% - 97.9% respectively when compared with the Mumps Stat Test Kit. Six equivocal samples were not included in the calculations which were based on a 95% confidence interval as determined by the Exact Method.

CONCLUSIONS:

The Mumps IgG ELISA Test is believed to be substantially equivalent to the Mumps Stat Test Kit. This assessment is based on (1) the two tests are technologically equivalent, both being based on the enzyme-linked immunosorbent

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assay methods, (2) the intended use of each test is comparable with only slight differences in the wording, and (3) the data from clinical studies conducted at Gull Laboratories, Inc. and two outside clinical institutions in most instances demonstrated that the agreement between the two test systems and the relative sensitivity and relative specificity when comparing the two test systems.

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Image /page/4/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol. The text is in all capital letters and is evenly spaced around the circle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV - 4 1997

· Fred W. Rachford, Ph.D. Senior Vice President Gull Laboratories, Inc. 1011 East 4800 South Salt Lake City, Utah 84117

Re: K971857

Trade Name: Mumps IgG ELISA Test Regulatory Class: I Product Code: LJY Dated: August 18, 1997 Received: August 19, 1997

Dear Dr. Rachford:

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 requirement, 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.

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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

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EXHIBIT F - REVISED 10/02/97

INDICATIONS FOR USE STATEMENT

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: _________________________________________________________________________________________________________________________________________________________________

Product Number:

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dan Cooper

(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number_K 971857

Regulation Number and Section

§ 866.3380 Mumps virus serological reagents.

(a)
Identification. Mumps virus serological reagents consist of antigens and antisera used in serological tests to identify antibodies to mumps virus in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used in serological tests to identify mumps viruses from tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of mumps and provides epidemiological information on mumps. Mumps is an acute contagious disease, particularly in children, characterized by an enlargement of one or both of the parotid glands (glands situated near the ear), although other organs may also be involved.(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 § 866.9.