(143 days)
Wampole Mumps IgG ELISA Kit
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No
The summary describes a standard ELISA kit and an automated processor, with no mention of AI or ML in the device description, intended use, or performance studies.
No
This device is an in vitro diagnostic (IVD) test used to detect Mumps IgG antibodies in human serum as an aid in diagnosis, not to treat or directly manage a condition in a patient.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "as an aid in the diagnosis of Mumps infection."
No
The device is an ELISA kit, which is a laboratory assay involving physical reagents and processes, not solely software. While it can be used with an automated processor (MAGO® Plus), the core device itself is a physical kit.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative and semi-quantitative determination of IgG antibodies to Mumps virus in human serum... as an aid in the diagnosis of Mumps infection." This clearly indicates it's used to test samples taken from the human body to provide information for diagnostic purposes.
- Device Description: The description states it's an "Enzyme-Linked ImmunoSorbent Assay (E.L.I.S.A) for the detection of IgG antibodies to Mumps antigen in human serum." This confirms it's a laboratory test performed on a biological sample (serum).
- Sample Type: The test is performed on "human serum."
- Purpose: The purpose is to aid in the diagnosis of Mumps infection.
All of these points align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the compatibility of human tissues, organs or blood, or to monitor therapeutic measures.
N/A
Intended Use / Indications for Use
For the qualitative and semi-quantitative determination of IgGi antibodies to Mumps virus m human serum of adults over cighteen vears of age by indirect enzyme immunoassay as an aid in the diaunosis at Mumps infection. The evaluation of paired sera, to determine a significant increase in Mumps IgG antihody itel can also aid in the diagnosis of acute infection by seroconversion through testing acute and convalescent sera. The test can be performed either manually or in conjunction with the MAGO® Plus Automated EIA processor. Performance characteristics have not been established on children
Product codes (comma separated list FDA assigned to the subject device)
LJY
Device Description
The & Mumps IgG ELISA Kit is an Enzyme-Linked ImmunoSorbent Assay (E.I.S.A) (6) the detection of IgG antibodies to Mumps antigen in human serum.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
human serum
Indicated Patient Age Range
adults over cighteen vears of age
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Fresh sera from one hundred seventy-thece patients were tested at a chnical commercial laboratory, hosacd m the Mid-Atlante area, using the Is-Munps IgG Test Kit and a commercially available kit for Mumps IgG antibodies.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparison with Another ELISA Test:
Study Size: 173 fresh sera samples.
Results:
Relative Sensitivity = 100% (160/160) with a 95% CI of 97.7% - 100%
Relative Specificity = 76.9% (10/13) with a 95% CI of 46.2% - 95.0%
Overall Agreement = 98.3% (170/173) with a 95% CI of 95.0% - 99.5%
Equivocal results were excluded from calculations.
Reproducibility:
To determine the reproducibility of the Is-Mumps IgG Test Kit, four positive and two negative sera were assayed across three sites (manufacturer, research and development laboratory, and clinical laboratory). Intra-assay and interassay reproducibility was assessed.
Site #1 (Manufacturer):
Serum A (POS): Interassay Mean Index = 1.17, CV% = 8.70
Serum B (POS): Interassay Mean Index = 1.33, CV% = 6.36
Serum C (POS): Interassay Mean Index = 2.05, CV% = 7.55
Serum D (POS): Interassay Mean Index = 1.70, CV% = 7.48
Serum E (NEG): Interassay Mean Index = 0.18, CV% = 32.18
Serum F (NEG): Interassay Mean Index = 0.14, CV% = 39.03
Site #2: (Clinical Laboratory)
Serum A (POS): Interassay Mean Index = 1.269, CV% = 9.63
Serum B (POS): Interassay Mean Index = 1.412, CV% = 9.43
Serum C (POS): Interassay Mean Index = 2.111, CV% = 9.09
Serum D (POS): Interassay Mean Index = 1.787, CV% = 8.92
Serum E (NEG): Interassay Mean Index = 0.263, CV% = 18.06
Serum F (NEG): Interassay Mean Index = 0.200, CV% = 13.02
Site #3: (Research and Development Laboratory)
Serum A (POS): Interassay Mean Index = 1.21, CV% = 8.04
Serum B (POS): Interassay Mean Index = 1.31, CV% = 4.06
Serum C (POS): Interassay Mean Index = 2.09, CV% = 6.28
Serum D (POS): Interassay Mean Index = 1.74, CV% = 7.54
Serum E (NEG): Interassay Mean Index = 0.23, CV% = 35.19
Serum F (NEG): Interassay Mean Index = 0.19, CV% = 17.49
Correlation of Manual and MAGO Plus Results:
Study Size: 153 serum samples.
Results: Pearson Correlation Coefficient of 0.954 (indicating good correlation). The regression line equation is Y = 0.1382 + 0.9552X, with r = 0.9537.
MAGO Plus Reproducibility:
Six sera assayed ten times each in three different runs on the MAGO Plus Automated EIA Processor.
Serum A (POS): Interassay Mean Index = 1.2, CV% = 10.03
Serum B (POS): Interassay Mean Index = 1.5, CV% = 11.50
Serum C (POS): Interassay Mean Index = 2.2, CV% = 9.62
Serum D (POS): Interassay Mean Index = 1.9, CV% = 8.84
Serum E (NEG): Interassay Mean Index = 0.2, CV% = 21.19
Serum F (NEG): Interassay Mean Index = 0.1, CV% = 23.79
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Relative Sensitivity = 100%
Relative Specificity = 76.9%
Overall Agreement = 98.3%
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 Mumps IgG ELISA Kit
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
§ 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.
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SEP 3 1999
LG91274
Job 497
510k Summary of Safety and Effectiveness
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: | March 29, 1999 |
|---|---|
| Name: | Columbia Bioscience, Inc. |
| Address: | 8775 M Centre Park Ddrive, #559 |
| Columbia, MD 21045 | |
| Contact Person: | Norman Jenkins |
Comfact Person PhoneNumber. 410-995-1278 410-995-0508 Fax Number
Device Information:
| Trade Name | ් Mumps IgG ELISA Kit |
|---|---|
| Common Name | Mumps lgG EIA Test |
| Classification Name: | Mumps Serological Reagent |
Equivalent Device: Wampole Mumps IgG ELISA Kit
Device Description: The & Mumps IgG ELISA Kit is an Enzyme-Linked ImmunoSorbent Assay (E.I.S.A) (6) the detection of IgG antibodies to Mumps antigen in human serum.
Intended Use: For the qualitative and semi-quantitative determination of IgGi antibodies to Mumps virus m human serum of adults over cighteen vears of age by indirect enzyme immunoassay as an aid in the diaunosis at Mumps infection. The evaluation of paired sera, to determine a significant increase in Mumps IgG antihody itel can also aid in the diagnosis of acute infection by seroconversion through testing acute and convalescent sera. The test can be performed either manually or in conjunction with the MAGO® Plus Automated EIA processor. Performance characteristics have not been established on children
Principle of Procedure:
Purified Mumps antigen is bound to microwells. Diluted patient sera, Cut-Off Calibrator and controls are placed in the microwells and incubated. Anti-Mumps IgG antibodies, if present, will bind to the antigen forming antigenantibody complexes. Residual sample is eliminated by aspirating Conjugate (horseradish 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 4.0 nm (reference 600-630 mm) and is directly proportional to the concentration of 126 antibodies to Mumps present in the sample.
1
Performance Characteristics
A. Comparison with Another ELISA Test
Fresh sera from one hundred seventy-thece patients were tested at a chnical commercial laboratory, hosacd m the Mid-Atlante area, using the Is-Munps IgG Test Kit and a commercially available kit for Mumps IgG antibodies. The data in Table is show the relative sensitivity, specificity and overall agreement of the Is-Mumps IgG Test Kit versus this commercial Mumps IgG ELISA.
TABLE I
| /s-Mumps IgG Test Kit |
|---|
| ﺍﻟﻤﺪﻳﺮ ﺍﻟﻤﺪﻳﺮ ﺍﻟﻤﺪﻳﺮ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻘﺪﻡ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻘﺪﻡ ﺍﻟﻤﺘ | *FQUIVOCAL | NEGATIVE | |
|---|---|---|---|
| POSITIVE | l ()() | () | () |
| *1:QUIVOCAL | () | () | () |
| NEGALIVE: | ું એ: મઃ | 34. *** | (() |
( )ther 1 :1 TISA
95% Cl
| Relative Sensitivity = 160/160 = 100% | 97.7% - 100% | |
|---|---|---|
| Relative Specificity = 10/13 = 76.9% | 46.2% - 95.0% | |
| Overall Agreement = 170/173 = 98.3% | 95.0% - 99.5% |
- Equivocal results were excluded from ealeutlations.
** 313 sera were positive by IFA.
*** 373 sera were positive by II/A
NOTE : Please be advised that 'refers to the comparison of the assay's results to that of a sumta 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 discase.
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B. Reproducibility
To decemine the reproducibility of the Is-Mumps IgG Test Kit, four positive and two negative sera were assayed Ien to decembe tic repredictions of the as manipalign included: the manufacturer, a research and development laboratory, and a clineral career and interassay reproducibility obtained at cach site is shown in Tables2 , 3 and 9.
| SERUM | INTRA-ASSAY RUN 1
MEAN
INDEX | CV% | INTRA-ASSAY RUN 2
MEAN
INDEX | CV% | INTRA-ASSAY RUN 3
MEAN
INDEX | CV% | INTERASSAY
MEAN
INDEX | CV% |
|---------|------------------------------------|-------|------------------------------------|-------|------------------------------------|-------|-----------------------------|-------|
| A (POS) | 1.11 | 4.26 | 1.17 | 8.82 | 1.24 | 8.90 | 1.17 | 8.70 |
| B (POS) | 1.26 | 5.19 | 1.34 | 6.04 | 1.38 | 4.82 | 1.33 | 6.36 |
| C (POS) | 1.95 | 9.02 | 2.02 | 5.33 | 2.17 | 4.22 | 2.05 | 7.55 |
| D (POS) | 1.74 | 7.27 | 1.64 | 6.67 | 1.73 | 7.68 | 1.70 | 7.48 |
| E (NEG) | 0.15 | 40.25 | 0.18 | 23.53 | 0.23 | 21.39 | 0.18 | 32.18 |
| F (NEG) | 0.14 | 39.81 | 0.13 | 39.09 | 0.16 | 39.88 | 0.14 | 39.03 |
TABLE 2 : Site #1 - Intra-Assay and Interassay Reproducibility
| TABLE 1: Site #2 - Intra-Assay and Interassay Reproducibility | |||
|---|---|---|---|
| SERUM | INTRA-ASSAY RUN 1
MEAN INDEX | CV% | INTRA-ASSAY RUN 2
MEAN INDEX | CV% | INTRA-ASSAY RUN 3
MEAN INDEX | CV% | INTERASSAY
MEAN INDEX | CV% |
|---------|---------------------------------|-------|---------------------------------|-------|---------------------------------|-------|--------------------------|-------|
| A (POS) | 1.188 | 6.30 | 1.248 | 6.53 | 1.371 | 9.35 | 1.269 | 9.63 |
| B (POS) | 1.384 | 10.51 | 1.338 | 6.30 | 1.515 | 6.57 | 1.412 | 9.43 |
| C (POS) | 2.110 | 6.94 | 1.976 | 6.74 | 2.247 | 8.75 | 2.111 | 9.09 |
| D (POS) | 1.673 | 4.86 | 1.738 | 7.98 | 1.949 | 5.05 | 1.787 | 8.92 |
| E (NEG) | 0.227 | 9.44 | 0.247 | 15.95 | 0.314 | 11.60 | 0.263 | 18.06 |
| F (NEG) | 0.175 | 8.14 | 0.198 | 4.37 | 0.228 | 8.18 | 0.200 | 13.02 |
TABLE4 : Site #3 - Intra-assay and Interassay Reproducibility
| 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) | 1.21 | 10.20 | 1.24 | 7.00 | 1.18 | 6.15 | 1.21 | 8.04 |
| B (POS) | 1.31 | 4.49 | 1.31 | 2.57 | 1.31 | 5.12 | 1.31 | 4.06 |
| C (POS) | 2.10 | 7.04 | 2.08 | 5.84 | 2.09 | 6.51 | 2.09 | 6.28 |
| D (POS) | 1.83 | 5.75 | 1.71 | 8.72 | 1.67 | 4.69 | 1.74 | 7.54 |
| E (NEG) | 0.28 | 34.40 | 0.24 | 15.53 | 0.16 | 24.35 | 0.23 | 35.19 |
| F (NEG) | 0.20 | 15.41 | 0.21 | 8.87 | 0.16 | 15.88 | 0.19 | 17.49 |
C. Correlation of Manual and MAGO Plus Results
The 1/-Mumps IgG Test Kit has been developed for antomated as . To demonstrate the equivalence of the manual and MAGO Plus procedures, the results of 153 serum samples, were plotted. A scattergram and regression line of the results oblained with 95% confidence intervals is shown in ligure 1. The data indicate good correlation with a Pearson Correlation Coefficient of 0.954.
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Image /page/3/Figure/3 description: The image shows the title of a figure. The title is "FIGURE I : Manual and MAGO Plus Result Correlation". The title is written in a bold, sans-serif font.
Image /page/3/Figure/4 description: The image is a scatter plot that shows the relationship between manual index values and MAGO plus index values. The x-axis represents the manual index values, and the y-axis represents the MAGO plus index values. The plot includes a regression line with the equation Y = 0.1382 + 0.9552X, and the correlation coefficient r = 0.9537, indicating a strong positive correlation between the two variables.
D. MAGO Plus Reproducibility
The reproducibility of the assay when performed on the MACO Plus Automated FIA Processor was determined by assaying six sera ten times each in three different runs, Tables shows the interassy reproducibility obtanced 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) | 1.2 | 9.26 | 1.3 | 10.04 | 1.2 | 9.91 | 1.2 | 10.03 |
| B (POS) | 1.4 | 11.60 | 1.5 | 6.92 | 1.5 | 13.06 | 1.5 | 11.50 |
| C (POS) | 2.2 | 10.96 | 2.3 | 8.93 | 2.3 | 8.72 | 2.2 | 9.62 |
| D (POS) | 1.9 | 10.27 | 1.9 | 8.06 | 1.8 | 8.42 | 1.9 | 8.84 |
| E (NEG) | 0.2 | 28.41 | 0.2 | 0.00 | 0.2 | 23.57 | 0.2 | 21.19 |
| F (NEG) | 0.1 | 0.00 | 0.1 | 28.75 | 0.1 | 28.75 | 0.1 | 23.79 |
TABLE 5 : Site #2-Intra-Assay and interassay Reproducibility - MAGO Plus
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Image /page/4/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines above them.
SEP 3 1999 Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DIAMEDIX Corporation c/o Mr. William Boteler ImmunoProbe, Inc. 1306F Bailes Lane Frederick, Maryland 21701
Re: K991274 Trade Name: Mumps IgG ELISA Test System Regulatory Class: I Product Code: LJY Dated: June 25, 1999 Received: June 28, 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 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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Page I of I
510(k) Number: Not Known
Device Name: & Mumps IgG ELISA
Indications For Use: For the qualitative and semi-quantitative determination of G antibodies to Mumps virus in human serum of adults over eighteen years of age by indirect enzyme immunoassay as an aid in the diagnosis of Mumps infection. The evaluation of paired sera, to determine a significant increase in Mumps IgG antibody titer, can also aid in the diagnosis of acute infection by seroconversion determination through testing acute and convalescent sera. The test can be performed either manually or in conjunction with the MAGO® Plus Automated E1A processor Performance characteristics have not hecn established on children
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
Over-The Counter Lise
(Optional Format 1-2-96)
Woody Dubois
(Division Sign Off)
Division of Clinical Laboratory Devices
510(k) Number. K991274