(96 days)
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No
The description details a standard ELISA assay which relies on chemical reactions and photometric measurement, not AI/ML algorithms for analysis or interpretation. There is no mention of AI, ML, or related concepts in the document.
No.
This device is an in vitro diagnostic test used to detect antibodies for diagnosis, not to treat a condition or disease.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device "may be used... as an aid in the diagnosis of Mycoplasma pneumoniae infection". This directly indicates its role as a diagnostic tool.
No
The device is an ELISA kit, which is a laboratory-based assay involving physical reagents and a photometric reader, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states the kit is for the "determination of IgG antibodies in human serum to Mycoplasma pneumoniae" and is used "as an aid in the diagnosis of Mycoplasma pneumoniae infection." This clearly indicates it's intended for use on biological specimens (human serum) to provide information for diagnostic purposes.
- Device Description: The description reiterates the intended use and explicitly states "For In Vitro Diagnostic Use Only." This is a definitive statement indicating its classification as an IVD.
- Mechanism: The description details an ELISA process, which is a common method used in in vitro diagnostic testing to detect the presence of specific substances (in this case, antibodies) in a sample.
- Performance Studies: The document includes performance studies (Relative Sensitivity and Specificity, Precision, Linearity, etc.) which are typical evaluations required for IVD devices to demonstrate their analytical and clinical performance.
All these factors align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Mycoplasma IgG ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for semiquantitative or qualitative determination of IgG antibodies in human serum to Mycoplasma pneumoniae for the determination of immunological experience. The Mycoplasma IgG ELISA kit may be used to evaluate paired sera for the presence of seroconversions and a significant increase in specific IgG as an aid in the diagnosis of Mycoplasma pneumoniae infection in the adult population. For In Vitro Diagnostic Use Only.
Product codes
LJZ
Device Description
The Mycoplasma IgG ELISA test is an enzyme linked immunosorbent assay to detect IgG antibodies to Mycoplasma pneumoniae. Purified Mycoplasma pneumoniae antigen is attached to a solid phase microtiter well. Diluted test sera is added to each well. If the antibodies are present that recognize the antigen, they will bind to the antigen in the well. After incubation the wells are washed to remove unbound antibody. An enzyme labeled anti-human IgG is added to each well. If antibody is present it will bind to the antibody attached to the antigen 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.
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
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Indicated Patient Age Range
adult population
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Relative Sensitivity and Specificity: Two different sites compared the Wampole Mycoplasma IgG ELISA test relative to a commercial IFA kit. The two sites were R&D laboratories at commercial companies located in Maryland and New York, and affiliated with the manufacturer of the kit.
Study 1: 187 frozen retrospective sera from normal individuals of various ages, gender, from Lyme diseases endemic and non-endemic areas.
Study 2: 176 frozen retrospective sera from randomly selected sera from normal individuals of various ages, gender, and geographical location.
None of the performance characteristics were established with specimens from patients having documented mycoplasma infections.
Precision: Seven sera were assayed ten times each on three different assays at two different sites, both affiliated with the manufacturer. Intra and inter assay precision were measured at each site, and intersite precision was also determined.
Linearity: 20 positive sera were serially two-fold diluted and run on the assay. ISR values were compared to logs of dilution by standard linear regression. The r values were all >=0.974.
Simulated paired sera evaluation: Percent rise in ISR values were calculated for 56 pairs that had a four-fold dilution where the acute sera had a value of less than 2.18. All 56 pairs demonstrated a >46% rise in ISR value, showing a significant rise in antibody.
Complement Fixation Paired Serum Study: Eleven serum pairs tested by CF from patients suspected of having acute Mycoplasma pneumoniae infection were assayed. Four pairs could not be used due to high acute serum value. The remaining seven pairs all demonstrated a >46% rise in ISR values.
Reproducibility Study: Fifty different sera with various levels of activity were assayed at three different sites. Two sites were R&D laboratories at commercial companies located in Maryland and New York, and the third was a large clinical laboratory in Pennsylvania. Pearson product moment correlation coefficients were >0.987 between sites.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Study 1: Relative Sensitivity = 117/123 = 95.1% (95% Confidence interval = 91.2% - 99.0%). Relative Specificity = 25/45 = 55.6% (95% Confidence interval = 40.7% - 70.4%). Relative Agreement = 142/168 = 84.5% (95% Confidence interval = 78.1% - 90.1%).
Study 2: Relative Sensitivity = 132/134 = 98.5% (95% Confidence interval = 96.4% -100.0%). Relative Specificity = 17/37 = 45.9% (95% Confidence interval = 29.6% - 62.3%). Relative Agreement = 149/171 = 87.1% (95% Confidence interval = 82.0% - 92.3%).
Precision: The user should obtain precision of =0.974.
Simulated paired sera evaluation: The paired sera procedure demonstrated 100% sensitivity in being able to detect a four-fold increase in antibody level when the acute sera has a value of 0.987 between the sites. Percent agreement of expected results between the three sites of 99.3% (145/146).
Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 866.3375
Mycoplasma spp. serological reagents.(a)
Identification. Mycoplasma spp. serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies toMycoplasma spp. in serum. Additionally, some of these reagents consist ofMycoplasma spp. antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identifyMycoplasma spp. directly from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genusMycoplasma and provides epidemiological information on diseases caused by these microorganisms.Mycoplasma spp. are associated with inflammatory conditions of the urinary and respiratory tracts, the genitals, and the mouth. The effects in humans of infection withMycoplasma pneumoniae range from inapparent infection to mild or severe upper respiratory disease, ear infection, and bronchial pneumonia.(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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Summary of Safety and Effectiveness Information Mycoplasma IgG ELISA Test Kit
JUL 14 1997
I. Immuno Probe Inc. 1306 Bailes Lane, Suite F Frederick, Maryland 21701 Contact person: William Boteler Telephone: 301-695-7920 Date of preparation: June 11, 1997
II. Description of Device
The Mycoplasma IgG ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for semiquantitative or qualitative determination of IgG antibodies in human serum to Mycoplasma pneumoniae for the determination of immunological experience. The Mycoplasma IgG ELISA kit may be used to evaluate paired sera for the presence of seroconversions and a significant increase in specific IgG as an aid in the diagnosis of Mycoplasma pneumoniae infection in the adult population. For In Vitro Diagnostic Use Only.
The Mycoplasma IgG ELISA test is an enzyme linked immunosorbent assay to detect IgG antibodies to Mycoplasma pneumoniae. Purified Mycoplasma pneumoniae antigen is attached to a solid phase microtiter well. Diluted test sera is added to each well. If the antibodies are present that recognize the antigen, they will bind to the antigen in the well. After incubation the wells are washed to remove unbound antibody. An enzyme labeled anti-human IgG is added to each well. If antibody is present it will bind to the antibody attached to the antigen 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.
III. Predicate Device
The Mycoplasma IgG ELISA test is substantially equivalent to the IFA test. Equivalence is demonstrated by the following comparative results:
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PERFORMANCE CHARACTERISTICS
Relative Sensitivity and Specificity
Two different sites compared the Wampole Mycoplasma IgG ELISA test relative to a commercial IFA kit. The two sites were R&D laboratories at commercial companies located in Maryland and New York, and affiliated with the manufacturer of the kit. The 187 frozen retrospective sera from the first study were from normal individuals of various ages, gender, from Lyme diseases endemic and non-endemic areas. The results of the first study are summarized in Table 2. The 176 frozen retrospective sera from the second study were randomly selected sera from normal inividuals of various ages, gender, and geographical location. The results of the second study are summarized in Table 3. None of the performance characteristics were established with specimens from patients having documented mycoplasma infections.
Table 2 Comparison of Wampole Mycoplasma IgG ELISA and IFA Study 1
Wampole Mycoplasma IgG ELISA
| + | eq | - | Total | |
|---|---|---|---|---|
| + | 117 | 13 | 6 | 136 |
| Mycoplasma | ||||
| IFA (1:32) - | 20* | 6 | 25 | 51 |
| Total | 137 | 19 | 31 | 187 |
| Relative Sensitivity = 117/123 = 95.1% | 95% Confidence interval = 91.2% - 99.0% |
|---|---|
| Relative Specificity = 25/45 = 55.6% | 95% Confidence interval = 40.7% - 70.4% |
| Relative Agreement = 142/168 = 84.5% | 95% Confidence interval = 78.19 - 90.1% |
- All 20 sera were found to be positive by an alternate ELISA.
Equivocals were not included in the above calculations.
The 95% Confidence Intervals were calculated using the normal method.
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Table 3 Comparison of Wampole Mycoplasma IgG ELISA and IFA Study 2
Wampole Mycoplasma IgG ELISA
| + | eq | - | Total | ||
|---|---|---|---|---|---|
| + | 132 | 5 | 2 | 139 | |
| Mycoplasma | |||||
| IFA (1:32) | - | 20* | 0 | 17 | 37 |
| Total | 152 | 5 | 19 | 176 |
| Relative Sensitivity = 132/134 = 98.5% | 95% Confidence interval = 96.4% -100.0% |
|---|---|
| Relative Specificity = 17/37 = 45.9% | 95% Confidence interval = 29.6% - 62.3% |
| Relative Agreement = 149/171 = 87.1% | 95% Confidence interval = 82.0% - 92.3% |
- All 20 sera were found to be positive by an alternate ELISA. Equivocals were not included in the above calculations. The 95% Confidence Intervals were calculated using the normal method.
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.
PRECISION
Seven sera were assayed ten times each on three different assays at two different sites. Both sites were affiliated with the manufacturer of the kit. The intra and inter assay precision at each site is shown in Tables 4 and 5. The intersite precision is shown in Table 6. With appropriate technique the user should obtain precision of 46% rise in ISR value, showing a significant rise in antibody. Therefore, the paired sera procedure demonstrated 100% sensitivity in being able to detect a four-fold increase in antibody level when the acute sera has a value of 46% rise in ISR values thus giving a 100% sensitivity versus CF for showing a significant rise in antibody for serum meeting the paired sera criteria.
Reproducibility Study
Fifty different sera with various levels of activity were assayed at three different sites. Two sites were R&D laboratories at commercial companies located in Maryland and New York. The third site was a large clinical laboratory located in Pennsylvania. The data from the three sites show good correlation with Pearson product moment correlation coefficients of >0.987 between the sites. Excluding equivocals (n = 4) one determination varied from its expected result (negative result for a positive specimen) giving a percent agreement of expected results between the three sites of 99.3% (145/146). The expected results were derived from previous Wampole ELISA testing of the samples. Three sera changed status in this study: one serum was equivocal at one site and negative at the other two sites; the second serum was equivocal at two sites and positive at the third serum was positive at one site, equivocal at second site, and negative at the third site.
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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird symbol, with three human profiles incorporated into the design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the bird symbol.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
William L. Boteler President -Immuno Probe, Inc. 1306F Bailes Lane Frederick, Maryland 21701
JUL 1 4 1997
K971393 Trade Name: Mycoplasma IgG ELISA Test Kit Regulatory Class: I Product Code: LJZ Dated: June 11, 1997 Received: June 11, 1997
Dear Mr. Boteler:
Re:
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, Paris 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FIDA) 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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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 Sutman
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 1 of 1
510(k) Number: Not known
Device Name: Mycoplasma IgG ELISA
Indications For Use: The Mycoptasma IgG ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for semi-quantitative or qualitative determination of IgG antibodies in human serum to Mycoplasma pneumoniae for the determination of immunological experience The Mycoplasma IgG ELISA kit may be used to evaluate paired sera for seroconversions and the presence of a significant increase in specific IgG as an aid in the diagnosis of Mycoplasma pneumoniae infection in the adult population.
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use v (Per 21 CFR 801.109)
OR
Over-The Counter Use (Optional Format 1-2-96)
Aila Rinke
(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number _