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Clinical signs of the onset of illness are gradual and characterized by headache, malaise, and fever; cough is prominent, and sore throat is frequent. For patients presenting such clinical symptoms, this test system may aid in the determination of the patient's serological status, and therefore, may aid in the diagnosis of disease associated with M. pneumoniae. The test system provides a means for the manual or automated, qualitative detection of IgM-class antibody to M. pneumoniae in adult human serum. The test system is for in vitro diagnostic use.

Aptus (automated) Application for the Mycoplasma IgM ELISA Test System

This is a letter from the FDA to Zeus Scientific, Inc. regarding the 510(k) premarket notification for their Aptus (automated) Application of the Mycoplasma IgM ELISA Test System. This document DOES NOT contain the acceptance criteria or details of a study proving the device meets acceptance criteria. It primarily addresses the substantial equivalence determination and regulatory requirements for marketing the device.

Therefore, I cannot provide the requested information based on the provided text.

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For patients presenting such clinical symptoms, this test system may aid in the patient's serological status, and therefore, may aid in the diagnosis of disease associated with M. pneumoniae. The test system provides a means for the qualitative detection of IgM-class antibody to M. pneumoniae in adult human serum. The test system is for in vitro diagnostic use.

Zeus Scientific Mycoplasma IgM ELISA Test System.

The provided text is a 510(k) premarket notification approval letter for the "Zeus Scientific Mycoplasma IgM ELISA Test System." This document primarily indicates that the device has been found substantially equivalent to a legally marketed predicate device. It certifies the device's classification and permits its marketing.

However, the document does not contain the detailed study information, acceptance criteria, or performance data that would be required to answer your specific questions about the device's performance, sample sizes, ground truth establishment, or expert involvement. The letter references "indications for use stated in the enclosure," but the enclosure itself is not provided in a format that includes a table of acceptance criteria or performance results.

Therefore, I cannot extract the information requested. The document confirms the device's regulatory approval based on substantial equivalence, but it does not describe the specific studies or their results in the level of detail you are asking for.

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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.

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.

K971393 Mycoplasma IgG ELISA Test Kit: Acceptance Criteria and Study Details

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Mycoplasma IgG ELISA Test Kit are primarily defined by its "relative" performance against a predicate commercial IFA kit, rather than absolute diagnostic accuracy against a confirmed disease state.

Note on "Relative" Performance: The report explicitly states, "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." This is crucial context for interpreting the results.

2. Sample Size and Data Provenance

• Test Set (Comparative Studies):

  • Study 1: 187 frozen retrospective sera.
  • Study 2: 176 frozen retrospective sera.
  • Data Provenance: From two R&D laboratories at commercial companies in Maryland and New York, affiliated with the manufacturer. Sera in Study 1 were from "normal individuals of various ages, gender, from Lyme diseases endemic and non-endemic areas." Sera in Study 2 were "randomly selected sera from normal individuals of various ages, gender, and geographical location." Crucially, none of the performance characteristics were established with specimens from patients having documented mycoplasma infections.

• Test Set (Linearity): 20 positive sera (serially diluted).

• Test Set (Paired Sera Evaluation): 56 pairs of sera (acute sera with ISR

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M. pneumoniae is the simplest self-replicating microorganism known. It is primarily a respiratory tract pathogen, and is one of the most common causes of pneumonia and upper-respiratory tract infections. Symptomatic infections attributable to this organism most commonly occur in children and young adults; however, the elderly may also be at risk.

Clinical signs of the onset of illness are gradual and characterized by headache, malaise, and fever, cough is prominent, and sore throat is frequent. For patients presenting such clinical symptoms, this test system may aid in the determination of the patient's serological status, and therefore, may aid in the diagnosis of disease associated with M. pneumoniae. The test system provides a means for the qualitative detection of IgG-class antibody to M. pneumoniae in human serum. The test system is for in vitro diagnostic use.

Not Found

This document is a 510(k) clearance letter for an in vitro diagnostic device, the Mycoplasma IgG ELISA Test System. It does not contain the detailed study information required to fill out the table of acceptance criteria and device performance as it's a regulatory approval document, not a clinical study report. Therefore, most of the requested information is not available in the provided text.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

• Cannot be answered from the provided text. This document is a clearance letter, not a performance study report. It states that the device is "substantially equivalent" to a predicate device, implying its performance is acceptable, but does not specify the acceptance criteria or reported performance metrics (e.g., sensitivity, specificity, accuracy).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Cannot be answered from the provided text. The document does not discuss the specifics of any test sets or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Cannot be answered from the provided text. This information would typically be found in a study report, not a clearance letter.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Cannot be answered from the provided text. Study design details like adjudication methods are not included in this regulatory letter.

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

• Cannot be answered from the provided text. This device is an ELISA test system, an in vitro diagnostic for antibody detection, not an AI-assisted imaging device. Therefore, an MRMC study or AI-related metrics are irrelevant and not present.

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

• Cannot be answered from the provided text. This question is formulated for AI/algorithm-based devices. An ELISA test system inherently has a "standalone" performance, as it's a laboratory test, but the question's premise doesn't directly apply. The document does not describe the specific laboratory validation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Cannot be answered from the provided text. While the test aims to "aid in the diagnosis of disease associated with M. pneumoniae" by detecting IgG-class antibody, the specific ground truth used for validating the test (e.g., culture, PCR, a reference serological method) is not mentioned.

8. The sample size for the training set

• Cannot be answered from the provided text. The concept of a "training set" as understood for machine learning models is not directly applicable to an ELISA test system in the same way. The document does not provide details on sample sizes used for internal assay development or calibration.

9. How the ground truth for the training set was established

• Cannot be answered from the provided text. Similar to point 8, this question is not directly applicable to the type of device and the information provided.

Summary of available information from the document:

• Device Name: Mycoplasma IgG ELISA Test System
• 510(k) Number: K970150
• Regulatory Class: I
• Product Code: LJZ
• Intended Use: Qualitative detection of IgG-class antibody to M. pneumoniae in human serum to aid in the diagnosis of disease associated with M. pneumoniae. For in vitro diagnostic use.
• Type of device: ELISA (Enzyme-Linked Immunosorbent Assay) for serological testing.
• Approval Type: Substantial Equivalence to a predicate device.

To obtain the requested information, one would need to review the actual 510(k) submission document or any peer-reviewed publications detailing the device's validation studies, which are not included in this regulatory clearance letter.

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