MYCOPLASMA IGG ELISA TEST SYSTEM by ZEUS SCIENTIFIC, INC.

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.

Device Description

Not Found

AI/ML Overview

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.

Summary

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 1 6 1997

Mark J. Kopnitsky Vice President, Research & Development Zeus Scientific, Inc. P.O. Box 38 Raritan, NJ 08869

ત્ત્ર

Re: K970150

Trade Name: Mycoplasma IgG ELISA Test System Regulatory Class: I Product Code: LJZ Dated: January 13, 1997 Received: January 15, 1997

Dear Mr. Kopnitsky:

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 cquivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through veriodic GMP 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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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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1 8301 594 5941

CDRH ODE

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Labels	Values
510(k) Number (if known):	K970150
Device Name:	Mycoplasma IgG ELISA Test System

Indications For Use:

参

Mycoplasma IgG ELISA test system; K970150

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	Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number	K970150

Prescription Use(Per 21 CFR 801.109)	X
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Over-The-Counter Use
(Optional Format 1-2-96)

(Optional Format 1-2-96)

Regulation Number and Section

§ 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.