(113 days)
Alexon ProspecT Giardia Microplate Assay
Not Found
No
The summary describes a standard enzyme immunoassay (EIA) for detecting antigens, which is a biochemical method and does not involve AI/ML. There are no mentions of AI, ML, image processing, or data sets typically associated with AI/ML development.
No
The device is an in vitro diagnostic test for detecting Giardia antigens in stool, intended for diagnosis, not for treatment or therapy.
Yes
The 'Intended Use / Indications for Use' section explicitly states, "Test results are intended to aid in the diagnosis of Giardia infection (giardiasis)." This indicates that the device provides information used to identify a medical condition.
No
The device description clearly states it utilizes "polyclonal anti-Giardia capture antibody adsorbed to microwells," indicating a physical, in vitro diagnostic test kit, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The Premier Giardia enzyme immunoassay (EIA) is an in vitro qualitative procedure for the detection of Giardia antigens in human stool."
The term "in vitro" is the key indicator that this device is intended for use outside of the living body, which is the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Premier Giardia enzyme immunoassay (EIA) is an in vitro qualitative procedure for the detection of Giardia antigens in human stool. Test results are intended to aid in the diagnosis of Giardia infection (giardiasis).
Product codes (comma separated list FDA assigned to the subject device)
MHI
Device Description
The Premier Giardia test utilizes polyclonal anti-Giardia capture antibody adsorbed to microwells.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Laboratory Technician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance vs. Reference Methods: Sensitivity 98%, Specificity 98%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity 98%, Specificity 98%
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.
Alexon ProspecT Giardia Microplate Assay
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
§ 866.3220
Entamoeba histolytica serological reagents.(a)
Identification. Entamoeba histolytica serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies toEntamoeba histolytica in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identifyEntamoeba histolytica directly from clinical specimens. The identification aids in the diagnosis of amebiasis caused by the microscopic protozoan parasiteEntamoeba histolytica and provides epidemiological information on diseases caused by this parasite. The parasite may invade the skin, liver, intestines, lungs, and diaphragm, causing disease conditions such as indolent ulcers, an amebic hepatitis, amebic dysentery, and pulmonary lesions.(b)
Classification. Class II (special 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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NOV 2.5 1998
Meridian Diagnostics, Inc. Cincinnati, OH 45244
510(k) Notification Premier Giardia
A. 510(k) Summary Identification Information
Submitter's Information:
Submitter's Name and Address:
Allen D. Nickol, PhD Meridian Diagnostics, Inc. 3471 River Hills Drive Cincinnati, OH 45244
Phone Number: 1-800-543-1980
Contact Person: Allen D. Nickol, PhD Director of Clinical and Regulatory Affairs
Date Summary Prepared: August 3, 1998
Name of Device: Premier Giardia
Classification Name: Giardia spp., 83 MHI
Predicate Equivalent Device: Alexon ProspecT Giardia Microplate Assay
Description of Device: The Premier Giardia test utilizes polyclonal anti-Giardia capture antibody adsorbed to microwells.
Intended Use:
The Premier Giardia enzyme immunoassay (EIA) is an in vitro qualitative procedure for the detection of Giardia antigens in human stool. Test results are intended to aid in the diagnosis of Giardia infection (giardiasis).
Comparison with Predicate Device: The following comparison of the use, technology, function and performance supports the Statement of Equivalence between the Premier Giardia test and Alexon Prospect-T Giardia EIA. The differences in technology do not raise additional concerns regarding safety and Safety and effectiveness are demonstrated to be substantially effectiveness. equivalent.
1
Meridian Diagnostics, Inc. Cincinnati, OH 45244
510(k) Notification Premier Giardia
| Method | Premier Giardia | Alexon ProspecT Giardia |
|---|---|---|
| Intended Use | Detection of Giardia antigens in patient stool | Detection of Giardia Specific Antigen (GSA 65) in aqueous extracts of fecal specimens |
| Results | Qualitative | Qualitative |
| Specimen Required | Preserved (Formalin, SAF) and Unpreserved Stools | Preserved (Formalin, SAF, MF), Unpreserved Stool, and stools in C&S (or equivalent) transport media |
| Technology | Sandwich Enzyme Immunoassay | |
| Polyclonal capture, monoclonal detect, polyclonal conjugate, TMB substrate | Sandwich Enzyme Immunoassay | |
| Polyclonal capture, monoclonal conjugate, TMB substrate | ||
| Level of Skill Required | Laboratory Technician | Laboratory Technician |
| Function | 1. Specimen diluted 1/4 and 200µl added to well containing rabbit anti-Giardia capture Ab. |
- Incubate 1 hr at room temperature.
- Wash 5 times.
- Add 2 drops detection Ab and two drops enzyme conjugate per well.
- Incubate 30 minutes at room temperature.
- Wash 5 times.
- Add 4 drops substrate.
- Incubate 10 minutes at room temperature.
- Add two drops stop solution and read visually or spectrophotometrically | 1. Sample preparation varies with specimen type. Some are diluted 1/4, others are not diluted. Add 0.2ml to wells.
- Incubate 1 hr at room temperature.
- Wash 3 times.
- Add 4 drops Enzyme Conjugate.
- Incubate 30 minutes at room temperature
- Wash 5 times.
- Add 4 drops Substrate
- Incubate 10 minutes at room temperature.
- Add 1 drop Stop Solution and read visually or spectrophotometrically |
| Interpretation | Pos/Neg read visually or spectrophotometrically. Fixed cutoff 0.140 single wavelength (450nm) or 0.100 dual wavelength (450-630nm) | Pos / Neg read visually or spectrophotometrically. Color chart for visual; single wavelength read pos if ≥0.05 absorbance units above negative control |
| Performance vs.
Reference Methods
Sensitivity
Specificity | 98%
98% | 98%
98% |
..
Interfering Substances: Blood and Barium Sulfate do not interfere with results.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 2 5 1998
Allen D. Nickol. Ph.D. Director of Clinical and ·Regulatory Affairs Meridian Diagnostics, Inc. 3471 River Hills Drive Cincinnati, Ohio 45244
Re: K982711 Trade Name: Premier Giardia Regulatory Class: II Product Code: MHI Dated: October 21, 1998 Received: October 22, 1998
Dear Dr. Nickol:
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 (OS) 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 Butman
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
4
Meridian Diagnostics, Inc. Cincinnati, OH 45244
E. Indications for Use Statement
510(k) Number (if known): K982711
Device Name: Premier Giardia
Indications For Use:
The Premier Giardia enzyme immunoassay (EIA) is an in vitro qualitative procedure for the detection of Giardia antigens in human stool. Test results are intended to aid in the diagnosis of Giardia infection (giardiasis).
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Woody Dubois
Division of Clinical Laboratory Devices 510(k) Number
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)