(119 days)
Not Found
None
No
The device description and performance metrics indicate a standard enzyme immunoassay, with no mention of AI or ML.
No
This device is an in vitro diagnostic test designed to detect Cryptosporidium antigens in stool, aiding in diagnosis rather than providing treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states, "Test results are intended to aid in the diagnosis of Cryptosporidium infection."
No
The device description clearly states it is a "conventional microwell sandwich enzyme immunoassay," which is a laboratory test involving physical reagents and equipment, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the Premier Cryptosporidium EIA is an "in vitro qualitative procedure for the detection of Cryptosporidium antigens in stool." The term "in vitro" means "in glass" or "outside the body," which is a key characteristic of IVDs.
- Sample Type: The test is performed on "stool," which is a biological sample taken from the human body.
- Purpose: The test is intended to "aid in the diagnosis of Cryptosporidium infection," which is a medical condition.
These elements clearly align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition.
N/A
Intended Use / Indications for Use
The Premier Cryptosporidium enzyme immunoassay (EIA) is an in vitro qualitative procedure for the detection of Cryptosporidium antigens in stool. Test results are intended to aid in the diagnosis of Cryptosporidium infection.
Product codes
MHJ
Device Description
The assay is a conventional microwell sandwich enzyme immunoassay, utilizing polyclonal capture and monoclonal detection antibodies.
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)
Comparison vs. Reference Methods:
Sensitivity: 100%
Specificity: 99%
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: 100%
Specificity: 99%
Predicate Device(s)
ProSpecT Cryptosporidium Microplate Assay
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
982764
DEC - 3 1998
Meridian Diagnostics, Inc. Cincinnati, OH 45244
510(k) Notification
Premier Cryptosporidium
A. 510(k) Summary Identification Information
Submitter's Information:
Submitter's Name and Address:
Meridian Diagnostics, Inc. 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 5, 1998
Name of Device: Premier Cryptosporidium.
Classification Name:
Cryptosporidium spp. (MHJ)
Predicate Equivalent Device:
ProSpecT Cryptosporidium Microplate Assay
Description of Device:
The assay is a conventional microwell sandwich enzyme immunoassay, utilizing polyclonal capture and monoclonal detection antibodies.
Intended Use:
The Premier Cryptosporidium enzyme immunoassay (EIA) is an in vitro qualitative procedure for the detection of Cryptosporidium antigens in stool. Test results are intended to aid in the diagnosis of Cryptosporidium infection.
Comparison with Predicate Device:
The following comparison of the use, technology, function and performance supports the Statement of Equivalence between the Premier Cryptosporidium test and the ProSpect Cryptosporidium Microplate Assay. The differences do not
1
Meridian Diagnostics, Inc. Cincinnati, OH 45244
510(k) Notification Premier Cryptosporidium
raise additional concerns regarding safety and effectiveness. Safety and effectiveness are demonstrated to be substantially equivalent.
| Method | Premier Cryptosporidium | Alexon ProspecT Cryptosporidium |
|---|---|---|
| Intended Use | Detection of Cryptosporidium antigens | |
| in patient stool | Detection of Cryptosporidium Antigen | |
| 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 | Specimen diluted 1/4 and 200µl added to | |
| well containing rabbit anti- | ||
| Cryptosporidium 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 | 10. 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 | 100%
99% | 97%
98% |
Interfering Substances: None observed.
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with outstretched wings, rendered in black. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the bird, also in black. The overall design is simple and conveys a sense of national identity and governmental authority.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC - 2 1998
Allen D. Nickol. Ph.D. Director of Clinical and ·Regulatory Affairs Meridian Diagnostics, Inc. 3471 River Hills Drive Cincinnati, Ohio 45244
Re: K982764
Trade Name: Premier Cryptosporidium Regulatory Class: II Product Code: MHJ 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.
3
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 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
4
E. Indications for Use Statement
510(k) Number (if known):
Device Name: Premier Cryptosporidium
Indications For Use:
The Premier Cryptosporidium enzyme immunoassay (EIA) is an in vitro qualitative procedure for the detection of Cryptosporidium antigens in stool. Test results are intended to aid in the diagnosis of Cryptosporidium infection.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Woody Dubois
510(k) Number
Prescription Use . (Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)