(119 days)
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.
The assay is a conventional microwell sandwich enzyme immunoassay, utilizing polyclonal capture and monoclonal detection antibodies.
Here's a breakdown of the acceptance criteria and study information for the Premier Cryptosporidium device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" as a separate section with predefined thresholds. However, it provides performance metrics for the Premier Cryptosporidium and compares them to a predicate device. We can infer the "acceptance criteria" were implicitly met if the Premier Cryptosporidium's performance was considered substantially equivalent to or better than the predicate.
| Performance Metric | Acceptance Criteria (Inferred from Predicate Performance or clinical utility) | Reported Device Performance (Premier Cryptosporidium) |
|---|---|---|
| Sensitivity | At least comparable to the predicate (97%) | 100% |
| Specificity | At least comparable to the predicate (98%) | 99% |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only provides the summarized performance metrics.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not provided in the document.
4. Adjudication Method for the Test Set:
This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
This information is not provided in the document. This type of study is more common for diagnostic imaging devices where human interpretation is a primary component. For an immunoassay like this, the focus is typically on the standalone performance of the assay.
6. Standalone Performance Study:
Yes, a standalone performance study was done. The reported sensitivity of 100% and specificity of 99% for the Premier Cryptosporidium are results of its standalone performance. The document explicitly states "Performance vs. Reference Methods," indicating that the device was evaluated on its own against established reference methods (which serve as the ground truth).
7. Type of Ground Truth Used:
The document states "Performance vs. Reference Methods." While the specific reference methods are not detailed, in the context of diagnostic assays for infections, this typically implies:
- Culture: Growing the Cryptosporidium parasite in a laboratory setting.
- Microscopy: Direct observation of Cryptosporidium oocysts in stool samples by trained personnel using specific staining techniques (e.g., acid-fast stain).
- PCR (Polymerase Chain Reaction): Molecular detection of Cryptosporidium DNA.
Without more detail, it's most likely a combination of these, with microscopy and potentially culture being the gold standards at the time for direct detection of the parasite.
8. Sample Size for the Training Set:
This information is not provided in the document. Given that this is an immunoassay, the "training set" concept (as used in machine learning) may not directly apply in the same way. Immunoassays are typically developed and validated through a series of experiments to optimize reagents and conditions, rather than being "trained" on a data set.
9. How the Ground Truth for the Training Set Was Established:
This information is not provided in the document. As mentioned above, the concept of a "training set" with ground truth in the machine learning sense is unlikely to be directly applicable to this type of device. The development process would involve extensive analytical sensitivity and specificity testing, cross-reactivity studies, and optimization of assay components and protocols against known positive and negative samples.
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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
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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 antigensin patient stool | Detection of Cryptosporidium Antigenin aqueous extracts of fecal specimens |
| Results | Qualitative | Qualitative |
| Specimen Required | Preserved (Formalin, SAF) andUnpreserved Stools | Preserved (Formalin, SAF, MF)Unpreserved Stool, and stools in C&S(or equivalent) transport media |
| Technology | Sandwich Enzyme ImmunoassayPolyclonal capture, monoclonal detect,polyclonal conjugate, TMB substrate | Sandwich Enzyme ImmunoassayPolyclonal capture, monoclonalconjugate, TMB substrate |
| Level of Skill Required | Laboratory Technician | Laboratory Technician |
| Function | Specimen diluted 1/4 and 200µl added towell containing rabbit anti-Cryptosporidium capture Ab.Incubate 1 hr at room temperature.Wash 5 times.Add 2 drops detection Ab and two dropsenzyme conjugate per well.Incubate 30 minutes at roomtemperature.Wash 5 times.Add 4 drops substrate.Incubate 10 minutes at roomtemperature.Add two drops stop solution and readvisually or spectrophotometrically | 10. Sample preparation varies withspecimen type. Some are diluted 1/4,others are not diluted. Add 0.2ml towells.11. Incubate 1 hr at room temperature.12. Wash 3 times.13. Add 4 drops Enzyme Conjugate.14. Incubate 30 minutes at roomtemperature15. Wash 5 times.16. Add 4 drops Substrate17. Incubate 10 minutes at roomtemperature.18. Add 1 drop Stop Solution and readvisually or spectrophotometrically |
| Interpretation | Pos/Neg read visually orspectrophotometrically. Fixed cutoff0.140 single wavelength (450nm) or0.100 dual wavelength (450-630nm) | Pos/Neg read visually orspectrophotometrically. Color chart forvisual; single wavelength read pos if≥0.05 absorbance units above negativecontrol |
| Performancevs.Reference MethodsSensitivitySpecificity | 100%99% | 97%98% |
Interfering Substances: None observed.
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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.
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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 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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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)
§ 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.