PREMIER CRYPTOSPORIDIUM

K982764 · Meridian Diagnostics, Inc. · MHJ · Dec 3, 1998 · Microbiology

Device Facts

• Record ID: K982764
• Device Name: PREMIER CRYPTOSPORIDIUM
• Applicant: Meridian Diagnostics, Inc.
• Product Code: MHJ · Microbiology
• Decision Date: Dec 3, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3220
• Device Class: Class 2

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.

Device Story

Premier Cryptosporidium is a sandwich enzyme immunoassay (EIA) for detecting Cryptosporidium antigens in patient stool samples. The assay utilizes rabbit anti-Cryptosporidium capture antibodies, monoclonal detection antibodies, and an enzyme conjugate with TMB substrate. Performed in a laboratory setting by technicians, the procedure involves diluting stool specimens, incubating in microwells, washing, adding detection antibodies and conjugate, and finally adding substrate. Results are interpreted visually or spectrophotometrically (fixed cutoff at 450nm or 450-630nm). The output aids clinicians in diagnosing Cryptosporidium infection, facilitating appropriate patient management.

Clinical Evidence

Performance evaluated against reference methods. Sensitivity reported at 100% and specificity at 99%. No further clinical study details provided.

Technological Characteristics

Sandwich enzyme immunoassay; utilizes polyclonal capture and monoclonal detection antibodies; TMB substrate; qualitative output; spectrophotometric or visual reading; compatible with preserved (formalin, SAF) and unpreserved stool.

Indications for Use

Indicated for the qualitative detection of Cryptosporidium antigens in human stool specimens to aid in the diagnosis of Cryptosporidium infection.

Regulatory Classification

Identification

Entamoeba histolytica serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Entamoeba histolytica in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identify Entamoeba histolytica directly from clinical specimens. The identification aids in the diagnosis of amebiasis caused by the microscopic protozoan parasite Entamoeba 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.

Special Controls

*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.

Predicate Devices

• ProSpecT Cryptosporidium Microplate Assay

Submission Summary (Full Text)

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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 antigens<br>in patient stool | Detection of Cryptosporidium Antigen<br>in aqueous extracts of fecal specimens |
| Results | Qualitative | Qualitative |
| Specimen Required | Preserved (Formalin, SAF) and<br>Unpreserved Stools | Preserved (Formalin, SAF, MF)<br>Unpreserved Stool, and stools in C&S<br>(or equivalent) transport media |
| Technology | Sandwich Enzyme Immunoassay<br>Polyclonal capture, monoclonal detect,<br>polyclonal conjugate, TMB substrate | Sandwich Enzyme Immunoassay<br>Polyclonal capture, monoclonal<br>conjugate, TMB substrate |
| Level of Skill Required | Laboratory Technician | Laboratory Technician |
| Function | Specimen diluted 1/4 and 200µl added to<br>well containing rabbit anti-<br>Cryptosporidium capture Ab.<br>Incubate 1 hr at room temperature.<br>Wash 5 times.<br>Add 2 drops detection Ab and two drops<br>enzyme conjugate per well.<br>Incubate 30 minutes at room<br>temperature.<br>Wash 5 times.<br>Add 4 drops substrate.<br>Incubate 10 minutes at room<br>temperature.<br>Add two drops stop solution and read<br>visually or spectrophotometrically | 10. Sample preparation varies with<br>specimen type. Some are diluted 1/4,<br>others are not diluted. Add 0.2ml to<br>wells.<br>11. Incubate 1 hr at room temperature.<br>12. Wash 3 times.<br>13. Add 4 drops Enzyme Conjugate.<br>14. Incubate 30 minutes at room<br>temperature<br>15. Wash 5 times.<br>16. Add 4 drops Substrate<br>17. Incubate 10 minutes at room<br>temperature.<br>18. Add 1 drop Stop Solution and read<br>visually or spectrophotometrically |
| Interpretation | Pos/Neg read visually or<br>spectrophotometrically. Fixed cutoff<br>0.140 single wavelength (450nm) or<br>0.100 dual wavelength (450-630nm) | Pos/Neg read visually or<br>spectrophotometrically. Color chart for<br>visual; single wavelength read pos if<br>≥0.05 absorbance units above negative<br>control |
| Performance<br>vs.<br>Reference Methods<br>Sensitivity<br>Specificity | 100%<br>99% | 97%<br>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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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 [phone].

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or at [phone] 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)