PARA-PAK SPINCON

K980077 · Meridian Diagnostics, Inc. · LKS · Apr 2, 1998 · Microbiology

Device Facts

• Record ID: K980077
• Device Name: PARA-PAK SPINCON
• Applicant: Meridian Diagnostics, Inc.
• Product Code: LKS · Microbiology
• Decision Date: Apr 2, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.2900
• Device Class: Class 1

Intended Use

Para-Pak SPINCON is a unique, patent pending system for the concentration of eggs, larvae, and protozoa from preserved fecal specimens. Specimens preserved in 10% Formalin, Sodium Acetate Formalin (SAF), and ECOFIX may be used with the system.

Device Story

Para-Pak SPINCON is a fecal parasite concentration system used in clinical laboratories. It processes preserved stool specimens (10% Formalin, SAF, or ECOFIX) to isolate parasites for microscopic evaluation. The device uses a surfactant to break down fecal aggregates, followed by gravity flow through a preliminary screen. The specimen is then centrifuged through a dual-screen system with successively smaller mesh sizes; this filtration traps debris while allowing parasites to pass through. This process eliminates the need for organic solvent extraction. The resulting concentrated pellet is resuspended for saline or iodine wet mount preparation. By simplifying the concentration process and removing the requirement for hazardous solvents, the device aids clinicians in the identification of helminth eggs, larvae, and protozoa, facilitating accurate diagnosis of parasitic infections.

Clinical Evidence

Clinical studies demonstrated equivalent performance and parasite recovery for the Para-Pak SPINCON compared to the predicate device. No specific sensitivity, specificity, or p-values were provided in the summary.

Technological Characteristics

The device consists of a funnel, dual-mesh screens, and surfactant. It utilizes mechanical filtration and centrifugation to concentrate parasites. It is a manual, non-electronic, in vitro diagnostic device.

Indications for Use

Indicated for the concentration of helminth eggs, larvae, and protozoan cysts from fecal specimens preserved in 10% Formalin, SAF, or ECOFIX for subsequent microscopic examination.

Regulatory Classification

Identification

A microbiological specimen collection and transport device is a specimen collecting chamber intended for medical purposes to preserve the viability or integrity of microorganisms in specimens during storage of specimens after their collection and during their transport from the collecting area to the laboratory. The device may be labeled or otherwise represented as sterile. The device aids in the diagnosis of disease caused by pathogenic microorganisms.

Predicate Devices

• Para-Pak CON-Trate

Submission Summary (Full Text)

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KA80077

APR - 2 1998

Meridian Diagnostics, Inc. Cincinnati, OH 45244

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510(k) Notification Para-Pak SPINCON

## APPENDIX A - 510(k) Summary

## A. Identification Information

- Submitter's Information: 1)
- a) Submitter's Name and Address:

Meridian Diagnostics, Inc. 3471 River Hills Drive Cincinnati, OH 45244

- b) Phone Number: 1-800-543-1980
- c) Contact Person: Allen D. Nickol, Ph.D. Director of Scientific and Regulatory Affairs
- d) Date Summary Prepared: December 24, 1997
- Name of Device: Para-Pak SPINCON. 2)

Classification Name: Device, Parasite Concentration 83LKS

- Predicate Equivalent Device: Para-Pak CON-Trate 3)
- Description of Device: Para-Pak SPINCON involves passing a surfactant treated, 4) preserved stool specimen through a preliminary screen by gravity flow. The surfactant helps to break down fecal aggregates, thus freeing parasites. The specimen is then forced by centrifugation through a series of two screens with successively smaller mesh. The series of screens, not present in other devices, trap stool debris, yet allow even the larger parasites to pass through. This second filtration step eliminates the need for organic solvent extraction of the stool specimen. The resulting pellet may be examined for the presence of parasites by standard wet mount procedures.

SPINCON Devices: 200/500 SPINCON Caps: 200/500 SPINCON Preliminary Funnel Screens: 200/500 Para-Pak Surfactant: 33ml

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Meridian Diagnostics, Inc. Cincinnati, OH 45244

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- Intended Use: Para-Pak SPINCON is a unique, patent pending system for the ર) concentration of eggs, larvae, and protozoa from preserved fecal specimens. Specimens preserved in 10% Formalin, Sodium Acetate Formalin (SAF), and ECOFIX may be used with the system.
- Comparison with Predicate Device: The following comparison of the use, 6) technology, function and performance supports the Statement of Equivalence with the predicate device.

| Method | Para-Pak®<br>SPINCON | Para-Pak®<br>CON-Trate |
|--------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | System for concentrating and recovering helminth eggs, larvae, and protozoan cysts from feces | |
| Results | Final pellet consists of concentrated parasites | |
| Technology | Utilizes filtration and centrifugation | |
| Function | Treat stool with surfactant.<br>Filter through primary funnel with mesh screen.<br>Add saline.<br>Centrifuge through series of smaller mesh<br>screens.<br>Remove supernatant.<br>Resuspend in fixative.<br>Prepare wet mount. | Treat stool with surfactant.<br>Filter through primary Funnel with mesh screen.<br>Add saline.<br>Centrifuge.<br>Remove supernatant.<br>Resuspend in buffered formalin and ethyl<br>acetate.<br>Centrifuge.<br>Remove supernatant.<br>Prepare wet mount. |
| Final Pellet | Useable for saline or iodine wet mount microscopic evaluation | |
| Performance | Clinical studies demonstrate equivalent performance and recovery | |

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Allen D. Nickol, Ph.D. Director of Scientific and Regulatory Affairs Meridian Diagnostics, Inc. 3471 River Hills Drive Cincinnati, Ohio 45244

APR - 2 1998

Re: K980077 Trade Name: Para-Pak® SPINCON Regulatory Class: I Product Code: LKS Dated: June 30, 1997 Received: March 25, 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 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 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

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Meridian Diagnostics, Inc. Cincinnati, OH 45244

510(k) Notification Para-Pak SPINCON

## Indications for Use Statement: C.

510(k) Number (if known): __ NA K980077

Device Name: Para-Pak® SPINCON

Indications For Use: Para-Pak SPINCON is for the concentration of eggs, larvae, and protozoa from preserved fecal specimens. Specimens preserved in 10% Formalin, Sodium Acetate Formalin (SAF), and ECOFIX may be used with the system.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Bla
(Division Sign-Off)

Division of Clinical Laboratory Devices K980077 510(k) Number_

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use (Optional Format 1-2-96)

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